VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on December 15, 2010, 07:44:32 AM



Title: Chest Pain
Post by: dennis100 on December 15, 2010, 07:44:32 AM
Model Number 103
Event Date 11/10/2014
Event Type Injury
Event Description
It was reported that the vns patient was experiencing shocking sensations in his abdomen that travelled up to his chest. The patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed lead impedance within normal limits (impedance value ¿ 4272 ohms). The patient¿s device was disabled on (b)(6) 2014. It was noted that the patient was unable to tolerate stimulation on-times with the output current programmed greater than 0. 25ma. The nurse stated that the patient¿s pain may not be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4316922


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:47:15 AM
Event Date 07/23/2002
Event Type Injury
Patient Outcome Disability; .
Event Description
Reporter indicated that the day after their device was programmed to on, they began to experience pain at the generator site. The pain was described as feeling like someone hit the pt in the chest. The pain does not seem to correlate with stimulation, although there are times that the discomfort is more pronounced. The pt indicated that their left arm feels a bit weaker when the pain is at its worst. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=412824


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:49:58 AM
Event Date 10/14/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
The pt was walking across the yard and grabbed their chest in the area of the generator. They then fell to the ground in pain. The pt experienced sharp pains and they lasted for approx 2-5 minutes. The reporter also stated that this was not the first time that the pt had pain since vns implant, but that this most recent occurrence was the worst. The pt's neurologist reduced programmed parameters in 10/2002, but the pain did not subside. Neurologist referred pt to their family dr.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=428363


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:53:50 AM
Event Date 08/12/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Patient's device was programmed to off in 2002 following an emergency room visit due to difficulty breathing and chest pain. The patient reported that they felt as if they were having a heart attack. The patient complained of numbness and left arm tingling, but not with stimulation. Device diagnostic testing at that time was within normal limits. In august 2002, the patient reported that they were no longer having any pain or numbness with the device still programmed to off. Physician instructed patient to follow-up with their cardiologist to rule out any heart problems, but it is not known whether or not pt has been seen by cardiologist. The patient's device is still programmed to off at this time. Patient was again seen by neurologist in 10/2002 at which time they reported that pt no longer had any numbness or chest discomfort since the vns was programmed to off and there are no plans to program the vns back to on at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=426771


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:55:38 AM
Event Date 11/01/2001
Event Type Malfunction
Event Description
Reporter indicated that patient's ncp system was being explanted because the patient was complaining of shocking in their chest by the generator. It was reported that the surgeon decided to replace the leads as well as the generator since previous lead tests resulted in high lead impedance reading. Further follow-up revealed that the patient complained of shocking in their chest in 2001. Lead test in 02/2002 resulted in high lead impedance reading, indicating possible device malfunction. The ncp system was programmed to off at this visit and later explanted. Attempts to obtain information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=390018


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:56:48 AM
Event Date 02/11/2002
Event Type Malfunction
Event Description
Reporter indicated that the patient has been experiencing pain in chest area. The patient indicated that the pain was not bad when it started and it only occurred at the generator site. The patient indicated that the pain has worsened and now their whole chest hurts. The patient claims that the pain is intermittent and inconsistent. The patient feels the pain when the device is stimulating; however, it is not always painful during stimulation. The patient taped the magnet over the device to turn it off. Lead test resulted in a dc-dc code 7 and limit, indicating possible device malfunction. It was reported that since generator replacement due to end of service, the patient was receiving good seizure control and had not had high impedance before this incident. Reporter indicated that the patient did not fall nor did they suffer any trauma to their chest area. Reporter also indicated that the patient does not manipulate or twiddle the generator and lead. Physician parogrammed the device to off in 2002. Further follow-up revealed that the pt underwent exploratory surgery the following month. It was reported that the surgeon noticed drops of blood in one of the connector cavities in the generator header. The pins were removed, cleaned and reconnected. Lead test following this procedure resulted in a dc-dc code 2. Eventhough the lead test ran ok, the generator was explanted and a new generator was implanted because the neurologist felt that he wanted to avoid another surgery if it was later determined that the generator was malfunctioning. The physician indicated that the chest pains were related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=382984


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:57:49 AM
Event Date 01/22/2002
Event Type No Answer Provided
Event Description
Reporter indicated that the pt was admitted to the hospital in 2002 with severe pain located at the generator site. The ncp system was disabled. Further investigation revealed that the pt continues to dislocate their shoulder during seizure activity. The pt had been seen in a&f one week previous with this same event. The following day the pt's device was programmed on, and the pain has resolved. An x-ray was taken and revealed no abnormalities. Site is investigating possible pulmonary embolism.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=378884


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:58:53 AM
Event Date 02/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that the pt began to experience heart fluttering and shortness of breath after parameter increase. The pt's device was programmed to on two weeks post-implant (output current 0. 25ma). Within a two-week period after being programmed to on, the programmed output current was increased (0. 75ma). The physician reduced the programmed output current to 0. 50ma after the pt complained of heart fluttering and shortness of breath. Three attempts to obtain additional info have been unsuccessful to date (1 via u. S. Mail to physician, 2 via telephone call to physician's office - unable to leave message, no answering machine or answering service)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=376920


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 07:59:40 AM
Event Date 08/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient is experiencing chest pain at the generator site. Investigation to date has been unable to determine whether the reported event was cardiac-related. The patient reportedly complained of neck pain in june 2002 at which time the device pulse width was decreased with no effect. In august 2002, the patient complained of pain at the generator site. In 10/2002, the patient's ncp system was programmed to off, but the patient continues to complain of intermittent pain. No cardiac consult has been recommended. Physician plans to leave device programmed to off and see how the patient does.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=431202


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:06:18 AM
Event Date 08/14/2002
Event Type Malfunction
Event Description
The patient indicated that they were experiencing an increase in seizures and pain. The patient was examined in 2002. At that time, the patient was still having an increase in seizures and pain at the stimulation site. The physician performed a lead test and indicated that the device is working appropriately. This report is being submitted due to theoretical emi anomaly

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=417298


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:07:07 AM
Event Date 08/01/2002
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that the pt is experiencing severe chest pain at the generator site and an increase in seizures. The pt was seen by physician in 2002. Device diagnostic testing at office visit was within normal limits, indicating that the device was functioning properly. Physician believes that the event may be due to scar tissue and suggested that the pt follow-up with neurosurgeon. Investigation to date has been unable to determine the severity of the chest pain or whether the seizure increase is above the pt's baseline seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=416506


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:07:57 AM
Event Date 01/11/2002
Event Type Malfunction
Event Description
Reporter indicated that the patient has always felt stimulation in their chest and up their neck into their ear. The patient's output current is set at 2. 5ma every 3 minutes. The patient tolerates this feeling, but reports that they have a high pain threshold and the stimulation is uncomfortable. Reporter also indicated that a recent ct scan showed an abnormality around the area of the leads. Attempts to obtain additional information have been unsuccessful

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=415718


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:09:10 AM
Event Date 06/05/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt is experiencing several complications that are believed to be related to the vns. The reported complications include: shortness of breath leading to loss of consciousness, occasional pain with stimulation, burning at the generator site, stomach complications including pain and discomfort, headaches (migraines) have increased in intensity, pt still feels stimulation at times when magnet is taped over device to turn it off. It was reported that the intensity of the pt's seizures has not decreased much since vns implant. On 06/02, the pt had difficulty breathing. The magnet was taped over the device to temporarily stop stimulation until the pt could be seen by physician on 07/02. During this time, the pt reported that the device was still stimulating while the magnet was taped over it and the pt experienced a burning sensation at the generator site. The pt was seen by physician on 07/02 at which time the programmed parameters for the device were adjusted. This adjustment seemed to worsen the difficulty in breathing over time. On 07/02, the pt experienced an episode of difficulty in breathing and gagged, lost consciousness and had a grand mal seizure. The pt described the episode as a suffocating feeling. The magnet was again taped over the device until the pt could be seen by physician on 07/02. At office visit on 07/02, the pt's device output current was programmed to off, but magnet output current was not. After this office visit, the pt reported that when they swipe the device with the magnet, they feel stimulation for a few seconds but it makes the headache worse, eyes blurry and feel the burning sensation at the generator site. The pt's reported symptoms stopped for 2-3 days after programming the device to off, but after those few days the pt began to have neck pain on the left side, ear pain, migraines and a swelling sensation in the throat. The migraines became so bad that the pt was taken to the emergency room several times during the week of august 2002. The pt was admitted to the hosp on 08/02 and released the next day, at which time was instructed to increase the carbatrol dosage from 800mg to 1200mg qd. A few days later, the pt reportedly became delirious and weak to the point where they couldn't walk. The pt was again hospitalized on 08/02 and discharged three days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=414499


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:10:50 AM
Event Date 05/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention .
Event Description
Reporter indicated that the patient has been hospitalized for severe pain and that their heart rate increases with stimulation. The pain reportedly began approximately one week after stimulation was initiated. The pain is described as constant, but worse with stimulation. Patient's neurosurgeon indicated that the patient's pain was not related to the vns. The patient has reportedly undergone a cardiac work-up during their hospital stay that was negative. The patient reports that they have attempted to stop stimulation with the magnet, but was unsuccessful. The patient is on a duragesis patch, oxycontin and morphine pca for the pain. These treatments have been unsuccessful in relieving the patient's pain. The patient's device was explanted and the patient is no longer experiencing the pain that they had before explant. Attempts to obtain additional informaion have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403455


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:12:05 AM
Event Date 02/20/2001
Event Type Malfunction  
Event Description
At the time that the initial report of pain was received, the event did not meet the criteria for mdr reportability. It was reported on 09/2000 that the patient began to experience intense, sharp pain at the generator site after returning from a gun shooting range. The patient applied the magnet to the device to temporarily stop stimulation. The patient was evaluated by a physician the following day. Removing the magnet to interrogate the device for a short time frame caused the patient's intense, sharp pain to resume. The physician programmed the device to off. The physician planned to take an x-ray to determine any anomalies. Attempts to gather additional information regarding this event were unsuccessful. The file was closed. Investigation was re-opened upon receipt of the patient's explanted ncp system. It was determined that the generator and lead had both been explanted in 2001. Products appear to have been sent to the wrong manufacturer orginally, and were then sent to cyberonics. The paper work returned with the product indicates the reason for explant was "malfunction". Analysis of the returned products did not identify any anomalies nor abnormalities. The devices were within specification. No malfunction was noted. Attempts to obtain additional information have been unsuccessful to date. It is unknown whether or not the alleged malfunction is related to the original report of pain at the generator site.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403999


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:12:55 AM
Event Date 04/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention  
Event Description
Reporter indicated that patient was seen by physician on 04/2002 complaining of chest sensations felt ever since pt fell forward on their chest. The patient did not feel simulation in their throat anymore and reportedly had a decrease in seizure control. The patient was hospitalized during the week of 06/2002 because of seizures. Lead test resulted in high lead impedance reading (dc-dc code 7 and high), indicating possible device malfunction. Physician decreased the device output current from 3. 0ma (what the patient has always been set to) to 2. 5ma and also reduced the duty cycle to 30 seconds on and 5 minutes off to decrease the sensation in the chest. On 06-2002, the site performed evoke potential monitoring and determined that there is no output from the generator. The patient's ncp system was explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=404058


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:13:44 AM
Event Date 03/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention .
Event Description
Reporter indicated that the patient began to experience a jolting feeling on their left side in their neck, chest and leg areas when the vns was stimulating. The patient also complained of a pulling feeling on the left side of their neck. The patient used their magnet to turn the device off and then suffered a grand mal seizure. Further investigation revealed that the patient's generator and lead were replaced. The patient was reportedly doing well with their original ncp system prior to the development of the jolting feeling and was having great seizure control prior to 2002. It was reported that the patient's seizures were not as frequent or severe with the vns. Since 2002, the patient had an increase in seizures similar to frequency pre-vns. It was reported that the patient's parameters were adjusted in 08/2001 because the patient was having small twitching motions, but it was not determined whether this was related to the vns. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=399711


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:15:17 AM
Model Number 101
Event Date 03/31/2001
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that patient began to experience constant heart palpitations the day after device was programmed to on. By the next day, the patient was unable to tolerate these symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=330454


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:16:15 AM
Event Date 06/01/2001
Event Type Malfunction  
Event Description  
Reporter incident that pt is experiencing stimulation that does not coincide with pt's programmed parameters and that at times the stimulation is discomforting. Pt is experiencing chest pain and neck pain that coincides with some of the random stimulations.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=341245


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:17:21 AM
Event Date 05/29/2001
Event Type Injury
Patient Outcome Life Threatening;  
Event Description  
Reporter indicated that patient has been experiencing constant shortness of breath and chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=339905


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 08:18:06 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:35:26 AM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
During routine follow-up with pt post-implant, the pt reported that they were experiencing a squeezing pressure in their neck. Pt also reported that early in the afternoon, they have a tightness in their chest that stays until bedtime. The pt's neck pain reportedly correlates with stimulation. The pt indicated that the chest pain is at night after meals and was initially believed to be gas or indigestion. The pt's overall seizure control has improved with the vns therapy and the pt is reportedly able to stop most seizures by initiating magnet mode stimulation. Further follow-up with treating neurologist revealed that the pt was doing well but that the neurologist believed that the pt had angina pectoris. The neurologist reduced the device pulse width due to the neck tightness. The pt is reportedly scheduled to see both their cardiologist and interninst. Neurologist indicated that the pt's symptoms were not related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=449663


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:36:23 AM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
A vns pt has been experiencing episodes of tachycardia. The physician later indicated that the pt did not have tachycardia; they reproted a pulse of 77-85 during the episodes and referred to the pt's symptoms as palpitations. The physician also reported that these events could possibly be related to the vns therapy. The physician indicated that the device remains programmed to on and they will continue to monitor the pt. The pt was referred to a cardiologist for consult but has not yet been evaluated by cardiologist. Device settings are programmed to normal values.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=445874


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:37:32 AM
Event Date 06/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt was having some memory problems and wondered if the vns had anything to do with it. The pt also reports irregular heart rhythms (for which pt takes toprol), pain around the vns site since generator replacement surgery for end of service in 2002, and feeling like the leads are "too tight". Pt does not feel stimulation in their throat anymore, just throat spasms, and wonders if the vns is still working. The pt's medications were reportedly increased in december 2002. Pt reports that when pt bends their neck back too quickly or when pt looks up that pt has cramps in their neck. Pt reportedly has to use only one arm while lifting due to pain in shoulder on left side and chest. Further follow-up with pt revealed that the pt was diagnosed with "super-ventricular" tachycardia approximately one and a half years ago, shortly after being re-implanted in 2002. According to the pt, physician believes that pt's condition is related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=443012


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:38:19 AM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that patient is experiencing pains in the chest. It was reported that the patient has "always had these pains" in the chest. The pain was described as going from left to right and right to left. Additionally, the patient reports that the left arm pit feels irritated with a stinging feeling and itches all of the time. The patient reports sore feet and weak knees. Investigation to date has been unable to determine whether the chest pain is cardiac related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461862


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:39:10 AM
Event Date 04/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Pt's device would be programmed to off because the pt has been experiencing electrical stimulation at neck and shoulder sites and intermittent shortness of breath. The pt has recently begun a strenuous exercise routine including some head movements. Previous reductions in programmed parameters did not resolve the shortness of breath. Further follow-up revealed that the pt's device was programmed back to on at office visit at low settings. X-rays reviewed by treating neurologist did not reveal any discontinuities in the ncp system. The pt is reportedly still experiencing the "shocking" sensation and indicates that it is very uncomfortable. Neurologist is considering exploratory surgery to check electrode placement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=458900


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:39:59 AM
Event Date 03/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
When patient experienced their first seizure since vns implant, it was followed by severe chest pain in the area of the generator. Investigation to date has been unable to determine whether the chest pain is cardiac related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=457225


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:40:51 AM
Event Date 03/17/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
The patient has experienced heart palpitations since stimulation was initiated was reported that the patient was evaluated for 24 hours using a holter monitor (results unkown). The patient reports that their heart rate increases with stimulation and that they also have shortness of breath with stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=456023


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 11:59:25 AM
Event Date 04/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
On two occasions, the device stimulated and "felt like it was stuck". The pt reported that they could not get their breath and that they felt like their heart was "going" to stop". The pt placed the magnet over the device to deactivate the stimulation. The pt is still experiencing approximately 6-7 seizures per week.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=474990


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 12:00:49 PM
Event Date 05/05/2003
Event Type Malfunction  
Event Description
Reporter indicated that this is the pt's second model 101 vns generator and they continue to have problems which include the device activating whenever the pt is near a magnetic field (i. E. Cell phones). Pt is also complaining of chest pain, neck pain and a choking sensation. The reporter also stated that the device was tested and found to be working appropriately. While the device was turned off, the pt claimed that the device was continuing to stimulate when near magnetic fields. Pt previously had a model 100 vns generator and reports having no problems with that generator. The reporter also indicated that the pt continues to experience seizures: pt does not have the efficacy that pt had with the model 100 vns generator. The pt also claimed feeling shocking sensations and breathing difficulties.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=469611


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 12:01:37 PM
Model Number 102
Event Date 06/13/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.

Event Description
Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.

Event Description
Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.

Manufacturer Narrative
Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.

Event Description
A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648409


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 12:02:21 PM
Event Date 04/22/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that the pt has been experiencing chest pain and hyperventilation since adjustment of programmed parameters. The pt also complains of left arm pain from the elbow up and having problems cathing the breath when the device stimulates. Investigation to date has been unable to determine whether the chest pain is cardiac-related. The pt contacted the neurologist who instructed to temporarily stop stimulation by placing the magnet over the device for a couple of hours and to call him back for an appointment if the symptoms subsided during that time. Neurologist planned to bring the pt back in for adjustment of programmed parameters if the symptoms subsided when stimulation was stopped with the magnet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=464839


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:02:09 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Vns patient has experienced a slowed heart rate. The patient had recently been seen by a cardiologist for reasons unrelated to the vns at which time the cardiologist reportedly told the patient that their heart rate was below normal and that is was probably caused by the vns device. The patient reportedly did not notice the abnormal heart rate before their visit with the cardiologist. Treating neurologist indicated that the patient has a history of major psychiatric problems and over using of the magnet which results in chest pain. The patient is reportedly hospitalized for their psychiatric problems at this time. Investigation to date has been unable to determine whether the patient has previous cardiac history.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484515


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:03:27 PM
Event Date 01/31/2003
Event Type Injury
Patient Outcome Required Intervention;  
Event Description
Reporter indicated that vns patient had an infection when implanted and was treated with antibiotics. Six months post-operatively, the patient is reportedly scheduled for a surgical consult as it is believed that their incision sites may have not have properly healed. It was later reported that the patient is experiencing a reduction in seizures with the vns therapy, but that they complain of difficulty swallowing, shortness of breath, choking sensation and localized burning sensation with stimulation. The localized burning sensation is reportedly present all of the time but is worse with stimulation. Re-implant is scheduled as the generator has reportedly migrated from below the clavicle to under the arm and the lead wires are protruding under the skin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481353


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:04:36 PM
Event Date 07/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization  
Event Description
The reporter indicated that recently the pt began experiencing a sharp pain in the chest when pt "sits down to relax". The pt claims that it doesn't happen at work, it only happens at home, it was also reported that the pt is experiencing painful magnet stimulation. The vns system was evaluated and reported to be functioning properly. The pt was referred to a cardiologist. It was further reported that the device "shocks pt where the implant is" and it only does it at night. The shocking sensation wakes the pt up. X-rays were taken and nothing was seen that could cause the reported adverse event. The reporter also stated that the pt has had the vns implant for approximately 4 years and has had good seizure control. It is unk at this time if the vns system is contributing the pt's chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479705


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:05:33 PM
Event Date 07/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt has been experiencing varying heart rate and tightness in the chest. It was reported that the heart beats very fast and then slows down at times with stimulation. It was reported that the pt had been seen by a cardiologist and was wearing a heart monitor for eval of heart rate. Investigation to date has been unable to determine whether the vns therapy was causing or contributing to the pt's varying heart rate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479869


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:06:21 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that patient's generator was explanted due to chest pain. The patient was reportedly hospitalized for the chest pain approximately six months prior. It was rpeorted that the chest pain did not subside when the device was programmed to off. The patient reportedly had some cardiac issues that may or may not be related to the vns. Treating neurologist indicated that the patient no longer needed the vns therapy as the seizures were being well-controlled with medications. Investigation to date has not been unable to determine whether the patient's pain was cardiac-related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476515


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:07:08 PM
Event Date 07/12/2003
Event Type Malfunction
Event Description
Reporter indicated that vns pt was experiencing an electric pulse at the generator site whenever the device is stimulating. It was reported that the sensation is in the chest area and felt like it was strong to "start their heart if they had a heart attack". Investigation to date has been unable to determine whether a device malfunction has occurred. No serious injury was reported in conjunction with the reported event. The pt temporarily stopped stimulation by taping the magnet over the device until this could be seen by their neurologist for device diagnostic testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477077


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:08:04 PM
Event Date 03/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient was seen by neurologist for chest pain and increased heart rate. Device diagnostic testing was within normal limits. Normal mode output current was decreased. The patient was seen again the next month and reported no further problems. The increase in heart rate reportedly resolved with the decrease in output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476372


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 09:08:52 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt was experiencing chest tightness. It was also reported that the pt had a seizure recently and pt fell down the stairs and hurt their hand. The pt did not see a physician for the hand. Further follow-up revealed that the physician does not know if the chest tightness is cardiac-related and it was indicated that the pt had not had an ekg done.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477468


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:32:56 PM
Event Date 11/22/2003
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt was hospitalized for two days due to chest pain. It was reported that the pt experienced severe pain at the generator site. The pt experienced the same pain after pt was discharged from the hosp when pt was helping their family member make the bed. The pt starts when pt does activities and that it goes away when pt rests. The pt feels short of breath when pt walks or runs. Further follow-up revealed that device diagnostic testing performed approx one month prior to initial report was within normal limits. Treating neurologist indicated that the pt has experienced no further episodes of chest pain or dyspnea and that the relationship between the reported events and the ncp system was unknown. The pt has been referred to their primary care physician for cardiac work up to rule out cardiac cause.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=503150


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:33:37 PM
Event Date 11/24/2003
Event Type Malfunction
Event Description
Vnd pt experienced an episode of erratic stimulation while watching television. The erratic stimulation was described as "several random magnetic stimulations", it was reported that the pt was not near any electrical devices or anything that had a large magnetic field. The pt reportedly placed the magnet over the device to stop stimulation, but stimulation reportedly continued. The erratic stimulation continued through the next day. The pt also reported that they had been having chest pains and breathing problems for a few weeks prior to the erratic stimulation event. The chest pain does not coincide with stimulation but stimulation reported makes that chest pain worse.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=506004


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:34:22 PM
Event Date 11/22/2003
Event Type Malfunction
Patient Outcome Life Threatening;
Event Description
Vns pt had experienced 5 hours of continuous pain at the generator site and felt as if the device was shocking. The pt reportedly placed the magnet over the device to stop stimulation, but the pain did not resolve. It was reported that the pt lives 1/2 mile from some high power lines and has lost use of home phone due to the power lines. The pt also reported some problems with depth perception and memory loss, but thought that these symptoms may be medication-related. Further follow-up revealed that the pt later experienced an increase in pain and an increase in seizures. Investigation to date has been unable to determine whether the device is functioning properly or whether the increase in seizures is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=505129


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:35:06 PM
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Pt is experiencing painful stimulation, but the device was programmed to off over a year ago. It was reported that the pt's device continues to stimulate even after being programmed to off. It was also reported that the pt experienced decreased heart rate (64 bpm) when the device was on. The pt's hands reportedly turned purple and cold during these episodes. It was reported that the pt's heart rate decreased further (40 bpm) after the device was programmed to off. Treating neurologist reportedly does not believe that the pt's symptoms are related to the vns. Cardiologist has reportedly inquired about when the vns would be explanted as they reportedly believed that the pt's symptoms could be related to the device. It was reported that the cardiologist instructed the pt to drink gatorade which seemed to help. Reporter also indicated that the pt had a tumor in their neck.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=500268


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:35:56 PM
Event Date 10/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt was experiencing an increase in heart rate and a feeling that the device "was shocking their heart". Programmed output current had recently been increased to 2. 5ma. Further follow-up revealed that the pt was no longer experiencing the aforementioned symptoms and that no intervention was taken. Treating neurologist indicated that the relationship between the vns and the pt's symptoms was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=496986


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:36:45 PM
Event Date 10/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has been experiencing heart palpitations. The pt did not know whether the heart palpitations coincided with stimulation. It was reported that the palpitations began within a few weeks of parameter increase. The pt has reportedly been seen by their neurologist since the palpitations began, but no intervention has been taken to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=497015


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:37:30 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient's device was scheduled to be programmed to off due to swallowing difficulties and shortness of breath until a later time when different programming parameters may be tried. It was reported that the patient experienced a "weird feeling" with stimulation a few months prior during which they could feel the stimulation going from back to neck when the device cycles. This feeling reportedly went away but is now happening again. The patient reports that body gets numb on the left side including face and neck. This feeling does not occur with every stimulation cycle, but only on occasion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493439


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:38:14 PM
Event Type Malfunction  
Event Description
Reporter indicated that pt's device "went off full blast" causing severe pain approximately one minute after being lightly hit in the chest in the area of the device. It was reported that the device continued to stimulate this way every 30 seconds for ten minutes until the pt could get to a magnet and use it to stop stimulation. Further follow-up concluded that the event has not occurred again.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493646


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2010, 10:38:52 PM
Event Date 09/12/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention  
Event Description
Reporter indicated that after an increase in device output current, vns patient's device was programmed to off due to chest pain, dyspnea, tremors and hospitalization for an increase in seizures. It was reported that the day after the device output current was increased, the non-verbal patient began grabbing their chest, sticking their hands in their throat and crying all night. Device output current was reduced three days later from 1. 25ma to 1. 0ma in an effort to resolve the patient's symptoms. The patient's condition has reportedly improved. It was reported that the patient's family member claimed that the vns caused excessive sleepiness and the patient was better within two hours of discontinuing stimulation. Treating neurologist indicated that the incident was possibly related to the vns and that if not related, the possible causes were progression of neurological condition and drug toxicity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=489060


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:47:07 AM
Event Date 02/27/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt experienced a strong stimulation while working near a laser that suddenly caused shortness of breath, coughing and pain in left shoulder and arm. The strong stimulation reportedly lasted for about one minute. The pt reportedly works as a service technician with electronic equipment such as computers, robots and laser equipment. When the pt arrived at the hospital an hour later, they were reportedly in shock as well as tired and worried. The pt was so tired that they could not walk from the emergency room to the department of neurology. After arriving in the neurology department, the pt swiped their device with the magnet resulting in 30 seconds of stimulation with severe coughing. The magnet was then placed over the device and stimulation reportedly stopped, as expected. Upon removing the magnet, normal mode stimulation cycles resumed and the pt reported that they could not feel the stimulation. The pt indicated that they do not normally feel normal mode stimulation. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. Treating physician believes that the magnetic field surrounding the laser equipment caused an activation of the stimulator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517908


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:47:53 AM
Event Date 02/19/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced feelings of heart fluttering and light-headedness while using a microwave. It was reported that the pt had been microwaving several dishes (approximately 6 plates of food, approximately 3 minutes each) when pt experienced light-headedness, irregular heartbeat and a fluttering feeling in their heart that made pt have to go lie down. The pt has a pre-vns history of heart murmur, chest pain and irregular heartbeat, but what pt felt while using the microwave was different. The pt plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517933


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:48:30 AM
Event Type Malfunction
Event Description
Reporter indicated that the pt believes that their device may be malfunctioning. It was reported that the pt feels as if their generator is stimulating at higher output current than it is programmed to and at random times. These higher, random, stimulations reportedly cause the pt's heart to race and they become nauseated. The pt did not believe that the events were due to inadvertent magnet mode activations. The pt reports experiencing improved seizure control with the vns therapy. The pt had an appointment to follow-up with their neurologist, but did not go to their scheduled appointment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=538796


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:49:08 AM
Model Number 101
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt was experiencing chest pain and constant shortness of breath, not associated with stimulation. The pt also indicated that their neck was swelling and puffing out at the lead site. The pt has been seen in hospital emergency room and no infection was noted. The pt is receiving efficacy from the vns therapy, but has had trouble with their body rejecting implants and is considering having the generator moved to the right side of their chest.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515685


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:49:53 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt has recently experienced night-time seizures, which pt apparently never had prior to implant. The pt experiences painful stimulation with the night-time seizures and reportedly has chronic ear, neck and chest pain due to the vns. The pt's device was programmed to off with plans to possibly explant to check for scar tissue and proper device function. Will possibly reimplant with newer model.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515411


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:50:36 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt has complained of a continuous "prickly, sticky, warm pain" at the generator site for approximately 4 weeks. The pain does not coincide with stimulation and the generator site appears to be intact with no swelling or redness. The pt has reportedly experienced efficacy with the vns therapy. The pt went to urgent care center due to the pain and was seen the next day by treating epileptologist. Chest x-rays reviewed by treating epileptologist revealed no discontinuities in the ncp system. Device diagnostic testing was within normal limits, indicating proper device function. The pain reportedly subsided when the device was programmed to off. Treating epileptologist plans to bring the pt back into his office and program the device back to on with some adjustments to device settings to see if the difference in settings will alleviate the pain. Investigation to date has been unable to determine the cause of the pt's pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=513425


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:51:24 AM
Event Date 01/20/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing heart palpitations. The pt was seen by a different neurologist than usual as their treating neurologist was out of town. They reported right frontal headache associated with blurred vision and nausea. The pt also reported that they feel like they will have a seizure and that they have been having jumping and jerking movements of their extremities which they commonly have just before they have a grand mal seizure. Neurologist programmed their device to rapid cycling. There was no mention of the heart palpitations in the notes from that office visit. Device diagnostic testing within normal limits, indicating proper device function. The pt was instructed to follow up with their treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=512380


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:52:33 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization  
Event Description
Reporter indicated that vns pt was hospitalized because pt thought that they were having another heart attack. The pt had reportedly had a recent heart attack after which they underwent stent placement. Treating cardiologist reportedly found nothing wrong with the pt's heart and indicated that no treatment was given at the time that they had the heart attack that may have damaged the ncp system. The pt continues to experience a feeling of their heart pounding in their ears that sometimes awakens them from sleep. The pt also reports feeling this sensation in their neck and that they can feel their heart rate increase at times. These feelings are constant and do not coincide with device stimulation. Treating cardiologist reportedly indicated that he does not believe that the pt's symptoms are related to their recent heart attack. Treating neurologist indicated that the events were not related to the ncp system and that no intervention was planned. Neurologist indicated that the events were possibly cardiogenic. The pt reported that their device is programmed to the lowest possible setting (0. 25ma normal mode output current) and that they sometimes feel as if the device stimulates longer than it is supposed to. The pt experienced similar problems with heart palpitations in the past when device settings were increased, but that the problems resolved with a decrease in parameters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=512577


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 12:53:30 AM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up revealed that the pt experienced a fall after having a breakthrough seizure and experienced a left shoulder injury. The pt indicated that she was hospitalized after experiencing chest pain with loss of consciousness. During hospitalization tested confirmed cardiac arrhythmia, but no cardiac structural abnormalities were evident. According to the pt, the physician declined to perform a cardiac cath due to the presence of the vns therapy system and attributed the pt's cardiac problems to vns therapy. Hosp physician also reportedly requested the pt to have the device programmed to off by treating neurologist. The pt is managed with holter monitoring. Treating neurologist plans to temporarily discontinue the device stimulation during the holter monitoring. Treating neurologist does not believe that the cardiac events are related to vns therapy because the pt had been implanted for approx 1 1/2 years without complication. The holter monitoring was performed and the pt reported that the monitoring showed that the arrhythmia is related to the device stimulation; however, it only occurred following magnet mode stimulation. The pt indicated that she does not want the device stimulation discontinued because of the efficacy she receives. The root cause of the reported event is unknown. The cause of the arrhythmia is possibly due to the lead becoming displaced during the pt's fall and becoming too close to the cardiac branches.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515302


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 05:58:07 AM
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Pt experiences muscle spasms down the left side of their body when they lie on their left side with their head elevated and their device stimulates. The pt underwent gall bladder surgery 1-2 weeks prior. The pt also reports pressure in their chest and difficulty exhaling. The pt was referred to a cardiologist for eval. Treating neurologist does not believe that the pt's symptoms are related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=523059


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 05:59:26 AM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient was experiencing shortness of breath and numbness radiating down their arm along with chest pain and pressure, not in the area of the vns. When patient feels these symptoms, patient "takes some nitro" and the symptoms resolve. Treating neurologist indicated that the reported event was not related to the vns therapy and may be related to the musculoskeletal or cardiac system. The patient was referred to a cardiologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522091


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 06:00:11 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
The reporter indicated that the pt is experiencing pain at the generator site and has had an increase in seizures. The reporter also indicated that the increase in seizures may be due to stress or tapering the pt off of their anti-epileptic medication. Investigation to date has been unable to determine whether the pt's chest pain is cardiac-related or whether the increase in seizures is above the pt's pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520781


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 06:01:08 AM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that the pt has been experiencing pain and a burning sensation in the chest, neck and left arm for the past 3-4 weeks. It was also reported that the pt began experiencing continuous blurred vision approximately 2 weeks ago. Further follow-up revealed that the pt's device was programmed to off. Epileptologist indicated that the pt's symptoms and blurred vision resolved after programming the device to off. Epileptologist referred the pt to neurosurgen for possible device explant. Epileptologist would like the pt to be seen for follow-up by a neurophthalmogloist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520134


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 06:01:51 AM
Event Date 03/09/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt has been experiencing pain to the left breast, tenderness, and tingling and numbness to their left arm, with pain felt up to their neck. It was also reported that the pain is not related to device stimulation. Pt believes that the device has migrated down into their breast and that the device is palpable through the skin. The pt had been trying to lose weight and has lost 60 pounds since initially being implanted. The pt reports that it feels as if the device may have migrated due to the weight loss. The pt experienced chest pressure and pain to their left chest along with numbness and tingling to their left arm; therefore, thought that pt was having a heart attack and went to the hosp emergency room where pt was told that pt has not had a heart attack. The pt has been seizure-free until two months ago and has since experienced a seizure. Their last seizure involved more of their body and pt experienced urinary incontinence with the seizure. The pt also believes that the device magnet stimulation is weaker than it has been in the past. Further follow-up revealed that device diagnostic testing was within normal limits, indicating proper device function. Neruologist indicated that pt's chest pain has resolved. Neurologist does not believe that the pt's device has migrated; however, has reffered the pt for follow-up wtih neurosurgeon for second opinion and possible generator replacement due to the likelihood of the device nearing end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520253


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 06:02:24 AM
Event Date 10/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention  
Event Description
Reporter indicated that patient's device was programmed to off due to adverse side effects. It was reported that the patient was experiencing neck and chest pain with shortness of breath and an increase in seizures. The patient reported that they have been having large seizures like they had before they were implanted with the vns. The patient reports that they sometimes fall with their seizures. Treating neurologist indicated that the patient currently complains of dizziness most of the time, lack of energy, some night time coughing, shortness of breath at times and continuous pain around the generator and along the left side of the neck. The patient also has trouble sleeping and has a noise in their ears at times. It was reported that the increase in seizures was above the patient's pre-vns baseline frequency and that the patient's device was programmed to off to see if symptoms subside wihtout the vns therapy. The device remains programmed to off at this time. Further follow-up revealed that the patient perviously experienced an increase in seizures shortly after implant. The patient's device was programmed to off approx two months after stimualtion was intiated and was programmed back to on two months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=519523


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 09:52:33 AM
Event Date 06/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt is experiencing constant pain in their upper chest. Additionally, it was reported that the pt feels magnet mode stimulation in their stomach and then in the center of their upper chest area. Stimulation had just been initiated four days prior to the report of chest pain. The pt was in a psychiatric hosp at the time of the initial report and indicated that pt could not be seen by their neurologist while pt was in the psychiatric hosp. Investigation to date has been unable to determine the cause of the chest-pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=534877


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 09:53:46 AM
Event Date 03/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention  
Event Description
Reporter indicated that vns pt was experiencing feeling like the device was "fluttering" and that pt could see the device move in their chest when pt is laying down. The pt can see their chest going up and down during these episodes and that it caused the pt severe pain for which pt has been seen in the hosp e. R. The pt also reports severe shortness of breath with stimulation. Device diagnostic testing was within normal limits, indicating proper device function. The pt has used the magnet to temporarily discontinue stimulation during the reported episodes. Treating neurologist indicated that the events were not related to the implant surgery or to the vns therapy system and no intervention is planned. The pt has requested a replacment vns therapy system. The pt reports that the use of the magnet does not stop stimulation. Cardiac issues have not been ruled out as the cause of the pt's symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=531735


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 09:54:50 AM
Event Date 05/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the pt's device was explanted due to pain at the generator site. It is unknown if the pain was cardiac related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=529263


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:49:33 PM
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt was experiencing heart palpitations. The pt reportedly lives in a home that is under large utility wires. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=552078


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:50:13 PM
Event Date 09/13/2004
Event Type Malfunction
Event Description
Reporter indicated that vns pt experienced "shooting electrical current" through their body after doing some heavy lifting earlier in the day. It was reported that the pt complained to the point of screaming that their device was shooting electrical current all across their chest and into their neck, causing constant sore throat and leading spouse to beleive that they were going to die. The pt's chest was described as being "red like if someone poured hot water on pt" and the pt was short of breath with difficulty swallowing during the episode. It was also reported that the pt had "red blisters" on their chest and that the pt experienced pain in their stomach and the bottom of their feet. The pt's spouse indicated that the pt has a history of heart problems and that spouse planned to sue the manufacturer if the pt died as a result of the shocking sensation. It was reported that the shocking stopped when the pt placed the magnet over the device. The pt was seen by treating neurologist who programmed the device to off. The device was successfully interrogated, but no diagnostic testing was performed because the pt was excessively belligerent to the point that the physician had to call security. It was reported that the pt had not experienced significant efficacy with the vns therapy prior to the incident. Treating neurologist does not believe that the device is malfunctioning and indicated that the pt has psychological issues. The device was later explanted at the pt's request.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612042


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:50:55 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt was diagnosed with sleep apnea after vns implant and that pt uses a bipap machine. The pt also reported slight "twinges" pain at their generator site with itching, and a quick electrical type shock. Device settings were lowered and the pt did not experience any more electrical shocks. Neurologist indicated that the pt is also experiencing hoarseness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=546877


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:51:38 PM
Event Date 08/16/2004
Event Type Malfunction
Patient Outcome Hospitalization;
Event Description
Reporter indicated that they were feeling "electrical surges" and experiencing erratic stimulation. The reporter also indicated that they were experiencing pain in the area of their pulse generator, and shortness of breath. The patient was subsequently admitted to the hospital. The patient indicated that the device was shocking them. At that time, the generator settings were decreased. Vns system diagnostic testing was performed and showed the device was delivering therapy; however, the magnet activations were not displaying. After the patient's settings were decreased, the patient no longer felt electrical surges, but the patient had seizures. X-rays were performed and didn't show any apparent anomalies. The generator was replaced. Vns system diagnostic testing was performed immediately prior to surgery and resulted in proper generator function. During generator replacement surgery no anomalies were noted with the replaced generator and the lead. The generator was programmed on to the same settings prior to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612049


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:52:18 PM
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient was scheduled for revision surgery due to device migration. It was reported that the patient has been experiencing sharp pain around the generator site that travels up to the lead electrode site. The patient reports that they cannot tell if the pain coincides with stimulation because they do not feel normal mode device stimulation as they have become accustomed to it, but they do feel this pain when they swipe their device with the magnet. The patient also reports constant pain in their left shoulder which causes them pain when they lift their arm. The patient indicated that the generator was "in a weird location" and was causing their pain. The patient continues to experience significant efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=544818


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2010, 11:53:20 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns patient experiences a tightening, smothering feeling to their chest wall during device stimulation cycles. The patient reported that during these episodes, their heart "beats faster and harder". Treating neurologist indicated that the patient's symptoms had subsided ant that the patient was feeling better. The patient had reportedly been depressed and under a lot of stress lately and is scheduled for follow-up with their cardiologist. Neurologist indicated that the reported event was not related to the vns, but was possibly caused by angina, anxiety and/or panic attack. No intervention is planned or was taken. Device diagnostic testing was reportedly within normal limits, indicating proper device function. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=554657


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:10:25 AM
Event Date 01/26/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Patient experienced an increase in seizure activity above pre-vns baseline frequency after undergoing physicial therapy. The pt reported that they had an "ultrasound" and that they believed that it may have disturbed their device. The pt reported that they underwent physical therapy twice in four days, during which they used heat and aggressive massage in their left neck area, upper shoulders, and upper back. The pt did not know the exact name of the physical therapy procedure and was not sure whether it included diathermy. Since the physical therapy, the pt feels pain to their left neck and feels as thought the device "fibrates in their chest". The pt reported that they do not feel normal mode stimulation 97% of the time, but that they do feel magnet mode stimulation. The pt reported that since the first physical therapy treatment, they have been having "microseizures" above their pre-vns baseline frequency. The pt planned to contact their neurologist for follow-up. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to confirm the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=576815


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:11:05 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient was experiencing pain in their neck and chest in the area of the device and that their blood pressure and heart rate were low. The pt reported that they felt the neck and chest pain with device stimulation, but not with every stimulation cycle. The pt reported that they were seen in hosp emergency room three days due to the pain, at which time the er physician indicated that their blood pressure and heart rate were low and that the vns could be causing it. The pt planned to follow-up with their neurologist for device diagnostic testing. Investigation to date has been unable to determine whether the vns therapy was contributing factor to the reported hypotension and/or bradycardia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=576859


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:37:32 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention .
Event Description
Reporter indicated that vns pt experiences occasional discomfort with stimulation, which they describe as "almost painful" and seeming as if it makes their heart beat "too fast". Treating neurologist indicates that pt is doing well and that the patient's symptoms are likely due to depression. The pt is scheduled for follow-up with neurologist, at which time medication adjustments may be made. The vns therapy system is reportedly functioning without problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545548


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:38:35 AM
Event Date 11/01/2004
Event Type Malfunction  
Event Description
Further follow-up revealed that when the pt's device was programmed to on two week post implant the pt responded by "throwing their arms up and their eyes rolled back in their head". The pt's family member also indicated that the pt is experiencing pain with stimulation. The pt's family member reported that the pain brings tears to the pt's eyes and keep him up at night. The pt's family member also reported that without sleep the pt experiences difficulties keeping food down. The pt's family member also indicated that the pt has experienced an increase in grand mel seizures since implant along with throat tightness and hoarseness. The pt was later seen by physician at which time device diagnostic testing was performed and was within normal limits. Physician decreased normal mode output current from 1. 0ma to 0. 75ma and the pt was much more comfortable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571431


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:40:34 AM
Event Date 11/01/2004
Event Type Malfunction
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery. During the surgery, device diagnostic testing was within normal limits and had no cardiac effects. The pulse generator was then disconnected from the bipolar lead and a new generator was connected to the existing lead. Subsequent lead tests were within normal limits and had no cardiac effects. The patient left the operating room with the device programmed to off. The patient reported that the device was initially programmed to off due to what patient believed to be an arrhythmia. The cause of the reported events is most likely due to device stilumlation because the patient's symptoms resolved when the device was programmed to off.

Event Description
Further follow-up revealed that the patient's arrhythmia began approximately on year following implant. Epileptologist indicated that the arrhythmia was related to vns therapy. Epileptologist reported that the patient's symptom were continous and that the symptoms have resolved with ncp system replacement. The cause of the reported event cannot be ascertained because the explanted generator will not be returned to device manufacturer for analysis per the explanting hospital's policy.

Event Description
Reporter indicated that vns pt was hospitalized due to continuous device stimulation for more than 4 hours. The pt experienced coughing, tightness and pain in their chest during the continuous stimulation episode. It was reported that the pt's magnet was taped over the device to discontinue stimulation. The pt's symptoms reportedly subsided when stimulation was temporarily discontinued with the magnet. Device diagnostic testing was reportedly with normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Further follow-up revealed that just prior to the reported continuous stimulation episode, the pt hit their left shoulder, causing them pain on left side of their neck with stimulation. Treating neurologist reportedly decreased normal mode output current from 2. 25ma to 1. 0ma, but the patient's pain did not subside. The pt's device was subsequently programmed to off later that same day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612054


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:41:45 AM
Event Date 11/24/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reported indicated that pt developed an infection at the incision site after vns implant surgery. Oral antibiotics wre prescribed. Additionally, the pt noticed problems with heart arrhythmia when stimulation was initiated two weeks post-op. The pt also indicated that the device caused depression during stimulation cycles and that the generator has migrated sideways, resulting in a "heavy feeling" and neck pain requiring vicodin. The device was subsequently programmed to off approximately three weeks after stimulation was initiated; however, the pt thinks pt still feels stimulation. The pt was seen for explant consultation by neurosurgeon who reportedly called pt a "baby" and indicated that he would not explant the vns therapy system and that the pt should simply have the device programmed to a lower setting. Treating neurologist reportedly indicated that the pt "is very sensitive to things" and that the pt still wanted to have the vns therapy system explanted. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571541


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:42:53 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt has recently experienced feelings of being very tired and weak with feelings of their heart pounding and soreness of the muscles in their upper body. The pt has reportedly discontinued device stimulation with use of the magnet on several occasions, after which their condition improves after "some hours. " the pt does not take any anti-epileptic medications. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=569107


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:43:42 AM
Event Date 03/01/2005
Event Type Malfunction  
Event Description
Reporter indicated that vns pt's device was stimulating erratically, causing the pt to have part in their chest. It was reported that the pt's device was stimulating every 2 seconds for a couple of days. The pt planned to follow-up with their neurologist. Programmed parameters were last adjusted approx one month prior to the erratic stimulation event. Review of the manufacturing records for the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=588160


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:45:52 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea and dizziness as potential adverse events possibly associated with surgery or stimulation. Additionally, vns therapy system labeling states that dyspnea may result from stimulation, pts with chronic obstructive pulmonary disease may have an increased risk of dyspnea. Treating neurologist indicated that the reported events were "positively" not related to the vns. Neurologist indicated that the source of the pt's shortness of breath and chest pain that have caused the pt to become dizzy and to pass out, are most likely cardiac or respiratory problems because of the pt's excessive smoking.

Event Description
Reporter indicated that vns pt has experienced an increase in shortness of breath with exertion over the past seven months and that pt recently experienced a fainting episode preceded by shortness of breath with activity dizziness and lightheadedness. The pt was walking to a bus stop, which was up an incline. When he reached the top of the incline, pt was winded and felt lighteadged. The next thing pt remembered was bieng in the back of an ambulance and having an ekg. The pt was taken to the hosp e. R. And diagnosed as having had a seizure episode, though the pt adamantly deries that the event was seizure-related. The pt expressed concern about their vns settings and the possibility that their lead may be constricted becaused pt feels tautness in the left pectoral area. The pt reportely planned to follow-up with their internist. During a follow-up telephone call to the pt from device mfr, the pt experienced a similar episode, during which pt stopped talking in mid-sentence, began to gasp for air and dropped the telephone. The pt continued to gasp for air for approximately 30 seconds. Afterward, the pt seemed to be experiencing severe postictal confusion. The event was immediately reported to the pt's neurologist who agreed to follow-up. Mfr rep then hung mfr back. When the sequence of evnets was explained to the pt, pt denied having had a seizure and did not recall any of it. The pt reported that this type of episode had never happened before and that pt would follow-up with their neurologist. While undergoing an eeg the following day, the pt experienced another similar episode. Before the tracing began and while the electrodes were being applied, the pt had a spell lasting approximately 30 seconds of total loss of consciousness without any convulsive movements and with a postictal period of confusion lasting 3 to 5 minutes. Treating neurologist has repeatedly referred the ot for chest x-ray and cardiac work-up, but the pt has yet to schedule those appointments.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578582


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:47:30 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure frequency. The pt has been feeling short of breath, even wtih inactivity and that their left arm occasionally twitches. The pt also reports feeling as if their whole chest is burning and itching. The pt has been seen by treating neurologist on two occasions due to the aforementioned events and that neurologist may have adjusted device settings at these office visits. The pt's neurologist instructed pt to relax and to calm down because pt is anxious.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=608260


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:48:37 AM
Event Type Malfunction  
Event Description
Vns pt underwent generator replacement surgery due to suspected device malfunction. The pt experienced efficacy with the vns therapy for the first six mos after implant, but that they "has gone downhill from there". The pt reports chest pain in the area of the generator and reportedly cannot lay down without increased pain at the site. The pt also reports periodic shocks in their chest. The pt can no longer feel device stimulation when they swipe the device with the magnet and reports that initiation of magnet mode stimulation no longer stop their seizures as it did previously. The pt reports trouble sleeping and less coughing and hoarseness than previously experienced. It was reported that the pt may manipulate the device through the skin. Device diagnostic testing was reportedly within normal limits, indicating proper device function and review of x-rays by treating physician did not reveal any obvious discontinuities in the vns therapy system. The elective replacement indicator was not indicating that the generator had not reached end of life. During the generator replacement surgery, the original lead was examined and determined to be intact. Device diagnostic testing of the replacement generator connected to the original lead was within normal limits, indicating proper device function. It was reported that because the pt was experiencing difficulty performing effective magnet swipes, the replacement generator was secured in a more medial position. It was noted that prior to explant of the original generator, there were greater than two inches of adipose tissue over the generator, which may have affected inition of magnet mode stimulation. The pt has previously complained of difficulty initiating magnet mode stimulation because the generator was placed deep in the tissue pocket. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to confirm proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=592170


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:50:05 AM
Event Date 03/01/2005
Event Type Malfunction
Event Description
Reporter indicated that vns patient can no longer feel device stimulation and no longer experiences voice change during stimulation cycles. The patient reportedly feels magnet mode stimulation, but does not feel normal mode stimulation, even when it is set to the same output current as the magnet mode stimulation, device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of life. The patient's family member indicated that the patient's device settings were recently increased and that stimulation after the increase "knocked them down" and they couldn't breathe, they coughed and they could hardly talk since the parameter adjustment. The patient reportedly felt normal mode stimulation 4 times in a row following the increase in parameters and hasn't felt it since. The patient's family member believes that the device is not functioning properly. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=592845


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:51:04 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 03:52:55 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
When vns patient is talking or laughing a lot, they feel their heart racing and their chest and arm hurt on the left side. The patient reports that when they are talking, they get tired very fast. The patient reports they occasionally experiences chest pain in the area of the device when they are talking. When this pain occurs, the patient begins to lose their voice and lose their breath and they feel their heart rate accelerate. The pain reportedly lasts for approximately 3 minutes and the patient drinks water to regain their voice and breath and takes over the counter pain medications for the pain. Additionally, the patient reports that they feel as though there is less tissue over the device now than when it was first implanted. The patient reported that months ago, their neurologist referred them back to the neurosurgeon due to complaints of pain in the area of the device and that the surgeon indicated that everything was fine at that time. Treating neurologist does not believe that the patient's complaints are related to the vns and indicated that they may psychogenic or related to anxiety. Treating neurologist indicated that the device had not migrated and that there were no signs or symptoms of infection or other problems. The patient currently experiences 1-2 seizures per day, but has not had to go to the hospital emergency room for seizures in some time. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=600068


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 11:31:21 AM
Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Vns patient has experienced needle-like chest pain during stimulation that radiates from them sternum to left chest and down their left arm along with becoming diaphoretic. The pain reportedly started when the patient began training for long distance marathon racing. The patient participates in a strenuous exercise class that involves much running and sprinting and reportedly becmes symptomatic during stimulation cycles when exerting this much energy. With these symptome, patient ends up stopping and having to kneel down until the symptoms subside. The patient has a history of asthma but was recently cleared by their pulmonologist. The patient has stopped all activity pending consult with a cardiologist. Investigation to date has been unable to determine whether the patient's chest pain is cardiac-related as results of evaluation by cardiologist were not yet available in physician's records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621150


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:14:41 PM
Event Date 06/28/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced voice changes, shortness of breath and chest pain with stimulation following an adjustment in device settings. The pt asked their neurologist when the voice changes and shortness of breath would go away, but did not mention chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622607


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:15:41 PM
Event Date 05/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt was explanted due to complaints of neck pain and chest tightness. Initial reporter indicated that the pt was not mentally stable and was not reliable when it comes to expressing how pt really feels. Both the generator and lead (excluding electrodes) were explanted. Investigation has been unable to determine whether the chest tightness was cardiac-rleated as no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=615372


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:16:24 PM
Event Date 06/30/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
The reporter was recently implanted with a new generator and is experiencing a rapid heart rate of 134 bpm, exhaustion, and slightly elevated blood pressure. It was further reported that the pt is also experiencincing pain in the generator area when the device stimulates. The generator was programmed on to 1. 25ma immediately following the implant. The generator was checked and found to be properly functioning. It was also reported that an attempt to alleviate the pain by adjusting the parameters was done, however, the pt still experienced pain during device stimulation. The pain stops when the gneerator is inactivated using the magnet. Further troubleshooting is currently being done. The cause of the reported event are unknown at this time; this event is currently being investigated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=623815


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:16:59 PM
Event Date 08/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient was experiencing sporadic stimulation that sometimes caused chest pain and pain in the neck area. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. Based on known device settings, remaining generator battery life was estimated to be approximately 1. 09 years. Investigation to date has been unable to determine whether the chest pain is cardiac-related as no response has been received to manufacturer's request for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=638687


Title: Re: Chest Pain
Post by: dennis100 on December 17, 2010, 12:17:35 PM
Event Date 11/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient has experienced palpitations and feelings like his heart was `racing' during device stimulation over the past week. Cardiac testing, including an ecg, was normal. Device diagnostic testing was within normal limits, indicating proper device function. The patient was reportedly instructed to temporarily discontinue stimulation with the magnet if the palpitations worsened.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=652998


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 01:28:04 AM
Event Date 01/25/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that upon initiation of device stilulation, vns pt experienced heart palpitations and shortness of breath with each stimulation cycle. The pt used the magnet to temporarily discontinue stimulation until she was seen by treating physician the following day. Programmed pulse width setting was reduced from 500u to 250u, after which the pt's symptoms resolved. No further action is planned by physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=679113


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 01:28:46 AM
Event Date 12/29/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that during device stimulation cycles, vns patient experienced heart palpitations and a burning sensation underneath the generator with pain to left chest which radiated to his heart. The patient reported the event to his neurologist who programmed the device to off pending evaluation by a cardiologist. The patient denies recurrence of this episode since stimulation was discontinued. Further follow-up revealed that the patient complained of chest pain approximately three months prior and that the pain subsided after device output current setting was reduced from 1. 0ma to 0. 75ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=668903


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 01:29:24 AM
Model Number 101
Event Date 12/07/2005
Event Type Injury
Event Description
Further follow-up revealed that the patient's shortness of breath and pain in the chest resolved when the generator's output current was reduced. The physician believes the events were related to the vns stimulation. The patient was never hospitalized for the shortness of breath. The cause of the reported pain and dyspnea was likely due to intolerable generator parameters.

Event Description
Vns patient has experienced trouble breathing since last 0. 25ma increment increase in device output current setting. The patient reportedly cannot tell whether she only experiences trouble breathing during device stimulation cycles. The patient reportedly went to the hospital emergency room, at which time a cardiac work-up was negative. Report is incomplete because no reponse has been received to manufacturer's request for additional information from treating physician (via fax x1).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=665071


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 01:30:06 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing 'ache-ness' in the area of the generator about twice per day. Review of x-rays by mfr revealed that the generator was implanted in left chest with lead connector pins fully inserted past the generator block, filter feed-throughs intact and lead wire intact at the connector pin. Only one lead electrode was visible. Strain relief loop and strain relief bend were noted and 2 tie downs were seen. No visible acute angles were observed in the lead. A portion of the lead was not visible as it was behind the generator that could possibly have been a lead discontinuity; however, this could not be confirmed due to the poor quality of the film. Further follow-up revealed that the pt's symptoms have increased, both in intensity and frequency (now between 4-7 times per day). Treating neurologist indicated that the symptoms may be related to the pt's lifting of moderately heavy boxes while at work (between 10-40 pounds), possibly resulting in current leakage due to potential damage to the device. Neurologist plans to perform device diagnostics testing at next office visit. Treating neurologist indicated that it was possible that the pt's pain was cardic-related due to her age and the fact that she was obese, but he also indicated that nothing suggests cardiac right now. Investigation to date has been unable to rule out cardiac involvement as the source of the pt's chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660582


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 01:30:44 AM
Event Date 12/02/2005
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was hospitalized in intensive care unit because her device 'went haywire' and she felt like it was shocking her from the generator site all the way up her neck, through her head, and down her back. The patient reported that the patient was unbearable. While hospitalized, a cardiologist reportedly told the patient that she had a heart problem and that if she experienced a similar incident again, she would die; however, the patient did admit that she was medicated at the time of her discussion with the cardiologist and that she did not remember the entire conversation. It was reported that normal mode stimulation was discontinued while the patient was hospitalized but that magnet mode stimulation remained active. The patient reports that 'her voice was damaged and it was difficult to swallow' since being discharged from the hospital three days later and that she is subsequently not able to swallow her medications. The patient reports that she has not experienced any pain since the normal mode output current was programmed to off and she has not had any seizures. Further follow-up with treating neurologist revealed that the patient has irregular heartbeats and that she will be evaluated at an upcoming appointment to determine what the cause of the cardiac problem is. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. Additionally, device tracking information was not forwarded to manufacturer at the time of initial implant and attempts to obtain it have been unsuccessful to date (via fax x2 to implanting facility).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660381


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 02:21:31 AM
Event Date 06/06/2006
Event Type Death
Patient Outcome Death;
Event Description
The deceased had a history of seizure disorder-grand mal and reportedly had a nerve stimulator placed since 2003 and replaced 2005. Prior to her death, she had complained of the stimulator "moving out of place" and "giving shocks. " the stimulator was last tested feb 2006 and was reportedly "fine. " she was found collapsed at home. Autopsy offered a nerve stimulator attached to a nerve in the upper chest with no other significant findings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=751310


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:21:44 AM
Event Date 12/02/2007
Event Type Malfunction
Event Description
It was reported to mfr that the vns pt was feeling that the "stimulation was shocking her and feels that she is being electrocuted". Additionally, it was reported that the magnet did not work to inhibit stimulation when placed over the generator site. Attempts to obtain add'l info from the treating physician are under way.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971186


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:22:21 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that a vns patient's generator was explanted due to end of service. Follow-up with the treating physician revealed that the patient's device was actually replaced due to pain at the generator site and the physician was "worried about local nerve compression or inflammation. " the pain was reported to be associated with arm movement or physically displacing the stimulator. During generator replacement surgery, neither neuroma nor obvious compression was found. The physician reported that the pain appeared to be of neuropathic origin. The explanted generator was returned to the manufacturer for analysis. No anomalies that could have contributed to the event were noted. The pain has reportedly somewhat improved following generator replacement surgery, but is still present in the left wrist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=866954


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:22:58 AM
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that pt was experiencing painful stimulation to the left shoulder, left arm, chest and stomach, and in addition, reported feeling a "loose piece of metal in the generator area". During the investigation, it was noted that the pt only had these complaints after she underwent two surgeries for implantation of bilateral prosthetic breast implants due to previous bilateral mastectomies. X-rays reviewed by mfr showed appearance of the connector block not in parallel alignment with the generator. Last known diagnostics indicated proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=967445


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:23:37 AM
Model Number PULSE MODEL 102
Event Type No Answer Provided
Event Description
Device placed earlier this year and patient has been experiencing chest and abdominal pain since.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788164


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:24:17 AM
Event Date 01/01/2006
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated a patient passed out due to a shocking sensation from the vns device. The patient subsequently had the vns device explanted. The pateint was implanted for intractable hiccups.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=817994


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:24:52 AM
Event Date 12/14/2006
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated the pt experienced midline chest pain and shortness of breath postoperatively. The pt was admitted to the hospital for eval and treatment. Intravenous morphine was administered for her chest pain. She also rec'd heparin and oxygen. The discharge summary indicated the symtpoms could be related to the pt's incisional type pain. The physician feels the chest pain and shortness of breath was related to the vns surgical procedure and not the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842015


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:25:30 AM
Event Date 02/01/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient was experiencing severe headaches, heart palpitations, and increased blood pressure since vns therapy system implant surgery. The patient was hospitalized for testing and the physician programmed the pulse generator off. While the device was programmed off, the patient's symptoms subsided. Diagnostics are not available. Explant surgery is likely. Attempts to gain additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842507


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:26:08 AM
Event Date 03/01/2007
Event Type Malfunction
Event Description
Reporter indicated that device was delivering painful stimulation longer and more often than programmed. Events reportedly discontinued after 3 days. Physician performed diagnostic testing and reported all results were within normal ranges. Good faith attempts to gain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950567


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:26:44 AM
Event Date 04/01/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient's generator and lead were explanted because the device was "shocking the patient. " implant card received by manufacturer indicated patient was reimplanted with the vns therapy system on the same day as he was explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=855645


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:27:19 AM
Event Date 10/01/2006
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient had severe pain during vns stimulation and device was unable to be interrogated. The patient underwent surgery where the vns therapy system was explanted. No records of diagnostic testing and attempts to obtain programming history were unsuccessful. The explanted generator has not been returned for product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=855806


Title: Re: Chest pain / Shortness of breath
Post by: dennis100 on December 18, 2010, 06:27:56 AM
Event Date 09/07/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a patient experienced tachycardia and heart palpitations after initial vns implant surgery. The vns device was not activated at that time. Medication was given and the tachycardia and heart palpitations resolved. The patient remains on vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=852424


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 06:28:33 AM
Event Date 06/23/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt was experiencing sharp pain at the vns generator site, even when the device was programmed off. The pt is a poor historian and may not remember any trauma per the reporter. Trauma is suspected, as well as the generator itself possibly causing the pain. The reporter has decided to proceed with a prophylactic generator replacement to see if the pain will resolve. Surgery is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=885280


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 09:34:37 AM
Event Date 10/29/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Initial reporter indicated that, the patient's physician is inserting a "right vns", but no new generator. Additionally, it was reported the surgeon was planning on replacing the lead only and implanting it on the right vagus nerve. The patient was experiencing pain and doctor associated the pain with the lead because, when the device was turned off, the pain resolved. The physician reported that diagnostic results were "great" and x-rays revealed no anomalies. He said that he "programmed off the generator and the pain went away. " he said he "can also lower settings and the pain is less intense. " he said the "patient also has psychiatric issues and that may be contributing to her ability to tolerate it", but "the pain is still bad enough that something has to be done. " he said that the painful stimulation started out of "nowhere" and he "does not know the cause" because of the good diagnostics and x-rays. The patient underwent the lead replacement surgery and the mfr is making good faith attempts for the explanted lead to be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=954402


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:10:29 PM
Event Date 07/01/2007
Event Type Injury
Patient Outcome Other;  
Event Description
Initial reporter indicated that the patient was involved in a "takedown" at his job at a correctional center. The patient reportedly came into the office two weeks later and reported that he was walking along the street to the mailbox and developed sudden chest pain, tightness in his throat, pain in his head and passed out. He was seen in the er and had a mri and eeg which yielded normal results. System diagnostics testing performed were within normal limits indicating proper device functioning. The patient reportedly had a second occurrence of sudden chest pain, tightness in the throat, pain in the head and "almost" passed out. The vns was disabled with the magnet and was subsequently programmed off. No events occurred with the vns programmed off. Chest films reviewed by manufacturer yielded no device anomalies. The vns therapy is now programmed back on and at this time the patient has not had any reoccurrence of the events. The patient's treating physician indicated the events are related to the patient's vns therapy stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902898


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:11:26 PM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that pt is to have her vns therapy system explanted due to chest pain and a lack of efficacy from the device. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=955859


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:12:20 PM
Event Date 07/20/2007
Event Type Injury Patient Outcome Other;
Event Description
It was reported to mfr that the vns pt is experiencing a "sensation of heart racing" that occurs only with stimulation on times. The magnet is used to temporarily disable stimulation to help with tolerability. Additionally, it was reported that the vns pt was experiencing intermittent shortness of breath. Medication changes were made to help with the event. In addition, it was reported that the pt experienced tightening in the chest and throat during stimulation on times. Use of the magnet to temporarily disable the device, and medication changes were made to help with this event. The physician believes that these events are possibly related to stimulation of the device. The heart racing event has resolved since the initial report. Review of the available programming history revealed that setting changes were made to decrease the output current following the onset of the reported events. Attempts to obtain add'l info from the physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948583


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:13:11 PM
Event Date 04/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated patient was undergoing a full revision procedure due to continued pain he was experiencing. It was reported that this pain was a shocking sensation that occurred in the chest and neck, but was not directly related to stimulation. Good faith attempts to obtain explanted products for analysis will be made once surgery occurs.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=933194


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:13:57 PM
Event Date 09/24/2007
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the vns epilepsy patient went to the emergency room complaining of severe chest pain. Further follow up with the treating physician revealed that the chest pain resolved when the device was disabled. The device has been turned back on, but at much lower settings due to tolerability. Device diagnostics were performed following the onset of the event and revealed normal device function. There has been no report of recent trauma, or any other event that could be contributing to the chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=929536


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:14:40 PM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that vns pt would have the vns device explanted due to painful stimulation near the generator site. It was reporter by the treating neurologist's office that device settings had been changed in attempt to reduce pain; however, the pain persisted. The office also stated that the vns device had been turned off "for awhile". It was also reported that device diagnostics have been within normal limits and there is no report of device malfunction. It is unk if the pt's vns device has been explanted. Attempts to gather add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=926548


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2010, 12:15:46 PM
Event Date 08/01/2007
Event Type Malfunction
Patient Outcome Hospitalization;
Event Description
Reporter indicated the patient, after doing some heavy lifting, began experiencing sharp chest pain with device stimulation. Subsequently, the patient went to the hospital. During hospital visit, a system diagnostics test was performed, and yielded good results. The patient's device was then programmed off. X-rays were taken and viewed by the physician. The physician indicated the x-rays were negative. The patient underwent vns therapy system replacement surgery. The implant and warranty registration card provided by the facility indicated that the patient vns therapy system was reimplanted as it was "non-functioning. " further follow-up with the surgeon's office indicated that the patient underwent a recent surgical procedure at which time he had his vns turned off. When the vns was turned back on the patient was experiencing a "shocking feeling". No other information was available. Good faith attempts are being made to obtain additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=925728


Title: Re: Chest Pain
Post by: dennis100 on December 19, 2010, 06:37:45 PM
Event Date 06/30/2008
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated experiencing an episode of severe chest pain. The hospital performed a cxr and informed the patient that "it looked like it may have been detached. " the patient did not know what was meant by this statement, and was referred the neurologist. The patient also reported experiencing an increase in seizures. The patient's seizure activity level prior to being implanted with vns is unknown. Follow up with the neurologist revealed diagnostic testing was within normal limits and was not at end of service. The pt elected to have the generator replaced. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1091623


Title: Re: Chest Pain
Post by: dennis100 on December 19, 2010, 06:38:29 PM
Event Date 05/26/2008
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Initial reporter indicated that the pt with a new vns is reporting having trouble with "changes in consciousness and complaints of chest pain. " reported the pt went to the er. The pt will have their vns evaluated. Their lead placement will be also checked via x-ray. No further info has been attained at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064801


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:18:58 AM
Event Date 08/27/2008
Event Type Malfunction
Event Description
Reporter indicated a vns patient presented with an intermittent shocking sensation on the left chest and his left leg, in addition to muscle spasms in the left side of the body. Diagnostic testing yielded high impedance and the device was disabled. The patient's pain continued after the device was disabled. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1191487


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:19:47 AM
Event Date 08/01/2008
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial reporter indicated that the patient had been explanted for pain in the chest and neck area with vns therapy. Good faith attempts are being made for additional details surrounding the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1181594


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:20:55 AM
Event Date 07/24/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt was explanted due to pain at the generator site. The vns had been disabled prior to the explant and the pain had decreased. All attempts to the reporter for additional information have been unsuccessful to date. Attempts for product model and serial numbers and return for analysis have been unsuccessful date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1283420


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:22:02 AM
Event Date 12/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt had a surgery due to having constant pain at the generator site. The generator was explanted. It is unk if lead was explanted or if any replacement surgery took place. Good faith attempts to get additional info and to have the product back to mfr have been unsuccessful. The cause of the pain at generator site is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1288588


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:23:43 AM
Event Date 02/11/2009
Event Type Injury
Patient Outcome Hospitalization;
Event Description
It was reported by the vns pt that she went to an emergency room, due to chest pain and, she believed she was experiencing a myocardial infarction (mi). Further f/u with the pts treating vns physician, revealed that she received a report from the pts primary care physician, and it was not clear whether the pt actually had an mi or not. The vns physician only received brief notes, stating that the pts' cardiac enzymes were negative as was a stress test, but that her large habitus limited interpretation of the results. The physician did not have the actual test results and was unable to provide further clarification. The treating vns physician last saw the pt three months prior to the reported event. Diagnostic tests have not been performed on the pt's vns device, as the settings are not optimal (low output current) to perform an accurate diagnostic test. The physician stated that the pt has struggled with weight issues and is at high risk for diabetes, additionally, it was noted that the pt has had chest discomfort of one kind or another since being implanted with vns. Additionally, it was reported that the pt "jumps around a lot". The pt saw the implanting surgeon so that the placement of the generator could be assessed and if this could be causing the chest pain. Good faith attempts to obtain additional info from the surgeon have been made, but have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1344253


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:25:06 AM
Event Date 06/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns patient began experiencing shortness of breath and chest pains, which the psychiatrist attributed to stress in her life. The patient's symptoms got worse and the patient was taken to er via ambulance and given oxygen. The er stated they "know it was not a heart attack. " the patient taped her magnet over the generator to disable the vns and the shortness of breath persisted, but was reportedly "not as bad. " follow up with the treating physician revealed diagnostics are within normal limits and the patient has not experienced any trauma or manipulated the device. The physician stated the "patient has been under a great deal of stress lately, which may have increased her intolerance of the side effects. " good faith attempts to obtain additional information, but have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1184420


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2010, 09:25:46 AM
Model Number 102
Event Date 05/04/2006
Event Type Injury
Event Description
Clinicals were received at manufacturer that reported a vns patient feels the device has not helped her that much and lately the stimulation sometimes becomes painful and she feels discomfort around the neck and chest. The battery also creates discomfort for her. The patient's vns battery has reported to have migrated. The cause of the patient's migration is unknown. She would like to have the stimulator removed. No surgery has been scheduled at this time as the patient is pending funding from insurance to cover the cost of the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1696057


Title: Re: Chest Pain
Post by: dennis100 on December 21, 2010, 04:02:22 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 21, 2010, 04:03:08 AM
Event Date 09/01/2009
Event Type Injury
Patient Outcome Hospitalization;
Event Description
It was reported that a pt went to the hospital due to chest pain. The pt had previously reported experiencing this pain whether he was around large magnets in his backyard. The pt followed up with his physician who decreased the pt's settings to a more tolerable level as the physician believed the pain was related to device stimulation. The physician performed device diagnostics which were within normal limits and does not suspect a malfunction of the device. There were no reports of pt manipulation or trauma that preceded the onset of the event and there were no programming or medication changes that preceded the onset of the event. The physician's current plan is to monitor the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1486566


Title: Re: Chest Pain
Post by: dennis100 on December 21, 2010, 04:03:58 AM
Event Date 01/01/2006
 Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt had their device removed due to pain in the chest and neck that was believed to be caused by the device. All attempts for further info have been unsuccessful to date. Due to procedures at the hospital where the pt had the device removed, the device will not be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478063


Title: Re: Chest Pain
Post by: dennis100 on December 21, 2010, 04:04:58 AM
Event Date 07/06/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that a vns patient experienced electrical shocking sensations in the chest area. The treating neurologist evaluated the patient's generator and found it to be working within normal limits. Further interventions were to program the patient's generator off. After the generator was programmed off, the patient continued to experience pain around the generator area along with a burning sensation that radiated to the underarm with swelling in the chest. Information received from the treating neurologist revealed the patient went to the er for intervention to be taken due to the chest pain. At the moment, it is known that the event is not related to stimulation, however, the root cause of the events is still unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464539


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:25:10 AM
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2015
Event Type  Injury   
Event Description
It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin. The patient mentioned that her device had been like this for two years. The patient's generator later migrated to her armpit and was causing her pain. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.
 
Event Description
The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to. The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration. The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator. As such, the physician believed that the generator must have fallen down on its own. The physician planned to resolve the protrusion and migration during replacement surgery. The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient underwent full revision surgery. The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6452971


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:25:54 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:26:53 AM
Event Date 09/30/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt experienced pain in his arm and shoulder along with coughing during stimulation. The event was reported by the pt's wife and indicated the event happened one time only. Additional information was received from a company representative indicating the pt was reporting a sharp stimulation every 2 mins that last up to an hour. The stimulation was "more in the neck first, then it went to the chest and towards the back" according to the pt. Pt described that after the hour of pain; the system will "shut itself off" and would then "turn itself back on". The pt was implanted in 2006 and was seen on a yearly basis. Since last (b)(6), he has been in every 6 weeks with the same type of complaints, which prompted the frequent visits. The treating physician would adjust the settings, the pt would feel fine in the office, and the pt would go home. He would feel fine there for a while, but then the device would seem to "malfunction" and he would need to come back in to the physician's office. However, based on previous diagnostics, the device would show to be working properly despite the pt's complaints. Additional information was received through clinic notes dated (b)(6) 2010. Notes stated that "pt has not had seizures but vns is going off every 2 minutes, at times for over hours, but is extreme sharp pain that is very different. He did not wish although i advised to place the magnet over his stimulator to turn it off, but he said that he has fear of return of his seizures". X-rays were received and evaluated by the manufacturer. Review of x-rays indicated the generator placement appeared to be normal, and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. No obvious lead discontinuities or acute angles were observed in the observed portions of the lead body that could be assessed. Although there was some lead behind the generator. Additional information was received from the pt's wife indicating her husband went to the specialist to go over the prognosis and his vns started shocking him at a higher voltage than he usually has. The wife indicated that there was nothing done to the device and the pt was not near electrical equipment that would have made it go off. Moreover, the pt's wife indicated the pt has chronic headaches ever since the device started shocking him and they are afraid to use the microwave in the house because he says it shocks him every time he uses it. At the moment, full revision surgery is planned at this time. Good faith attempts to obtain additional information from the treating epileptologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905622


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:29:05 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:29:58 AM
Event Date 06/01/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that the patient was having some shocking sensation at the generator site with stimulation. X-rays were taken and sent to mfr for review. Physician also stated that diagnostics results showed high lead impedance at one point and ok results during the other time. There was an intermittent high impedance reading. X-ray was reviewed by the mfr and no anomalies were identified in the visualized portion of the pt's vns device which could have contributed to the intermittent high lead impedance or painful stimulation although the presence of an unpronounced lead discontinuity or inadequate insertion of the connector pin cannot be ruled out. Good faith attempts to obtain add'l info has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1773494


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:30:50 AM
Event Date 01/09/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that a vns patient was experiencing painful stimulation in her chest and would feel pain and vibration in her neck at the electrode site with stimulation. The patient's current settings were 0. 25/20/250/30/5 and diagnostics gave an impedance value of 3696 ohms, 10 years to eos. The physician tried to increase the patient's output current but was unable to do so due to tolerability issues. The patient denied any trauma prior to the pain but stated she did fall after the onset of the pain. The patient's device was later programmed off due to the pain. The patient was referred to a surgeon, however, he believed that the device is functioning fine and even with the device programmed off, the patient is still complaining of pain. He believes the patient is making the event up, however, the patient was scheduled for device explant. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1782826


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:31:35 AM
Event Date 04/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the physician that patient was experiencing painful stimulation at the generator site for the past three months. Patient went to the er several times for the pain. It was stated that the pain resolves when the device is turned off. Diagnostics results showed everything working within normal limits. It was also stated that the patient is scheduled for generator replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1805132


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:32:22 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:33:14 AM
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the pt was complaining of chest pain and diagnostics were performed which showed high lead impedance results. Revision surgery is likely, but has not occurred to date. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1731634


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:34:07 AM
Event Date 01/01/2009
Event Type Malfunction
Event Description
Summary: it was reported that a vns patient experienced painful stimulation and constant soreness at the generator area. The patient does not recall if any trauma occurred as the event has been ongoing since about a year ago. However, the patient often experiences falls which could possibly contributed to the reported events. Additionally, system and normal diagnostics performed on the patient resulted within normal limits as the patient's settings were normal. Moreover, the patient was referred for removal of vns by one her neurologists as he does not deal with vns, but the patient is undergoing vns replacement surgery as vns was beneficial for the patient. At the moment, surgery has not been scheduled for the patient. X-rays were taken and sent to the manufacturer. Evaluation of the x-rays by the manufacturer revealed, the generator was placed in the left chest in normal orientation. The filter feed-thus appeared to be intact. The connector pin appeared to be fully inserted inside the connector block and the lead wires at the connector pin appeared to be intact. Furthermore, a large amount of the lead was located behind the generator and could not be assessed further. No lead discontinuities or acute angles were visualized in the lead body of the received images.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1734796


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:34:52 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:35:37 AM
Event Date 05/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns pt was experiencing painful stimulation in the chest at the generator site. Diagnostic tests were performed following the onset of the event which revealed normal device function. The output current was lowered and the painful stimulation persisted. There was no report of pt trauma prior to the onset of the pain. The physician referred the pt to have the device replaced by the surgeon. The pt subsequently had surgery where the lead and generator were replaced. Good faith attempts to obtain the explanted devices for analysis have been made, but have not been returned to date. In addition, good faith attempts to obtain additional info from the treating physician are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1745789


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:36:26 AM
Event Date 11/12/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the pt has recently been experiencing pain at the generator site and that it has began to migrate in her chest area. The pain is said to be so severe that she may have to use a fentanyl patch for relief. The migration is causing use of the magnet more difficult because it is moving. The pt is not having any other adverse issues. The pt may be referred for surgery to correct the issue. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676304


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:37:14 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:38:06 AM
Event Date 03/19/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient underwent generator replacement surgery as the patient experienced pain at the generator site due to unknown reason. No patient trauma or manipulation was reported to have contributed to the reported pain. Good faith attempts to obtain the explanted product resulted unsuccessful to date as the explant facility does not return explants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698782


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:38:50 AM
Event Date 04/01/2010
 Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the hospital nurse that the pt had his device explanted due to pain at the generator site. No additional information was provided. Explanted products were returned to manufacturer. Analysis was completed on the lead and no anomalies were found. Analysis is currently pending on the generator. Good faith attempts to obtain additional information has been unsuccessful till date. The cause of pain is unk at the moment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1700811


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:39:48 AM
Event Date 10/07/2009
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was initially reported that the patient was seen in the er complaining of heart palpitations. It was unclear if the palpitations were occurring with stimulation. Last diagnostics of the patient's device was system and normal mode within normal limits. The patient's settings were 0. 75/20/130/30/1. 8. The patient was noted to have been disabled in 2008 and recently turned back on at his appointment in 2009. It is unknown why the patient was disabled in 2008. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1541703


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:41:11 AM
Event Date 10/01/2009
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553673


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:42:00 AM
Event Date 07/10/2009
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that their pt had been over the past several months experiencing an intermittent sharp pain not necessarily associated with stimulation at the generator site and they wondered if the generator may be nearing end of service. Reported the pt also had a seizure in 2009 that was more intense and lasted longer than any other seizure the pt has ever had. The magnet did not abort the seizure as it usually does and the husband had to call 911. The pt was not admitted to the hosp. System diagnostics were done which were within normal limits. Estimated batter longevity showed 1. 63 yrs until eos=yes. The pt will be monitored at their three month visits. Good faith attempts are being made for add'l details surrounding the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1556355


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:42:42 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns pt had surgery a "few years back" where the pulse generator was moved from the left to the right chest, due to a burning sensation at the generator site. The pt's current treating physician was not seeing the pt at the time the event occurred, and is attempting to retrieve additional info from the pt, such as the pt's physician at that time, so that attempts for additional info can be made with the appropriate medical professional. In addition, the physician has indicated that the pt is a poor historian and that it is very difficult to get clear description of historical events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552700


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:43:52 AM
Event Date 10/20/2009
Event Type Malfunction
Event Description
It was initially reported that the pt had generator revision due to unk reasons. The pt had her generator replaced, and diagnostics performed in the operating room were within normal limits. The pt was said to have an increase in seizures while in the hospital recovering, so diagnostics were again performed, which resulted in high lead impedance. The diagnostics initially indicated 3100 ohms for the impedance value, but when ran add'l times, the impedance value increased in >10,000 ohms. The pt's settings were decreased from 0. 75ma to 0. 50ma and 0. 25ma, and it did not resolve the impedance value. Later it was indicated that the pt was seen on (b) (6) 2009, which the pt reported a "vibration" on the left side of the chest and shoulder and that she could feel it stimulating "internally and externally. " diagnostics were performed at that time, which were within normal limits. When the pt returned to the office in (b) (6) 2009, diagnostics were performed due to the continued "vibrations," which resulted in high lead impedance. The pt was disabled at this time. At a follow-up appointment on (b) (6) 2009, the pt's device was turned back on to 0. 50ma due to unk reasons. Diagnostics were again performed, which still resulted in high lead impedance. The pt was referred for surgery due to high lead impedance previously observed. The pt had x-rays taken prior to surgery and was said to be fine with no apparent fractures. The x-rays were not sent to the mfr for review and the mfr was not aware of the high impedance at that time. The pt was admitted to the hospital because she was having a lot of seizures, which is their protocol. The leads were not replaced at the time of surgery since there was not enough info to support lead issue. It was noted that prior to the surgery, diagnostics were performed, which resulted in high lead impedance. X-rays of pt that were taken on (b) (6) 2009, (b) (6) 2009 and (b) (6) 2009 were sent to the mfr for review. The x-rays taken on (b) (6) 2009 and (b) (6) 2009, which had the initial generator were assessed. Based on the x-rays received, there were no discontinuities visualized on the lead portions which could be contributing to the reported high lead impedance, but due to the availability of one view and image quality, the entire device could not be completely assessed. The x-rays taken on (b) (6) 2009 were assessed, which had the replacement generator implanted. Based on the x-rays received, there were no discontinuities visualized on the lead portions which could be contributing to the reported high lead impedance, but could not be confirmed due to image quality of the x-rays. In all x-rays reviewed, the pin appeared to be fully inserted into the generator. The pt has been referred for revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570478


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:44:32 AM
Event Date 01/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Initial reporter indicated that they had been having continuous pain around their generator site. Reported that the pain is pretty bad and gets worse when they move. It was reported that they had this pain for the last couple of months and that they had soreness in the area when touched, but it wasn't until this past week of jan 25th that it had gotten really bad pain especially when she moves. The pt had no fall or trauma prior to the onset of the event. Additionally reported that her generator has migrated and that the pt had been admitted to hospital for the pain she was having. The pt wants to have their vns explanted and at this time is in the process of trying to obtain funding for the surgery. Using the magnet to disable the vns did not resolve their reported pain. The pt reported that when in hospital they were told that they had an infection somewhere in their body unk relationship to the vns. The pt has been discharged from hospital. Good faith attempts are being made for additional details about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1611669


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:45:21 AM
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was initially reported by the patient that she had difficulty turning off her vns with the magnet. She experienced a sensation of pressure in her chest after magnet in place for keeping the magnet more than 15-20 minutes. Good faith attempts with the treating physician to obtain additional information have been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1604346


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:45:58 AM
Event Date 01/06/2010
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a patient was having chest pain that was unexplained via ekg testing and that the patient's vns generator was at end of service and could no longer be interrogated. The chest pain was attributed to the generator end of service per the reporter. The patient later underwent vns generator replacement. The explanted generator has been requested for return but has not been received to date. Further attempts for information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1603715


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:46:40 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported by the vns pt that she has been experiencing multiple symptoms, which began over the last two years. The pt explained that she had ulcers, heart palpitations which she believes are occurring with stimulation, fainting episodes, and red blotchy, warm sensation on the left chest in the location of the implanted pulse generator. The pt was implanted with the device in 2006. The pt stated that the physician who is treating these symptoms "did not know if it was related to vns". The pt explained that she had not informed her treating neurologist of these symptoms. Further f/u with the treating neurologist revealed that the pt has in fact not informed her of the symptoms, but also stated that they were not believed to be related to vns. The physician explained that the pt has received good efficacy with vns for seizure control. The physician stated that the pt was last seen in (b) (6) 2010, where diagnostic tests revealed normal device function, however, specific results were not provided. The pt is not scheduled for a f/u appointment until (b) (6) 2010.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1650534


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:47:20 AM
Model Number 103
Event Date 03/13/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the generator was replaced prophylactically and that the migration of the device was believed to be due to the trauma from the patient falling off of the porch. The increase in seizures was reported to be not related to vns. The patient was reported to be doing "fine" since generator replacement and no longer experiencing the reported events.

Event Description
It was reported that the patient suffered a fall off of the front porch which resulted in injury to her left neck. The patient indicated that she began experiencing an increase in seizures. It was reported that the patient began experiencing painful stimulation the night of the fall after she felt something "snap" while laying in bed. It was reported that the patient also began experiencing pain in her chest around the generator and felt as if the generator had slipped down lower toward her breast. The patient was awaiting scheduled prophylactic battery replacement at the time of the fall; however, the physician wanted to get the patient to surgery sooner as a result of the events. The patient underwent generator replacement. It was reported that pre-operative device diagnostics were within normal limits (2323 ohms). The generator was replaced and diagnostics were again within normal limits (2048 ohms). It was reported that the explanting facility does not return explanted devices; therefore, no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3757141


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:47:56 AM
Model Number 300-20
Device Problem High impedance
Event Date 06/01/2014
Event Type  Malfunction   
Event Description
Analysis of the lead identified that there were abraded openings in the outer and inner tubing in one area. For the observed fluid leaks, there were only observed in the inside of the outer tubing (not inner tubing).
 
Event Description
Additional information was received stating that x-rays were taken for the patient and the physician's office was able to visualize a lead fracture in the x-rays. Thus, the patient was referred for revision surgery. The lead fracture is thought to be due to the patient's fall over the summer, though this cannot be confirmed. The patient's recent increase in seizures is thought to be related to a loss of therapy from the high impedance. The increased seizure rate is around pre-vns levels. No known surgical interventions have occurred to date. Good faith attempts for additional relevant information have been unsuccessful.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had experienced an increase in seizures the past summer following a fall. The patient was referred for surgery but no known surgical interventions have occurred to date. The patient had been doing well with vns. It was noted that the patient had also been experiencing chest pain which was attributed to lateral device migration in the chest which occurred shortly after implant surgery.
 
Event Description
Additional information was received that the patient underwent vns generator and lead replacement surgery on (b)(6) 2015 due to high lead impedance. The generator was replaced prophylactically. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the generator concluded that the device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead confirmed a discontinuity of the positive quadfilar coil in the body region of the returned lead portions. The analysis also observed abraded openings of both outer and inner tubing near the break area with associated fluid leaks. Pitting was also observed on the coils at the break location. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4486745


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:48:33 AM
Event Date 02/16/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Summary: it was reported that a vns patient experienced pain due to unknown reason. Furthermore, the treating psychiatrist indicated the patient was likely experiencing pain due to short circuit as the physician had received a safety alert letter regarding the issue. A review of the patient's programming history revealed the patient's dc dc code at implant was 1 and impedance was ok, but no additional diagnostics were available. Additional information was received through a company representative indicating the patient was seen by a vascular surgeon as the word vns was misinterpreted and confused for varicose veins. The vascular surgeon was not familiar with vns, but stated the patient was experiencing an increase in depression. At the moment it is unknown if the patient's depression has increased as good faith attempts to obtain additional information with the treating psychiatrist have been unsuccessful to date. Furthermore, no device anomalies are suspected at the time as there is not enough information to confirm the event of short circuit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1635355


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:49:15 AM
Event Date 05/22/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A vns patient's mother reported that her son was implanted with their vns in (b) (6) 2009. It was reported he began experiencing muscle spasms on his left side near the generator, pain at the generator site, and headaches. It was reported to be constant and did not occur with stimulation. The patient had been on muscle relaxers and narcotics for this pain, and having physical therapy. The patient's treating physician's office at the time did not believe their pain events were related to their vns and were muscular in nature. The events did not start after any programming change, patient fall or injury. The patient was at low settings, related to their tolerability to the stimulation. Diagnostic testing on the device was within normal limits, ruling out a device malfunction as a cause of their pain events. The patient had their vns explanted related to their pain events and good faith attempts are being made to have the explanted product returned for product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1626286


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:49:53 AM
Event Date 02/01/2010
Event Type Malfunction
Event Description
Reporter indicated a vns pt had high lead impedance readings with diagnostics testing. No previous vns diagnostics tests are known. The pt has also experienced occasional painful stimulation at the generator site. The pt has had no clinical decline. Attempts for x-rays and further info from the site are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1632105


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:50:30 AM
Event Date 04/14/2010
Event Type Malfunction
Event Description
It was reported that a vns pt experienced pain in the upper left chest and neck region with stimulation settings which seemed to correspond to stimulation cycle. The treating physician programmed the pt's device off and stimulation parameters prior to disabling the device were 1. 5/250/20/7/. 5. System and normal mode diagnostics performed at the office visit resulted in dc dc 7. X-rays were taken and evaluated by the treating physician who did not visualize a lead break. Additionally, evoked potential measurement is currently being performed to further analyze the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1674182


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:51:16 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was originally reported the patient was kicked near her generator site and has since felt pain and would like to have the generator surgically moved to a different location. The surgeon stated he would replace the generator prophylactically. It was later reported the patient underwent prophylactic generator replacement. The system diagnostic results showed the results were within normal limits, indicating the vns was working as intended. When the new generator was placed, diagnostics were checked and were once again found within normal limits. The programming history database was reviewed and was found to contain information from (b)(6) 2015. No anomalies were noted and the diagnostics were found to be within normal limits. It was later reported that during the surgery, the surgeon examined the generator pocket when the old generator was removed and did not notice anything obvious that would have caused the reported pain. The surgeon did dissect and remove a bit of scar tissue and stated the lead ¿might have had a bend that might have caused some discomfort¿. The new generator was placed in basically the same location, though the surgeon did try to elevate it a bit further above the patient¿s ribs. The patient noted the pain was consistently present and not due to stimulation. The surgeon stated he felt the pain was likely due to soft tissue injury as a result of being kicked in that area. The patient reported she was very happy with vns and that it was working very well. The explanted generator is not expected to be returned for analysis. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6305940


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:53:21 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:54:06 AM
Event Date 01/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a patient developed cardiomyopathy. The device was programmed off and the patient was given lisinopril and coreg as a result. In 2008, the patient began to notice shortness of breath and decrease in energy. In 2009, the patient had an echocardiography which was abnormal and at that point, the patient was diagnosed with cardiomyopathy. The patient was diagnosed with ankylosing spondylitis and is taking methotrexate and endbrel for this condition. The patient is also morbidly obese and has hypothyroidism. The patient had ecg in 2005 that showed a nonspecific t wave abnormality and this procedure was repeated the next day with results that the nonspecific t wave abnormality improved. The device has been programmed off so that further testing can be performed. It is unk whether or not the cardiomyopathy is related to the device. The patient will follow up with the physician in 2010 at which time, the echocardiogram will be repeated. Good faith attempts to obtain additional information are in process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1565031


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:54:50 AM
Event Date 02/04/2010
Event Type Malfunction
Event Description
It was reported that high lead impedance was read in system , normal and magnet mode diagnostics during a follow up visit. Further information received from the nurse indicated the patient was not able to perceive normal stimulation as settings were increased to test the perception and were concluded to be negative perception from patient. Moreover, the patient reported pain from the generator to the left arm while performing movement since the past two months and feels the generator is moving. No patient trauma was reported at the moment and the device was not disabled as the patient did not agree to have it disabled. X-rays were taken and evaluated by the manufacturer. The review of the x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thru appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. The lead body was coiled beside the generator in the chest region, and there was no portion of the lead body located behind the generator that could not be visualized. Even though the lead body in the neck region could be visualized, the image quality in this area was poor. No obvious acute angles were observed in the portion of the lead body that could be assessed. However, a discontinuity in the lead body was observed in the chest region near the generator. At the moment interventions planned are unknown as good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1634010


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:55:37 AM
Event Date 02/04/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient experienced pain from the generator site to the left arm while performing movement since the past two months, and felt the generator was moving. No patient trauma was reported and x-rays were taken and reviewed by the manufacturer. The review of the x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. The lead body was coiled beside the generator in the chest region, and there was no portion of the lead body located behind the generator that could not be visualized. Interventions planned were to replace the patient's generator. Further information was received from a company representative indicating the patient's generator was removed. At the moment, good faith attempts to obtain the patient's generator returned to the manufacturer have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658139


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:56:41 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:57:25 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on December 26, 2010, 04:58:13 AM
Model Number 105
Event Date 10/28/2013
Event Type  Injury   
Event Description
It was reported that the patient had surgery on (b)(6) 2015. The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in. It was reported that the generator was not replaced, only repositioned. It was reported that the patient was doing okay. The explanted lead has not been received by the manufacturer to date.
 
Event Description
Analysis was completed on the explanted lead. A punctured opening was identified in the outer silicone tubing. Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious opening was noted on the inner silicone tubing other than the end of the returned lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure. " the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating. Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery. The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area. At that time, surgery was performed for patient comfort reasons. It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity. As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity. She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy. At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity. It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0. 5 ma. As a result, the device was temporarily disabled and turned on again on (b)(6) 2015. However, the neurologist felt this is not a therapeutic level of therapy. The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0. 5ma current. Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation. The pulse width was then adjusted up to 500usec which again worsened the sensation. The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant. The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on. The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0. 5ma. It was reported that a 4. 0-maxon suture (absorbable) was used to suture device to tissue. However, the device does move within the pocket and it creates considerable discomfort. The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back. Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014. The patient no longer had the ¿shocking pain¿ in the left neck and throat region. However, she still had pain in the left anterior chest wall due to the generator. On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation. Lyrica was added for the pain management. The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged. He assessed that the solution for the painful stimulation is revision of the leads. The surgeon recommends lead revision and repositioning the generator in the left chest. The patient was referred for surgery. Diagnostics have reportedly been within normal limits. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
The surgeon reported that the patient had been reporting painful stimulation prior to surgery. During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4566036


Title: Re: Chest Pain
Post by: dennis100 on January 04, 2011, 05:30:11 PM
Event Date 09/23/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient's device was programmed off due to painful stimulation at the generator site. The patient experienced an increase in depression while the vns device remained off. Further interventions were to program the patient's vns on, but the depression stage continued after vns was programmed on. At the moment it is unknown what triggered the patient's increase in depression and pre-vns depression levels are unknown. Additional information was received from the office of the treating psychiatrist asking for a company representative to be present at the patient's next office visit and ensure vns was working correctly. Further information was received from a company representative indicating she was present at the patient's most current office visit. Patient's current settings were 0. 75/30/500/14/10 magnet 0. Normal mode diagnostics results ok/ok dcdc:2 eos:no and system diagnostics were within normal limits dcdc:2 eos:no. The patient was seen at another follow-up appointment and patient settings were changed (decreased pw to 250 from 500) which helped the patient with the reported pain. The patient still continued to cough at these settings, but it would not cause the bronchial spasms that she had been experiencing before from the vns (patient pre-vns diagnosed with asthma). Good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924673


Title: Re: Chest Pain
Post by: dennis100 on January 04, 2011, 05:30:53 PM
Event


Title: Re: Chest Pain
Post by: dennis100 on February 03, 2011, 12:42:08 PM
Event


Title: Re: Chest Pain
Post by: dennis100 on February 05, 2011, 09:33:42 PM
Event Date 04/01/2005
Event Type  Death  
Patient Outcome  Death;  
Manufacturer Narrative  
Approx 21 months prior to death, the pt experiened shortness of breath, constant chest pain, and palpitations following an increase in programmed parameters. The symptoms reportedly subsided when device parameters were reduced to pre-symptomatic levels. Reference medwatch report 1644487-2003-00482.

Event Description  
Mfr periodically compares device-tracking info to the social security death index for the purpose of updating device-tracking data. During this process, mfr became aware of a pt death. Certifcate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died at his residence. Immediate cause of death is listed as sudden cardiopulmonary failure. Autopsy was not performed. Investigation to date has been unable to determine whether the reported event was related to the vns therapy system as the identity of the pt's last known treating physician is unk. There is no evidence that the vns therapy system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=678928
 
Report # 1644487-2003-00482
Event Date 07/12/2003
Event Type  Malfunction    
Event Description  
Reporter indicated that vns pt was experiencing an electric pulse at the generator site whenever the device is stimulating. It was reported that the sensation is in the chest area and felt like it was strong to "start their heart if they had a heart attack". Investigation to date has been unable to determine whether a device malfunction has occurred. No serious injury was reported in conjunction with the reported event. The pt temporarily stopped stimulation by taping the magnet over the device until this could be seen by their neurologist for device diagnostic testing.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477077


Title: Re: Chest Pain
Post by: dennis100 on March 08, 2011, 10:14:41 PM
Event Date 01/04/2011
Event Type Injury
Event Description
An operating room nurse contacted the manufacturer and reported that she had an explanted generator to return from a vns pt that was explanted because she was having pain in her chest. The pt had her vns generator replaced for a smaller model. The pt's generator was implanted more lateral and with her breast tissue had some movement that was causing the pt pain and discomfort. The generator was reimplanted to a more medial position. During surgery, a breach in the outer lead tubing was noted. The lead function was checked and a new generator implanted. Good faith attempts are underway for further information about the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979708


Title: Re: Chest Pain
Post by: dennis100 on March 08, 2011, 10:15:28 PM
Event


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2011, 08:41:58 AM
Event Date 01/26/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a vns depression patient that vns had never worked for him and caused him nothing but problems from inability to talk, hoarseness, and chest pain. Further information from the patient indicated that the would like to have his vagus nerve stimulator removed because he does not feel vns has helped him. The patient is no longer seeing his treating psychiatrist and was provided with the name of another physician but patient says he is unable to travel to the physician. Good faith attempts to obtain additional information from the previous psychiatrist regarding the reported events by the patient have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005793


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:50:10 AM
Event Date 03/23/2011
Event Type Injury
Event Description
A letter was received in our europe office from a vns treating physician reporting that they had explanted a vns patient's vns system related to chest/thorax pain in upper left body. The pain occurred when generator was at. 75 ma output current. The explanted product is at the manufacture pending completion of product analysis. Good faith attempts are underway for further details about the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2070188


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:51:30 AM
Event Date 01/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, it was reported by the vns treating physician to the mfr's consultant that the pt was experiencing pain in their chest consistently throughout the day, near the device. The pt does not recall how long the pain has gone on. A system diagnostics test was run and it showed a dcdc of 0. The pt has had a dcdc of 0 ever since visiting that practice, beginning on (b)(6) 2010. Review of prior programming and diagnostic history revealed that the pt had a dcdc code of 2 in 2003-2004 and then a dcdc code of 1 in 2005 and 2006 which led to the reported low impedance dcdc code of 0. The pt has also been experiencing an increase in seizures, with relationship to pre-vns baseline unk. The physician was referring the pt for a complete revision. The generator remained programmed on at that time. The physician did not request x-rays to be performed. The physician felt that the pt's clinical symptoms had gotten worse so he referred him for prophylactic replacement. On (b)(6) 2011 the pt went for prophylactic replacement; however, only the generator was replaced. Since the dcdc code was at 1 they did not replace the lead. The generator was returned to the mfr for product analysis on (b)(6) 2011. The generator is currently undergoing product analysis so no info is available at this point. Once add'l info is received regarding the product analysis, it will be reported. The physician reported that the increased seizures started around (b)(6) 2011. The physician did not provide a date for when the pain started nor the pain's relationship to vns. He says the pain is not associated with stimulation. No causal or contributory programming or medication changes preceded the onset of the pain or increased seizures. No pt manipulation or trauma is believed to have caused or contributed to the low impedance. The physician reported that it is unk whether the increased seizures are below, above, or back to pre-vns baseline levels. The physician also reported that the pt's clinical symptoms that are believed to be related to the low impedance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032411


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:52:20 AM
Event Date 10/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a neurologist that a vns pt was experiencing palpitations. The pt has been seizure free and had placed a magnet over her vns device for the past 1. 5 years. According to treating neurologist, the pt has long q-t interval but hasn't seen a cardiologist. The physician did not know if pt's cardiac symptoms have subsided since he just inherited the pt from another physician. Good faith attempts to obtain more info regarding pt's adverse event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039448


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:53:04 AM
Event Date 01/05/2011
Event Type No Answer Provided
Event Description
Explantation of cyberonics vns demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061420


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:53:39 AM
Model Number 104
Event Date 09/01/2013
Event Type Injury
Event Description
Follow up with the physician found that no causal or contributory programming or medication changes preceded the onset of the pain. No patient manipulation or truma occurred that is believed to have caused or contributed to the pain. The pain is not associated with (i. E. Occurring with) stimulation. It is not clear when the worsened seizures first began; however, they are believed to be related to the vns. The increased seizure frequency was back to pre-vns baseline levels. All of the patient's seizure types increased. No causal or contributory programming or medication changes preceded the onset of the worsened seizures. The vns replacement surgery was performed as intervention.

Event Description
Review of decoder data shows the device was at ifi-yes on (b)(6) 2013 (the date of explant). The device appears to have been functioning as intended to the date of explant. The battery was voltage was 2. 750v, and the noted ifi-yes condition is expected. With the information available, it appears that there is no device failure. The low output status reported in supplemental report 02 is most likely the result of the device being hit with electrocautery at the time of explant.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicate the patient's seizure control is poor lately and has become much worse. The vns device was replaced; however, the explanted device will not be returned to the manufacturer per hospital policy. Follow up with the physician found that the increase in seizures was likely related to the vns battery being at end of service. No other information was provided. Clinic notes dated (b)(6) 2013, indicate the patient has pain above the generator and suspicion of a lead insulation discontinuity there. Clinic notes dated (b)(6) 2013, similarly state that there is pain near the vns generator site and inflammation. However, clinic notes dated (b)(6) 2013 indicate the chest pain resolved and follow up with the physician found that the pain was not related to vns.

Manufacturer Narrative
Describe event or problem, corrected data: this information should have been included on supplemental report 02; however, it was inadvertently omitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484413


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2011, 03:54:14 AM
Model Number 102
Event Date 09/12/2011
Event Type Injury
Event Description
On (b)(6) 2013, it was reported by the patient that the pain she was experiencing was causing her depression to increase. She stated that she wanted the device explanted. Attempts were made for additional information on the pain; however, they were unsuccessful. No additional information has been provided. Surgery is likely, but has not occurred to date.

Event Description
Product analysis of the generator was performed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. A cut was identified in the positive coil. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Dried remnants of what appeared to be dried fluid was seen inside the inner tubing. There was no obvious point on entry other than the cut ends and the mentioned cuts. Other than the above mentioned observations typical wear, and explant related observations, no anomalies were identified in the returned lead portions.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full explant on (b)(6) 2013 due to pain the chest and arm although the device had not been disabled for some time. The lead and generator were returned on (b)(4) 2013 and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473303


Title: Re: Chest Pain
Post by: dennis100 on May 29, 2011, 01:24:58 AM
Event Date 06/08/2009
Event Type Malfunction
Event Description
It was reported that high lead impedance was read at a follow up appointment during diagnostic testing. The treating physician programmed the pt's generator off and will not recommend the pt for revision surgery as the pt will enter a drug study. Furthermore, the treating physician does want to have the pt's generator explanted due to reports of pain in the chest pocket. At the moment, no pt trauma or manipulation has been reported to the chest or neck area and good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1593306


Title: Re: Chest Pain
Post by: dennis100 on May 31, 2011, 11:11:01 AM
Event Date 11/09/2009
Event Type Injury
Patient Outcome Other;
Event Description
Information was received via clinic notes that a patient would be scheduled for prophylactic replacement of their vns generator. It was additionally reported that the patient had some vague discomfort in the lower left pectoral region approximately 2. 5 inch below the implanted generator itself. The patient had been trying to exercise more with the device that requires exertion with both legs and upper extremities. He had been seizure free for several months. Related to the patient's pain with stimulation their vns settings were lowered. The patient had been seizure free since 2007. Prior to that, they had frequent recurrent seizures. It is unknown if these seizures were above their prevns rate and the relationship to their vns. Good faith attempts are being made for additional details. The patient's explanted generator is in product analysis pending completion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1572582


Title: Re: Chest Pain
Post by: dennis100 on June 04, 2011, 04:20:29 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on June 05, 2011, 12:18:16 AM
Model Number 103
Event Date 08/17/2012
Event Type Injury
Manufacturer Narrative

Event Description
The physician reported that the patient's device was explanted on (b)(6) 2012. The patient was seen in the emergency room on (b)(6). The patient had a history of coming into the office complaining of multiple things - it hurt, he had trouble sleeping, pain over chest, etc. The device was disabled in (b)(6) 2012; however, the patient continued to have complaints. After the patient went to the emergency room, he wanted the device removed even though it was off. It was noted that the patient is an alcoholic, so his ability to accurately assess and recount is suspect. No additional information has been provided.

Event Description
Additional information was received stating that the vns patient continued to experience pain in his left chest despite disabling the device; therefore, the epileptologist and surgeon elected to remove the device as the pain appeared to be due to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479427


Title: Re: Chest Pain
Post by: dennis100 on June 05, 2011, 12:21:58 AM
Event Date 07/01/2001
Event Type Malfunction
Event Description
Reporter indicated that when device was programmed to on after implant, the patient experienced shortness of breath. The device was programmed to off for a month and then programmed back to on. The patient again experienced shortness of breath so the device was programmed back to off. Two weeks later the device was programmed back to on and the patient was fine for about 4 - 5 months. It was reported that during this time the patient had good seizure control. At a follow up visit in the spring of 2001, the physician increased the output current. Following the parameter increase, the patient began to have dizzy spells and ended up falling. Output current was decreased at a later office visit and the patient was referred to a cardiologist. The patient's family member is a cardiologist who felt that the pt was fine and that their problems were neurological. Since being decreased, every now and then the patient receives what was described as an electric shock and pain in their neck and shoulder. Further investigation revealed that the pt had all of these symptoms before the vns was implanted and that the pt has angina. Patient is non-compliant with physician's requests for monitoring. The physician does not believe that the symptoms are related to the vns because the symptoms persist even when the device is programmed to off. Patient was seen by physician in 2001. Lead test at this visit was ok with dc-dc code 2. Both normal mode and magnet mode output currents were programmed to off at this visit. The patient was later seen at another follow up office visit and was reported to be doing fine with the device turned off. Physician plans to see patient during 10/2001 and reprogram the device back to on at a low setting.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=357197


Title: Re: Chest pain/Shortness of breath
Post by: dennis100 on June 05, 2011, 12:22:51 AM
Model Number 103
Device Problem Migration of device or device component
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the team of physicians elected to proceed with a generator replacement in an attempt to resolve the complaint of intermittent radiating pain. Surgery was performed on (b)(6) 2015. A diagnostic test was performed which showed the device was working as intended prior to explant. During the surgery, the physician noticed inflammation surrounding the generator site that he thought to be caused by the original placement of the device. Upon closing the patient, the surgeon witnessed a small break in the lead about an inch away from the lead pin. A full revision was performed, having the lead and generator both replaced. A diagnostic test was run with the newly implanted device which still showed normal impedance levels. The explanted lead and generator were sent to the pathology department of the hospital. It was also found by the surgeon during surgery that the explanted lead did not appear to be attached to the correct nerve. Attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported that the patient's generator has migrated and is causing constant pain at the chest site. Device diagnostics were within normal limits. The patient was referred for x-rays. The physician believes that the migration is a result of weight change and growth since implant. It was reported that surgery will be required to reposition the device. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported by the physician that the patient has had chest pain, in the form of an intermittent shocking pain, for over a year. It was reported this pain radiates to the neck and epigastric regions. It was reported that deactivation of the vns system does not help. The patient's x-rays appeared normal and system diagnostics all appeared normal. The patient has been referred for replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4341541


Title: Re: Chest Pain
Post by: dennis100 on June 05, 2011, 12:51:23 PM
Model Number 105
Event Date 11/19/2014
Event Type Injury
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently stated that the incorrect explant date of (b)(6). Corrected to (b)(6).

Event Description
Product analysis for the lead was completed and approved on (b)(6) 2015. Analysis showed that other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Product analysis for the generator was completed and approved on (b)(6) 2015. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The final electrical test showed an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the vns patient was having of issues with his left arm and wrist and wanted his device repositioned. The patient noted feeling an electrical sensation at the generator site. Clinic notes were received indicating that the patient¿s generator was protruding and causing pain. Follow-up revealed that surgery was being performed for patient comfort. The patient¿s protrusion and pain were attributed to the initial placement of the device. The patient underwent surgery on (b)(6) 2014. The impedance value (3389 ohms) was within normal limits but the surgeon felt the value was too high. During the procedure, the patient also reported having cardiac pain. The surgeon was concerned that the lead may have not been implanted on the correct nerve, so a both the generator and lead were replaced at the time. The explanted devices have not been returned to date.

Event Description
The lead and generator were explanted (b)(6) 2014. The explanted generator and lead were received for analysis on 12/29/2014. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4343622


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2011, 02:36:04 AM
Event


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2011, 02:37:40 AM
Event Date 06/05/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt is experiencing several complications that are believed to be related to the vns. The reported complications include: shortness of breath leading to loss of consciousness, occasional pain with stimulation, burning at the generator site, stomach complications including pain and discomfort, headaches (migraines) have increased in intensity, pt still feels stimulation at times when magnet is taped over device to turn it off. It was reported that the intensity of the pt's seizures has not decreased much since vns implant. On 06/02, the pt had difficulty breathing. The magnet was taped over the device to temporarily stop stimulation until the pt could be seen by physician on 07/02. During this time, the pt reported that the device was still stimulating while the magnet was taped over it and the pt experienced a burning sensation at the generator site. The pt was seen by physician on 07/02 at which time the programmed parameters for the device were adjusted. This adjustment seemed to worsen the difficulty in breathing over time. On 07/02, the pt experienced an episode of difficulty in breathing and gagged, lost consciousness and had a grand mal seizure. The pt described the episode as a suffocating feeling. The magnet was again taped over the device until the pt could be seen by physician on 07/02. At office visit on 07/02, the pt's device output current was programmed to off, but magnet output current was not. After this office visit, the pt reported that when they swipe the device with the magnet, they feel stimulation for a few seconds but it makes the headache worse, eyes blurry and feel the burning sensation at the generator site. The pt's reported symptoms stopped for 2-3 days after programming the device to off, but after those few days the pt began to have neck pain on the left side, ear pain, migraines and a swelling sensation in the throat. The migraines became so bad that the pt was taken to the emergency room several times during the week of august 2002. The pt was admitted to the hosp on 08/02 and released the next day, at which time was instructed to increase the carbatrol dosage from 800mg to 1200mg qd. A few days later, the pt reportedly became delirious and weak to the point where they couldn't walk. The pt was again hospitalized on 08/02 and discharged three days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414499


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2011, 02:38:21 AM
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported that the patient铠voice issues have improved. The device was programmed back on to low settings.

Manufacturer Narrative

Event Description
It was reported that the low device settings were not tolerated by the patient. Vns removal is under consideration but has not been performed to date. The patient did not allow lower settings to be used and the device was programmed off.

Event Description
It was reported that the device was programmed on to 0. 25ma. The patient complained of pain, hoarseness, and chest pain that lasted through the weekend. The device was programmed off again on (b)(6) 2015.

Event Description
It was reported that the patient was hospitalized for vocal cord paralysis after initial vns implant. A scope was performed and confirmed vocal cord paralysis. The device has not yet been programmed on. The physician reported that the patient would be seen by and ent and that the device will not be programmed on yet. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that the vns was programmed on at low settings and the patient is tolerating them at this time.

Event Description
It was reported that an ent performed a scope and diagnosed the patient with vocal cord paresis. The patient refused steroid treatment and was discharged home. It was reported that the patient's voice has improved dramatically. The patient underwent a swallow evaluation that was normal and another ent scope identified that the patient was much improved and the vocal cord was working.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334503


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2011, 02:39:22 AM
Event Date 05/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the patient has been hospitalized for severe pain and that their heart rate increases with stimulation. The pain reportedly began approximately one week after stimulation was initiated. The pain is described as constant, but worse with stimulation. Patient's neurosurgeon indicated that the patient's pain was not related to the vns. The patient has reportedly undergone a cardiac work-up during their hospital stay that was negative. The patient reports that they have attempted to stop stimulation with the magnet, but was unsuccessful. The patient is on a duragesis patch, oxycontin and morphine pca for the pain. These treatments have been unsuccessful in relieving the patient's pain. The patient's device was explanted and the patient is no longer experiencing the pain that they had before explant. Attempts to obtain additional informaion have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=403455


Title: Re: Chest Pain
Post by: dennis100 on June 07, 2011, 12:08:26 AM
Event Date 04/25/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was experiencing severe dyspnea and in need of immediate care and that the patient's generator was malfunctioning and stimulating erratically. While taking a nap, the patient suddenly awoke feeling like they were suffocating. The patient was seen that same day by their neurologist. An ambulance was called to transport the patient from neurologist's office to the hospital emergency room. It was reported that stimulation had been initiated to lowest setting (0. 25ma output current) just four days earlier and that device diagnostic testing was within normal limits, indicating proper device function. X-rays did not reveal any obvious discontinuities in the vns therapy system. Neurologist indicated that they were not able to stop stimulation using the magnet. Both the normal mode and magnet mode output currents were programmed to off (0ma) and neurologist was considering emergency explant of the device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461874


Title: Re: Chest Pain
Post by: dennis100 on June 08, 2011, 12:41:11 AM
Model Number 102
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt's device was explanted due to infection. It was later reported that the pt's generator was explanted due to chest pain. Investigation to date has been unable to determine whether the device was explanted due to infection, chest pain or both.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522667


Title: Re: Chest Pain
Post by: dennis100 on June 13, 2011, 03:10:43 AM
Model Number 101
Event Type Malfunction
Manufacturer Narrative
Ncp system labeling lists pain, voice alteration (hoarseness) and dyspnea (difficulty breathing, shortness of breath) as potential adverse events possibly associated with surgery or stimulation.

Event Description
Treating neurologist was not able to communicate with the patient's device during recent office visit, indicating possible device malfunction. It was reported that the patient has been experiencing periodic pain around the device during stimulation and periodically losing her voice with stimulation as well as dyspnea with exertion during stimulation. The patient reports that she has experienced these symptoms before, but that they have recently worsened. The patient has previously reported pain around the generator site (aprroximately one year prior to the date of this report), at which time she refused to follow-up with a neurologist. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation has been unable to determine the cause of the reported communication difficulties as no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x1, via telephone x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=662259


Title: Re: Chest pain/Shortness of breath
Post by: dennis100 on June 13, 2011, 03:19:41 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns pt has experienced five episodes of feeling fluttering in their chest after bending over. It was reported that the episodes did not coincide with device stimulation cycles. Investigation has been unable to determine whether the events are cardiac-related and/or whether they are related to the vns therapy. No response has been received to mfr's requests for additional info from treating neurologist (via fx x2).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612586


Title: Re: Chest Pain
Post by: dennis100 on June 13, 2011, 12:54:35 PM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
A voluntary maude event report from department of health & human services was received, reporting that a pt was experiencing dyspnea and an erratic heart rate. The pt required nasal oxygen, and a cpap machine. It was also reported that the pt's parent deactivated the device by taping the magnet on the skin over the generator, which appeared to abate the issues. Follow up with the treating vns physician revealed that the pt's heart rate was low. The pt saw a cardiologist, and the cardiac work up was reportedly normal. The treating vns physician also noted that the pt was at relatively high settings for improved seizure control, but has since had the settings decreased to what appears to be a more tolerable level. The physician changed the settings as he believed the bradycardia, coughing and dyspnea were related to the vns stimulation. The pt's parents feel that the issues are too severe to keep the device on, and have deactivated the device again, and will keep it off until they are able to see the physician again to try new settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__ID=1344757


Title: Re: Chest Pain
Post by: dennis100 on June 14, 2011, 10:37:56 PM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity above pre-vns baseline frequency. It was also reported that the pt's seizure type had changed in that she has begun to experience grand mal seizures recently. There have reportedly been no medication changes that may have contributed to the reported events, but that she had recently been crushed by elevator doors. The pt reported that she has never experienced efficacy with the vns therapy. The pt also reports that she has experienced chest pain and pain shooting down her neck and back, shooting through her stomach and down her legs as well as muscle spasms in her leg. The pt was reportedly seen at a local hospital recently, at which time "the doctors there dismissed her as having the flu", although the pt maintains that she did not have the flu. Investigation to date has been unable to determine whether the pt's chest pain is cardiac related or whether it is related to the vns therapy as attempts to identify the pt's current treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=647201


Title: Re: Chest Pain
Post by: dennis100 on June 14, 2011, 10:51:51 PM
Event Date 09/30/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Further follow-up revealed that the pt is doing better with regards to all complaints since the device was programmed to off. There are no plans to program the device the device back to on at this time and the pt is scheduled for surgical consult for possible explant. The pt has been started on lamictal and will titrate up to 800mg, qd. The pt's psychiatrist indicated that the pt was seen by an ent for voice alteration, but was not diagnosed with vocal cord paralysis. Psychiatrist believes that the dyspnea and voice alteration are related to vns therapy.

Event Description
Reporter indicated that vns pt implanted for treatment of depression has experienced hoarseness (both with and without device stimulation), exacerbation of asthma, and tightness in her chest since implant surgery. Cardiac involvement has not been ruled out and the pt has not been referred to an ent for evaluation. The hoarseness has reportedly improved some over time. There have reporteldy been some medication changes during this time (specifics unk). Treating psychiatrist programmed the pt's device to off with plans to see the pt again in a month and determine if her symptoms subsided in the absence of the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=645669


Title: Re: Chest Pain
Post by: dennis100 on June 15, 2011, 03:15:01 AM
Event Date 11/27/2007
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated a vns pt is to have surgery for lead revision. Pt experienced painful stimulation in the chest, muscle twitching in the chest, and left arm pain. Normal mode diagnostic test performed before surgery was within normal conditions. No sys diagnostic test was performed since pt has not been set to the conditions necessary for the test. X-rays reviewed by the mfr did not identify any anomalies. During revision surgery, normal mode diagnostic test resulted again with normal parameters and lead pin were visualized to be fully inserted. Fluid was seen in the inner tubing of the lead and no cuts or breakages were noticed. A total revision was performed. All adverse events disappeared after new implants. Good faith attempts are being conducted for prod return.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=977110


Title: Re: Chest Pain
Post by: dennis100 on June 15, 2011, 03:23:06 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the vns patient was experiencing pain at the chest site, and a tingling sensation beginning at the chest site and propagating down the left arm. Additionally, it was reported that the patient was experiencing a "vibration feeling at the generator site. " diagnostic testing following the onset of the reported events revealed normal device function. The treating physician ordered x-rays to assess the device, and it was reported that the implanting surgeon reviewed the x-rays and "did not see anything out of the ordinary. " further information was communicated by the treating physician's office that the belief is that there is an infection present and has recommended removal of the device. Attempts to obtain additional information from the surgeon and treating physician have been made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=989370


Title: Re: Chest Pain
Post by: dennis100 on June 16, 2011, 12:56:09 AM
Event Date 12/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Vns patient has recently complained of breathing problems, increased coughing and difficulty swallowing. The patient is asthmatic. However, it is unknown whether the vns theray is exacerbating the patient's asthma. The patient reported that she has been feeling a cramping in her chest with stimulation and that the sensation causes difficulty breathing. She said the cramping last a little while after coming on intensely after stimulation. She said she had to go to the emergency room and that her psychiatrist has since programmed her device to off. The patient reports that she feels much better since the device has been programmed to off. The patient reported that the surgeon told her that current leakage from the lead may be causing her symptoms, but that he ordered x-rays to rule out pneumonia. X-rays were reportedly normal and did not reveal any obvious discontinuities in the vns therapy system. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=661231


Title: Re: Chest Pain
Post by: dennis100 on July 07, 2011, 03:11:45 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.
 
Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.
 
Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069093


Title: Re: Chest Pain
Post by: dennis100 on July 07, 2011, 03:12:26 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes and referral note were received for generator replacement. The referral form showed the reason for replacement was battery depletion. Clinic notes show the patient is concerned that his generator battery is dead because he can't feel it, but the physician explained he has been reassured on numerous occasions that this is not the case. Clinic notes show the device was interrogated and the impedance value was within normal limits. The physician documented that the vns is function adequately and that the replacement is due to battery being low. Additional information was received that the patient is experiencing pain at the generator site (unrelated to heart). No known trauma was reported. No additional relevant information has been received. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7765839


Title: Re: Chest Pain
Post by: dennis100 on July 07, 2011, 03:13:00 AM
Model Number 102
Event Date 12/01/2011
Event Type Injury
Event Description
It was reported that the patient had her generator moved to her right chest from her left chest due to pain at the generator implant site. Per physician, there is no reason to explain the pain and patient was benefiting from vns therapy, so it was decided to move the device. Diagnostics were run during surgery and everything was fine.

Event Description
Information from the treating surgeon indicated the intervention was not taken to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2406192


Title: Re: Chest Pain
Post by: dennis100 on August 25, 2011, 02:40:58 AM
Event Date 06/03/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt was experiencing chest pains "like a heart attack" that go away when they turn off the vns with the magnet and the pt's seizures have been worse lately. This has happened off and on since before 2009. The pt had brain surgery for seizures in 2009. Per pt's husband, the pt sleeps well at night with no chest pain. Pt's settings were increased by 0. 25 ma. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2156091


Title: Re: Chest pain/Shortness of breath
Post by: dennis100 on September 08, 2011, 05:32:48 AM
Model Number 102
Event Date 08/01/2010
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that a vns patient underwent generator revision due to pain. It was later confirmed that the patient's pain began at the time of implant. On (b)(6) 2011, it was reported that this vns patient had been experiencing localized pain at the generator site since implant in (b)(6) 2010. The pain was not with stimulation and was partially improved by nsaids. Both normal mode and system diagnostics were reported to be ok. It was believed that there was a local irritative or inflammatory phenomenon. The device was disabled to see if the pain would stop, but this had no effect. X-rays were taken. No lesions at the electrodes or the lead to the generator were seen. X-rays were assessed, and showed that there was no problem of pin insertion. The patient did not have any systemic signs; however, the physician assessed that the event was not bio-related as the pain was occurring for over a year but did not worsen. The patient was seen on (b)(6) 2011 and did not complain of pain since the device was disabled; however, the patient's pain was not occurring every day before the disablement. Additional x-rays were received and reviewed. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The placement of the electrodes could not be assessed due to lack of a full neck view. The presence of a strain relief bend, strain loop and tie-downs could not be assessed because of lack of a full neck and chest view. The lead could not be fully assessed. A portion of the lead was behind the generator and could not be assessed. No acute angles were observed in the assessed portions of the lead. No lead breaks were found on the visible portion of the lead. Based on the x-ray images, there was no evident cause for the reported pain. Additional follow-up showed that the patient did not experience pain post-operatively.

Manufacturer Narrative

Event Description
Additional information was received that the patient's generator was moved within the patient's chest pocket, which resolved the pain. At this date, the patient does not present with anymore pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2878641


Title: Re: Chest Pain
Post by: dennis100 on October 06, 2011, 06:23:14 AM
Event Date 07/12/2006
Event Type No Answer Provided
Patient Outcome Required Intervention;
Manufacturer Narrative
Initial mdr inadvertently listed wrong product.

Event Description
Additional information was received on (b)(6) 2011 when the implanting hospital provided the patient's generator product information. On (b)(6) 2011, the vns patient reported that a surgeon had scheduled her for breast reduction surgery on (b)(6) 2011 but that on (b)(6) 2011, the surgeon backed out of the surgery. The surgeon told the patient that he was worried that he might damage the vns device and had no assurance that insurance would replace it and could not subject the patient to seizures. The patient reported that he did not allow another colleague to review the case and stated that she should seek a university setting. The patient reported that she wants a breast reduction because there is tension on the vns device that is causing pain even after the device was moved in (b)(6) 2011.

Event Description
On (b)(6) 2011, a vns pt reported that she was experiencing painful stimulation and that it feels as though her breast is being "shocked". She said that she has had painful stimulation since the original implant on (b)(6) 2006. She had a battery replacement on (b)(6) 2011 and she is still experiencing the painful stimulation. The pt reported that the pain used to radiate down her arm but it is not as bad now. She said that the physician ran diagnostics but did not see any problems. As far as efficacy, she reported that she has not had a seizure in four years with vns. The physician's nurse later reported that the pt is having a breast reductions surgery at this time and after that procedure they are going to look into the pt's painful stimulation. The nurse reported that they were not going to provide any further information. Good faith attempts for product information from the implanting hospital were made but no information has been received to date. If additional information is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2228172


Title: Re: Chest Pain
Post by: dennis100 on October 06, 2011, 06:23:42 AM
Model Number 102
Event Date 07/25/2011
Event Type Injury
Event Description
Good faith attempts for product return have been unsuccessful to date.

Event Description
Additional information was received regarding the patient. The patient is going to be explanted and not replaced at this time. They are going to see if the pain subsides and potentially re-implant later. The pain was reported to still be present with the generator disabled. The generator had been explanted and has not been returned to the manufacturer.

Event Description
It was initially reported that the pt began experiencing pain and tightness in his chest following a mri. The pain is continuous and not related to stimulation. The physician recommended alternating disablement (2 hours on/off). The physician then disabled the pt for a week and the pain started to resolve. When the device was turned back on the pain returned immediately, so the physician turned him back off. A prophylactic replacement is planned, but has not occurred to date. (b)(6) attempts for more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245806


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2012, 08:34:19 AM
Lot Number 686260
Event Date 01/06/2012
Event Type Injury
Patient Outcome Disability;
Event Description
On the morning of (b)(6), i woke up with a shocking feeling in my head, accompanied by a migraine. When it didn't subside by monday the (b)(6), i decided to email the company that makes my vns, cyberonics. On tuesday the manager called me back and after telling him everything that was happening, he said to turn the device off and see if i still have the shocking feeling by taping my magnet to my vns for a few hours. After taping the magnet to the device, although the shocking went away, my skin started feeling like it was on fire. After removing the magnet a few hours later, the shocking feeling and migraine came back immediately, and there as a burn mark on my chest where the device is. Then on wednesday the (b)(6) i had to be taken to the hosp by ems for severe chest pains. The feeling still hasn't gone away. Frequency: on 30 sec off 1. 5 min.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2423729


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2012, 08:36:06 AM
Model Number 102
Event Date 07/25/2011
Event Type Injury
Event Description
It was reported through clinic notes received on (b)(6) 2011 that the patient was experiencing a choking sensation when she eats and trouble breathing and pain across her chest when the device stimulates. The patient indicated that she has this sensation about once a week. The patient is being scheduled for replacement because of this. The physician indicated; however that the device output and magnet mode currents are presently set to 0. 0ma. The physician indicated that the patient needed the device removed regardless of whether it was stimulating or just causing irritation. Explant is likely; however has not occurred to date.

Event Description
Additional information was received from the patient's treating neurologist indicating that the patient's device was initially programmed off in 2008 due to painful stimulation. In (b)(6) 2011, the patient first reported feeling the vns stimulate, despite being turned off. When the device was interrogated it was determined that the magnet had been left on to 1. 5ma, but diagnostics were within normal limits. The magnet mode current was disabled that day. There were no causal or contributory programming or medication changes that preceded the onset of the event. Manipulation and trauma were also no suspected. The physician indicated that the patient was still experiencing these sensations when the device was programmed off, but when the magnet was taped over the device, it helped. The patient did not experience these issues pre-vns.

Event Description
Review of available programming history revealed that the patient was disabled on (b)(6) 2007. It is unclear from the available history if the patient was re-enabled after that date.

Manufacturer Narrative

Event Description
Additional information was received that the patient had a generator and lead replacement. Product analysis was completed on the lead and still is in process for the generator. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

Event Description
Product analysis was completed on the generator. Although the negative septum appears to be split, there is no evidence of dried body fluids, corrosion in the connector block and there is no evidence of dried body fluids in the lead cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis in the pa lab determined that the generator had reached an end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414917


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2012, 08:37:06 AM
Model Number 102
Event Date 09/09/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6) 2012 a vns treating neurologist reported that the vns patient has been experiencing chest pain and voice alteration with stimulation since (b)(6), 2003. The device was disabled on (b)(6) 2003. No causal or contributory programming/medication changes preceded the onset of the events. No patient manipulation or trauma occurred. The physician stated that the device will be removed per patient request. Although surgery is likely, it has not occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2430061


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2012, 08:38:01 AM
Model Number 102
Event Date 01/05/2012
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was initially reported that the patient had painful stimulation over its chest and next that lasted for 8 minutes and occurred twice. Caregiver taped magnet over generator and after removing magnet pain was gone and the patient felt back to normal. The caregiver was concerned that the patient may have had a heart attack. The patient went to see their physician and there were no issues found. There was no reported manipulation or trauma and there are not interventions planned. Good faith attempts for product return have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2430420


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2012, 08:38:47 AM
Model Number 101
Event Date 12/09/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated via clinical notes received to the manufacturer that a vns patient had experienced a "small cardiac event" which the patient reported was a myocardial infarction. The patient has also been having intermittent episodes of chest pressure lasting one to ten minutes which have occurred five times in the last six months. The patient has not seen a cardiologist. The patient's vns generator was reported to be at end of service. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2406183


Title: Re: Chest Pain
Post by: dennis100 on March 24, 2012, 04:17:08 AM
Model


Title: Re: Chest Pain
Post by: dennis100 on April 05, 2012, 06:58:29 AM
Model Number 102
Event Date 12/02/2011
Event Type Injury
Manufacturer Narrative

Event Description
The physician reported that the patient's reported events, including pain and choking, were unrelated to vns. The physician attributes the patient's complaints to her "psychological issues. " after the device was disabled, the patient's pain and symptoms persisted. The patient also claimed that pain medications did not work either. The physician is referring the patient for explant surgery because the patient complained to administration. The physician originally did not want to remove the patient's vns, but the patient persisted that she wanted it explanted. As such, the patient is being referred for vns explant surgery, but it has not occurred to date. The physician clarified that this is not being done to preclude a serious injury.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the age incorrectly.

Event Description
It was reported that a vns patient wanted her device explanted due to constant pain in the left chest that spreads to the legs and right side of the body. The company representative reported that in clinic notes dated (b)(6) 2011, the patient was complaining of several months of left arm pain, chest pain, and a choking sensation which she attributes to vns. The patient's vns had since been turned off the previous month by neurologist. However, the patient still complained of left chest pain and arm pain. Diagnostics were reportedly not performed because the patient cannot tolerate 1. 0ma. Attempts for additional information have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Product analysis for the generator and lead was completed. The pulse generator diagnostics were as expected for the programmed parameters. The near end of service flag was set, n eos = yes. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. During visual analysis, it was noted that the septum was cored and evidence of body fluid remnants were observed in the header septum cavity. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaint.

Event Description
It was reported that the patient had her generator and lead explanted on (b)(6) 2012, due to the patient requesting for the device to be removed. No replacement was implanted at this time. The explanted products were received for analysis by the manufacturer, however it has not been completed to date. The return product form indicated that the products were explanted due to the patient wanting it out due to left chest and arm pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488371


Title: Re: Chest Pain
Post by: dennis100 on April 05, 2012, 06:59:50 AM
Model Number 102
Event Date 02/23/2012
Event Type  Injury  
Patient Outcome  Required Intervention;
Manufacturer Narrative

Event Description
Reporter indicated a patient was to have the vns generator and possibly the lead explanted and not replaced due to patient reports of constant pain in the left upper chest and neck. The surgery was to have taken place on (b)(6) 2012, but this has not been confirmed. Attempts for further information are in progress.
 
Event Description
All attempts to the reporter for additional information and if explant of the vns occurred have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2498646



Title: Re: Chest Pain
Post by: dennis100 on May 05, 2012, 01:37:49 PM
Model Number 101
Event Date 01/01/2003
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info from treating neurologist have been unsuccessful to date. H. 6. Method: ncp system labeling lists pain, insomnia, tooth pain, dyspnea, choking sensation and increased coughing as potential adverse events possibly associated with surgery or stimulation.
 
Event Description
Reporter indicated that pt was experiencing decreased sleep, chest pain, severe tooth pain that prevents pt from sleeping and choking/dyspnea with stimulation. It was reported that the pt's neurologist had decreased device settings several times but that the pt has had little relief from the above symptoms. Further follow-up revealed that the pt was hospitalized during the first week of march 2003 due to dilantin toxicity and that the pt was having coughing with stimulation. Device settings were decreased while the pt was in the emergency room. The pt reports that pt told neurologist at their last office visit when device settings were increased that pt could not tolerate the device settings, but the neurologist would reportedly not decrease the settings at that time. The pt reports that now that device settings have been decreased pt has no side effects and is starting to have less seizures. Investigation to date has been unable to determine the severity of the reported adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448084


Title: Re: Chest Pain
Post by: dennis100 on June 08, 2012, 08:08:18 AM
Model Number 102
Event Date 04/16/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was initially reported that a vns patient was referred for replacement surgery due to unknown reason. Additional information was received in the form of clinic notes indicating the patient was referred for generator replacement surgery due to patient complaining of chest pain in the generator area. The event was first noticed when the patient lost weight and now the treating physician decided to replace the generator based on implant age and pain due to pressure of the implant in the chest area. Moreover information from the area representative indicated the patient underwent generator replacement surgery as scheduled and the device was discarded after surgery. Good faith attempts to obtain further information from the patient's treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2566907


Title: Re: Chest Pain
Post by: dennis100 on June 08, 2012, 08:08:50 AM
Model


Title: Re: Chest Pain
Post by: dennis100 on June 08, 2012, 08:09:18 AM
Model Number 102
Event Date 11/15/2012
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2012. The notes indicate that the patient¿s device was not operational. Notes dated (b)(6) 2013 stated that the patient was considering explanting his device because he was experiencing some persistent irritation around the generator site in his upper chest. Additional information was received stating that the patient has been referred for explant surgery. No known interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. A battery life calculation using the available programming history showed 9. 5 years remaining until eri=yes. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717248


Title: Re: Chest Pain
Post by: dennis100 on July 24, 2012, 04:28:58 AM
Model Number 102
Event Date 08/01/2006
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Initial reporter indicated that the pt was having side effects with their vns therapy. It was reported they felt an "inability to breathe, hard to swallow and weight on chest. " programming changes were attempted and later the pt had their vns programmed off. The pt has now decided to have their vns removed since it is programmed off and they "don't like feeling the implant. " good faith attempts are being made for add'l information surrounding the reported events and product return for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=975409


Title: Re: Chest Pain
Post by: dennis100 on July 24, 2012, 04:38:38 AM
Model Number 102
Event Date 12/01/2007
Event Type  Malfunction  
Event Description
It was reported to mfr that the vns pt was being seen by the treating physician for painful stimulation in the chest at the generator site. A normal mode test was performed and revealed high lead impedance with the end of service indicator set to no. X-rays were sent to mfr for review, and there were no obvious anomalies observed on the x-rays that could be contributing to the reported events. No other adverse events were reported. There was no report of trauma, manipulation or any other believed cause provided by the physician. A worst case scenario battery life calculation was performed with the provided settings and the result did not indicate that the generator is near end of service. The physician has turned the device off. The pt has a surgical consult scheduled and revision surgery is likely.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no obvious anomalies visualized. Device failure is suspected, but did not cause or contribute to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=976431


Title: Re: Chest Pain
Post by: dennis100 on July 25, 2012, 11:46:13 AM
Model Number 102
Event Date 12/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Initial rptr indicated that the pt was seen in the er due to chest pain. Reported "started with persistent chest pain about 2 mos ago, prior to her last study visit in 2008. She also started with more intense localized stomach pain and nausea about the same time - she pointed to an area just below her sternum. " the pt has been prescribed medication for her stomach pain. The pt's "eeg and stress test and other heart-related tests have been within normal limits. " reported she had 2 heart scans the 2nd one "showed something". The pt immediately had an angiogram which was negative. Her chest pain is reported to be worse with stimulation and she also has the sensation of a lump in her throat with stimulation. Additionally reported the sensation of wheezing progressing from throat to her chest, with stimulation and has difficulty swallowing when stimulation is on. Since she has been experiencing these events she has been having difficulty sleeping. The vns was disabled for a week to see if the events would resolve. The pt saw a cardiologist and her heart testing was within normal limits. The cardiologist, therefore, concluded that the pt's symptoms must be caused by the vns stimulation. It was reported the pt did not want to consider an adjustment of parameters at this time, and she is considering having the device explanted. Her symptoms/side effects resolved when the device was turned off. The pt is unstable mentally at this time and she is voluntarily being admitted for psychiatric care. The pt's mental state is not over her pre vns events of depression, but being increased by the vns side effect issues she is having. No date set at this time for the pt to have their vns explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1030178


Title: Re: Chest Pain
Post by: dennis100 on July 25, 2012, 08:33:13 PM
Model Number 101
Event Date 10/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Initial reporter indicated that the pt was having an increase in seizure activity, below pre-vns baseline, normal stimulation was not being perceived, and the pt reported pain in the chest area. The cause of chest pain / increased seizures is unknown. No device issues are suspected to have contributed to pt's stimulation not perceived event. All diagnostic testing was within normal limits and the generator was not at or nearing end of battery life. It is likely that the pt accommodated to normal mode settings as the patient was able to feel magnet mode stimulation. The pt had a prophylactic generator replacement. It was additionally reported from the explanting hosp that it was replaced for pain and migration. The migration was not confirmed from the surgeon who did the procedure. Good faith attempts have been made for product return and additional info about the events. No further info has been attained. X-rays reviewed by mfr prior to surgery did not show any anomalies or gross lead fractures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1040264


Title: Re: Chest Pain
Post by: dennis100 on July 25, 2012, 08:40:22 PM
Model Number 102
Event Date 01/01/2008
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported to manufacturer that the vns patient "with problems will be scheduled for exploratory surgery". Further follow up with the treating physician revealed that the plan is to explant the generator due to chest pain at the generator site. The device was disabled "some time ago" and the pain persisted and became intolerable for the pt. The surgeon indicated that the device is placed in the left pectoralis region and the pain is likely due to generator placement, with a psychosomatic component. The surgeon does not plan to explant the leads in case the pt opts to be re-implanted in the future. The treating physician stated that the device had been checked and was always found to be functioning well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1040548


Title: Re: Chest Pain
Post by: dennis100 on July 25, 2012, 08:46:03 PM
Model Number 302-20
Event Date 04/01/2008
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that a vns pt was experiencing chest pain, and diagnostic testing resulted in high lead impedance at a followup office visit. No pt trauma or manipulation was reported other than a grand mal two weeks prior to the discovery of high impedance. The patient's vns device has been programmed off, and revision surgery is likely. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1054862


Title: Re: Chest Pain
Post by: dennis100 on July 25, 2012, 08:57:19 PM
Model Number 102
Event Date 04/30/2008
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated a vns pt was "admitted to the er in 2008, for chest pain and severe sinus bradycardia. She has a history of chest pain due to mitral valve prolapse, irregular heartbeat and episodes of bradycardia. See attached medical records. " good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1059682


Title: Re: Chest pain/Shortness of breath
Post by: dennis100 on August 10, 2012, 07:15:38 AM
Model Number 302-20
Event Date 06/28/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported by the neurosurgeon's office that the patient came into the clinic on (b)(6) 2012 complaining of sharp pains in the chest and neck that occur about three to four times per week. The surgeon thought it may be related to the vns lead at the time. The patient was scheduled for generator replacement with possible lead replacement at that time. X-rays were taken of the patient's vns system for review by the manufacturer. Film a/p and lateral views of the neck and chest were received and reviewed on (b)(6) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact and the connector pin appeared past the connector block. The lead was routed upwards to the left side of the neck. The lead wires appeared to be twisted and kinked in the chest area which formed sharp angles in the lead wire. No lead discontinuities were seen in the visible portions of the lead. Based on the x-ray images provided, there is no clear cause for the patient's pain in the chest and neck. However, it may be likely that the twisted and kinked lead wires in the chest are a result of patient manipulation which may be causing the pain. A micro-fracture that cannot be seen in the images provided or a break in the portion of the lead which could not be assessed cannot be ruled out as a casual factor. Attempts for additional information from the treating ent and neurosurgeon have been unsuccessful to date. The patient had surgery on (b)(6) 2012, however attempts for return of the generator and lead have been unsuccessful to date.
 
Event Description
The company representative followed up with the replacement facility, however the patient's explanted generator and lead were not available for return to the manufacturer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2662955



Title: Re: Chest Pain
Post by: dennis100 on September 07, 2012, 08:42:39 AM
Model Number 103
Event Date 07/27/2012
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was reported that a patient in (b)(6) who was implanted two months ago is presenting with an abnormal electrocardiogram. The patient was going to be followed by a cardiologist. The patient also had complaints of chest pain and she has a history of cardiac problems. Their chest pain was determined to not be vns related. Further investigation is underway in regards to their abnormal electrocardiogram.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713440


Title: Re: Chest Pain
Post by: dennis100 on October 05, 2012, 03:42:41 AM
Model


Title: Re: Chest Pain
Post by: dennis100 on October 05, 2012, 03:43:04 AM
Model Number 102
Event Date 12/12/2006
Event Type  Injury  
Patient Outcome  Required Intervention  
Event Description  
It was reported that the patient had her vns explanted on (b)(6) 2012 when it was originally believed that she would be getting a replacement surgery on that date. Follow up confirmed that a replacement system was not implanted. It was mentioned that the generator may have been at end of service and that the patient did not believe the device was helping her. Product analysis on the generator was completed on (b)(6) 2012. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications and no anomalies were found. Product analysis on the lead was completed on (b)(4) 2012. The lead connector had detachment at the ring/backfill interface. Both the positive and the negative coil were retracted against the connector ring assembly and in contact inside the connector boot resulting in a short circuit condition. Based on the appearance of the lead, it is believed that this condition was most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. On (b)(6) 2012 a vns implanting surgeon reported that the patient came to him to get her vns removed because it had already been determined by her neurologists that the device was not working and she did not want to go to her previous surgeon. Per the surgeon, the patient also expressed that the device was giving her pain. It was reported that the patient began having pain at the site of the vns immediately after her initial surgery and that the pain radiated to her left hand as well. This occurred 24/7 and affected how the patient sat, moved, and performed day to day activities. The pain was described as a "shocking"; sensation involving the arm and the shoulder. The patient notes that she cannot hold a coffee cup or wash dishes because she has "charley horses"; of the neck along the course of the vns wire. The patient also stated that she cannot turn her neck because it feels "squeezed tight"; and her whole chest tightens up. Per the surgeon, the neurologist had turned off the vns three months prior, however despite the shocking component of the pain becoming less often; she still had a frequent pain. During the time the vns was working, the patient did not recall the pain occurring solely during stimulation time, and the seizures did not increase once the device was turned off. The surgeon was unsure if the patient's symptoms could be explained based on the vagus nerve stimulator. He indicated that there are no nerves that go from the area of the vagus nerve or the left subcutaneous anterior chest to the left hand, so he could not explain most of the patient's symptoms based on the presence of the device. In addition, the fact that the symptoms persisted even when the device was turned off was additional evidence that the patient's current symptoms were not caused by the device and that removal of the device would not make her symptoms go away. On the other hand, the patient was quite clear that her symptoms began immediately after implantation of the device, so the surgeon explained that it was possible that the surgery to implant the device could have triggered the onset of symptoms. Follow up was performed with the neurologist, however, they stated that he had not seen the patient since (b)(6) 2011 and had no information on the patient.
 
Manufacturer Narrative  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2763658


Title: Re: Chest Pain
Post by: dennis100 on October 05, 2012, 03:43:32 AM
Model Number 105
Event Date 08/13/2012
Event Type  Injury    
Event Description  
A school nurse reported that she has a vns patient who has been experiencing pain in his chest at the generator site and also in his lower arm/hand on the left side. This pain has been constant for the past 2 weeks according to the reporter. In addition to this, the nurse reported that the lead is protruding in the neck, and the generator site has opened. Thus far no further information has been attained.
 
Manufacturer Narrative  
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2756656


Title: Re: Chest Pain
Post by: dennis100 on November 12, 2012, 02:06:08 PM
Model Number 103
Event Date 09/01/2012
Event Type  Injury   
Event Description
It was initially reported that he patient was referred for surgery on (b)(6) 2013 due to an unknown reason. Later, clinic notes dated (b)(6) 2013 were received which reported that the patient continued to complain of pain in the left breast at the generator site as she had for some time. When she rolls over onto her left side at night it causes a lot of pain and discomfort at the generator area. It is alleviated when she rolls onto her back or onto her right side, per the clinic notes. However, the pain had recently increased and became more intolerable. She reported mild discomfort when palpating the tissue around the device with no signs or symptoms of infection. Therefore, the patient was referred for surgical consult regarding moving the generator closer to the left axillary area. The device was interrogated with no indication of device malfunction. No parameters settings were adjusted at that time. Follow up with the treating nurse revealed that the pain began over 6 months ago, and surgery is being taken to preclude a serious injury. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the pain. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Event Description
Product analysis of the generator was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
The manufacturer's clinical specialist reported that the patient had generator replacement on (b)(6) 2013. The explanted device was received by the manufacturer for analysis on (b)(6) 2013. However, product analysis has not been completed to date. The return product form indicated the reason for replacement as prophylactic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3053807


Title: Re: Chest Pain
Post by: dennis100 on November 12, 2012, 02:07:18 PM
Model Number 103
Event Date 09/12/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the physician reported that the pain was first observed on (b)(6) 2012. The patient had complained to her mother that she felt a sharp sensation in the chest and the pain traveled around the chest and up to the neck for a few hours. The mother called the physician's office and was instructed to tape the magnet over the patient's device. The patient had a similar sensation in (b)(6) 2011, but the patient did not inform the physician of the pain. The patient was unable to tell the physician accurately if the pain was constant or with stimulation. The patient was seen in clinic on (b)(6) 2012, where the device was checked and the patient's settings were noted to be output=1. 75ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=1. 1/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. Diagnostics were performed which showed output=ok/lead impedance=ok/impedance value=1729ohms/eri=no. There were no medication changes or programming changes prior to the pain and no manipulation or trauma to the device. The patient's pain had resolved on (b)(6) 2012 and therefore the device was left on. However, on (b)(6) 2012, the pain returned and therefore the mother placed the magnet over the device and the patient was evaluated by neurosurgery department in the emergency room. The neurosurgeon on call felt that this was not an emergent situation and the device was disabled on (b)(6) 2012. Additional information was received on (b)(6) 2012, when it was reported that the surgeon decided to do a full revision surgery on the patient that day due to the patient's complaints of shocking. The surgeon completely removed the lead and took x-rays to confirm that there was no remaining lead. A system diagnostics test performed in the or showed output=ok/lead impedance=ok/impedance value=1312ohms/eri=no with the new vns system. The explanted products could not be returned for product analysis as the hospital does not return explanted products.

Manufacturer Narrative
Date of event; corrected data: inadvertently did not update the event date from the information that was reported on the follow-up report #1. If implanted, give date; corrected data: inadvertently listed incorrect implant date on initial report.

Event Description
On (b)(6) 2012, it was reported that the vns patient had his device turned off as he was experiencing discomfort and a "shock". The physician reported that system diagnostics were ok and the battery is not at end of service. The patient began to have more myoclonic and atomic seizures since the vns was turned off. The patient has been referred for battery replacement. Good faith attempts for further information were made to the physician but were unsuccessful. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784931


Title: Re: Chest pain/Shortness of breath
Post by: dennis100 on November 12, 2012, 02:08:19 PM
Model Number 103
Event Date 12/24/2014
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Adverse event and/or product problem; corrected data. Supplemental mdr #01 inadvertently did not update this field with the additional information that was received. This report is being submitted to correct this data. Outcomes attributed to adverse event; corrected data. Supplemental mdr #01 inadvertently did not update this field with the additional information that was received. This report is being submitted to correct this data.

Event Description
It was reported that the vns patient experienced a shocking sensation in his chest that lasted approximately five minutes after walking through a metal detector. The shocking sensation occurred later once more but otherwise the patient was not having any pain. It did not occur during normal stimulation on-times. Follow-up revealed that the patient was unable to tolerate stimulation on-times from his device even at low device settings and was experiencing pain in his chest. No further information relevant to the event has been received to date.

Event Description
Follow-up with the physician¿s office revealed that the patient was seen in (b)(6) 2015 following generator replacement surgery. The patient was doing well and no issues were noted.

Event Description
Additional information was received stating that the vns patient was referred for surgery. The patient underwent generator replacement surgery on (b)(6) 2015. Preoperative and postoperative diagnostic results showed normal device function. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description
Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The septum was cored but no bodily fluid remnants were observed in the header septum cavity. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430571


Title: Re: Chest Pain
Post by: dennis100 on February 03, 2013, 09:06:58 AM
Model Number 101
Event Date 11/27/2012
Event Type Injury
Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. The explanted generator has been returned and is pending analysis. All attempts to the reporter for additional information regarding the pain event have been unsuccessful to date.

Manufacturer Narrative

Event Description
Reporter indicated on (b)(6) 2012 that a patient was experiencing constant pain in her chest at the vns generator site. The pain was not occurring with vns stimulation. The area is tender to the touch and causes left arm pain to the point that the patient cannot sleep or lay on her side. The patient was seen last by the reporter on (b)(6) 2012, and vns diagnostics results were within normal limits. The patient has been scheduled for prophylactic replacement of the vns generator due to length of implant (>11 years). Attempts for additional information are in progress.

Event Description
Analysis of the vns generator was completed. Proper functionality of the pulse generator and its ability to provide appropriate programmed output currents was verified. The septa do not appear cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas; thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

Event Description
Reporter indicated the patient had no trauma, and did not manipulate the vns. The pain was attributed to the "vns battery dying". The patient was "tapering herself off" of vns with vns setting changes. The generator was replaced as an intervention for the pain, and for the patient's comfort and not to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887407


Title: Re: Chest Pain
Post by: dennis100 on February 03, 2013, 09:07:33 AM
Model Number 102
Event Date 10/09/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
A health history form dated (b)(6) 2012 indicated that the patient has or had the following symptoms within the past year: irregular heart beat, rapid heart, and fainting. The relationship to these events and vns was not indicated. Of note, the patient also has a history of high blood pressure, high cholesterol and chest pain. It is unknown what interventions have been taken. Attempts for additional information have been unsuccessful to date. The form also indicated the patient has or had cancer within the past year, as reported in mfg report number: 1644487-2012-03443.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883404


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2013, 10:37:28 AM
Model Number 103
Event Date 09/19/2012
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
It was reported by the physician that the vns patient was complaining of 'heart racing' and 'chest pain' over the past two weeks. The physician ordered a holter monitor to confirm if an arrhythmia was present. The relationship of the events to vns is unknown. Last known diagnostics were taken on (b)(6) 2010 and were normal. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that a faxed response was received from the physician. None of the questions were addressed but clinic notes were attached. In the clinic notes it reported that the patient had central apnea and obstructive sleep apnea. Additional follow-up indicated that it was unknown if the apneas were related to vns. The patient has vns placed prior to the sleep study that resulted in the formal diagnosis of the apnea but the patient has had a history of snoring and sleep disturbances prior to vns and is suspected that the patient has apnea prior to vns. The patient had large tonsils that contributed to obstructive component of the apnea and once those were removed her "scores" got better.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2817908


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2013, 10:38:25 AM
Model Number 102
Event Date 10/05/2013
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visits with the epileptologist and neurosurgeon. The patient was seen by the epileptologist on (b)(6) 2013 (approximately 2 weeks following the initial vns implant surgery) indicating that, according to the patient, the implant surgery went well without complication. However, the patient began experiencing severe pain around the generator surgical site a few days prior to the office visit. The patient did not report any discharges from either surgical site and did not have a fever at the time. The epileptologist noted that the neck wound was healing well and that the patient had no systemic signs of infection; however, he was worried that the local tenderness and swelling could be indicative of a local infection. The patient had a follow-up appointment with the neurosurgeon that same day, so the epileptologist did not have the patient¿s device programmed on until further evaluation was performed. The patient subsequently had surgery where the device was explanted due to an infection in (b)(6) 2013. Following explant, the patient spent the next four (4) weeks in the icu getting treatment for the infection. In addition, the surgeon had reported that the device was explanted because aspiration of a pocket of redness was found to be infected, and noted that the patient did not have any further complications with infection following explant surgery. The epileptologist advised the patient to re-implant the vns device during the office visit on (b)(6) 2014. Additional information was received stating that the vns patient underwent surgery where a new vns device was implanted on (b)(6) 2014.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.
 
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr indicated an event date of (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this information.
 
Event Description
On (b)(6) 2013, the physician reported that the patient's vns device needed to be completely explanted on (b)(6) 2013 due to an extreme infection. The patient's vns was originally implanted on (b)(6). The patient is being treated with antibiotics and will be scheduled for a new implant once the infection clears up. The infection site was primarily in the chest where the generator was placed, but it did slowly travel up to the neck, which is why a full vns explant was needed. Attempts will be made for additional information. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3481400


Title: Re: Chest Pain
Post by: dennis100 on February 08, 2013, 07:44:49 AM
Model Number 103
Event Date 08/09/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient was having a significant drop in heart rate with every stimulation; 90 beats per minute (bpm) to 45 bpm. The patient's off time was temporarily lowered to 1. 1 minutes to see if the drop in heart rate could be timed. The company representative was at the appointment with the cardiologist when this was confirmed. It was unclear how long this has been occurring, but the patient had been reporting he was very tired. The cardiologist informed the patient that he needed to go back and see his neurologist to determine how to proceed. That patient has seen a dramatic improvement in seizure frequency, so they do not want to discontinue therapy. It was suggested that the physician's try to see if the heart rate issues have corresponded with any increased settings or medication changes.

Event Description
The surgeon had also noted that the patient had lightheadedness and feels ill when the vns stimulates and causes bradycardia. It was noted the vns had impedance values within normal limits and that the neurologist does believe the bradycardia is due to vns as the bradycardia improved slightly when the parameters were adjusted; however, the patient had an increase in seizures due to the decreased vns therapy. The increase in seizures was still noted to be below pre-vns baseline levels. It was explained that the patient was unable to tolerate and increase in output current as she was having pain in her chest and coughing with stimulation. The settings were adjusted due to the reported pain and coughing.

Event Description
It was later reported the patient's vns frequency setting was reduced to 25hz and the pulse width was reduced to 130 usec. It was noted the patient's bradycardia improved. Instead of dropping into the 40 beats per minute range, her heart rate dropped to 60 beats per minute. However, the patient did have an increase in seizures due to the reduced settings. Due to the increased seizures, the vns settings were increased again, but the patient was unable to tolerate the increase. The current was reduced to what it was previously, and the patient still could not tolerate and began having chest pains. Clinic notes from the physician were later received, further describing the events and the adjustments listed above. Additionally, it was noted the patient's heart rate actually dropped into the 20-40 beats per minute range. Additionally, clinic notes from the surgeon were received and the surgeon discussed how the electrode array of the vns lead was already placed high on the patient's nerve, and he did not believe he would be able to place the lead any higher. The surgeon did not feel it was in the patient's best interest to undergo surgery at this time, as he felt he could not place the electrodes higher, so he suggested a pacemaker. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Describe event or problem; corrected data: "the surgeon had also noted that the patient had lightheadedness and feels ill when the vns stimulates and causes bradycardia. " this information was inadvertently left off of the supplemental #01 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5931921


Title: Re: Chest Pain
Post by: dennis100 on February 08, 2013, 07:45:15 AM
Model Number 102
Event Date 10/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
A physician reported that one of his patient's was having pain at the vns generator pocket located in the patient's chest for the past three weeks prior to the appointment on (b)(6) 2012 and that this pain has been progressively worsening. There was no known trauma, repetitive movements, and the physician did not feel like the vns device has moved. The pain is said to occur continuously and did not resolve when the device was programmed off. Per the physician, device diagnostics were performed and the results were within normal limits however the specific diagnostic results were not available at the time of the initial report. On (b)(6) 2012 it was reported that the patient had been seen again and the vns device would be replaced due to the pain at the generator site. The cause of the pain was unknown however the physician felt it could possibly be due to patient growth since the device was initially implanted. Clinic notes were received on (b)(6) 2012 from an office visit on (b)(6) 2012 where it was reported that the surgeon believed the vns generator has moved. The patient was prescribed 600 mg of ibuprofen for the pain however if the pain did not improve, the device would be replaced. Follow up with the surgeon's office revealed that a non-absorbable suture was used to secure the generator to the fascia. (b)(4) attempts to obtain additional information have been unsuccessful to date however the patient is scheduled for surgery however it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2895337


Title: Re: Chest Pain
Post by: dennis100 on February 08, 2013, 07:45:46 AM
Model Number 102
Event Date 07/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's prophylactic generator replacement, which indicated that the patient had no seizures since last seen in (b)(6) 2012. However, patient "has noted some intermittent little sharp stabbing pains sometimes associated with movement, not clearly associated with discharge of the unit, which is still going off, but she is 8 years out this month for placement and may need a replacement of her generator. " interrogation was performed on this date which confirmed the vns settings were unchanged from (b)(6) 2012, and device diagnostics showed no changes and were within normal limits. Device showed it was not at end of service. The patient was referred for surgical consult to assess whether she needed a prophylactic replacement generator and leads, as it was "that time. " the physician also noted that there are "possible adhesions in the vns generator pocket causing position related movement pain in the generator versus possible subclinical premature discharge of the unit because of end of service," as it has been implanted for eight years. Attempts for additional information from the treating physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
A letter was received from the treating physician in response to the follow-up on (b)(6) 2013. In relation to the patient's pain, she provided the physician a history of pain developing approximately 6 months prior to january. She describes it as being located in the left chest, predominantly around and below the generator device with a lesser degree of discomfort within the neck region of the attachment to the vagal nerve and less so within the left temporal parietal region of the head. The patient initially had reported some transient discomfort on the right side, but that has dissipated and is now predominantly in the left side. The patient has had plans for evaluation for replacement of the generator based on the timeframe involved for the placement of the generator, but has also undergone chest x-ray and lead integrity x-rays, the results of which are still pending. However, she is undergoing plans for pre-operative evaluation for replacement. Per the physician, these plans of course were not done to preclude a serious injury, as he doubts that there would be unless her seizures increase tremendously, which they have thus not done. For patient comfort, he believes these plans were necessary. The outcome of many of these tests for the patient's symptomatology are pending. The physician does not believe that there were any programming or medication changes that preceded the onset of pain based his my records, and there was no known manipulation or trauma that occurred that both the patient and physician are aware of that would contribute to her pain. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the date of the event and therefore the patient's age at the time of the event incorrectly based on the additional information received from the physician. Date of event, corrected data: the initial report inadvertently reported the date of the event incorrectly based on the additional information received from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2921077


Title: Re: Chest Pain
Post by: dennis100 on March 08, 2013, 12:57:09 PM
Model Number 103
Event Date 09/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
A vns patient's husband reported on (b)(6) 2012 that the patient's chest pain which has been present prior to vns implant has gotten stronger since (b)(6) 2012. The pain is described as going down the center of her chest and curving under her left breast. The pain is not associated with stimulation but is also not constant. The husband reported that the neurologist turned up the patient's settings at the last appointment to which the patient could not tolerate. As a result, the physician increased the patient's duty cycle, but he feels the patient's settings are really high. The husband also explained has noticed his wife has shortness of breath when the device is stimulating. She is only able to do very little activity and gets very tired and fatigued easily. Of note, he also reported that the patient has received great benefit from her vns since implant in (b)(6) 2011. Follow-up with the treating neurologist was performed. The patient had a follow-up appointment on (b)(6) 2012, and the output currents were decreased (from 2. 0ma/2. 25ma to 1. 75ma/2. 0ma). The physician states that the relationship of the chest pain, shortness of breath and fatigue is unknown. The patient did not complain of shortness of breath on the (b)(6) 2012 visit. It was noted that if the fatigue is related, but the patient suffers from chronic fatigue and appears depressed due to family stress. It is unknown if there were any causal or contributory programming or medication changes precede the onset of the events. The patient does not have a history of shortness of breath prior to vns implant. The physician later reported on (b)(6) 2013 that the patient continues to have shortness of breath with exertion since about september/october. The physician lowered the output current to see if it improved the shortness of breath, but it has not to date. She has recently increased the duty cycle from 1. 8min off, but there was no noted change in shortness of breath. The patient has been evaluated by a pulmonologist, which did not show any issues with her lungs. The patient has had on-going chest pains, even prior to vns and not related to the stimulation on-times, so she is being evaluated by a cardiologist. It was also indicated that the patient is having issues even with normal low impact daily activities. The physician recommended to the patient to tape the magnet over the generator to see if the device disablement helps resolve the issues. Of note, the physician indicated that the patient does have some anxieties, so there could be some exaggeration of issues by the patient. Additional follow-up was performed with the physician on (b)(6) 2013. She reported that she is not "absolutely sure" if the patient exhibited these symptoms (shortness of breath) prior to vns implant. However, she did think the shortness of breath may be worse with vns; it is not just with exertion but it is constant. Of note, the patient is reported to be anxious, so the physician has difficulty determining the severity of the patient's reports. The patient is having a cardiac cath, sleep study and possibly a few other studies done but there are no results and/or diagnosis as of yet. The physician continued to report that the patient asks if there could be anything wrong with the vns therapy system, but she is anxious. X-rays were taken of the vns system but did not show any anomalies. The physician indicated that since they did not show anything, they will not be mailed for review. The physician confirmed that the "machine is fine. " no device deficiencies are suspected. The patient still feels stimulation. The physician notes that she could rapid cycle more if she wants to, but she does not want to change anything until the tests come back. Everything is reportedly fine as far as seizures/headaches. The patient experienced increased seizures in (b)(6) 2012 that are not believed to be related to vns therapy. The patient is more comfortable as far as clinical symptoms recently, except she cannot stand long to do dishes, laundry, etc. The physician instructed the patient to do all activities normally to see if the disabled device by use of the vns magnet helps resolve symptoms. No additional information has been provided to date, but the physician reported she will report new information when it is available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950858


Title: Re: Chest Pain
Post by: dennis100 on March 08, 2013, 12:57:50 PM
Model Number 302-20
Event Date 01/09/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns treating neurologist reported to the manufacturer's consultant that the vns patient was experiencing a 'tightness" in her neck and that over the weekend the patient's range of motion decreased and she could only turn her head about 10% in either direction. There is no pain with stimulation and the range of motion is independent of stimulation. Over the weekend, the patient also experienced a seizure and went to the emergency room. It took the patient a few days to recover. It was reported that the patient does not take her medications on a regular basis and she has a stressful lifestyle. On the friday before the weekend, (b)(6) 2012, the physician increased the patient's settings from an output of 1. 5ma to 1. 75ma. The patient remained in the office for 10-15 minutes following the programming change and reported that she was tolerating the increase. The patient was also observed on friday for her report that she had a clicking noise in her throat, however, no clicking occurred during the clinical visit and it lasted for 45 minutes. The patient reported that she had experienced two episodes of clicking in the front of her throat during stimulation. She stated that the clicking lasted for 30-60 seconds and the episodes were two weeks apart. There was no discomfort associated with this. The patient stated that the previous weekend, she also had a breakthrough seizure on (b)(6) 2012. The patient self-medicated with dilantin which elevated her dilantin level. Previously it had been six weeks since she had a seizure. The patient further stated that her husband is not using the recommended magnet swipe technique for her seizures. The husband was reported to be holding the magnet over the chest during the entire seizure, which disables stimulation, and then moved it away when the seizure stops. This then results in an uncomfortable strong stimulation after the seizure. Additional information has been requested but no further information has been received from the physician to date.
 
Manufacturer Narrative

Event Description
Further reports regarding this patient's increased seizures with the suspect generator were received and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.
 
Event Description
Additional information was received on (b)(6) 2012 when the patient stated that her throat hurt with stimulation the night before but not as much in this morning. The patient said the magnet swipes help with seizures, but sometimes her husband swipes the magnet when she is coming out of a seizure and she can't tell him not to, and then it hurts. The patient was seen by the neurologist on (b)(6) 2012 and the vns device was interrogated and system diagnostics were performed which showed results within normal limits; lead impedance=ok/dcdc=2. The patient's generator was programmed to output=1. 5ma/frequency=30hz/pulse width=250usec/on time=7sec/off time=0. 3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. During the final interrogation, the patient appeared to have an absence seizure then coughed and said she was having pain at the generator site. During the seizure, the magnet had been swiped. The generator was then programmed off, both in normal and magnet mode. The neurologist stated that he is going to leave the generator off until a 3 day video eeg can be done. On (b)(6) 2012, the patient reported that she is 2 days into the ambulatory monitoring and says she has had nocturnal seizures and migraines while monitored, but these are better tolerated without vns; she stated that vns gives her after effects like pain. The patient said she has discomfort above the generator randomly for 20-30 minutes at a time which is the same as before vns was turned off. The patient was seen for a follow-up visit on (b)(6) 2012 and the physician stated that he believes the patient's pain and "tightness" or limited range of movement, are psychiatric in nature and not related to vns. The physician turned the patient's device back on and the patient will not be seen again for another month.
 
Event Description
The patient called and was crying and upset. Frustrated that she cannot tolerate the increases to her device. She is depressed because she has not been able to return to her former level of functioning prior to her re-implant last year. The patient's treating physician is aware of the patient's issues tolerating their stimulation and an appointment was going to be made for the patient to be seen for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2461478


Title: Re: Chest Pain
Post by: dennis100 on April 06, 2013, 05:16:15 AM
Model Number 304-20
Event Date 04/15/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was being referred for generator replacement surgery due to an unknown reason. Further clarification was provided stating that the patient was being referred for generator replacement due to the impedance being on the "higher end". The event date provided is the date that the impedance value on the "higher end" was noted. Diagnostics were performed and showed that the impedance values were at higher values, but not values considered high impedance by the manufacturer. After device explant, the implant card was received stating that a full replacement was done and the reason for the lead explant was lead discontinuity and an adverse event. Post-op impedance values were reportedly within normal limits. The lead has been returned to manufacturer, but product analysis has not been completed to date. The implant card received by the manufacturer also indicated that an adverse event occurred which was part of the reason for device explant. No further relevant information has been received to date.
 
Event Description
It was reported that the patient had a diagnostic run before replacement which showed impedance values within normal limits. The patient had reportedly dropped a weight on his chest and was experiencing painful stimulation in his chest after that occurred at output currents greater than 1ma. High impedance was reportedly never found. The explanted lead and generator were returned for product analysis. The explanted lead was returned in 1 piece and product analysis was completed on 07/25/2016. The connector pin contained two sets of screw marks providing evidence that proper contact between the setscrew and connector pin existed at least once. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The explanted generator was analyzed and showed that the generator exhibited proper functionality in its ability to provide appropriate programmed output currents. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data from the pulse generator was reviewed and showed that no high impedance instances were identified and the generator battery depleted at normal levels.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5788108


Title: Re: Chest Pain
Post by: dennis100 on June 07, 2013, 12:09:01 PM
Model Number 102
Event Date 04/18/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
It was reported that the patient went to the emergency room on (b)(6) 2013 due to suspected problems with his vns device. The patient had the magnet taped over the device to shut it off. The patient's following neurologist advised the patient's mother to have a cardiologist check the patient as the patient was having chest pain and experiencing a shocking sensation. The patient was seen by the treating neurologist and implanting surgeon on (b)(6) 2013 and it was reported that the patient was doing fine. Device diagnostics were within normal limits. However, the treating physician planned to refer the patient to neurosurgery because he felt that the device is not working properly because the patient was experiencing a shocking feeling in the chest area, even though device diagnostics were within normal limits and the vns magnet was taped over the device to disable the stimulation. The physician believed the painful stimulation was related to the device since it occurred with stimulation on-times. The mother reported that when she attempted to disable the patient's device, the magnet did not appear to turn of the device. The patient was seen by cardiology with no issues found. The neurologist reported that the patient had fallen on multiple occasions but did not have details or dates of the falls. He believes these falls may have caused trauma to the device and/or lead. The neurologist believes that the generator is defective and wants the generator replaced due to the reported pain. The patient's device was turned off on (b)(6) 2013 which resolved the patient's pain. The surgeon was planning on scheduling the patient was revision surgery as soon as possible because the patient's seizures increased since the device was turned off. The plan was to replace the generator and possibly the lead if there was an issue identified with the lead during surgery. An x-ray reportedly did not show a lead fracture. The radiology report dated (b)(6) 2013 reported that the chest x-ray was performed due to "possible electrode disruption. " the visualized leads appeared intact per the report with no evidence of fracture. The patient saw another vns treating physician on (b)(6) 2013 for a second opinion regarding the shocking sensation. Attempts for additional information, including specific diagnostic results, have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3116580


Title: Re: Chest Pain
Post by: dennis100 on June 07, 2013, 12:09:27 PM
Model Number 304-20
Event Date 06/01/2012
Event Type Injury
Event Description
On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.

Event Description
On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122977


Title: Re: Chest Pain
Post by: dennis100 on August 10, 2013, 08:31:14 AM
Model Number 103
Event Date 06/01/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Additional information was received that the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Follow-up with the physician¿s office did not provide any additional information. They provided clinic notes which had previous been received.
 
Event Description
It was initially reported that the patient was experiencing pain around his vns. The mother reported that one night it was so bad he had difficulty sleeping. The patient generator was nearing end of service although the eri flag was still "no" and the physician felt he needed it replacement as well as it may be the cause of the intermittent pain. Diagnostics were within normal limits. The patient had a generator replacement. The patient had been hit by a car at the end of 2012. Good faith attempts for additional information and product return have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3198659


Title: Re: Chest Pain
Post by: dennis100 on August 10, 2013, 08:31:43 AM
Model Number 105
Event Date 10/28/2013
Event Type  Injury   
Event Description
It was reported that the patient had surgery on (b)(6) 2015. The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in. It was reported that the generator was not replaced, only repositioned. It was reported that the patient was doing okay. The explanted lead has not been received by the manufacturer to date.
 
Event Description
Analysis was completed on the explanted lead. A punctured opening was identified in the outer silicone tubing. Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious opening was noted on the inner silicone tubing other than the end of the returned lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure. " the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating. Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery. The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area. At that time, surgery was performed for patient comfort reasons. It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity. As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity. She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy. At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity. It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0. 5 ma. As a result, the device was temporarily disabled and turned on again on (b)(6) 2015. However, the neurologist felt this is not a therapeutic level of therapy. The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0. 5ma current. Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation. The pulse width was then adjusted up to 500usec which again worsened the sensation. The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant. The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on. The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0. 5ma. It was reported that a 4. 0-maxon suture (absorbable) was used to suture device to tissue. However, the device does move within the pocket and it creates considerable discomfort. The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back. Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014. The patient no longer had the ¿shocking pain¿ in the left neck and throat region. However, she still had pain in the left anterior chest wall due to the generator. On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation. Lyrica was added for the pain management. The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged. He assessed that the solution for the painful stimulation is revision of the leads. The surgeon recommends lead revision and repositioning the generator in the left chest. The patient was referred for surgery. Diagnostics have reportedly been within normal limits. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
The surgeon reported that the patient had been reporting painful stimulation prior to surgery. During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4566036


Title: Re: Chest Pain
Post by: dennis100 on September 04, 2013, 11:39:40 AM
Type


Title: Re: Chest Pain
Post by: dennis100 on September 06, 2013, 09:10:54 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/06/2017
Event Type  Injury   
Event Description
Report received that a patient's generator had migrated which caused pain and protrusion. The generator had been reportedly moving in the patient's chest. X-rays were taken and showed that the generator was in a different spot in the chest than the patient's previous generator. The physician was reportedly able to feel the edge of the generator when she palpated the left breast. It reportedly migrated to the axillary area. The physician reported that trauma did not occur which would have caused the migration. Information from the surgeon indicated non-absorbable sutures were used during the initial implant. The patient was referred to a surgeon for pocket revision. Although a surgery has not been planned to date, the information from the physician indicated she expected a correction to be performed. No surgical intervention has occurred to date and no relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6905564


Title: Re: Chest Pain
Post by: dennis100 on September 06, 2013, 09:12:38 AM
Model Number 103
Event Date 01/01/2013
Event Type  Injury  
Patient Outcome  Other,Required Intervention
Manufacturer Narrative

Event Description
It was reported that the patient underwent prophylactic generator replacement due to pain and discomfort in the left chest and shoulder area due to the generator physically moving around. It was reported that the discomfort was not associated with device stimulation. The surgeon indicated that since he would be repositioning the device he wanted to prophylactically replace the generator at the same time. It was reported that the old generator was explanted from the axilla area and the new generator was implanted through the same incision, but was placed more medially and secured with a suture. It was reported that the hospital policy requires that all explants be sent to the pathology department. It is unknown if the generator was secured per device manufacturer's recommendations during the initial implant surgery. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3296000


Title: Re: Chest Pain
Post by: dennis100 on October 03, 2013, 11:26:03 PM
Model


Title: Re: Chest Pain
Post by: dennis100 on October 04, 2013, 12:08:30 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported that the patient is scheduled for surgery due to pain in the chest and migration of the generator due to recent weight loss. No additional information was provided by the physician's office at the time of the initial report. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely, but has not been performed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3358853


Title: Re: Chest Pain
Post by: dennis100 on November 08, 2013, 03:24:43 AM
Model Number 102
Event Date 05/14/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicate that the device settings were increased from 5 mins off to 0. 2 mins off, but that it was too bothersome to the patient so the settings was changed back. The notes indicate that the battery is ok, but in the past few months a few times a week the patient feels a sharp pain over the device intermittently. It was noted that despite the reading the battery is likely running low and the patient will be scheduled for surgery in the summer. The physician indicated that no patient manipulation or trauma occurred that is believed to have caused or contributed to the sharp pain. The physician indicated that the patient will undergo generator replacement due to the pain. It is unknown if the generator replacement will be done for patient comfort or to preclude a serious injury. Surgery is likely, but has not occurred to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425035


Title: Re: Chest Pain
Post by: dennis100 on November 08, 2013, 03:25:35 AM
Model Number 103
Event Date 07/19/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406219


Title: Re: Chest Pain
Post by: dennis100 on December 06, 2013, 02:06:44 AM
Model


Title: Re: Chest Pain
Post by: dennis100 on December 06, 2013, 02:07:06 AM
Model Number 104
Event Date 10/26/2013
Event Type  Injury  
Patient Outcome  Other
Event Description
The patient was hospitalized on (b)(6) 2013 for complaints of pain in the chest at the generator site along with diagnosed left vocal cord paralysis. The chest pain was not occurring with vns stimulation. The patient was seen by the ear nose throat (ent) doctor and the vns was disabled for the day, which resulted in the chest pain resolving. The ent felt that the vns could be turned back on after one day and the patient's settings were reduced from the previous ones (1. 0ma instead of 2. 75 ma). Diagnostics were all ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3485389


Title: Re: Chest Pain
Post by: dennis100 on January 12, 2014, 09:25:28 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4): inadvertently listed the date as (b)(6) 2013 on the initial report when it should have been (b)(6) 2013.

Event Description
On (b)(6) 2013 it was reported that the patient is scheduled for vns explant due to pain. Although surgery is likely, it has not occurred to date. The patient was noted to have had the device disabled because of chest pain. Despite being turned off the patient was still having neck pain on the left side and wanted the device explanted. The physician¿s office later stated that they have only seen the patient once and the patient had stated that the device has been off for 6-7 years. Per the physician, the patient just said that she wanted the device removed and did not give a reason. The physician¿s notes indicated that the ¿pain is related to vns¿. The patient was given medication. No further information was provided. Review of the patient¿s programming history revealed that the device was disabled on (b)(6) 2009.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3495196


Title: Re: Chest Pain
Post by: dennis100 on January 12, 2014, 09:38:37 AM
Model Number 103
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
 
Event Description
It was reported through clinic notes received on (b)(4) 2013 that the patient was diagnosed with sleep apnea and was having pain around the chest area.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3501163


Title: Re: Chest Pain
Post by: dennis100 on March 14, 2014, 03:53:28 AM
Model Number 303-30
Event Date 09/09/2011
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
On (b)(4) 2014, it was reported that the patient¿s generator and lead were explanted electively on (b)(6) 2014 as the patient reported no improvements to their seizure control since being implanted with the device and was experiencing some discomfort. The explanted lead and generator were returned for product analysis on (b)(4) 2014. The nurse later clarified that the discomfort the patient was feeling was in fact shortness of breath and numbness extending from the incision to the chin. The numbness was felt by neurosurgery to be due to injury to subcutaneous nerve during incision. The device had been disabled since (b)(6) 2012. The patient wanted the device off and refused parameter adjustment. The shortness of breath was due to device stimulation. It was stated that the explant surgery was not to preclude a serious injury. Diagnostics were not performed on the vns as the highest the patient was programmed to was an output of 0. 75ma. No causal or contributory programming or medication changes preceded the onset of the events. The nurse stated that she believed vns was not programmed to more therapeutic parameters due to poor tolerance and therefore was not effective. Product analysis was completed on the generator on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead is still underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637198


Title: Re: Chest Pain
Post by: dennis100 on March 14, 2014, 03:54:16 AM
Event Date 01/01/2011
Event Type  Injury  
Patient Outcome  Other
Event Description
This vns patient reported that she has been having pain off and on that started three years earlier that has progressively gotten worse. Her current neurologist had made adjustments, lowered her dosing, and started her on medication to try and manage the pain. Approximately one month earlier, the device was disable, but the patient still reported pain as if there was swelling on the inside. When the patient lies down, it cuts off her air way. Follow-up with the neurologist showed that the pain was present at the left neck and left chest. The dyspnea was not occurring with stimulation. As intervention, the patient was referred to a surgeon to remove the lead. Explant surgery is likely but has not taken place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639783


Title: Re: Chest Pain
Post by: dennis100 on April 04, 2014, 08:02:05 AM
Model Number 103
Event Date 12/01/2011
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by physician thru company representative that vns patient had pain on the generator site which was not related to vns stimulation. Physician initially referred patient to surgery to investigate the source of pain and probably re-site the generator. Xrays were taken and provided to manufacturer for review. From x-rays images, generator is visualized in a normal placement in the left upper chest. The filter feed-through wires and lead wires at the connector pin appear to be intact. The lead connector pin appears to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement in the neck. There is part of the lead behind the generator and could not be fully assessed. No obvious lead breaks or acute angle were observed in the assessed portions. Additional info was received from physician that patient may have psychological issues regarding the reported pain; surgery was cancelled and not re-scheduled at this moment. Nonetheless, it is unknown if surgical intervention will be taken to preclude a patient injury.
 
Event Description
Additional information was received on (b)(6) 2012, when it was discovered that on (b)(6) 2012, the vns patient was interrogated and found programmed to 0ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2451222


Title: Re: Chest Pain
Post by: dennis100 on May 09, 2014, 04:37:42 AM
Model Number 102
Event Date 06/06/2013
Event Type  Injury  
Patient Outcome  Required Intervention  
Event Description  
On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain. Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well. The patient¿s device settings were increased during the visit. The patient presented with increased chest pain during an office visit on (b)(6) 2014. A chest ct was reported by the physician to be unremarkable. The patient¿s device settings were lowered during the office visit. The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014. The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation. The patient reported that she was still feeling electricity-like pain in her arm and palm. The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013. It was confirmed that the events are occurring continuously as well as with stimulation. She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously. Additionally, she was seizure-free for a while and had one seizure. At that time, diagnostics were normal and the battery was reported to be fine as well. Attempts for additional relevant information were made but have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717363


Title: Re: Chest Pain
Post by: dennis100 on May 09, 2014, 04:38:43 AM
Model Number 103
Event Date 02/19/2014
Event Type Injury
Patient Outcome Other
Event Description
On (b)(6) 2014, it was reported that this vns patient¿s device was disabled due to vomiting on (b)(6) 2014. It was previously reported recently had device settings turned back up and vomiting, pain, and stomach issues returned. In addition to reporting the device disablement, the physician stated that the events were occurring continuous, not just with stimulation, and were possibly related to vns; however, the patient had not been evaluated by a gastroenterologist. Interventions included disabling the device. The patient was reportedly experiencing pain in the throat and chest. On (b)(6) 2010, this vns patient caregiver reported that the patient had discomfort in the neck and chest region with stimulation. He also experienced voice alteration, dyspepsia, and difficulty sleeping with stimulation. The patient did not experience any adverse events when the settings were low. Follow-up at the time showed that there were no reports of trauma or manipulation; however, device settings were changed on (b)(6) 2010 where the output current was increased from 1. 50 to 1. 75 ma, and the signal frequency was increased from 25 to 30 hz. The patient did not have a history of sleep disturbances or dyspepsia prior to vns. The sleep disturbances and dyspepsia were related to device stimulation. The physician stated that the settings were lowered but then increased because the patient felt the device was not as efficacious at lower settings. In the past, the patient complained of pain, voice alteration, and emesis (if he already had concurrent nausea) during stimulation. He also complained of pain, too frequent stimulation, and that device stimulation would wake him up at night. There were no casual or contributory factors that preceded the onset of any of the events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3728867


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2014, 12:30:24 PM
Model Number 102R
Event Date 12/01/2010
Event Type Injury
Patient Outcome Other
Event Description
It was reported that the vns patient had intermittent pain at her implant site and developed a post-operative infection at her implant site.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3790294


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2014, 05:49:52 PM
Model Number 103
Event Date 01/01/2012
Event Type Injury
Event Description
It was reported that the patient was referred for explant surgery due to pain. Although surgery was likely, it has not been reported that surgical intervention has occurred to date.

Event Description
It was reported that the patient has been complaining of sporatic pain in his chest at the generator site and some in his neck area. It was reported that the patient has been complaining of intermittent pain since reimplant in 2012. X-rays were performed, but reported to not show any issues. The patient has a history of cervical spine issues and the physician feels that the pain may be related to that; however, has not been confirmed. The patient has been referred for device revision or replacement. The device off time was changed from on time has been changed from one minute to five minutes off. Clinic notes dated (b)(6) 2014 note that the patient believes that the pain in front of his neck and chest is from vns. Clinic notes indicate that the patient experienced a hard shock the day prior. It was noted that the patient has a bad disk in his neck that is aggravating the neck pain. It was also noted that it appears that the patient has cervical spondylosis with radiculopathy. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3806124


Title: Re: Chest Pain
Post by: dennis100 on June 06, 2014, 05:50:38 PM
Model Number 103
Event Date 03/25/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient underwent surgery to explant her generator on (b)(6) 2014. It is unknown if the patient¿s lead was explanted during the procedure. Following vns implant surgery, the patient was experiencing dyspnea, severe personality changes, chest pain, voice hoarseness and cough. The explanting facility will not return the explanted device to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Event Description
Additional information received from the physician¿s office revealed that there was no indication anything was wrong with the vns device. The patient presented at the office on (b)(6) 2014 to have the device programmed on and stated that she did not like the feeling of a foreign metal object in her body. The patient had anxiety due to the presence of the device and did not have any personality changes. It did not appear that the patient had any anxiety about the device until after it was implanted. The device was programmed on as planned and the next day, the patient complained of chest pain, shortness of breath, voice alteration, and coughing. The voice alteration and coughing were due to stimulation but the chest pain and shortness of breath were anxiety related. The physician¿s office advised the patient not to have the device explanted but did not see her again until after the explant occurred. The physician¿s office did not feel that any of the events were serious in nature and removal of the device did not occur to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808552


Title: Re: Chest Pain
Post by: dennis100 on June 10, 2014, 07:07:33 PM
Model Number 103
Event Date 01/24/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the patient was scheduled for exploratory surgery and possible generator replacement. It was reported that the patient experienced pain (9/10) at the generator site which the patient was seen at the emergency room for. The physician reported that the pain has been occurring for approximately three months and the pain goes from the generator to the patient's shoulder down into the patient's arm which the physician reported is not a normal radicular pattern. It was reported that cardiac issues and pulmonary embolism were ruled out. A ct scan of the chest did not identify any abnormal fluid collections around the generator. It was reported that the patient underwent exploratory surgery with generator replacement due to ifi - yes on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3718781


Title: Re: Chest Pain
Post by: dennis100 on June 10, 2014, 07:09:10 PM
Model Number 102
Event Date 03/06/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that surgery will likely occur. Clinic notes note that the patient underwent surgical consult. It was noted that the laboratory results point to an infection, but that the source of the infection is not known. It was noted that the surgeon recommends wound wash out and generator replacement. It was reported that the patient underwent surgery. During the surgery only the generator was replaced. The generator was placed in a new pocket. The surgeon did not see any visual characteristics of infection; therefore the device was replaced rather than explanted. It was reported that cultures were performed, but that the results were not know at the time of the surgery. Diagnostics with the new generator connected to the existing lead was within normal limits. (2805 ohms). Further follow-up revealed that no infection was present.

Event Description
It was reported that the vns patient went to the emergency room due to chest pain. Blood cultures were positive and the patient was diagnosed with an infection at her generator site. The patient was placed on a course of antibiotics. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. No known interventions have occurred to date. Attempts for additional information will be made.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3720937


Title: Re: Chest Pain
Post by: dennis100 on July 04, 2014, 01:29:25 AM
Model Number 102
Event Date 05/27/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced a stinging sensation at the generator site. It was noted that the patient feels that the device is still working. It was noted that the patient's mother feels like the generator is slipping lower. It was noted that the vns is causing the patient pain for the last month and that it seems to be slipping down in her chest. X-rays were performed which showed the generator at the left heart border. Attempts to obtain additional information have been unsuccessful to date. No surgical intervention has been performed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3900196


Title: Re: Chest Pain
Post by: dennis100 on August 08, 2014, 01:43:51 AM
Model Number 103
Event Date 01/01/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the patient would undergo vns explant due to intractable pain at the generator site. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3919754


Title: Re: Chest Pain
Post by: dennis100 on September 05, 2014, 12:29:18 AM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the vns patient was admitted to the hospital on (b)(6) 2014 because the patient was unable to perceive stimulation and believed his device was not working. The patient¿s device was disabled while the patient was in the hospital. At discharge, the neurologist programmed the patient¿s device back on to its original settings; however, the patient was unable to tolerate stimulation so the device settings were decrease. Clinic notes were received indicating that the vns patient was admitted to the hospital on (b)(6) 2014. Since the patient¿s last hospitalization on (b)(6) 2014, the patient was experiencing an increase in seizures and had 20 seizures in the past two weeks prior to hospitalization. The patient¿s device settings were increased upon admission and again on (b)(6) 2014. The patient subsequently complained of chest pressure, coughing and voice changes, but the symptoms resolved and the patient was able to tolerate the new device settings. The patient¿s new settings were still lower than his baseline device settings. The patient stated that his device was not working properly; however, the notes indicate that the patient¿s voice changes and coughing showed that the patient¿s device was providing stimulation. Furthermore, the patient¿s device was tested and system diagnostics showed normal device function at the time. Continuous video-eeg monitoring showed that the patient was not in status. The patient¿s medications were adjusted for better seizure control; however, the patient subsequently had a cluster of seizures on (b)(6) 2014 after the medication adjustments. The patient¿s medications were re-adjusted and the patient did not have any more seizures while hospitalized. The patient was discharged on (b)(6) 2014. The patient was referred for surgery but no known surgical interventions have occurred to date. Follow-up revealed that the patient¿s increase in seizures began in (b)(6) 2014. The neurologist attributes the voice changes to stimulation and stated that the increase in seizures may have been related to the patient¿s medications. The patient has since had better seizure control with medication adjustments but continues to have painful stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3980999


Title: Re: Chest Pain
Post by: dennis100 on September 05, 2014, 12:30:01 AM
Model Number 102
Event Date 11/01/2011
Event Type Injury
Patient Outcome Other
Event Description
On (b)(6) 2014 it was reported that the patient will undergo a possible explant due to the vns being off for years (patient had hippocampus removed) and because the device slides around and bothers him. The patient underwent explant of the vns on (b)(6) 2014. The explanted generator was returned for product analysis on (b)(4 2014. Product analysis is currently underway and has not yet been completed. It was previously reported in (b)(6) 2012 that the patient had gained a lot of weight and thought the device had migrated, causing him pain. It was stated that the generator was turned off 3 years ago after brain surgery. The patient had been experiencing a sharp pain in the chest since around (b)(6) 2011. X-rays were taken. Based on the x-rays received the cause for the patient's pain cannot be determined. No gross lead discontinuities or sharp angles could be visualized that could explain the chest pain experienced by the patient. However, an unpronounced lead discontinuity cannot be ruled out. It was reported that there were no changes to the vns prior to the pain. The pain had subsided and was no longer experiencing any more pain. The physician noted that the pain is not due to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979058


Title: Re: Chest Pain
Post by: dennis100 on September 05, 2014, 06:45:31 AM
Model Number 105
Event Date 08/30/2013
Event Type  Injury   
Event Description
It was reported that the patient was seen in the emergency room due to discomfort in the chest. The emergency room doctor informed the patient that the vns site was infected. The patient had recently underwent vns replacement surgery. The patient was prescribed an oral antibiotic for 10 days. The patient was seen by the primary car physician on (b)(6) 2013 at which time was told everything looked ok. The patient was scheduled for follow-up with the surgeon to check the wound prior to programming the device on. It was reported that no cultures were performed and that there was no patient manipulation or trauma that occurred that may have contributed to the infection. It was reported that the physician believes that the infection was related to the implant procedure. It was reported that the patient was seen by the surgeon and the infection has cleared. The device was programmed on.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3376475


Title: Re: Chest Pain
Post by: dennis100 on September 05, 2014, 06:46:03 AM
Model Number 105
Event Date 07/22/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value - 7503 ohms). The patient¿s device was tested a second time and the device continued to show high impedance. The neurologist had the patient¿s device programmed on during the office visit. Diagnostic results from the implant procedure showed lead impedance within normal limits. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin does not appear fully inserted into the generator connector block. The electrodes appear to be aligned at a steep angle away from the nerve, nearly perpendicular to the nerve. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance is likely due to incomplete lead pin insertion. The patient experienced a seizure cluster so she swiped her magnet. Immediately, she began feeling intense chest pain and went to the er. The patient was hospitalized overnight. No known surgical interventions have occurred to date.

Manufacturer Narrative
Corrected data: the initial manufacturer report inadvertently did not include that the patient device had been disabled.

Event Description
Follow-up revealed that the patient was experiencing a ¿pinching¿ sensation across her chest and down her left side during stimulation on-times. The patient¿s device frequency and pulse width were decreased from 30hz to 20hz and from 500usec to 250usec, respectively. The patient¿s symptoms subsequently improved. The patient reportedly continued to have pain in her chest, but the physician indicated that the pain was not related to vns.

Event Description
Follow-up revealed that the patient铠device was disabled. Additional information was received indicating that the vns patient's medications were increased and the patient had gone to the er on two occasions to received iv anti-epileptic medications. The patient's seizure frequency was back to pre-vns baseline levels (2-3 small seizures per week). The patient's seizure cluster is not believed to be due to vns. Prior to the seizure cluster, the patient was given a new medication. After the seizure cluster, the patient was taken off the medication but it is unknown if this medication was the source of the seizure cluster. It was noted that the patient had poor seizure control prior to implant surgery. The patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostic results showed high impedance (impedance value - 7076 ohms). The surgeon noted that the lead pin was not fully inserted into the generator header. The patient's lead pin was reinserted and multiple diagnostic results showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013657


Title: Re: Chest Pain
Post by: dennis100 on October 10, 2014, 12:48:22 AM
Model Number 102
Event Date 02/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the vns patient began experiencing pain at her generator site approximately 6-7 months ago and wanted to explant her device. Patient trauma is not believed to have caused or contributed to the patient¿s pain. The patient was referred for surgery but no known surgical interventions have occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4124391


Title: Re: Chest Pain
Post by: dennis100 on October 10, 2014, 11:31:19 AM
Model Number 102R
Event Date 05/14/2014
Event Type Injury
Event Description
It was reported that the patient was still very weak. The device was not checked. It was later reported that the patient was doing better and walking and gaining strength. It was reported that the plan is for the patient to be seen in a few weeks to discuss proceeding forward with the revision. No surgical intervention was performed to date.

Event Description
Additional information was received stating that the vns patient¿s seizures had improved but the patient¿s magnet appeared to making the seizures worse. The patient was also experiencing pain in her neck whenever the magnet was used. The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
Additional information reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2015 but the lead was not replaced.

Event Description
Additional information was received that the patient is now going to have generator replacement and prophylactically replace the lead to prevent a potential revision in the future for patient comfort. No known surgical intervention has occurred to date.

Event Description
It was reported that the lead revision had been cancelled. Additional information was later received that the patient was referred for generator replacement for an unrelated reason.

Event Description
The explanted generator was received on 6/3/2015. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the vns patient was hospitalized due to a seizure she experienced when a system diagnostic test was performed on (b)(6) 2014. The patient had also been experiencing painful stimulation in her chest and neck as well as coughing and facial twitching with stimulation. The patient again experienced a seizure when the next system diagnostic test was performed on (b)(6) 2014 so the patient¿s neurologist stated that the system diagnostic tests were causing the seizures. The patient was given medication and taken to the er. It was noted that the patient¿s device settings were higher than those for system diagnostics and that system diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient¿s seizures were above pre-vns baseline levels. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had been experiencing an increase in seizures since she began using a hearing aid and that she had three seizures since her last office visit. The patient experienced a seizure the before the office visited which resulted in bruising in the arms. The patient stated that she was unable to tolerate magnet mode stimulation. The patient¿s device was tested during the office visit and the patient again experienced a seizure. Diagnostic results showed lead impedance within normal limits. The patient was sent to the er where the patient¿s device settings were lowered. X-rays were taken and were reported by the physician to be unremarkable. The physician recommended replacement surgery due to concerns with the patient¿s lead. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4052095


Title: Re: Chest Pain
Post by: dennis100 on October 10, 2014, 11:31:57 AM
Model Number 103
Event Date 04/23/2011
Event Type  Injury   
Event Description
It was reported by a pt that she had undergone a replacement surgery on (b)(6) 2011. A couple of days later she saw her neurologist and her incisions "looked good" and the device was turned on. However, on (b)(6) 2011, she began running a fever and had difficulty raising her left arm, she had a swollen left breast, and had discomfort to the chest area. An er physician stated he believed it to be a skin rash when she was evaluated, but on (b)(6) 2011, she began having drainage from the incision site when she leaned forward. She was prescribed medication for the issues and now reports no further discomfort, very minimal swelling, and mild redness. A review of the generator's design history records showed that it had been sterilized. Further info from the pt stated that she noticed a lump arise on the left side of her neck on (b)(6) 2011. On friday (b)(6) 2011, she was directed to her surgeon and was admitted on (b)(6) 2011. The pt was discharged on (b)(6) 2011 with a course of augmentin. The pt indicated that she had not had an incision in her neck during the replacement surgery on (b)(6) 2011; however, the lump was not decreasing in size and the incision on her left chest no longer has drainage. According to the pt, the surgeon stated the lump on her left neck was not related to the generator replacement surgery. F/u with the pt's neurologist revealed that he wanted all questions directed to the pt's surgeon. Attempts for further info have been unsuccessful to date.
 
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129929


Title: Re: Chest Pain
Post by: dennis100 on November 07, 2014, 12:44:39 AM
Model Number 302-20
Event Date 09/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that they saw the vns patient on (b)(6) 2011, because the patient was experiencing an increase in seizures, below pre-vns baseline levels, for the past (b)(6) weeks. When diagnostics were performed in the office visit, high impedance was discovered. The physician did not disable the device. The patient was still able to perceive stimulation and did not report any changes in the way it felt. The nurse then reported that the patient's generator was implanted very auxiliary, but now the device has migrated almost to the center of her chest. The patient has not reported any trauma or manipulation. The physician believes the generator migration has something to do with the high impedance. On (b)(6) 2011, the patient's spouse reported that when the patient's generator migrates, it causes the patient excruciating pain. Additionally he stated that she only randomly feels stimulation now and it is not as consistent as it was before. On (b)(6) 2011, the patient's x-rays were received by the manufacturer. Based on the x-ray review there was a suspect area in the lead near the electrodes, in the strain relief bend. However a lead break was unable to be confirmed at this location due to poor contrast of the x-rays. Also, an unpronounced lead fracture could not be ruled out. On (b)(6) 2011, the vns patient's husband reported that they have been having a lot of problems with the patient's increased seizures and her neck swelling. A worst case blc was performed with the patient's limited programming history which revealed 10. 4 years until eri=yes. Attempts for additional information have been made to the physician, but no further information has been received to date. Although surgery is likely, it has not yet occurred.
 
Event Description
On (b)(6) 2011, additional information was received when it was discovered that the vns patient was scheduled for a revision surgery in october. The physician later reported that the generator migration and decreased perception of stimulation were first noticed on (b)(6) 2011. The physician also provided clinic notes dated (b)(6) 2011, which reported that the patient has had some breakthrough seizures. The clinic notes also state that the generator has been mobile and the patient has some pain associated with this. The patient reported that she can still feel vns firing. The physician referred the patient for x-rays but they were apparently not sent to the manufacturer for review. The patient went for a full revision surgery on (b)(6) 2011 and although good faith attempts for product return have been made, the explanted product has not been returned to the manufacturer to date. The lead was replaced due to the high impedance but it is unknown why the generator was replaced at this time. Attempts for further information are underway, but no additional information has been received to date.
 
Event Description
On (b)(6) 2011, additional information was received when the manufacturer's consultant reported that the patient's generator had been replaced due to prophylactic reasons when the lead was replaced due to high impedance on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2284091


Title: Re: Chest Pain
Post by: dennis100 on November 07, 2014, 01:57:10 AM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
It was reported on (b)(6) 2014 that the patient reported pain near the generator that persisted mildly even when the device was off for several months. The patient did not believe it improved his seizures, although the surgeon¿s nurse indicated that it may have after it was initially implanted. The patient¿s device was explanted on (b)(6) 2014. The explanted device could not be returned for product analysis as the hospital does not return. Good faith attempts for further information were unsuccessful. It had been reported on (b)(6) 2014 that the patient was on low settings, output=0. 25ma, and felt a pressure in the chest and tingling in the left arm. The physician didn¿t know if the issues were related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4191919


Title: Re: Chest Pain
Post by: dennis100 on November 07, 2014, 01:57:53 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was referred for vns replacement due to left neck pain, that was suspected as due to migration of the vns and a mass on the left side of the neck. The physician felt that the vns generator was slipping down and tension could be placed on the vns tie-downs and the patient's muscle, which could be causing the pain. A ct scan revealed no soft tissue mass nor fluid collection and everything appeared intact and normal. The impression from the ct results was that the palpable abnormality was likely related to the vns lead. The patient underwent vns repositioning surgery with no replacements instead. The surgeon repositioned the strain relief bend and loop for the lead and repositioned the generator. Diagnostics were reported as within normal limits. It was reported that the patient had weight loss surgery and lost a significant amount of weight and that the vns was pulling due to the weight loss. The patient settings were not adjusted. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to generator migration as it was bothering the patient. Follow up with the surgeon's office revealed that the surgical interventions were for the patient's comfort. Clinic notes were received by the manufacturer and indicated that the leads were "scarred in her neck and causing significant tension on the neck muscles. " it was noted that the generator pocket was very low on the patient's chest, more on top of the patient's breast, and created tension to the area when the patient was moving or standing, continuing to cause pain. It was noted that the generator pocket was not severe at first and the pocket was not revised. However, following the repositioning surgery, the neck pain resolved and the pain from the generator pocket was worse. The physician believed that this was due to tension due to the patient's breasts. A lidocaine patch was prescribed to the patient, but if the pain does not improve with the patch, repositioning surgery was to be performed. The patient underwent prophylactic vns generator replacement surgery. During attempts at product return, it was revealed that the explanted generator was discarded by the facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7534983


Title: Re: Chest Pain
Post by: dennis100 on November 07, 2014, 04:02:55 AM
Model Number 101
Event Date 09/22/2014
Event Type Injury
Event Description
Initially, it was reported that the patient complained of pain at the neck area. It was later reported that the patient was at the hospital. It was reported that the patient had gone to the hospital for complaints of chest pain at the generator site. The device was programmed off. It was reported that the generator was at end of service. The patient is currently in the psychiatric hospital and no further action is being taken at this time. No additional relevant information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4175290


Title: Re: Chest Pain
Post by: dennis100 on November 07, 2014, 04:37:33 AM
Model Number 102
Event Date 05/29/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 clinic notes from the patient¿s (b)(6) 2013 visit were received which reported that the patient developed acute onset of mid-sternal chest pain described as a squeezing, non-radiating 10/10 pain associated with palpitations, diaphoresis, vomiting, and shortness of breath. The physician stated that none of these events were related to vns. The pain was relieved after receiving nitroglycerin and oxygen by ems. Since her hospital visit, she has had a negative heart catheterization and negative workup. During her hospital visit, there was confusion with her home medications and her history of seizures and she was noted to be having increased seizure frequency. It was reported that her vns was later interrogated over a year ago and that the patient has had difficulty finding a neurologist/epileptologist in her hometown who interrogates vns; thus, she has not had close follow up. The physician stated that during this visit voice alteration was noted during stimulation and the patient noticed a sensation of mild sharp shooting pains in the neck. The physician stated that she attempted to interrogate the vns but was unsuccessful and believes it was due to eos. The patient was noted to have a past medical history of ventricular tachycardia and that since implantation of the vns, her tachycardia episodes have decreased in frequency. The physician indicated that the recent increase in seizures activity is likely due to the decreasing battery strength of her vns and because of missing several doses of her keppra. It was reported that the patient had been admitted to the hospital on (b)(6) 2013 because the patient was having chest pain and thought she was having a heart attack. The physician confirmed that neither of these events is related to vns and that the patient was not actually having a heart attack; she had just misinterpreted her chest pain as such. It was stated that the handheld was not plugged into the wall, the wand battery was fine, and all cables and connections on the programming system were secured and properly seated. The physician confirmed that the wand was placed directly over the skin and was pressed firmly against the generator as the patient was wearing a hospital gown. The patient¿s vns still could not be interrogated. The patient was also moved away from all medical equipment that could be causing emi. The physician stated that she believes the patient¿s battery is depleted.
 
Event Description
The explanted generator was returned for analysis which has been completed. During the analysis of the generator it was found to be at end of service as the result of normal battery depletion. There was no abnormal performance or any other type of adverse condition found with the returned generator.
 
Manufacturer Narrative

Event Description
Additional information received revealed that patient was scheduled for generator revision surgery on (b)(6) 2013. The surgery occurred as planned with only the generator being replaced due to end of service. Attempts to obtain the explanted product for analysis will be made.
 
Event Description
Additional information was received stating that diagnostic results subsequent to explant revealed lead impedance was within normal limits (dc dc = 2), confirming proper functioning of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3250143


Title: Re: Chest Pain
Post by: dennis100 on December 05, 2014, 05:11:19 AM
Model Number 102R
Event Date 04/01/2014
Event Type Injury
Event Description
It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table. The pain resolved when the magnet was used to temporarily disable the device. The device was programmed off during an office visit on (b)(6) 2014. Diagnostic results did not indicate any issues with the patient¿s device. The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived. The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014. The portion of the lead that was explanted was discarded by the explant facility. The explanted generator was received on (b)(6) 2015. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. During the product analysis, there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262629


Title: Re: Chest Pain
Post by: dennis100 on January 09, 2015, 01:15:55 AM
Model Number 106
Event Date 08/18/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient underwent a battery replacement on (b)(6) 2016. At a follow-up visit the patient reported having pain at the incision site in his left chest. The paint also could not raise their arm due to the pain. There was flushing at the incision site. The doctor prescribed pain medication and antibiotics on (b)(6) 2016. The patient was doing much better as of 08/29/2016. A design history record review was performed on (b)(6) 2016. The review indicated that the generator passed all test and was sterilized. The expiration date of the sterility is (b)(6) 2018. The patient's symptoms were still present but improved as of 09/07/2016. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5954267


Title: Re: Chest Pain
Post by: dennis100 on January 09, 2015, 02:54:47 AM
Model Number 105
Event Date 11/14/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The patient was found dead at her home. The cause of death is believed to be status epilepticus and possibly sudep. It was noted that the patient complained of chest pain a week prior to her death. The patient¿s devices were explanted but have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Analysis of the generator was completed on 03/02/2015. The battery showed an ifi=no condition. The device performed according to specifications. The as-received internal device data showed that the last 99. 4% change in the impedance value was estimated to have occurred after explant surgery on 02/09/2015, where the impedance value changed from high lead impedance to a normal limits range. No anomalies were identified. Analysis of the lead was completed on 03/04/2015. No anomalies other that typical wear and explant-related conditions were identified in the returned lead portion. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s seizures were well controlled with her device. The patient did not have any tonic/clonic seizures for a few months prior to her death.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
The generator was explanted. The explanted generator was received on 02/09/2015 and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334656


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2015, 06:00:59 AM
Model Number 103
Event Date 12/05/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the vns patient was experiencing pain in her neck and chest during stimulation on-times and was constantly sore at areas around the lead. The patient¿s lead was found to be visible in the patient¿s neck where it previously was not visible. The patient¿s device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 3062 ohms). Patient trauma is not believed to have caused or contributed to the high impedance. The physician believed that the issues were related to an end of service condition with the patient¿s device. A battery life calculation using the available programming history showed approximately 7. 4 years until near end of service. The patient was referred for surgery but no known surgical interventions have occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4397157


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2015, 08:22:40 AM
Model Number 103
Event Date 12/08/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the vns patient was referred for surgery due to chest pain and potential generator migration. No known surgical interventions have occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4391038


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2015, 08:23:19 AM
Model Number 103
Event Date 12/05/2014
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient was experiencing pain in the neck, throat, jugular, and chest during stimulation on-times. The patient described it as a choking feeling. It was also noted that the patient¿s apnea had worsened since vns. The physician did not decrease the patient's device settings due to potential effects of the decrease in therapy. The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description
Additional information was received that the patient underwent generator replacement on (b)(6) 2015. The explanted generator is suspected to have been discarded by the explanting facility and will not be returned to the manufacturer; therefore, no product analysis can be performed.

Manufacturer Narrative

Event Description
The explanted generator was received on 03/10/2015. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Additional information was received that the patient¿s explanted generator will be returned to the manufacturer but the explanted product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377482



Title: Re: Chest Pain
Post by: dennis100 on March 06, 2015, 04:41:57 AM
Model Number 102
Event Date 10/25/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns study patient presented with pain at the generator site. The event started on (b)(6) 2014 and ended on (b)(6) 2014. It was deemed as ¿severe¿, definitely related to implantation and not related to stimulation. Vns therapy was withdrawn as a treatment to the reported pain, which subsequently resolved. The adverse event caused the subject to discontinue from the study. The event was indicated to be a serious adverse event which resulted in an initial or prolonged hospitalization. The patient underwent explant surgery on (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4473052


Title: Re: Chest Pain
Post by: dennis100 on March 06, 2015, 04:42:37 AM
Model Number 102
Event Date 02/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient¿s mother called and stated that her daughter¿s stimulator¿s batteries are not working and she is having chest pain in the area where the device is located. The mother stated that at the last appointment in (b)(6), the physician had stated that the generator had reached eos. The mother said that the generator appears to have migrated in the patient¿s chest. She has grown and gained weight since the generator was implanted. She said that her daughter was having pain at the generator site. The mother took the daughter to the emergency room for the pain she was experiencing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4551956


Title: Re: Chest Pain
Post by: dennis100 on March 06, 2015, 04:43:35 AM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
It was reported that a vns patient experienced pain in the chest at the generator site and at the shoulder for several months. This pain was reported to be occurring at intermittent and irregular intervals. The patient¿s device had previously been disabled due to high lead impedance, which was previously reported in manufacturer report # 1644487-2007-01666. The device was confirmed to be disabled presently and a vns explant surgery is planned. However, no known surgical interventions have been performed to date.

Event Description
Additional information was received that the patient had visited the er on (b)(6) 2015 due to electrical shock she received from her vns. The shock was described as hot and burning sensation in the left side of the chest. It was reported that the electrical shock was powerful enough to "throw her across the bed" and the er doctor said she needs to have it removed immediately. Additional information was received from the neurologist that the patient's vns remains disabled and was not turned on. The physician was unable to provide an assessment on the believed relationship of the electrical shock to vns therapy and had ordered ct for further evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542494


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2015, 12:24:54 AM
Model Number 103
Event Date 10/25/2010
Event Type Injury
Event Description
It was reported that the patient was scheduled for a vns removal surgery. It was originally implanted for seizures and then she later learned she had pseudo seizures. The device was off for some time and she still had chest wall pain and when on stated her head was twitching. It was noted that the patient could not even tolerate mild stimulation. The physician reported that no causal or contributory programming or medication changes precede the onset of the head twitching and pain. He stated that he did not know if interventions were taken. He also stated that he didn¿t know the relationship of the head twitching and pain to vns. No manipulation or trauma occurred that is believed to have caused/contributed to the chest pain. He was also unable to provide the date of disablement. The patient¿s programming history was reviewed and the patient was disabled on (b)(6) 2010. Diagnostics were normal on that date as well.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4609356


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2015, 12:25:53 AM
Model Number 102
Event Date 01/28/2015
Event Type Injury
Event Description
Product analysis for the lead was completed and approved on 03/19/2015. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Product analysis for the generator was completed and approved on 04/01/2015. In the analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Event Description
It was reported that the vns patient presented with a shocking sensation at the generator site that travelled up to his neck. No patient trauma was reported. X-rays were taken and were reported by the physician to be unremarkable. Clinic notes were received indicating that the patient was seen a week prior to the office visit on (b)(6) 2015 and reported having shocking sensations in the right chest. The patient was experiencing fairly strong shocking sensations 2-3 times a day which lasted up to a minute. The shocking sensations normally preceded the patient feeling stimulation on-times in the neck. On (b)(6) 2014, the patient returned to the office and it was determined that surgery would be performed to check the lead pin insertion into the generator header and replace the device. Additional x-rays were taken and were reported by the physician to be unremarkable. The patient¿s device was tested and diagnostic results showed normal device function. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4591615


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2015, 12:27:05 AM
Model Number 103
Event Date 01/26/2015
Event Type Injury
Event Description
Product analysis was completed on the lead on 04/09/2015. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the generator on 04/13/2015. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that after the patient left her office visit she complained of pain at the generator site as well as pain going half way up her neck. The physician had the patient tape the magnet over the generator until he could see her. When he saw her again he turned off the generator but did not do a system diagnostics test. He did take x-rays and believes the generator may have shifted a quarter turn. His plan is to bring the patient back hopefully next week and turn the device back on and run a system diagnostics test. The patient was seen again on (b)(6) 2015 and system diagnostics showed 3400 ohms. He did have an x-ray done that was reviewed by a local radiologist that said a lead fracture could not be identified. The patient has reported an increase in seizures as of late. The physician said he is going to send the patient for a revision as he believes that there could be a micro fracture. Since she is presenting with both pain and an increase in seizures, he would like to do this sooner rather than later. He did mention that even with turning down the patient's generator to an output of 0. 25 ma and 250 usec pulse width, the patient still could feel it going off. The physician indicated that patient¿s prior setting to the present problem was 1. 75 ma/30 sec on/3 min off. The physician stated that due to the pain and muscle spasms at the generator site the vns was turned off which led to an increase in seizures. The vns has been restarted at a very low level, 0. 25 ma/30 sec on/5 min off as the patient barely tolerates it. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. It was noted that both the cps and gm type seizures increased for the patient. The patient denied any trauma or manipulation preceding the migration. The patient underwent a full revision surgery on (b)(6) 2015. System diagnostics test results prior to surgery were output=ok/lead impedance=ok/impedance value=3600ohms/neos=no. And the patient was programmed to output=0. 25ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0. 25ma/magnet on time=60sec/magnet pulse width=130usec. The patient¿s painful stimulation in the generator pocket was noted to have started in early (b)(6). The patient said that she does occasionally have seizures that involve falls, and that she did have one around that time. When she fell, she was wearing a heavy backpack on her left shoulder so she added that this might have had an impact on the vns. The explanted generator and lead have not been returned for product analysis to date despite attempts.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587309


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2015, 12:27:54 AM
Event Date 09/08/2014
Event Type Injury
Manufacturer Narrative
Adverse event and/or product problem; additional information indicates that the event was not a product problem but an adverse event. Type of reportable event; additional information indicates that the event type was not a malfunction but a serious injury.

Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient was experiencing painful stimulation and went to the er on (b)(6) 2014. The er physician stated that the patient¿s device was ¿misfiring¿. Follow-up revealed that during the er visit, the er physician had concerns of a potential lead break and subsequently disabled the device. The patient was sent for x-rays. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis and discard explants after 30 days; therefore, no analysis can be performed. Clinic notes were received indicating that the patient's device was tested during an office visit on (b)(6) 2014 and diagnostics showed lead impedance within normal limits (impedance value - 3000 ohms). After disabling the patient's device, the er physician prescribed medication for the patient. The notes indicate that the patient's painful stimulation occurred abruptly at her until the device was disabled and subsequently began having breakthrough seizures. A lead issue was suspected because of the patient's painful stimulation and not based on diagnostic results or x-rays. Operative notes for the patient's replacement surgery indicate that there was a significant amount of scarring around the nerve which required an external neurolysis as well as neurorrhaphy to prepare the nerve for placement of the new lead. The notes indicate that following placement of the new devices, the device was programmed on and showed low impedance. It is unclear whether the notes were referring to a low impedance reading or a low numerical impedance value that was within normal limits.

Event Description
Additional information was received from the physician¿s office that the patient experienced painful stimulation on the left side of the face, neck and chest abruptly on (b)(6) 2014. The patient was seen post- surgery by the physician on (b)(6) 2014 and that the incision sites were reported to be healing well. Attempts were made for product information but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4171248


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2015, 12:29:04 AM
Model Number 105
Event Date 11/16/2014
Event Type Injury
Event Description
The patient had generator replacement surgery on (b)(6) 2015 due to the physicians suspecting generator "malfunction" due to erratic stimulation. Pre-operative system diagnostics were within normal limits, indicating proper device function. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date.

Manufacturer Narrative
Manufacturer device history records reviewed. Review of the generator device history records confirmed all quality specifications were passed prior to distribution.

Event Description
It was reported that the patient would like to have his vns replaced. The physician¿s office reported that this patient had his vns ¿go bonkers. ¿ upon follow-up, the physician's office reported that the patient called on (b)(6) 2015 that he felt the vns settings were too high. He used the magnet and had an unbearable pain at the generator site that brought him to the knees. On (b)(6) 2014, he reported coughing with stimulation which kept him up all night. The patient then presented to the office with the magnet taped to his chest. The settings were lowered and the patient has been fine since. X-rays were taken in (b)(6) 2014. The plan was to send the patient to surgical evaluation, as the patient is fearful of return of seizures, that there is an issue with the device and that the pain may reoccur. It was reported on (b)(6) 2014 that the patient began experiencing coughing associated with vns stimulation about two days prior and felt stimulation stronger. The patient taped the magnet over the generator and the coughing subsided. Diagnostic results were within normal limits. However during diagnostic testing, the patient was unable to catch his breath. There was no specific activity that coincided with the change in stimulation. The generator was programmed off. X-rays were provided to the manufacturer for review. No obvious discontinuities were identified with the vns system, although the presence of micro fractures is possible and no indication of what was causing the symptoms. The surgeon believes the generator is malfunctioning. The treating physician reported wanting to move forward with replacement because the complaints started months after parameter changes. Although surgical intervention is likely, it has not occurred to date.

Manufacturer Narrative

Event Description
It was reported on 04/02/2015 that the patient¿s erratic stimulation feeling resolved after generator replacement. Analysis of the generator was completed. In the analysis lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Initial reporter: name and address, corrected data: the initial report inadvertently reported the address, phone number and fax number incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4578650


Title: Re: Chest Pain
Post by: dennis100 on June 05, 2015, 02:21:17 AM
Model Number 103
Event Date 03/01/2015
Event Type Injury
Event Description
It was reported that the patient complained of increased seizures and chest pains while the device has been turned on. The device was originally turned off in (b)(6) 2014, but was turned back on (b)(6) 2015. As a result, the device was turned back off on (b)(6) 2015. Clinic notes dated (b)(6) 2015 reported that the patient¿s anti-seizure medication was never increased at the last appointment. However, the patient had not had a seizure for 9 days. She even made through her menstrual cycle without a seizure which is rare for her. However at this visit, the patient reported that she was having seizures almost daily feeling pain in her chest around her generator. She asked that the vns be turned off. Device diagnostics were within normal limits on this date, indicating proper device function. Good faith attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4752121


Title: Re: Chest Pain
Post by: dennis100 on July 12, 2015, 07:35:10 AM
Model Number 102
Event Date 06/01/2015
Event Type Injury
Event Description
It was reported that the patient's vns needs to be replaced as she still has pain in her neck and upper chest area. It was also reported that the patient had a vns generator replacement that occurred on (b)(6) 2015. Good faith attempts for additional, relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877842


Title: Re: Chest Pain
Post by: dennis100 on July 12, 2015, 07:36:02 AM
Model Number 102
Event Date 05/26/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 from an e. R. Physician that states the patient¿s device is shocking her and causing some pain. The patient came into the er with pain in her left neck, top of her chest and behind her left eye that appears to be caused from the vns device. The patient expressed intense pain in these areas. He could not confirm if the pain occurred with stimulation. The er physician was instructed to use a pacemaker magnet to temporarily disable the device until a following physician could be reached to check the device. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4855843


Title: Re: Chest Pain
Post by: dennis100 on July 12, 2015, 07:37:02 AM
Model Number 103
Event Date 12/27/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, this patient reported that something was not right with her device. The patient went to the emergency room on (b)(6) 2014. The patient had bad bruising, and x-rays were taken which reportedly showed no wire (lead) issue. The device was not going off every five minutes as it was supposed to. The device was reportedly randomly giving ¿double doses¿ (magnet mode stimulation) and was causing pain. On (b)(6) 2013, an er physician reported that the patient was complaining of shocking at the battery site. On (b)(6) 2013, the patient reported an increase in seizures since being implanted in (b)(6) 2013. Per the patient¿s stepfather, the device was malfunctioning, constantly shocking, and could not be turned off. Clinic notes dated (b)(6) 2014 indicated that the patient had a vns placed on (b)(6) 2013 and had no benefit from it. [clinic notes dated (b)(6) 2013 (prior to vns implant) indicate the patient had six seizures in the last two months. ] the device began to be dysfunctional on (b)(6) 2013. The patient felt like she had a tens unit in her chest. She felt the shocking at the generator site, not the electrode site. The patient felt like the generator had fallen down and to the left. The patient¿s mother felt a buzzing when she touched the patient¿s chest. The patient was seen in the er for this and a bloody nose. Per the patient¿s mother, the patient was having double seizures: a gtc seizure followed by another one a few minutes later. This happened three times since the device began to malfunction. At a previous visit, the device was programmed off, but the symptoms persisted. Give the patient¿s history of psychiatric overlay, it was unclear if this was an actual dysfunction of the device or another manifestation of psychiatric diagnostic. On (b)(6) 2013, it was reported that the patient¿s device was disabled on (b)(6) 2014 due to the shocking sensations; however, it was also reported that it was disabled due to random activations reported in manufacturer report number: 1644487-2013-03481. On (b)(6) 2013, it was reported that the generator had migrated. It was also reported that this vns patient was beaten by her ex-boyfriend. Since that time, the generator has migrated, and she has been feeling ¿shocking¿ sensations with stimulation. Per the patient, the physician could not disable the device; however, it was confirmed the device was disabled. On (b)(6) 2014, it was reported that the patient¿s device was disabled but was still shocking her. The patient was only titrated up one time since implant, which is likely the reason for lack of efficacy. The patient was referred for an eeg. There was no high lead impedance. Clinic notes dated (b)(6) 2014 were received which indicate that around christmas, the patient was beaten up by her boyfriend at the time. Per the notes, the patient was beat so severely that she has had trouble with the vns since. The patient says the generator will shock her at times and there has been difficulty turning the device off. The notes state the incisions appear to be well healed and there is no evidence of infection. The generator does not appear to be off and does not appear to have any gross malfunction to it. However, when the patient swipes the magnet she experiences coughing as well as a change in her voice. The generator was interrogated again and seen to be turned off, so the physician states that it is unclear what is happening, but the patient is experiencing symptoms. The physician states that they will keep the device off for now, and consider replacing the generator. Surgery is likely, but has not occurred to date.
 
Event Description
The patient reported that she can see the lead protruding under her skin when she bends over. It was reported that the patient underwent generator replacement on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3597907


Title: Re: Chest Pain
Post by: dennis100 on August 07, 2015, 04:19:01 AM
Model Number 105
Event Date 06/19/2015
Event Type Injury
Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2015. The patient had come in for chest pain and had an increase in seizures. It was requested that a company representative come and program the vns device off in order for the patient to have an mri. It is unknown if there is a relationship between the chest pain and the vns device. It is also unknown if there is a relationship between the increased seizures and the vns device. It was also reported that the patient was transferred to a different hospital. It is unknown why the patient was transferred. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4916205


Title: Re: Chest Pain
Post by: dennis100 on September 04, 2015, 06:35:58 AM
Model Number 105
Event Date 07/13/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient visited the er as she was experiencing an altered perception of stimulation as it was stated she could feel it, go off, every 30 seconds; however, the patient claimed the neurologist had set the device to go off every 3 minutes. It was also noted that this stimulation was painful. During this visit to the er, she was given ativan for her anxiety. The patient visited the er the following day with the same complaints. She also stated the ativan was not helping; however, later she states that she felt much better after her shot of ativan. The patient then stated that she does not usually have an aura, but she now has a sense of smell and burnt toast almost all the time recently. It was also reported that the patient has some discomfort earlier in her chest radiating to the left shoulder. There was no additional information on the chest pain other than it was not related to exertion or breathing. The patient's pain was treated with dilaudid. It was noted that the patient's device has been checked several times since it was implanted in (b)(6) of 2014 and there have been no issues. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5005006


Title: Re: Chest Pain
Post by: dennis100 on October 09, 2015, 01:37:45 AM
Model Number 102
Event Date 11/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was in clinic back in (b)(6) with chest pain. The patient has had recent x-rays and the radiologist said that the device had moved down under the armpit and is pushing on a nerve which now causes pain in the patient's neck. The generator battery was reported to have reached end of service sometime in 2013. A battery life calculation was performed with the available data and assumptions were made for any gaps found if present. The result revealed 0. 0 years remaining until eri = yes. Additional information was received that the patient's device was unable to be interrogated in (b)(6) 2015 due to end of service. The pain had been occurring for the previous 6 months. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5109770


Title: Re: Chest Pain
Post by: dennis100 on December 04, 2015, 12:15:07 PM
Model Number 103
Event Date 11/19/2012
Event Type Injury
Event Description
It was reported that the patient started experiencing pain in the chest shortly after vns was implanted. Patient also experiences neck pain that came recently, which is associated with stimulation. Patient disabled the device using the magnet and the device was programmed off by the neurologist office on (b)(6) 2015. Additional information was received that the patient started to have pain on (b)(6) 2015 after he suffered a bad fall from a seizure. Patient was seen on (b)(6) 2015 by the nurse and diagnostics were checked. The lead impedance was reported to be within normal limits. Patient was however referred for surgery to remove the device due to the pain. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5212587


Title: Re: Chest Pain
Post by: dennis100 on December 04, 2015, 12:15:44 PM
Model Number 106
Event Date 09/02/2015
Event Type Injury
Event Description
It was reported that the patient's incision has not healed completed since vns implant. Clinic notes dated (b)(6) 2015 note that the patient returns with concerns with her incision. It was noted that the patient experiences pain in the left chest and neck following activation of vns therapy. The patient developed a redness and hypersensitivity over both the generator and lead incisions and appears to be having a site reaction to the sutures. The patient was given bactrim ds and norco for the pain. The patient was advised to use dry heat to the chest wall. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5199270


Title: Re: Chest Pain
Post by: dennis100 on December 04, 2015, 12:16:15 PM
Model Number 105
Event Date 10/15/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that the patient had erratic stimulation. The patient had pain felt in the chest and the device seemed to drain the patient and make him tired. The output current was only 0. 75 ma and pulse width 130 and signal frequency 15. According to the patient this has been occurring for quite some time. Diagnostics are within normal limits and the physician has referred him for battery change to obtain the new m106 device as soon as possible. From the referral notes received, it appears that the referral is to replace prophylactically to help with the erratic painful stimulation and fatigue. Surgery is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5212316


Title: Re: Chest Pain
Post by: dennis100 on December 14, 2015, 03:56:35 AM
Event Date 09/19/2014
Event Type Injury
Event Description
It was reported that the neurologist noted redness at the generator site and thought the surgeon should order antibiotics. The patient denied pain or drainage but indicated that the generator site was warm. The patient later reported that she was seen by her primary care physician for an upper respiratory infection and that the antibiotics she was given for that also decreased the redness to the generator site. The patient has been applying neosporin to the incision sites and the chest incision is now light pink and no longer feels warm.

Manufacturer Narrative

Event Description
Additional information was received stating that the patient went to the er on (b)(6) 2014 due to chest pain associated with stimulation. The er physician was advised to use the magnet to temporarily disable the device. Further follow up with the physician's office indicated that the patient had recovered from infection on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262265


Title: Re: Chest Pain
Post by: dennis100 on December 15, 2015, 02:36:44 AM
Model Number 102
Event Date 09/23/2014
Event Type Death
Event Description
It was reported that the patient had pre-existing cardiac issues and was 5'8" tall and over 300 pounds. The physician reported that the cause of death was not related to vns.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The patient was experiencing chest pain the night before his death but did not go to the hospital. The patient was found dead on his bed the morninig of (b)(6) 2014. The death certificate listed that caused of death as cardiac arrest due to acute myocardial infarction. The patient was buried with his device so no analysis can be performed. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4186604


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2015, 02:56:48 AM
Event Date 11/01/2013
Event Type Injury
Event Description
An article titled "perforated peptic ulcer in a child with a vagus nerve stimulator for seizure control" was reviewed. The article indicates that a (b)(6) year old male with a severe form of epilepsy presented with a perforated peptic ulcer. The patient presented to the emergency department with fatigue, decreased appetite, headaches and chest pain. There was no recent seizures activity, nausea, or vomiting. The patient subsequently underwent exploratory laparotomy, which demonstrated a perforation of the anterior aspect of the duodenal bulb. It was noted that the patient subsequently recovered and was treated with a proton pump inhibitor for acid suppression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3939274


Title: Re: Chest Pain
Post by: dennis100 on December 18, 2015, 12:44:21 PM
Model Number 103
Event Date 06/05/2014
Event Type Injury
Event Description
It was reported that the vns patient¿s generator had migrated toward the anterior axillary line. The patient had been experiencing some pain at her generator site. The patient did not have any fever, abrasions, or discoloration; however, the patient felt her generator was protruding into her armpit. The generator incision had healed well and the device was still functioning as expected. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
On (b)(6) 2014 it was reported that the patient had pocket revision surgery to correct the pain in july 2014 but that the pain started again recently. Now the patient is experiencing a headache, chest pain, and pain on the left side of the neck. The patient was referred for x-rays. The patient saw the neurologist on (b)(6) 2014 complaining of pain and per the neurologist, the lead is protruding in the armpit area. The neurologist did not have a programmer to turn off the vns. The neurologist referred the patient for surgery as the patient wants the vns removed. Although surgery is likely, it has not occurred to date. On (b)(6) 2014 it was reported that the physician had the vns turned off due to the patient¿s complaints of pain radiating up her neck, migraines, and pain at the generator site. The settings prior to being disabled were noted to be current output: 0. 25ma/frequency: 15hz/pulse width: 250usec/time on: 30 sec/time off: 1. 1 min/magnet output: 0. 50ma/mag time on: 60 sec/mag pw: 500usec. System diagnostics test was performed which showed lead impedance: ok/impedance value: 3647ohms/ifi: no. Attempts were made for further information but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3906342


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2015, 03:42:17 AM
Model Number 102R
Event Date 01/23/2014
Event Type Death
Manufacturer Narrative

Event Description
The funeral home manager reported that there was no documentation indicating that the devices were explanted prior to burial.

Event Description
Additional information was received from the hospital where the patient passed away. The patient presented to the emergency room on (b)(6) 2014 with lower back pain and pleuritic chest pain. He was subsequently diagnosed with community acquired pneumonia and admitted. He was started on antibiotics and pain medication. When the patient was being moved to the nursing floor from the emergency department he became unresponsive with a heart rate in the 30s and blood pressure that could not be measured. He was given one dose of atropine, but the patient¿s pulse stopped and his skin grew cold. The patient was coded do not resuscitate so no further interventions were performed and he was pronounced dead. The cause of death was determined to be: 1) community-acquired pneumonia 2) bradycardia, hypotension, and cardiac arrest.

Event Description
It was reported that the vns patient passed away. The cause of death was not provided. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808898


Title: Re: Chest Pain
Post by: dennis100 on December 27, 2015, 05:18:21 AM
Model Number 103
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient reported the following: vns not working, chest pain, shoulder pain, migraine headaches, difficulty sleeping, memory loss, and that his vns is sticking out due to a weight loss of 300 lbs. Follow up with the physician found that it was unknown if there was a relationship between these events to vns and it is unknown why the patient believes the vns is not working. The nurse stated that the patient has other medical problems and has multiple complaints. Additionally, they do not know why the patient had the weight loss and if it was intentional or unplanned. No other information was known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3411788


Title: Re: Chest Pain
Post by: dennis100 on December 27, 2015, 05:19:02 AM
Model Number 102
Event Date 07/01/2012
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2012 were received which indicate that for the past few months, the patient has complained of intermittent severe, but brief pain in the chest wall. It was unknown if this was coming from the vns or not; however, the pain has been present since the last visit; however, no settings were changed in over a year. The patient's vns was interrogated and output current was decreased. Follow up with the physician found that the physician believes the pain is related to "battery fade" and expects the issue to resolve after the prophylactic generator replacement. Surgery is likely, but has not occurred to date.

Event Description
The patient underwent generator replacement surgery on (b)(6) 2014. The generator has not been received for analysis to date.

Manufacturer Narrative

Event Description
Additional information was received stating that the generator was replaced prophylactically. The explanted generator is not available for evaluation due to the facility¿s return policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3412985


Title: Re: Chest Pain
Post by: dennis100 on December 31, 2015, 01:57:46 AM
Model Number 102
Event Date 11/22/2010
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had a full revision in 2010 and since then has reported pain in both of her arms and chest/ rib cage area. The physician disabled the patient's vns device for a brief period; however, they could not determine the relationship to vns or if the pain was related to stimulation. It was also reported that the patient had an extreme allergic reaction to the anesthesia during the full revision, but the connection to vns and the reports of pain were unclear. The patient's last known settings were provided and it was noted that ifi = no. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
On (b)(6) 2013, the nurse from physician's office called back about the patient. She stated that the patient is still in pain. The patient was tested for infections, musculersclerosis, "everything", but everything turned out negative. It was reported that it was possible it could be pain syndrome, but the cause of the pain is unknown. On (b)(6) the patient's device was turned off; however, the patient was still experiencing pain. It was concluded that the pain was not associated with stimulation on times and the nurse stated that they could not see any relationship between the pain and vns. It was also reported that the patient had shortness of breath related to the vagus nerve. Physical therapy was suggested to the patient for thoracic syndrome and the nurse stated that they would be following up with that. The patient also has anxiety issues, which was a possible contributing factor, per the nurse. In regards to the allergy, the patient was given benadryl and referred to the primary care physician. There was no verification from physician's office that anything was done. The nurse clarified that the parent reported there was an allergic reaction, but there was no documentation to support that there ever was such a reaction. The only information the physician has on the allergy was the parent's report. The patient is experiencing pain in the knees, chest, and arms. There have been no medication changes or external factors (from a neurological standpoint) that would have caused or contributed to the event. No direct correlation has been found for the cause of the pain. The nurse stated that at this point everything is speculation. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194207


Title: Re: Chest Pain
Post by: dennis100 on January 01, 2016, 10:14:47 AM
Model Number 103
Event Type Injury
Event Description
An implant card was received that noted that the generator was replaced due to "malfunction".

Event Description
On (b)(6) 2013, the surgeon reported that he met with the patient that day and the patient complained of pain at the lead site in between stimulation, but not during stimulation. Follow up with the surgeon's office found that the patient complained of pain in the ear, neck, throat, and chest as well. There was no pain with stimulation, but it was stated that the patient sometimes feels as though there is a "lump feeling" in her throat. It was discussed that the patient would proceed with a battery replacement to see if this helps the pain. If not, lead revision surgery would be considered. It was unknown if the surgery was to preclude a serious injury or if it was for patient comfort. Surgery took place on (b)(6), 2013. Programming history was reviewed. The last available diagnostics and programming data was from (b)(6) 2012 which showed results within normal limits. No other information was provided.

Event Description
Additional information received from the patient¿s physician revealed that the patient has last seen on (b)(6) 2013 (three weeks after revision surgery) and was doing well at that time with no issues. The nurse at the facility stated that it was not confirmed that the device was malfunctioning, only that the patient was experiencing pain prior to surgery. The reason for surgery was the pain. The site did not have any additional information available.

Event Description
The explanted devices will not be returned to the manufacturer as the site will not return material per institution policy. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3145632


Title: Re: Chest Pain
Post by: dennis100 on January 02, 2016, 12:07:47 AM
Model Number 101
Event Date 04/15/2013
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the event reported was not vns related. Chest pain heart flutters. Start date of event was (b)(6) 2013. Device was off at the time related to being at or near end of battery life. The patient heart flutters were related to the patient having a low potassium level that caused a palpitation. No cardiac ischemia their chest pain resolved and was not vns related.

Event Description
It was reported that a vns patient reported that she was in the hospital with a heart attack 2 weeks ago. When questioned further, she reported that she just had chest pain. She stated that she has severe anxiety and her heart flutters sometimes. Good faith attempts are underway for further details about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129863


Title: Re: Chest Pain
Post by: dennis100 on January 04, 2016, 01:00:07 PM
Model Number 103
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
The ap and lateral chest x-ray report was provided by the physician¿s office which reported the patient had a history of chest pain. The vns generator was observed in the anterior chest walls with leads terminating within the left lower neck. No anomalies were noted by the radiology group. The patient had a prophylactic generator replacement surgery on (b)(6) 2013. The patient wanted the generator placed on the right side versus the left side (off-label). The explanted generator was received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The implant card reported the reason for replacement as prophylactic and confirmed the date of surgery as (b)(6) 2013. Lead impedance following surgery was okay.

Event Description
The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2012 with no further seizures noted since vns increased. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. Product analysis was completed on the explanted generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead impedance prior to surgery was within normal limits.

Manufacturer Narrative

Manufacturer Narrative
The first sentence was inadvertently listed the date as (b)(6) 2013 incorrectly on the initial report as it should have read as (b)(6) 2012. Additionally, the information in the second paragraph inadvertently reported the date of events incorrectly. This information was from clinic notes dated (b)(6) 2012.

Event Description
It was reported that he patient was referred for generator repositioning surgery due to the device shifting around. Follow up with the treating ent's office revealed that the patient was at the office on (b)(6) 2013. The patient has been complaining of pain for the last year or year and a half. The pain has been so bad that the patient went to the surgeon who decided to replace the device. The plan is due replace it on the right side of the chest, off-label because the patient's skin is so irritated. The patient has been wearing a lidoderm patch all the time, and it looks like the lead wires are too close to the skin so it's been rubbing. No patient psychological changes were mentioned, nor any patient manipulation or trauma. It is unclear why the device migrated as the nurse indicated that she does not remember this being a problem after the implant in 2008. The patient is unable to function due to the irritation and pain and the patient is left-handed. The nurse indicated that there is the possibility in the future that "it could come out of the device" (detachment of lead). Attempts for additional information from the surgeon have been unsuccessful to date. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. In clinic notes dated (b)(6) 2012, it was reported that the physician's assistant (pa) adjusted the vns to tolerability on (b)(6) 2012 where the patient miscommunicated with the pa. The patient reports not having tolerability issues and did not make the request. Additionally, the pa recommended having the vns removed-something not documented in her note. The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2013 with no further seizures noted since vns increased. Side effects were denied. However, the patient was noted to have "focal pain in the chest at the site of the vns implant that she treated with a patch. The source of this pain is not clear - it is not in the neck and is not associated with device activation, suggesting more of a mechanical process, perhaps related to scar tissue or to device movement or current leak. Interestingly, she notes increased pain at the implant site when she has a seizure, which does not make physiological sense unless she has increased sensitivity associated with her seizures. Her pain was not reduced when my former pa reduced her vns settings. She prefers not to make any major changes to her vns because she feels that it has made all the difference with respect to her seizure control. Overall, the patient is doing about the same since the last visit. The patient is satisfied with seizure control. The patient is satisfied with side effects. " chest pa and lateral x-rays were planned to assess vns placement and lead integrity. The plan was to adjust vns for tolerability after (b)(6) 2012. Clinic notes dated (b)(6) 2013 reported the patient had the vns adjusted at the last visit and the patient presented on (b)(6) 2013 reporting that everything was going well and was satisfied with seizure control. No pain was noted. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3038963


Title: Re: Chest Pain
Post by: dennis100 on January 05, 2016, 12:57:08 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported that the patient was explanted due to unknown reason. Additional information was received in the surgical consult notes that the patient had been having pain at the generator site. It is unknown if the explant was done due to the pain or if it was done to prevent a serious injury. The patient reported pain to another surgeon back in 2007 and wanted it removed at that time. The generator was returned to the manufacturer for evaluation. The generator was confirmed at end of service as result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Good faith attempt for additional information have been unsuccessful to date. No additional information is known by the physician's office.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3035041


Title: Re: Chest Pain
Post by: dennis100 on January 07, 2016, 08:02:47 AM
Model Number 102
Event Date 07/29/2012
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2012 indicated that this vns patient was diagnosed with a pulmonary embolism and pneumonia on (b)(6) 2012. The patient's device was interrogated on (b)(6) 2012 and found to be operating nominally and was not at end of service. (the patient had a seizure on (b)(6) 2012 that resulted in her going to hd. ) settings from (b)(6) 2012 were provided. A review of systems was positive for chest pain and irregular heartbeat/palpitations; however, the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Notes dated (b)(4) 2012 were provided. Notes on both dates indicated that the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995749


Title: Re: Chest Pain
Post by: dennis100 on January 08, 2016, 04:44:58 AM
Model Number 302-20
Event Date 11/23/2015
Event Type Malfunction
Event Description
It was reported on (b)(6) 2015 that this patient has high lead impedance. The patient had an appointment that day and upon interrogation of the device, a high lead impedance warning was triggered. The physician turned both the normal mode and magnet mode output currents to 0. 00ma. He will also refer patient to neurosurgeon for evaluation for possible full system replacement. The patient stated that in the last few weeks she has had painful stimulation (shocking feeling) in her neck and chest area. Although surgery its likely, replacement has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5293108


Title: Re: Chest Pain
Post by: dennis100 on January 08, 2016, 04:45:29 AM
Model Number 304-30
Event Date 10/19/2015
Event Type Injury
Event Description
It was reported that the patient was experiencing intermittent pain at the generator site. The physician instructed the patient to use the magnet to disable the device to see if the pain was related to device stimulation. The patient was later seen in the emergency room due to the pain and the mother claimed she could feel the device stimulation when touching the patient's chest. The nurse indicated that this may be muscle spasms. It was reported that the physician programmed the device off and then the patient suffered a seizure. The patient was referred to surgery for consult and then scheduled for surgery as the surgeon feels the device needs to be evaluated. The patient underwent exploratory surgery where a break in the lead tubing was identified. The surgeon indicated that there was fluid visible in the tubing. Device diagnostics were within normal limits. The neck incision was opened; however, the surgeon indicated that the vagus nerve was heavily scarred. The lead was cut and explanted along with the generator. The surgeon felt that the nerve was too scarred to implant another vns system and the patient's mother opted not to proceed with reimplant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5307942


Title: Re: Chest Pain
Post by: dennis100 on January 21, 2016, 08:50:02 AM
Model Number 103
Event Date 02/19/2009
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the physician reported that the lack of efficacy was first observed prior to becoming their patient. Clinic notes from (b)(6) 2012, were provided which stated that the patient had several episodes that day, one of which was a pseudoseizure. The patient stated that the vns is uncomfortable and would like it turned off. The patient is undergoing treatment for psuedoseizures. The patient's initial settings were output=1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 25ma/magnet on time=30sec/magnet pulse width=500usec. The patient was then disabled. Diagnostics showed the device to be functioning properly with output=ok/lead impedance=ok/impedance value=2764ohms/ifi=yes. Good faith attempts were made for the return of the explanted generator but it was reported to have been discarded in surgery.

Event Description
On (b)(6) 2012 it was reported that the vns patient had his vns removed on (b)(6) 2012 as the patient was experiencing a shocking sensation from the vns when he was at work where he was in close proximity to large magnets and he also felt the device was ineffective. It was previously reported on (b)(6) 2012 by a nurse who reported that the vns patient stated he was experiencing a shocking sensation in his neck intermittently since being implanted in (b)(6) 2009. The shocking sensation occurs with stimulation, every 3 minutes, but he has experienced periods since implant where the shock doesn't seem so bad (why she stated it was intermittent). The patient reported he went to the er and also saw his neurologist last week due to the issue. The generator was reported to have been programmed off on (b)(6) 2012 but the patient is still experiencing the pain. The nurse was who the patient had seen prior to moving, the patient now sees a different neurologist's office. The nurse informed the patient that he might not have fully turned off the device or the magnet current was left on. The nurse told the patient to see his neurologist again. The patient's wife later reported that the patient was being checked by the eeg specialist and when the device was interrogated both the normal mode and magnet mode were confirmed to be 0ma. The specialist also stated that the patient suffers from seizures as well as pseudoseizures. The patient had his magnet taped to his chest when he came in. The patient stated that he still feels pain at times even while the magnet was taped over his device. The patient¿s wife stated that the pain began on july 14, 2012. The wife didn¿t recall any event that may have caused it. She stated that the patient did have a seizure friday night or saturday morning but nothing else. She reports that the pain is in his chest and throat and is intermittent around every 5 minutes. She stated that they will follow-up with their neurologist. The patient¿s wife reported that they were referred to another neurologist because their neurologist is currently out of town. The physician has ordered pa/lateral of both chest and neck to assess the lead. Good faith attempts for additional information from the physician were made but were unsuccessful. The programming history database was searched and it contained programming history from date of implant, 2/19/2009, through 1/27/2011. No anomalies were noted. The patient was last programmed to output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min on 01/27/2011. Attempts for product return are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2805676


Title: Re: Chest Pain
Post by: dennis100 on January 22, 2016, 09:05:51 AM
Model Number 102
Event Date 07/01/2012
Event Type Malfunction
Event Description
It was reported that the patient was referred for a prophylactic battery change. The date of surgery is scheduled for (b)(6) 2013.

Event Description
New information received reveals that the vns generator was replaced due to prophylactic replacement. The generator was replaced with an m102 in (b)(6) 2013. An implant card was received on (b)(6) 2013 stating that the lead impedance was ok and the patient's vns generator was replaced due to prophylactic reasons. The product was returned to the manufacturer on (b)(6) 2013. Additional information from the physician stated that by 'device was not working' meant that the patient could not feel the stimulation. The increase in seizures and pain were observed on (b)(6) 2012. The last normal diagnostics was in (b)(6) 2013 which was output status = ok, lead impedance = ok, dcdc code = 5, eos = no. The physician attributed the increase in seizures to battery depletion and said that the pain is unrelated. According to the physician the increase in seizures is below pre-vns baseline and the partial seizures type is what increased. There were no medication, programming changes, and no pain associated with stimulation.

Event Description
Clinic notes were received in regards to a vns patient's device. It was reported via a clinic note dated (b)(6) 2012: that the patient was 'having more frequent seizures. Every other day. She thinks that she is having sharp pains in the left side of the body;' it is unknown the relationship of her seizures to her vns. It is unknown if over their pre vns rate. The patient states that she has been having a lot of seizures, occuring every day. She states that her chest has been hurting a lot and she has been swiping her magnet. The patient was set to: 1. 75 output current / 20 signal frequency / 130 pulse width / 30 seconds on time / 5. 0 minutes off time, 2. 00 output current / 60 seconds on time /130 pulse width. Neos = no. The patient's chest pain is described as : stabbing, intensity = 9, duration = constant. It was additionally reported that patient went to the hospital and that they felt their vns is not working and she thinks the battery has gone out. This has not been confirmed to be the case at this time. No surgical interventions are planned at this time. Good faith attempts will be made for further details about the reported events.

Event Description
Product analysis on the vns generator was complete. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative
Adverse event, corrected data: adverse event was inadvertently not checked. Outcomes attributed to adverse event, corrected data: required intervention to prevent permanent impairment/damage was inadvertently not checked.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2801789


Title: Re: Chest Pain
Post by: dennis100 on January 24, 2016, 03:51:23 AM
Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912


Title: Re: Chest Pain
Post by: dennis100 on January 25, 2016, 01:25:18 PM
Model Number 300-20
Event Date 08/30/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by manufacturer; no gross lead discontinuities visualized.

Event Description
On (b)(6) 2012, it was reported that a vns patient had a generalized tonic-clonic seizure the earlier day (date unknown). After the seizure, the patient experienced painful stimulation in her chest. The patient's diagnostics were output status: limit, impedance: high ((b)(4);10000 ohms), eos = no. The last known diagnostics, current settings, device disablement after the event, and product information were unknown. X-rays were going to be taken and would be sent into the manufacturer for review. The patient was being referred for a full revision. On (b)(6) 2012, the patient's nurse indicated that the patient's chest and neck x-rays were available and would be sent into the manufacturer for review. The nurse stated that x-rays were taken because the patient was seen the previous day, and upon running diagnostics, high impedance (b)(4);10,000 ohms) was observed. The nurse also indicated that the patient has had very few seizures since being implanted with vns; however, the patient had a generalized tonic-clonic seizure the previous week. For the past month, the patient experienced discomfort in her chest with stimulation. (this was not a shock-like sensation. ) the nurse stated that high impedance was first seen on (b)(6) 2012. It was stated that the device was not disabled. The patient was still experiencing her normal voice alteration; therefore, the device was not programmed off as it appeared that the patient was still receiving stimulation. When asked about manipulation or trauma, the nurse stated that when the patient first called regarding the discomfort, she indicated that she was dizzy. The nurse was pretty sure, but could not confirm, that the patient had fallen at that time, which could explain the dizziness and the painful stimulation. Additional information was received with the patient's x-rays. On (b)(6) 2012, the patient had a partial complex seizure at 14:10 and had a grand mal seizure at 15:10. The patient felt pretty beat up: the patient bruised up her shoulder and back. The patient was evaluated in urgent care and was told that there were no fractures, only bruise. The patient denied any missed medication and no acute illnesses. On (b)(6) 2012, the patient reported dizziness and her medication was adjusted. On (b)(6) 2012, the patient reported that she had missed medications. Since (b)(6) 2012, the patient did not report dizziness and these were the first seizures since the appointment. The patient reported a "different" feeling regarding the generator. It was not a shock, but just different. The patient had a number of seizures since her last visit. The device was stimulation her voice but she felt a weight in her chest with stimulation. The seizures were possibly secondary to an automobile accident. The patient had significant ecchymosis and pain in the left upper arm and should from the fall on her should with the seizures. It was assessed that the patient had the gtc possibly secondary to a fractured lead on the vns. The x-rays were assessed and it was written that the vns wire appears to have a break or crack based on high impedance. Vns replacement including wires was likely. The device was interrogated and diagnostics were run. X-ray images were reviewed by the manufacturer. The generator was visible and appeared to be normally placed. The connector pins appeared to be fully inserted inside the connector blocks. The feedthru wires also appeared intact. The lead was also visible. Lead was present behind the generator. There were no suspect fractures, discontinuities, or sharp angles visible. The lead wires appeared intact at the connector pins. The patient underwent total revision on (b)(6) 2012. The explanted generator and lead were received on (b)(6) 2012 and are currently undergoing product analysis. The returned product form indicated that the lead was explanted due erosion of the lead and parasthesia in the chest.

Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Product analysis on the generator showed that the high impedance noted in the lead section was not duplicated in product analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death or serious injury.

Event Description
Additional programming history was reviewed on (b)(6) 2012. High impedance was first seen on (b)(6) 2012. Impedance values and output status varied with diagnostics.

Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769777


Title: Re: Chest Pain
Post by: dennis100 on January 26, 2016, 03:49:52 AM
Model Number 102
Event Date 11/23/2011
Event Type Injury
Event Description
Additional information was received from the surgeon's office indicating that the patient will be monitored, and no interventions are planned at this time. The surgeon's office indicated that if the generator moves more, or if the patient reaches end of service, interventions will be planned if necessary. The surgeon's office was unaware of any manipulation or trauma to the device and indicated that the migration was gradual and appeared to have occurred over a long period of time. The patient was told to keep in touch with the surgeon's office if any additional migration occurred, however they have not heard back from the patient to date. No additional information was provided.

Manufacturer Narrative

Event Description
It was reported that the patient was experiencing some pain caused by generator migration in her chest. The surgeon indicated that the patient's recent diagnostics were all ok; however, the exact results were not provided. The surgeon indicated that she was considering revision, however, no information was provided as to whether the revision would be for patient comfort or to preclude a serious injury. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2382612


Title: Re: Chest Pain
Post by: dennis100 on January 26, 2016, 07:53:31 AM
Model Number 100
Event Date 09/13/2012
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that this patient would be undergoing explant surgery due to pain at the chest and lack of efficacy. The patient underwent explant surgery on (b)(6) 2012. The device was reportedly implanted in 2000. Attempts for additional information and product return have been unsuccessful.

Event Description
On (b)(6) 2012, it was determined that the product was disposed of per hospital policy. Product information was also obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2777683


Title: Re: Chest Pain
Post by: dennis100 on January 27, 2016, 10:24:41 AM
Model Number 103
Event Date 08/15/2012
Event Type Injury
Manufacturer Narrative

Event Description
A vns programming physician reported that he had a vns patient who was having painful stimulation in the chest and throat area. The event was reported to have started after they had a mammogram performed. The patient's pain is just during stimulation on times only. It was reported that their device had different timings. It was reported to their physician that their friend documented that the patient has had stimulation times of 7, 19, and 30 seconds. It did not happen every time. The patient is programmed to 2. 5/20/130/7/3. 0 and 2. 5/30/130. The patient was at 3. 5 before the mammogram but could not tolerate this so their output current was lowered to 2. 5ma. The diagnostic results were around 2900 ohms each time the diagnostics were performed. Four tests were performed with the patient's neck in different orientations which all resulted in 2900-3000 ohms. The patient has a port o cath on the left hand side of their chest so the implant is actually on the right hand side but connected to the left vagus nerve. With the patient's lowered therapy she started to have seizures and were attributed to the lowering of their therapy in relation to their pain event. The patient was sent to surgery with the intentions of a full revision. The patient only had a battery change under local anesthesia and with the device programmed off they were still experiencing some pain. It is questioned if this was a psychological issue. The patient did just have surgery so some pain would be expected around this time. The explanted product is being returned for analysis.

Event Description
The patient's explanted product has not been returned at this time. It needed to go to risk management. It is unknown if it will be returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739814


Title: Re: Chest Pain
Post by: dennis100 on January 30, 2016, 02:48:12 AM
Event Date 05/27/2008
Event Type Death
Patient Outcome Death;
Event Description
Initial reporter indicated that they had some explanted vns products to return on a pt that died. It was not known the cause of death. Reporter indicated that "an autopsy was done in 2008 and heart looked soft, spongy, could not find anything. Ruled out a brain aneurysm, did not have this. Pt had chest pain 2 days before the date of her death. She went to the hospital and they sent her home. Has been having seizures for about 1 month. Was 6 months pregnant. Pt's spouse reported she had 2 seizures the night before and the am of her death. Spouse returned from work and found pt face down on the floor, fell out of the bed". The pt had been seen by their treating physician 10-14 days before their death, but did not report any health issues to them. Good faith attempts have been made to get the explanted product back for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1065451


Title: Re: Chest Pain
Post by: dennis100 on February 01, 2016, 02:03:02 AM
Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
Lead product analysis was approved on (b)(6) 2012. The lead assembly was returned for analysis. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. A section of the lead assembly was returned for analysis in two pieces. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Inspection of the first portion of the returned lead showed that setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. An abrasion was identified on the connector boot. The lead assembly appears to have been cut at near the end of the connector boot. The lead coils are cut/torn at this location. Inspection of the second portion of the returned lead showed that abrasions most likely caused by the presence of a tie-down were identified. Abrasions were identified on the outer silicone tubing at multiple locations. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the ends of the returned lead portions. Generator pa was approved on (b)(6) 2012. The generator did perform according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). Testing demonstrated proper device functionality (in both programmed and "on-demand" operational modes) including outputs that meet specifications. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. No performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2012, this vns patient reported that she was hospitalized last month due to incontrollable seizures. The patient reported that problems with device pain began around (b)(6) 2012, and the problems have continued. The patient reported that she had a stroke last month and is unable to move her left arm and left leg. At the time of the report, the patient was receiving physical therapy in her home. An mri was likely to rule out stroke. The patient underwent generator and lead explant on (b)(6) 2012. The electrodes were not removed as they were scarred in. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis.

Event Description
On (b)(6) 2012, this vns patient reported that a surgeon would be removing the generator and "snipping" the leads. The patient was unsure if she would be undergoing explant or revision. The patient last met with her neurologist (b)(6) months ago ((b)(6) 2012), at which time the settings were increased. The patient reported that she was having some pain in the neck (like it was poking through), throat tightening, continuous pain in the chest, the generator moving around in her chest when she lays on her side, and tingling in the arm and hands, which causes her to not lift her arm. The patient stated that the issues began one and a half months ago ((b)(6) 2012). The patient stated that the only traumatic incident that occurred just prior to the events was getting her hair washed in the sink at the hair dresser. The patient stated that the positioning may have pulled on her device or positioned her in an awkward way. The patient met with her neurologist's pa (physician's assistant) and was prescribed pain medication to which the patient had an allergic response. The pa referred the patient to the surgeon because her "device was messed up" and was causing these issues. The patient stated that no diagnostics were performed at this time. Attempts for additional information are underway.

Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
The physician did not believe the patient's stroke was related to vns.

Event Description
On (b)(6) 2012, the surgeon and patient reported that following information: the pain in the neck, lead protrusion, and pain in the chest began shortly after the vns surgery. The patient bent down to get something and injured her back. The physician stated that the back pain is not related to the vns, and it was probably a coincidence that it occurred close to the date of surgery. The throat tightening began after the patient's settings were adjusted by a physician in another state. The neurologist adjusted the pulsewidth, and the throat tightening ceased. The tingling in the arms and hand occurs when the patient lies on her left side. The patient reported experiencing feeling this for some time but did not have an exact date. The patient reported lateral migration of the device and stated that it was sitting on her right pectoral muscle. The patient experiences pain from this when moving her left arm. The patient did not know on what this date event began. The pain in the neck, lead protrusion, and pain in the chest were reported to have no relationship to vns. The throat tightening was experienced with stimulation; however, reducing the puslewidth resolved this issue. The tingling was reported due to the lateral device migration interventions for the generator migration included a referral from the surgeon to revise the generator to a newer model and move the generator. No interventions have been planned for the tingling. Aside from the throat tightening due to increased pulsewidth, no causal or contributory programming changes, medication changes, patient manipulation, patient trauma, or physiological changes (i. E. Weight loss) preceded the pain in the neck, lead protrusion, pain in the chest, tingling in the arms and hands, and generator migration. The patient has no history of pain in the neck or chest, throat tightening, or tingling pre-vns. It is unclear if a non-absorbable suture was used to secure the generator fascia during implant as the surgery was performed at another facility. Normal mode and system diagnostics indicated "ok" lead impedance and that the battery was not at end of service. The reference the patient made to the generator being "messed up" was clarified by the surgeon. The surgeon reported that it is likely that the pain she is experiencing is due to device size and migration and is recommending the device be replaced with a 103. The patient's output current was reported to be 0. 75 ma. The surgeon also recommended a revision from a model 102 generator to a model 103 generator and movement of the generator placement. The patient reported that the device was helping and that she did well at settings from her previous physician; however, her current physician has reduced the settings, and, as a result, she is experiencing more seizures. Additional information was received on (b)(6) 2012, that the patient's increase in seizures was below the pre-vns baseline. On (b)(6) 2012, the implanting surgeon confirmed that a non-absorbable suture was used during the initial implant of the device. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597650


Title: Re: Chest Pain
Post by: dennis100 on February 02, 2016, 07:05:51 AM
Model Number 102
Event Date 04/19/2012
Event Type Malfunction
Event Description
The patient underwent a generator revision on (b)(6) 2012. The generator will not be returned as it has been discarded by the hospital. Additional information was received indicating that prior to the replacement the patient had his device disabled for a short period of time, but that the generator was re-enabled to lower settings because the patient started having more seizures due to not receiving therapy. It was also indicated that the vomiting was not believed to be related to the device, just medication that the patient was given in the hospital. The patient's settings prior to the revision were provided, however no diagnostics were made available. The patient has reported feeling much better since the revision. Attempts for additional information have been unsuccessful to date as the site has not provided any additional information.

Event Description
It was initially reported by an er physician that the patient was complaining of painful stimulation to the neck and chest area that began on (b)(6) 2012. No trauma or manipulation to the device was suspected, but the er doctor did not have programming equipment to check the device. Additional information was then received from the patient's caregiver indicating that, the patient felt like the inside of his neck where the wires were felt like it was "burning and the stimulation kept staying on". This was when they went to the emergency room. While at the er, the magnet was taped over the device in an attempt to disable it. However the caregiver reported that it did not stop the stimulation still feeling like it was shocking him. She indicated that the device stayed on and the patient began to vomit. They then removed the magnet and gave the patient some pain medications. It was later reported that following this incident, the patient spoke with a representative on (b)(6) 2012 and indicated that he had thought of suicide and also killing someone else. He also mentioned to the representative that he was having dreams about crows coming down and eating his muscles. The patient was seen by his physician and has been referred for a generator replacement procedure and exploratory surgery. Attempts for additional information have been unsuccessful to date. Revision is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2578791


Title: Re: Chest Pain
Post by: dennis100 on February 03, 2016, 10:32:28 AM
Model Number 302-20
Event Date 10/01/2011
Event Type Malfunction
Event Description
It was initially reported on (b)(6) 2012, that a patient presented high lead impedance on systems diagnostics (7/limit/high/no) during a routine office visit. The patient had some chest pain with stimulation that began a few weeks prior to the office visit. There were no reports of trauma or manipulation. The patient was no longer able to feel stimulation in her neck. The last acceptable diagnostics were (b)(6) 2011, on systems that resulted in ok/ok/2/no and ok/ok/4/no on normal mode. The patient's current settings are 2. 25/30/750/21/3/0/750/60. The patient began to experience an increase in depression since december however it is below baseline levels and the physician believes it is due to the high lead impedance. There were no recent changes in settings, medications, or lifestyle. X-rays were taken and sent to the manufacturer for review. No lead discontinuity was found however there was a portion of the lead is behind the generator and continuity in that portion of the lead cannot be assessed. Clinic notes were received dated (b)(6) 2012, where it was noted that the patient had gradually increasing depression from (b)(6) 2011. Adjustments to the patient's medications were being made at the same time so the patient was not alarmed however the patient began to notice her depression worsening with an increase in manic episodes with rushed thoughts and speech along with a mild spending spree. The patient also had one episode of self-mutilation were she cut her left forearm however there were no current thoughts of self-harm. The self-mutilation is part of the patient's depression as well as the mania. When the depression is worse, these events are more pronounced. The patient does have a history or mania as well as self-harm prior to being implanted with vns. The patient was referred to a surgeon for an appointment on (b)(6) 2012, for evaluation prior to lead replacement. It is unknown when/if revision surgery will occur at this time. In notes dated (b)(6) 2012, it stated that the patient had some mild discomfort in her left chest and no longer had pain in her throat with device stimulation. The chest pain was described as sharp and would increase whenever the physician's assistant pressed on the generator. The device was programmed off on (b)(6) 2012.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but cannot be confirmed as the device remains implanted in the patient and analysis is not possible at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2536485


Title: Re: Chest Pain
Post by: dennis100 on February 08, 2016, 07:47:52 AM
Model Number 102
Event Date 01/04/2016
Event Type Injury
Event Description
It was reported on (b)(6) 2016 from a hospital nurse that the patient is having chest pain and headaches with vns stimulation. She was admitted to the hospital on (b)(6) 2016. She also reported increased seizures. Blood tests showed that her medication levels were low, and her dilantin was increased as a result. The nurse who reported these events stated that she did not know if the increase in seizures was due to low medication or due to the pains from the device. It was recommended that the patient follow-up with her neurologist; however, follow-up with the neurologist was unsuccessful as the patient has not seen to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5393091


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2016, 08:28:22 AM
Model Number 102
Event Date 11/07/2011
Event Type Injury
Event Description
Reporter indicated a patient had the vns generator explanted on (b)(6) 2012 due to constant pain at the generator site in the chest and neck which was felt to be due to the presence of the device. Previously, the reporter felt the pain was not due to the vns but to the patient's psychiatric problems. No infection was present per the reporter. The patient has had no trauma and does not manipulate the vns. The pain began on (b)(6) 2012, and was not related to vns stimulation. No causal or contributory vns programming changes, medication changes, or other external factors preceded the onset of the pain. The vns was programmed off prior to explant and the reporter stated he does not feel there is a vns malfunction occurring. Attempts to the reporter to confirm if the vns was explanted to preclude a serious injury or for patient comfort are in progress. Attempts for return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2514808


Title: Re: Chest Pain
Post by: dennis100 on February 11, 2016, 02:49:15 AM
Model Number 102
Event Date 04/01/2011
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2011 were received for a vns patient which revealed that the patient had previously had a stroke. The patient was reportedly "recovering okay from the stroke. " the patient requested on this clinic visit for the vns settings to be increased. In the notes dated (b)(6) 2011, the stroke was mentioned again, and it was also noted that the patient has left hemiparesis. It may be assumed that the patient was hospitalized for the stroke, but it is unknown if any additional interventions were taken. Attempts for additional information regarding these events from the physician have been unsuccessful to date. In addition, attempts to medical records to obtain product information have been unsuccessful to date.

Manufacturer Narrative
(b)(4). Device manufacturer date:the initial report did not include the specific device information.

Event Description
Additional information was received from the neurologist on (b)(6) 2012 which revealed that the stroke and left hemiparesis were first observed in (b)(6) 2011. The neurologist doubts there is any relationship between vns and the patient's stroke and let hemiparesis. The relationship of the patient's chest pains to vns is unknown. No causal or contributory programming or medication changes preceded the onset of the events. No additional information was provided. The neurologist wants to replace the patient's vns generator due to end of service as reported in manufacturer report #: 1644487-2012-00784.

Event Description
The patient's implanting facility health information department provided the patient's product information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2492977


Title: Re: Chest Pain
Post by: dennis100 on February 14, 2016, 11:01:54 AM
Model Number 102
Event Date 12/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received from the treating nurse indicating the reason for the reported pain was unknown and was not associated with vns stimulation. The pain was reported to have been located in the chest area and even some in the neck and left arm. Diagnostics at the time were within normal limits. Moreover, the nurse reported the patient's seizures increased; however the patient is noted to have an increase in seizures yearly. Analysis was completed on the returned generator. Analysis of the generator indicated pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description
It was reported by a nurse that a vns patient was explanted due to local pain and sensibility. The patient was reported to have an increase in seizures after explant; however the patient's pain resolved after explant. The explanted generator was returned to the manufacturer and currently undergoing analysis. Good faith attempts to obtain further information from the treating nurse have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465722


Title: Re: Chest Pain
Post by: dennis100 on February 15, 2016, 04:03:20 AM
Model Number 302-20
Event Date 01/23/2012
Event Type Malfunction
Event Description
Additional information was received indicating that the high impedance was first observed on (b)(6) 2012 and the pain was first observed in (b)(6) 2011. No manipulation or trauma suspected and the physician indicated that the pain was not occurring with stimulation. The cause of the pain is unknown, as is its relationship to vns. It was stated that the vns has been programmed off; however programming history was not provided. It was also indicated that x-rays were taken, however they have not been sent to the manufacturer for review.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient had high impedance with an ohms value >10,000ohms. It was indicated that the physician would likely disable device and send the patient for x-rays. The patient was also experiencing chest pain at the generator site, but it was unknown at the time of the report if the pain was related to the high impedance and/or occurring with stimulation. Attempts for additional information have been unsuccessful to date. Revision is likely however it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2461712


Title: Re: Chest Pain
Post by: dennis100 on February 16, 2016, 03:40:03 AM
Model Number 302-20
Event Date 01/09/2012
Event Type Injury
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the vns patient had a full revision surgery that day. The hospital discarded the explanted lead and generator after the surgery therefore product analysis cannot be performed on the devices.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the lead impedance after the patient's full revision surgery on (b)(6), 2012 was reported to be within normal limits. The implant card from the surgery stated that the reason for the revision was a lead discontinuity; however follow-up with the surgeon revealed that no lead discontinuity was seen during surgery. The neurologist had previously reported that he had suspected a lead break due to the patient's painful stimulation although diagnostic results had shown the device to be functioning properly.

Event Description
On (b)(6) 2012 a vns treating physician reported that the vns patient felt painful stimulation in the neck and chest area. The patient was previously set at 1. 5/30/500/30/3. The diagnostics showed ok/ok/2260 ohms. He also ordered x-ray but did not find anything unusual about the lead but he suspected a lead fracture somewhere. When he lowered the patient to 0. 75 ma and 250 us pulsewidth the patient was feeling ok. The physician said the patient did not have any medication changes prior to the onset of the event. He also said patient did not report any trauma or manipulation of the device to him. The physician's nurse reported that the patient was experiencing an electrical shock for a couple of weeks. The physician performed diagnostics which showed results within normal limits. X-rays were ordered and the physician stated that no abnormalities were observed. The physician's nurse later reported that the patient was seen a couple of weeks ago because he started to feel a shocking sensation and high degree of pain during stimulation around the chest area. The physician turned the device off and the pain was gone. The nurse stated that before last week's visit, the patient wasn't seen since november 2011 where diagnostics back then were within normal limits as well as last week's visit. The patient was referred for a full revision surgery due to the painful stimulation. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2453229


Title: Re: Chest Pain
Post by: dennis100 on February 17, 2016, 01:45:03 AM
Model Number 101
Event Date 01/04/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported a nurse that a vns patient experienced pain at the generator site due to unknown reason and wishes to have the generator removed. Further information was received from the nurse indicating the patient does a lot of manual work which in turn causes trauma to the chest area and provokes local chest pain. The most recent system diagnostics are within normal limits (no specifics). At the moment generator removal surgery is likely but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2436590


Title: Re: Chest Pain
Post by: dennis100 on February 19, 2016, 04:56:58 AM
Model Number 102
Event Date 12/20/2011
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns patient wants his device explanted due to painful stimulation in his chest just above the generator. The patient is not currently seeing a psychiatrist for his vns and consulted directly with the surgeon for the removal of his vns. The surgeon does not know when the pain first started and was not able to provide any further information. A battery life calculation was performed with the programming history available which revealed 2. 9 years until the elective replacement indicator (eri) shows yes. The explant surgery took place on (b)(6) 2011 and the explanted lead and generator were returned for product analysis on (b)(6) 2012 that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2413731


Title: Re: Chest Pain
Post by: dennis100 on February 20, 2016, 01:01:36 AM
Model Number 302-20
Event Date 12/01/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012, when the explanted lead and generator were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead was completed on (b)(6) 2012. During the visual analysis the electrode coil appeared to be broken near the electrode bifurcation area. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The coil showed characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Event Description
On (b)(6) 2011, a physician reported that the vns patient has high impedance. The physician reported that they discovered the high impedance from a recent report from the patient's psychiatrist. The patient has also been experiencing painful stimulation in her chest described as almost a shocking sensation. The patient also reported that she feels that her generator has migrated and the patient's depression has worsened. The physician did not know the relationship of the increase in depression to pre-vns baseline levels. No interventions had been planned at that point. The patient's settings were disabled that day but were previously at output=0. 25ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=5min/magnet=0ma. The system diagnostics showed output=limit/lead impedance=high/dcdc=7/eri=no. X-rays were received by the manufacturer on (b)(6) 2011. Based on the x-rays received, the cause of the high lead impedance could not be identified. The lead pin appeared to be fully inserted into the connector block, and there did not appear to be any sharp angles or discontinuities in the visible portions of the lead. However, an unpronounced lead discontinuity cannot be ruled out. A battery life calculation was performed which showed 7. 32 years until elective replacement indicator (eri) shows yes. Although surgery is likely, it has not yet occurred. Additional information has been requested from the physician but no further information has been received to date.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient was scheduled for a full revision surgery. The surgery took place on (b)(6) 2012. The leads were replaced due to high impedance, but the generator was replaced for prophylactic reasons. Attempts were made for the return of the explanted lead and generator but they have not yet been received.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2391601


Title: Re: Chest Pain
Post by: dennis100 on February 22, 2016, 04:11:53 AM
Model Number 300-30
Event Date 12/02/2011
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2387860


Title: Re: Chest Pain
Post by: dennis100 on February 25, 2016, 07:18:15 AM
Model Number 102
Event Date 08/11/2011
Event Type Injury
Event Description
Further information reveals that the patient has fibromyalgia and other problems, so her personality changes quite a bit and she blames things. The patient also had an ear infection that has been treated. Recent diagnostic tests were normal and ok (system and normal mode). Her vns settings have been the same since she's had it, once it reached a therapeutic dose. Nothing has changed with her other than her other non-vns related issues. There has not actually been an increase in seizures, she just had one. She said she has not had any seizures in 6 months, and this seizure was believed to be due to the ear infection and sickness. It is unknown whether chest pain is due to stimulation. The patient taped the magnet over her chest for days and had no stimulation, but said she still had the pain occasionally. The physicians do not know what the pain is from, possibly anxiety. It is unknown what kind of suture was used to secure the generator. The patient had previously indicated that a horse fell on her, but diagnostics were normal after that event. No patient manipulation of device has occurred. No interventions have been taken.

Event Description
Additional information was received that they have tried to increase the patient's settings but she developed ringing in her ears. The patient reported that her vns has been moving. About a year ago she was run over by a horse and has had issues with vns since. She was in the hospital for concussion. It was reported her lead was ok. She was seen by a surgeon and the generator for the device has become dislodged from the subclavicular area into her left breast. This is causing tension on the implant wires and the device is quite painful within her breast. She feels the device is still functional and she can feel when it activates with temporary hoarseness. Fiberoptic laryngoscopy shows normal true vocal fold movement. She does have some baseline hoarseness and she does smoke. Her seizures have been under much better control with the device. If the patient has surgery they will attempt to create a new pocket higher on the chest and secure the implant to the pectoralis fascia. At this time surgery is not scheduled.

Event Description
The patient's generator was confirmed to have migrated during revision surgery. The suture attaching the generator in the pocket had become dislodged likely when the patient fell off their horse. The product analysis was completed on the patient's explanted lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the explanted generator. Although the reported allegation of "painful stimulation", "increased seizures", and "pain" cannot be evaluated in the laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, addressing the allegations of "painful stimulation" and "pain". In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
Additional information was received from the patient. She reported that diagnostics had been run on her vns since her horse accident. She reported that one time they were inconclusive and then the next time they were fine. She also mentioned that sometimes she has a pain with stimulation and then at times the magnet doesn't always work and she has to swipe it twice. The patient had a prophylactic replacement of their lead and generator. Their explanted products were returned for analysis and they are pending completion. The patient's voice alteration was a preexisting condition, but she still had it with vns stimulation as well.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

Event Description
It was reported that the patient was feeling a "shocking feeling" in chest near generator when sleeping on side. Per patient, a horse fell on her, and she had an x-ray in (b)(6) 2010. Further information reveals that the patient also has pain in her neck and chest below the neck and has experienced an increase in seizures recently. Per reporter, the lead was checked awhile ago and everything was okay. The patient later went to the er due to the pain and she feels her generator is moving around. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353195


Title: Re: Chest Pain
Post by: dennis100 on February 26, 2016, 03:44:39 AM
Model Number 102
Event Date 10/17/2011
Event Type Injury
Manufacturer Narrative

Event Description
All attempts for further information from the reporter have been unsuccessful to date. A vns battery life estimate performed with available programming history yielded approximately 11. 78 years remaining, indicating the generator is not likely at end of service.

Event Description
Reporter indicated a vns patient was hospitalized overnight due to chest pain. The next two days, he then was experiencing erratic vns stimulation. Vns diagnostics tests were reported as normal. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2342405


Title: Re: Chest Pain
Post by: dennis100 on February 27, 2016, 07:52:54 AM
Model Number 102
Event Date 09/01/2011
Event Type Injury
Event Description
Additional information was received that product analysis was completed on the generator. In the pa lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6), 2011 additional information was received when the neurologist's office reported that the patient was explanted on (b)(6), 2011. The hospital reported that they have the explanted devices but they are snowed under and will mail them to the manufacturer for product analysis as soon as they are able. The product still has not been received by the manufacturer.

Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis is completed on the lead but has not been completed on the generator. Note that the majority of the lead assembly (body) including the electrode section was not returned for analysis and, therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
It was reported that the pt is now wanting her device explanted due to her recent events. Reporter indicated that after the pt's recent settings adjustment on (b)(6) 2011, she started having some nausea. It appears that the issue wasn't immediately taken care of by the physician, so the pt then began to report tightness in her throat, chest pain, shortness of breath and then increase in seizures, so the pt went to the er where no cardiac issues found by the hosp or physician. It was indicated that the physician was frustrated with the pt since her issues appeared to be due to anxiety from the settings adjustment, so he disabled her device. When the device was disabled, all issues resolved, but the pt still wants device immediately explanted due the events. The physician does not want to explant, and would like to go back to the previous settings, but the pt is adamant about the removal, so the pt is being referred to a surgeon for explant. Reporter also notes that since implant, the pt was responding to stimulation and magnet activations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2328831


Title: Re: Chest Pain
Post by: dennis100 on February 27, 2016, 07:53:39 AM
Model Number 102
Event Date 10/01/2011
Event Type Malfunction
Event Description
On (b)(6) 2015 it was reported that the patient¿s vns was explanted. It was unknown when and where the surgery occurred; therefore, product return attempts cannot be made. Good faith attempts to the physician for further information were unsuccessful.

Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was reported that a patient's device could not be interrogated. The wand was repositioned several times and the programming system worked successfully on other patients a few days prior to this appointment however communication could not be established with this patient's device. The physician stated the last time the device was checked was about a year ago. The patient could feel stimulation in the neck and was having voice alteration with magnet stimulation. There was no increase in seizure activity. The patient was reporting some painful stimulation in the chest area over the past few weeks which led to the appointment. The wand battery was checked and was verified to be sufficient and the handheld device was not plugged into the wall. All cable connections were verified to be secure however the physician would obtain various warning messages indicating that communication with the patient's device could not be established. The physician was unsure as to whether or not the patient's device was at end of service and wanted to have the device checked again. It was suggested to the physician that the device be checked soon so there are no breaks in the patient's therapy if the device is at end of service. A battery life calculation was performed using the patient's programming history available in the manufacturer's programming history database which indicated the device was at or nearing end of service. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316948


Title: Re: Chest Pain
Post by: dennis100 on February 28, 2016, 03:30:28 AM
Model Number 102R
Event Date 04/04/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient was experiencing breakthrough seizures at the patient's previous visit. On (b)(6) 2012 the patient's generator was reported to have physically slipped about 1 inch downward and was causing the patient significant pain at the generator site. The patient was referred to a surgeon for evaluation and possible re-implant to fix the migration. Additional information has been requested from the physician but no further information has been received to date.
 
Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op normal mode diagnostics showed a dcdc code of 4 and lead impedance=ok. The patient's old settings were output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=2ma/magnet pulse width=500usec/magnet on time=60sec. The generator was relocated to the right side of chest per patient request. System diagnostic performed in or with new generator showed results within normal limits of dcdc=2/lead impedance=ok. The patient's device was turned on in the o. R. And programmed to output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted generator was returned to the manufacturer on (b)(4) 2012 for product analysis that is still underway and has not yet been completed.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2561466&pc=LYJ


Title: Re: Chest Pain
Post by: dennis100 on February 28, 2016, 03:31:24 AM
Model Number 102
Event Date 07/16/2011
Event Type Malfunction
Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. The explanted vns generator has been returned and is currently pending product analysis.

Event Description
Product analysis of the vns generator was completed. No anomalies were identified during the analysis and the generator performed per specifications. The generator was not at end of service.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated a patient had vns generator migration, neck, shoulder, and chest pain, swelling over the generator site, erratic vns stimulation, and increased seizures. The vns generator was also reported to be nearing end of service and not working at full power. The patient had vns generator replacement surgery performed on (b)(6) 2011. A battery life estimation for the generator performed by the manufacturer yielded approximately 2. 69 years remaining, but 1. 5 years of programming history was missing. Attempts for further information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2330300


Title: Re: Chest Pain
Post by: dennis100 on February 28, 2016, 03:33:13 AM
Model Number 103
Event Date 10/04/2011
Event Type Malfunction
Event Description
It was reported that the pt's vns indicated high impedance during a routine office visit. The pt reported that he had been experiencing an increase in seizures below the pre-vns baseline seizure frequency and having sharp pains in his neck that began around the same time. No trauma or manipulation was reported. No x-rays were taken. The pt's generator was not disabled but the pt was referred for surgery. During surgery, high impedance was not observed and the surgeon opted to just replace the pt's generator. Diagnostics following generator replacement were normal with an impedance value of about 3000 ohms. Per hosp policy, the site does not normally return the generator. Add'l info was received from a mfr rep indicating that the pt's pain was located in the chest and associated with vns stimulation. The pt has reportedly not had any issues following surgery. Attempts for further programming history have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2380274


Title: Re: Chest Pain
Post by: dennis100 on February 29, 2016, 07:02:00 AM
Model Number 102
Event Date 02/22/2011
Event Type Malfunction
Event Description
Reporter indicated the patient presented at clinic on (b)(6) 2013 with pain, burning, itching and "random firing of the vns. " surgery to replace the vns appears likely. Attempts for additional information are in progress.

Event Description
Reporter indicated that vns generator replacement surgery is still planned. The vns generator is to be replaced for patient comfort and to preclude a serious injury.

Manufacturer Narrative
Event is both a serious injury and a product problem. Overall reportability of event is a malfunction. Manufacturer reviewed x-rays of implanted device. This code was inadvertently omitted form the initial mdr report. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. This code was inadvertently omitted form the initial mdr report.

Manufacturer Narrative

Event Description
Reporter indicated a vns patient was having painful, erratic stimulation in the neck and chest. Vns settings were lowered and the painful stimulation improved. The patient had no known trauma. Current vns diagnostics cannot be performed as the patient cannot tolerate the 1ma output current necessary to complete the test. X-rays were reviewed by the manufacturer and no obvious anomalies were identified. A vns generator battery estimate performed yielded approximately 7. 97 years remaining. Vns generator replacement appears likely, but has not been scheduled to date. Attempts for further information are in progress.

Event Description
Analysis was completed on the returned vns generator. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
Reporter indicated the patient's vns generator replacement surgery was on hold due to insurance issues, but surgery is still planned. Although vns diagnostics are within normal limits, the reporter feels there may be a "problem with the generator" and that the patient may benefit from having generator replacement surgery performed prophylactically.

Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. Preoperative vns diagnostics indicated normal device function. It was the opinion of the current surgeon that the original implanting surgeon ¿probably had the coils a little close to the laryngeal nerve¿. The explanted generator was received back to the manufacturer on (b)(4) 2013 and is pending analysis.

Event Description
The reporter indicated that the patient had no trauma or events that led up to the pain, burning, itching, and "random firing of the vns. " surgery to replace the vns appears likely and is tentatively scheduled for (b)(6) 2013. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2299589


Title: Re: Chest Pain
Post by: dennis100 on February 29, 2016, 03:01:08 PM
Model Number 103
Event Date 11/13/2010
Event Type Injury
Event Description
Product analysis was completed on the returned vns generator. No anomalies were identified, and the generator performed per specifications.

Event Description
Manufacturer follow-up with the surgeon's office revealed the patient has scheduled and cancelled her surgical consult appointment for the vns generator migration and pain three times. Due to the multiple cancellations, the surgeon's office will no longer see the patient for a surgical consult. All attempts to the reporter for additional information have been unsuccessful to date.

Event Description
Reporter indicated the patient presented to the office on (b)(6) 2012 complaining of painful stimulation on her left side and when lying down. Vns diagnostics were reported as ok, and the vns output current is set to 0. 5ma. The patient then reported to the manufacturer on (b)(6) 2012 that she was having pain in her neck and chest. Before the pain started, the patient had been in a physical domestic dispute, and was assaulted. There is also swelling at the generator site per the patient. The patient was referred back to her treating physicians, who were also notified of the events by the manufacturer. The patient has been referred for vns lead and generator revision surgery, but a consult has not occurred to date.

Event Description
Reporter indicated a patient was being referred for a surgical consult due to the vns generator migrating in the chest and causing pain. Attempts for further information are in progress. Surgery to reposition or replace the generator appears likely. The patient previously had generator repositioning surgery on (b)(6) 2011 due to migration; the surgery was done for patient comfort only and not to preclude a serious injury.

Event Description
Reporter indicated vns revision surgery was tentatively planned for (b)(6) 2012. The patient later had vns generator and lead replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. The explanted lead was discarded by the hospital.

Event Description
Reporter indicated the patient was seen in clinic on (b)(6) 2011 and vns diagnostics were normal and the patient is doing well at this time. Surgical intervention is no longer planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2288147


Title: Re: Chest Pain
Post by: dennis100 on February 29, 2016, 03:01:50 PM
Model Number 102
Event Date 05/04/2011
Event Type Injury
Manufacturer Narrative

Event Description
Reporter indicated a patient's vns generator had migrated upward in the chest, and the patient would massage the generator back down into the correct position. The patient was also experiencing painful stimulation in her neck and in her chest at the generator site. The vns hz setting was decreased as an intervention for the painful stimulation. The patient had no known trauma. Surgery to reposition or remove the vns appears likely, but has not been scheduled to date.

Event Description
Manufacturer follow-up with the vns implanting surgeon revealed a non-absorbable suture was used to secure the generator to the fascia during implant of the vns on (b)(6) 2011, which is recommended per manufacturer labeling. Reporter indicated surgery is not planned at this time. The vns has been disabled and the patient will be monitored for the next 3-6 months for seizure activity and the need for surgery will be reassessed at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2292738


Title: Re: Chest Pain
Post by: dennis100 on March 04, 2016, 09:29:01 AM
Model Number 103
Event Date 04/30/2012
Event Type Injury
Event Description
It was reported that the patient was referred for vns removal surgery due to significant pain from the presence of device in the chest. The patient's device has remained off since (b)(6) 2013 when it was disabled due to patient experiencing continuous coughing, throat pain and nausea from severe gastric acid reflux. Patient's seizures remains controlled despite vns therapy being disabled. No surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5403153


Title: Re: Chest Pain
Post by: dennis100 on March 04, 2016, 09:30:00 AM
Model Number 106
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient stated she has been having a burning sensation under her skin where the vns generator was placed and had a burn mark. It was reported that the issue has been going on for a while (exact date not reported). The patient's mother also mentioned that she can sometimes smell a burning smoke smell coming from the patient's mouth when she talks. It was also reported that the patient feels the generator gets warm whenever it is interrogated. Additional information was received that the patient's device was disabled on (b)(6) 2016 due to persistent chest pain, and the patient was also referred to a surgeon for evaluation. The chest pain did reportedly resolve once the patient's device was disabled. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5405291


Title: Re: Chest Pain
Post by: dennis100 on March 10, 2016, 05:22:35 AM
Model Number 100
Event Date 04/21/2011
Event Type Injury
Event Description
It was reported to the manufacture from explanting physician in (b)(6) that he had a patient with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular. In the last 2 years, the patient had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 years due to battery exhaustion. The patient insisted on having their vns system explanted related to their pain events. It is unknown if this surgery was for patient comfort or to preclude a serious injury to the patient. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted here as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Their explanted generator was returned for analysis. In the product analysis laboratory, it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specification. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133608


Title: Re: Chest Pain
Post by: dennis100 on March 11, 2016, 02:34:11 AM
Model Number 102
Event Date 05/01/2011
Event Type Injury
Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the lead impedance after surgery was within normal limits. Product analysis of the explanted generator was completed on (b)(6) 2011. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2011, additional information was received when the surgeon reported that the patient had a surgery consultation on (b)(6) 2011 and he wants to replace the generator to one that is a smaller size but the patient wants the whole vns system removed. The patient's physician is going to talk with the patient. Surgery is likely but has not yet occurred. When additional information is received, it will be reported.

Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient is experiencing pain at her generator pocket that occurs whenever she picks her child up. The pain is not occurring with stimulation. The patient wants the device explanted but the neurologist does not think that it would be good to remove the device since the patient's seizures are under control with vns. The possibility that the patient could have the device re-positioned or replaced with a smaller generator was also discussed as an option. The patient has been referred for x-rays but they have not been taken yet. When they are taken, the manufacturer will request a copy for review. The physician thinks that the patient's pain may be based on the location of the generator; that it might be putting pressure on muscle or tissue and causing discomfort. The consultant said that the patient's last diagnostics showed normal results; specific details were not provided. No surgery consult date has been scheduled yet. Additional information has been requested from the physician; however, no further information has been received to date. When additional information is received, it will be reported.

Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the vns patient had their generator replaced that day due to pain in the chest. The explanted generator was returned for product analysis on (b)(6) 2011 that has not yet been completed. When additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107191


Title: Re: Chest Pain
Post by: dennis100 on March 19, 2016, 01:53:21 AM
Model Number 302-20
Event Date 01/07/2010
Event Type Injury
Event Description
It was reported by a nurse that a vns pt experienced a loss in weight and had to decrease the pt's vns settings due to the pt losing weight. The event of loss in weight started last yr. Further info from the nurse indicated the pt was also complaining of severe neck and left lateral chest pain which was positional. Additional info was received from the treating nurse indicating the cause of the pt's loss of weight was related to vns pain in the throat as the pt could not eat due to pain. The nurse did not know a cause for the pt's positional pain as the pt stated that the event has been ongoing since vns placed. Interventions planned are to have a second opinion and replace vns as it significantly improves the pt's seizures. Additional info was received through clinic dated (b)(6) 2011 notes indicating the pt's seizures are worse due to lack of rest, pt is experiencing painful stim, cannot swallow, increase in acid reflux allegedly due to vns, device disabled (b)(6) 2011 - pain stopped as a result of device being disabled. Interventions taken were to increase meds as vns is disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999589


Title: Re: Chest Pain
Post by: dennis100 on March 20, 2016, 03:22:13 AM
Model Number 302-20
Event Date 07/19/2010
Event Type Injury
Event Description
It was reported by an epileptologist that a vns pt experienced intermittent pain in the chest generator area and electrode site due to unk reason. The epileptologist indicated the pain was not always associated with stimulation and current diagnostics were within normal limits (no specifics). The epileptologist reduced the pt's settings from 1. 75 ma to 1ma, in turn this reduced the pt's pain. Moreover, f/u from a company rep with the epileptologist revealed the pt is doing well and was not complaining of pain or any migration. The epileptologist does not believe the pt's device migrated as there might have been a complaint from the pt regarding the event. Additional information was rec'd from a company rep indicating the pt continued to have painful stimulation at the neck site and now felt like there was a knot there. The pt's epileptologist was now referring the pt to the surgeon for possible full revision. At the moment, it is unk if medical intervention is being taken for the reported painful stimulation as good faith attempts to the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000313


Title: Re: Chest Pain
Post by: dennis100 on March 21, 2016, 12:47:03 AM
Model Number 102
Event Date 01/28/2011
Event Type Malfunction
Event Description
It was reported that a vns pt is "having problems" with her vns and now "wants it removed". No other info regarding the pt problems were given upon the initial report. Further info indicated that the pt would be seeing a different doctor for her f/u. Updated info from this doctor indicated that he did not know what problems the pt was having or when they began, but they were not serious in nature and no intervention was taken to preclude a serious injury. It was unk the vns was the cause of the problems, but the physician indicated diagnostics were available, although no specific details on the results were given. Notes rec'd from the physician stated the pt was to have a chest x-ray as she was complaining of left anterior chest wall pain in order to document there were no vns leadwire issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2023001


Title: Re: Chest Pain
Post by: dennis100 on April 01, 2016, 02:48:01 AM
Model Number 300-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the patient was experiencing chest pain with device stimulation. The pt was programmed off and x-rays were taken and sent to the mfr for review. During review of the x-rays, a gross lead discontinuity was visualized below the anchor tether. Good faith attempts to obtain add'l info from the pt's neurologist have been unsuccessful to date. Revision surgery is likely.

Manufacturer Narrative
Method: mfr reviewed x-rays of implanted device. Results: review of x-rays by the mfr revealed a gross lead discontinuity. Conclusions: device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1542718


Title: Re: Chest Pain
Post by: dennis100 on April 02, 2016, 04:03:44 AM
Model Number 302-20
Event Date 08/01/2009
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to mfr that the vns pt began experiencing a recent onset of painful stimulation in the chest and abdominal area, which occurred erratically, not with every stimulation cycle. Additionally, there was report of an increase in seizures activity, below the pre-vns baseline. Both system and normal mode diagnostic tests were preformed following the onset of the reported event and revealed normal device function. The physician believes that there is a device issue, and has referred the pt for surgery to replace the lead and the generator. X-rays were taken and sent to mfr for review where there were no gross lead discontinuities observed, and there were no other obvious anomalies visualized which could be contributing to the events. There was no report of trauma or manipulation of the device prior to the onset of the reported events, however, the mother reports that the pt is a "rowdy kid".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1510635


Title: Re: Chest Pain
Post by: dennis100 on April 03, 2016, 02:21:06 AM
Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
It was reported that the patient was experiencing painful stimulation in the chest that would go to her neck and sometimes her ear if she raised her arm and the physician believes it is related to vns. Patient was referred to an ent physician who ran diagnostic tests and the results came back "fine", so he sent the patient back to the neurologist. Available diagnostics are all within normal limits. No trauma or manipulation is suspected to have contributed to the event. No contributory programming or medication changes were made prior to the event onset. Patient has been referred for surgery, but it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1486200


Title: Re: Chest Pain
Post by: dennis100 on April 04, 2016, 02:20:32 AM
Model Number 102
Event Date 04/20/2009
Event Type Injury
Event Description
It was reported initially that the vns patient was seen by a surgeon to possibly have the vns device removed, due to an unknown reason. Further follow up with the surgeon's office revealed that surgery is not planned, and they had referred the patient back to the neurologist to possibly have the device disabled. Despite good faith attempts made at the time to obtain additional information regarding the reason the device was to be disabled, no additional information had been received. It was later reported that the patient was scheduled for surgery to have the device removed as the patient was experiencing severe neck and chest pain where the vns device was located. Further follow up with the neurologist's office revealed that the pain was constant and there were no causal or contributory programmed setting changes, trauma, or manipulation reported to have occurred prior to the onset of the pain. It was noted that the patient had complained for months of excessive pain. Surgery occurred where it is known that the generator was explanted, which has been returned to manufacturer and analysis is underway. Despite good faith attempts with the surgeon to obtain whether the lead was explanted, no additional information has been received. There are no specific diagnostic test results available; however, the neurologist noted that the device was working properly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1445400


Title: Re: Chest Pain
Post by: dennis100 on April 05, 2016, 03:11:35 AM
Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported that the pt was going in for revision surgery due to high lead impedance. During a diagnostic test, it was noted that there was dcdc=7 observed. The pt was also reportedly experiencing intermittent sharp pain in the chest and throat approx 2 months prior to the diagnostic testing. The pt also had a "bad seizure" approx 2-3 weeks prior to the diagnostic testing. The pt was referred for x-rays and the device was disabled until decision on surgery was made. X-rays were not provided to the mfr for review. The pt's generator was also replaced prophylactically at that time. The generator and lead were returned to the mfr for analysis, but it has yet to be performed. Good faith attempts to obtain add'l information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485556


Title: Re: Chest Pain
Post by: dennis100 on April 07, 2016, 10:08:40 PM
Model Number 106
Event Date 12/16/2015
Event Type Injury
Event Description
It was reported that a patient was experiencing a sharp pain in the chest that was not related to stimulation. The patient had a recent generator replacement surgery, and the surgeon believed that the patient had an infection on (b)(6) 2016. The surgeon disabled the normal mode stimulation, but the pain continued. The surgeon then disabled the magnet mode and autostimulation mode on (b)(6) 2016. The patient's mother reported a red spot or rash on the patient's chest. She stated that the last time the patient's settings were changed was in the middle of (b)(6) 2016. The patient was also prescribed an antibiotic regimen by the surgeon that was to be completed on (b)(6) 2016. The patient reported feeling burning in his left chest on (b)(6) 2016 and that the area was red and warm to the touch. Chest x-rays were performed, and the surgeon stated that the generator had "shifted a little. " clarification was requested, and the notes stated that there was a foreign object next the generator. However, it was discovered that the patient's mother placed the magnet over the generator for the x-ray, which was the "foreign object" that the surgeon saw. The patient's neurologist did not believe that the redness in the chest was related to vns in any way, and he advised against turning off the patient's output currents because the patient had good seizure control with vns. The device history records of the generator and lead were reviewed, and the devices were both sterilized prior to release. Due to the conflicting information, it is not known at this time if the patient has an infection or not. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529212


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2016, 01:39:25 AM
Model Number 105
Event Date 02/24/2016
Event Type Injury
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2016, 01:40:11 AM
Model Number 300-20
Event Date 06/21/2001
Event Type Malfunction
Event Description
It was reported that a patient's device was disabled about 8 years ago due to shortness of breath. The patient was seen by a new physician on (b)(6) 2016, and high impedance was identified during normal mode and system diagnostics. The patient was referred for full revision surgery. Programming history was available from the date of implant, (b)(6) 2001, and a system diagnostic test performed during implant showed high impedance. No further diagnostic results were available, so it is unknown if the high impedance resolved during surgery or not. Clinic notes were received on 02/29/2016. The patient felt that the vns took his breath away, especially when he used the magnet. The patient then had his vns turned off. The physician discussed turning the vns back on, and the patient agreed. The notes also mention that the patient was positive for chest pains, shortness of breath, and wheezing on (b)(6) 2016. This indicates that the patient still had shortness of breath after the vns was disabled. However, the shortness of breath may have been worsened by the magnet stimulation. Also, it is unknown if the shortness of breath was related to the high impedance or not. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5512641


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2016, 07:14:22 AM
Model Number 106
Event Date 01/24/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported on (b)(6) 2016 that the patient has complained of pain in the neck and chest 3-4 days post-op. The patient recently had a battery replacement on (b)(6) 2016. High impedance >10,000 ohms was found. On the day of the patient's replacement on (b)(6) 2016, diagnostics showed ok/ok/1880 ohms. Clinic notes were received on (b)(6) 2016 and dated (b)(6) 2016. They state that the patient underwent generator replacement about 3 weeks ago. She was doing well for a couple of weeks but then developed some discomfort in the neck and the chest region around the new implant which prompted a visit to the er. She was then seen by the neurologist who interrogated the device and found the impedance as elevated and turned the device off. A few days later all of her symptoms disappeared. There is no swelling around the area. The incision healed well. The intraoperative notes show that the impedance had been fine upon replacement with the new m106, otherwise they would not have implanted it. Therefore, she will be scheduled for another revision of the device. The plan is to revise the implant starting with reopening the chest wall incision and verifying connection and if they find that impedance values remain high despite re-connecting and re-verifying everything then they will have to revise the neck electrode as well. The patient had surgery on (b)(6) 2016. The surgeon first removed the lead pin from the generator. He reset the generator using the hex screwdriver. He tested the impedance in pocket and the results were ok 2272 ohms. The second test inside the pocket was again ok at 2198 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5477199


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2016, 07:14:53 AM
Model Number 103
Event Date 02/01/2016
Event Type Injury
Event Description
It was reported that the patient has been experiencing pain and tenderness at the chest area. It was reported that there is no correlation with settings and that this is similar to the pain the patient felt following generator replacement. The patient was scheduled for generator replacement due to the pain. The patient underwent generator replacement. The explanted generator has not been received for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5487162


Title: Re: Chest Pain
Post by: dennis100 on April 08, 2016, 07:15:18 AM
Model Number 102
Event Date 12/01/2015
Event Type Injury
Event Description
Initially, it was reported that the patient was admitted as an inpatient to the hospital due to an increase in seizures and this was the first visit the patient had with the physician. It was later reported by the physician that the patient was not experiencing an increase in seizures and that the patient had been admitted to the hospital for chest pain. Further follow-up revealed that the patient's chest pain radiated into her back and the pain was sharp and stabbing. Cardiology notes indicated that the patient was experiencing shortness of breath and nausea for two weeks prior to hospital admittance. The patient was evaluated by the cardiologist during hospitalization. Attempts to obtain additional relevant information have been unsuccessful to date. The relationship of the chest pain to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5480353


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2016, 02:06:55 PM
Model Number 102
Event Date 01/01/2007
Event Type Malfunction
Event Description
It was reported by a patient that his vns therapy system is "not working properly. " the patient reportedly experiences painful stimulation in the "neck, chest, shoulder and chin. " it was also reported the events cause "irregular respirations leading to shortness of breath. " in addition, the patient stated that his device has not been checked for more than two years and his last treating neurologist "did not know what he was doing". On the other hand, the severity of the adverse events is unknown at the moment and good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425022


Title: Re: Chest Pain
Post by: dennis100 on April 21, 2016, 02:50:39 AM
Model Number 102
Event Date 01/12/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was hospitalized due to painful stimulation in the neck, chest, and arm in addition to a choking sensation with stimulation. The vns device was disabled and the pain was still present, but the dysphagia resolved. Diagnostic tests were performed following the onset of the events, and were reported to be within normal limits. There was no report of trauma, manipulation or other believed cause prior to the onset of the event. As intervention, the physician opted to have the entire device replaced. The explanted lead and generator were returned to manufacturer and analysis underway. Attempts to obtain additional information in regards to the patient status following revision surgery from the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310986


Title: Re: Chest Pain
Post by: dennis100 on May 04, 2016, 06:49:18 AM
Model Number 102
Event Date 01/01/2006
Event Type Malfunction
Event Description
Reporter initially indicated that a vns patient experienced painful stimulation at the throat and chest. The vns settings were changed in response to the event. It was later reported that the patient was continuing to experience painful stimulation at the chest and muscle spasms at the chest and neck sites. It was reported that decreasing the signal frequency alleviated the symptoms. Mfr's review of x-rays did not reveal any anomalies or potential cause of the reported events, although it was noted that the strain relief was not placed according to labeling. It was also noted that two small objects, which appeared to be staples or similar objects, were visible in the area of the electrodes. Reporter indicated that the patient underwent exploratory surgery in response to the events. The surgeon only opened the generator site and the generator was repositioned. The surgeon identified a "kink" in the lead, although the lead appeared intact and diagnostics were within normal limits. The surgeon elected to leave the lead implanted with no further actions taken during surgery.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no probable cause of events identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=932480


Title: Re: Chest Pain
Post by: dennis100 on May 04, 2016, 09:47:16 PM
Model Number 102
Event Date 04/01/2013
Event Type Injury
Event Description
The physician reported that the patient had experienced pain in the chest after vns implant in 2013. The patient was referred for a cardiac and pulmonary evaluation which did not find any abnormalities. The patient was then referred for surgery to evaluate the generator site. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5615085


Title: Re: Chest Pain
Post by: dennis100 on June 15, 2016, 08:02:18 AM
Model Number 102
Event Date 04/20/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the nurse practitioner the patient had been hit in the chest a couple of times, and since then has experienced chest pain which was bad enough she went to the emergency room. Eventually, the magnet was placed over the generator and the pain stopped immediately. The patient's settings were low and when system diagnostics were performed, it showed a dcdc value of 0 and the lead was ok. There were no previous diagnostic results to compare the dcdc value against. It was noted the patient had only recently been set to 1ma, and it was explained this could possibly be the cause of the pain. It was also noted that, based on the dcdc value of 0, there could also be a short circuit, but it is unknown for sure. The nurse practitioner then began the process of having the patient's vns replaced. The generator replacement occurred on (b)(6) 2016 and it was found there were no issues with the lead; therefore, it was not replaced. After replacement of the generator, the impedance value was checked and found to be 2516 ohms, which is within normal limits. It was reported the generator was discarded after surgery. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5672553


Title: Re: Chest Pain
Post by: dennis100 on June 15, 2016, 08:03:05 AM
Model Number 105
Event Date 02/20/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was originally reported in that a patient had his output current reduced to 1. 0ma due to painful stimulation. The lowering of the output current was reportedly for patient comfort. It was later reported that a patient was having his device programmed off on due to painful stimulation occurring in his chest near the generator. The pain had reportedly become worse since the initial report. No traumatic events were known to have potentially caused the increased pain; only stimulation was occurring. Diagnostic tests were run on the device and showed values within normal limits. X-rays were taken and there were no abnormalities found in review of the x-rays. The patient's nurse believed there was potentially a product problem due to the device previously working without causing the patient pain. No surgical intervention has occurred to date. No further relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5678457


Title: Re: Chest Pain
Post by: dennis100 on June 17, 2016, 02:00:02 AM
Model Number 106
Event Date 04/12/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016. The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck. The ct of the chest identified focal induration within the left breast which was nonspecific. There was no pathologically enlarged adenopathy or mass. In the neck. There was no evidence of discrete fluid collection or mass. The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle. There was no discrete fluid collection to suggest abscess. The patient also had a picc line placed from the right arm for the infection.

Event Description
It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system. Clinic and operative notes were received on 04/21/2016 regarding the patient's infection. The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck. The patient started having drainage at the neck area. After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis. There was evidence of inflammatory changes/edema in soft tissue of the left check and neck. The patient was diagnosed with sepsis secondary to left chest wall cellulitis. The patient's vns system was explanted on (b)(6) 2016 due to the infection. The patient was treated with antibiotics for a streptococcus pyogenes (group a). The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision. The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted. Irrigation and debridement of the cervical wound and a revision of the wound was performed. It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing. The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655090


Title: Re: Chest Pain
Post by: dennis100 on June 18, 2016, 07:17:33 AM
Model Number 304-20
Event Date 04/20/2016
Event Type Malfunction
Event Description
It was reported that a vns patient was seen at a surgeon¿s office for high lead impedance after referral from her neurologist, who wants to replace the lead. Clinic notes were received indicating the patient¿s chest feels hot and hurts with pain at ¿(b)(6)¿. Follow-up to the physician¿s office by the company representative revealed that the physician believed that the device had high impedance at a value of 3500 ohms, which was within normal limits. The lead was replaced (b)(6) 2016. The explanted lead has not been received to-date. Additional relevant information has not been received to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5668205


Title: Re: Chest Pain
Post by: dennis100 on July 09, 2016, 01:49:18 AM
Model Number 104
Event Date 10/30/2014
Event Type Injury
Event Description
It was reported the patient was scheduled for generator explant due to pain and discomfort. The patient reported that after the most recent generator replacement, he was experiencing pain; however, this was not with stimulation as the device had been disabled in (b)(6) 2015 and the pain continued. The patient also reported he felt pain with diagnostic testing. The system diagnostics were 2331 ohms and the battery life indicator still showed 3/4 battery life remaining. No migration had been observed or reported. The pain was described as chest pain which radiates from his generator into the rest of his chest. The vns output current was programmed down for evaluation. Additionally, prior to (b)(6) 2016 the pain would make the patient throw up. It is unknown if surgical interventions have been taken to date. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5695874


Title: Re: Chest Pain
Post by: dennis100 on August 05, 2016, 09:44:56 AM
Model Number 103
Event Date 05/15/2014
Event Type Injury
Event Description
It was reported by the patient the she had been implanted with vns for approximately 8 years. About 2. 5 years ago, it was noted there was an issue with her lead and it needed to be replaced. She noted immediately after surgery she had vocal cord paralysis and she has to have a second surgery by an ent to make the vocal cord mobile. After that, she has problems swallowing. The patient's psychiatrist noted the patient was programmed off prior to (b)(6) 2016 due to an mri and it was decided to leave the patient programmed off. The psychiatrist stated that the patient noted only slight improvement since that time. She noted the patient had seen an ent (ear, nose, and throat) who showed the patient had little to no peristalsis. The patient called again and noted she had a history of chest pain which got worse. She noted the vns was programmed off and there was only slight improvement. The psychiatrist was called and it was noted that since programming the device off, the patient did not notice much difference; however, she was more depresses. The psychiatrist decided to leave the device programmed off due to the low peristalsis. The patient called again and stated she had permanent damage to her esophagus and her vocal cords due to vns. The issue with the patient's lead about 2. 5 years ago has previously been captured in mfr. Report 1644487-2014-01151. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5804912


Title: Re: Chest Pain
Post by: dennis100 on September 09, 2016, 06:09:22 AM
Model Number 304-20
Event Date 07/21/2016
Event Type Malfunction
Event Description
It was reported that during an office appointment high impedance was observed. X-rays were taken and received by the manufacturer. A review of the x-rays found that due to the poor quality of the images most of the lead could not be assessed. Therefore a potential lead fracture could not be ruled out in this portion of the lead. The lead portion that could be evaluated did not have any obvious lead fractures. Additionally due to the poor image quality and angle of the generator the adequacy of the insertion of the pin could not be determined. It was later reported that the generator was turned off due to the patient experiencing pain in her chest. The patient was then referred for a lead and generator replacement. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5878811


Title: Re: Chest Pain
Post by: dennis100 on November 28, 2016, 09:15:14 AM
Model Number 105
Event Date 09/20/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received on 09/20/2016. The notes indicates that the vns is shocking him in the chest and neck. The patient is referred for replacement surgery. The notes further state that anytime he swipes the generator manually with the magnet, he experiences a significant electric shock in his chest and his neck which the physician witnessed in office. It was indicated that the reason for the replacement was due to the painful stimulation and possibly avoid injury. The patient underwent replacement surgery on (b)(6) 2016. The explanted device has not been received back for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6030518


Title: Re: Chest Pain
Post by: dennis100 on December 08, 2016, 01:57:23 PM
Model Number 250
Event Date 12/09/2010
Event Type Malfunction
Event Description
It was initially reported that a pt went to the neurologist's office to have his device checked as he was experiencing chest pain by the generator site. The pain began after the pt had a seizure and fell on the area. The physician indicated (through clinic notes) that each time she tried to perform device diagnostics, the generator would be disabled. Therefore, she was not able to complete them as she did not want to program the generator off. The pt is being referred for generator revision surgery because the generator has been implanted for 6 years and the physician feels the generator probably needs to be replaced. Good faith attempts to obtain additional info have been successful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1961253


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2016, 10:55:56 AM
Model Number 302-20
Event Date 10/13/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
High impedance >10,000 ohms was detected on the patient's generator. The patient was experiencing erratic stimulation and discomfort in the upper chest. Her settings were decreased to address her discomfort. The patient underwent a generator and lead replacement surgery on (b)(6) 2016. The patient's lead was reportedly discarded. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6084324


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2016, 10:56:41 AM
Model Number 106
Event Date 10/15/2016
Event Type Injury
Event Description
Manufacturing report # 1644487-2016-02688 houses the reports of lead fracture, painful stimulation and device disablement that was also reported. Information was received that the patient had chest pain which the patient¿s physician attributed to the presence of the device. The patient then elected to consult a surgeon regarding the pain. The surgeon chose to perform exploratory surgery to determine the cause of the patient¿s pain. The surgeon determined that the patient¿s subcutaneous pocket was lying over a muscle and elected to move the pocket more medially to reduce the patient's pain. The surgeon also tested the insertion of the pin in the header of the generator and found that there was an adequate connection present. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6120637


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2016, 10:57:46 AM
Model Number 103
Event Date 10/19/2016
Event Type Injury
Event Description
A call was received from a physician stating that a patient was reporting that their lead neck site was "heating up" and the vns was causing pain at the chest wall. The patient was also experiencing jaw pain which stimulation, and her heart slowed down when the vns was stimulating. The patient stated that she was supposed to receive stimulation every 5 minutes but she was feeling the device go off every 30 seconds. A review of the available programming history showed that the patient's settings from (b)(6) 2012 had a 5 minute off time. The physician was told to use a magnet to inhibit stimulation for the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096084


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2016, 10:58:43 AM
Model Number 102
Event Date 10/16/2016
Event Type Injury
Event Description
It was reported the patient was having some pain in her neck and chest, she was coughing a lot, and had shortness of breath. These symptoms were explained to be associated with stimulation. Diagnostics showed the device was working as intended and showed dcdc = 2, which is within normal limits. It was also noted the patient was laying tiles and may have injured the area of the device and was having pain at the generator site, but it was also noted that the patient tried to restrain her son who pulled at hear vns implant site. The patient became concerned that the device was damaged and noted that she can visualize the lead body. X-rays were taken, but it was noted by the physician that there was nothing out of the ordinary observed. The patient had her generator replaced on (b)(6) 2013 as it was noted the generator had migrated, and since the generator had been implanted for a few years, they decided to go ahead and replace the generator during the repositioning surgery. It was noted the generator was discarded after surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6098307


Title: Re: Chest Pain
Post by: dennis100 on January 16, 2017, 04:03:51 AM
Model Number MODEL 250
Event Date 10/04/2007
Event Type Malfunction
Manufacturer Narrative
Patient sex, corrected data: the initial mdr report inadvertently identified the patient as female. The patient is male.

Event Description
Reporter indicated a patient's vns had "powered off for no apparent reason" in the past and that the patient subsequently had increased seizures as a result. After the vns was turned back on, the patient had left chest pain which later subsided. The increase in seizures also subsided after the vns was turned back on. Manufacturer review of the patient's vns programming history revealed the patient's vns was interrogated on 01/24/2008 and the vns was set to 0ma. The vns settings were then corrected this day. At the previous office visit on (b)(6) 2007, systems diagnostics were performed but no interrogations or programming was done after the test. It is likely the systems test faulted on (b)(6) 2007 and disabled the vns.

Manufacturer Narrative
Eval, method: analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2642873


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2017, 04:49:28 AM
Model Number 300-20
Event Date 01/22/2013
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a patient presented with high lead impedance and pain at the vns generator site in the chest. The generator was also noted to have moved; the patient has grown and this is felt to be the cause. The generator is not moving freely in the pocket. No trauma or device manipulation occurred. Vns diagnostics were last within normal limits in (b)(6) 2012. The reporter was advised to disable the vns, but chose to leave it on due to the patient's mother's wishes. The vns was later disabled on (b)(6) 2013. The pain resolved after the vns was disabled. X-rays were reviewed by the manufacturer. A lead discontinuity was visualized after the strain relief area of the lead. Vns lead and generator replacement surgery occurred on (b)(6) 2013. Attempts for return of the explanted devices are in progress.

Event Description
An implant card was received to the manufacturer indicating the patient's lead and generator were replaced due to a lead discontinuity. Diagnostics with the new devices were within normal limits. The explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2981132


Title: Re: Chest Pain
Post by: dennis100 on February 06, 2017, 04:50:28 AM
Model Number 302-20
Event Date 02/04/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the patient underwent generator replacement surgery that day (reported on mfr. Report # 1644487-2013-00527). System diagnostics with the new generator showed results within normal limits of output=ok/lead impedance=ok/impedance value=2657ohms. The explanted generator could not be returned for product analysis since it was discarded by the hospital.

Event Description
On (b)(6) 2013 the patient's mother reported that the patient has been complaining of chest pain at the generator site for the past two days. The physician then referred the patient for a vns replacement. On (b)(6) 2013 it wa reported that the patient recently started feeling erratic stimulation and pain at the chest. The nurse didn't think that the pain was related to the device issue reported so the patient was referred to the emergency room for evaluation. It was reported that it was still unclear what the physician's belief of a lead issue is. The physician later reported that the pain has been going on for several months but it is unknown when the erratic stimulation was first observed. No causal or contributory programming or medication changes precede the onset of the erratic stimulation or pain. No patient manipulation or trauma occur that is believed to have caused/contributed to the events. The physician again mentioned that the device was unable to be interrogated (captured on mfr. Report # 1644487-2013-00527). The physician stated that surgery is pending. The physician stated that the pain is not related to vns. X-ray reviews dated (b)(6) 2011 and (b)(6) 2013 from the radiology department were received which indicate that the patient has had chest pain. X-ray reviews dated (b)(6) 2010 indicate again that the patient has chest pain but "probable pneumonia" was indicated. Clinic notes dated (b)(6) 2013 were received which indicated that the patient's device could not be interrogated (captured on mfr. Report # 1644487-2013-00527). Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

Event Description
On (b)(6) 2013, it was reported that the vns patient was that day and the generator could not be interrogated (failure to program reported on mfr. Report # 1644487-2013-00527). The physician's programming system was reported to be working fine on other patients. It was also stated that the patient is not feeling stimulation. The physician indicated that he believes there is a lead issue and had x-rays taken, but the x-rays appeared normal. Clinic notes dated (b)(6) 2013 were received that indicated the patient's generator could not be communicated with (failure to program reported on mfr. Report # 1644487-2013-00527). The patient was referred for surgery. A battery life calculation was performed which showed 0 years remaining until eri=yes. A copy of the patient's a/p and lateral neck and chest x-rays were received for review. The lead pin appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, no anomalies were observed that could be contributing to the reported events. However, a portion of the lead behind the generator could not be visualized. The physician later indicated that the failure to program could possibly be due to eos or a lead issue (failure to program reported on mfr. Report # 1644487-2013-00527). The physician indicated that he believes there may be a lead issue due to the lack of feeling stimulation. The patient has not felt stimulation for several weeks. No causal or contributory programming or medication changes precede the onset of the stimulation not being perceived and no patient manipulation or trauma occur that is believed to have caused/contributed to the stimulation not being perceived. The patient was seen again on (b)(6) 2013 but the physician did not try and interrogate the vns again. The manufacturer's consultant stated that the physician just suspects that there is a lead issue, has a "gut feeling", and also thinks so because the patient cannot perceive stimulation. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2979689


Title: Re: Chest Pain
Post by: dennis100 on February 09, 2017, 02:26:26 AM
Model Number 104
Event Date 01/17/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2013 that the patient was experiencing an increase in seizures and chest pain that radiated across the sternum up to the patient's neck after having a fall a couple of weeks prior. A cardiac workup was done and was within normal limits. The patient was to follow-up with physician to check the vns device. Further follow-up revealed that the patient was seen by neurologist to check the integrity of the vns system. It was reported that the vns device was found to be performing as intended. It was also reported that the patient's muscle surrounding the generator was bruised and no further action is required. Attempts to obtain additional information have been unsuccessful to date. It is unknown if the increase in seizures is above the patient's pre-vns baseline frequency.

Event Description
Further follow-up revealed that the physician does not believe that the vns therapy is related to the patient's seizures. The physician noted that the patient's seizures are not above the patient's pre-vns baseline. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the patient's seizures. The physician noted that no increase in seizure was noted and that the patient was one week seizure free.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2985662


Title: Re: Chest Pain
Post by: dennis100 on February 10, 2017, 05:24:34 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 08/22/2016
Event Type Injury
Event Description
A report was received which indicated that the patient's generator was not working. Clinic notes were received which indicate that the patient reported that the vns was firing inappropriately causing her discomfort. The patient's device was then disabled and the patient indicated that they wanted the device removed. On (b)(6) 2016 the patient's device was disabled and the patient was referred for removal surgery, which has not occurred to date. Follow up with the neurologist's office indicated that the patient had experienced a burning sensation in her chest and throat and had pressure in her neck as well. No diagnostic information was available for the patient's device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6230392&pc=LYJ


Title: Re: Chest Pain
Post by: dennis100 on February 10, 2017, 05:25:10 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/13/2016
Event Type Injury
Event Description
It was reported that a vns patient had been complaining of pain, but more in the chest area. The generator has dropped to the left breast level. The pain and discomfort wasn¿t there all the time but was not due to stimulation. High lead impedance was discovered and has been reported in mfr report# 1644487-2017-03018. The lead and generator were replaced on (b)(6) 2016. The explanted devices were discarded by the explant facility. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6244726&pc=LYJ


Title: Re: Chest Pain
Post by: dennis100 on February 11, 2017, 02:54:00 AM
Model Number 302-20
Event Date 01/01/2010
Event Type Injury
Event Description
Upon further follow up with the nurse, it was revealed that the patient is experiencing pain and a "shocking sensation in chest due to wires being bunched up". The lead appears to be protruding from mid-neck to the collarbone with a "knot" felt at the lead body. The only intervention taken to date is assessment by the surgeon. Both the surgeon and the treating vns physician tested the device, and it was reported to be working okay. The patient's severe body spasms are believed to be the likely cause of the lead protrusion and caused the extreme pain and feeling of being shocked. No other physiological changes are believed to have contributed to the lead protrusion. Since the surgeon is afraid the lead wires may break if not replaced and due to the length of implant, the patient is referred for full revision surgery. Although surgery is likely, it has not occurred to date.

Event Description
It was reported on (b)(6) 2013, that the patient is experiencing lead wires "bulging" accompanied with tension/pain in the neck that occurred right after she had a severe episode of body spasms about 10 days prior. The patient has a variety of physical illnesses, one of which includes these body spasms. The treating rn believed the body spasms may have been experienced as an extreme case due to stress as the patient was on her way to her brother's funeral. She also thought that the protrusion was due to the spasms that the patient experienced. The rn also mentioned that the patient's depression had been worsening recently, but that she believes that the patient's stress (brother passing away, dog being ill) have contributed to this recent increase in depression. The patient was evaluated again by the treating vns psychiatrist on (b)(6) 2013. Diagnostics on the patient's vns are within normal limits. The psychiatrist reports that the lead "bulging out a little bit like a vein" but was unsure if this bulge has always been there all along. Later, it was reported that the patient has also been experiencing pain and swelling in the tongue due to little cuts on her tongue which occurs with stimulation, and the surgeon believes this is related to vns. The patient has been experiencing this for a while; however, it has worsened lately with the other events. The treating rn did not have further details at that time. Clinic notes from the surgeon dated (b)(6) 2013, indicate that the patient complains of tension/pain in the left neck/leads and had been worsening over the past few years. The surgeon indicated in the notes that he can offer operation for lead revision for severe excess lead tension and generator change for end of life which the patient agreed. The patient was scheduled for surgery for possible generator and lead revision due to pain and swelling with stimulation. The surgeon reportedly believes the patient does not need an x-ray because he can see the wires bunched "where it goes into the vns. " as of (b)(6) 2013, the rn reported the patient indicates that she has a "white line in her skin going along the vagal nerve" and a knot at the electrode site which the patient and physician can feel. The rn also indicated that the patient has a lot of accompanying medical, physical and psychological problems. Although surgery is likely, it has not occurred to date. Attempts for additional information from the treating psychiatrist's office ( rn) have been unsuccessful to date. Follow up with the surgeon's office revealed that per the psychiatrist's notes, the patient "denies any pain or discomfort from vns. She has been diagnosed with major depression disorder and major psychotic disorder which may be a psychotic manifestation of her symptoms. Would like to rule out psychotic or psychological disorder. " the nurse indicated that the surgeon appears to be due to not to preclude a serious injury as the notes indicate that she denies pain or discomfort and the symptoms appear to be thought to be related to her other mental/physician illnesses. However, it remains unclear at this time.

Manufacturer Narrative

Manufacturer Narrative
The initial report inadvertently reported the age incorrectly as the date of event was listed incorrectly. The initial report inadvertently reported the event date incorrectly as it was reported that the tension and pain in the neck was worsening over the past couple of years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027374


Title: Re: Chest Pain
Post by: dennis100 on February 11, 2017, 02:54:53 AM
Model Number 102
Event Date 12/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
The patient reported that since implant, she has lost over 100 pounds and now feels that her generator has moved and is pinching her. She stated that this was painful and could not pinpoint the exact location, but it was in the chest area. The patient had noticed if the pain was with stimulation or not, but said that it was not constant. It occurrs every so often. Follow up with the physician found that the patient was scheduled for a replacement and/or repositioning surgery for the migration of the device. It was not clarified if this was to preclude a serious injury. No other information was provided.

Event Description
It was confirmed that the patient only had a generator pocket revision in (b)(6) 2014. A new generator was not implanted.

Event Description
It was reported that the patient underwent a revision surgery. Eos was no; therefore the generator was not replaced and was only repositioned. Device diagnostics were within normal limits and the patient left the surgery with the device programmed to the same settings as pre-op.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551465


Title: Re: Chest Pain
Post by: dennis100 on February 11, 2017, 02:55:38 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 11/01/2016
Event Type Injury
Event Description
It was reported that the patient could not tolerate the initial dosing settings, and the generator was turned off to let this discomfort resolve. Upon returning to the clinic, device diagnostic results were performed. The patient doubled over from pain in the chest. The device diagnostics were within normal limits. The patient was later referred to have her vns removed due to the experienced painful stimulation. The vns was removed, but the date of removal was not indicated. No additional pertinent information has been received to date.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6229706&pc=LYJ


Title: Re: Chest Pain
Post by: dennis100 on February 12, 2017, 09:37:29 AM
Model Number 102
Event Date 12/11/2012
Event Type Injury
Manufacturer Narrative

Event Description
Follow up with the physician's office found that the pain was first observed on (b)(6) 2009. It was stated that the patient complains of pian with sleep and that these symptoms were due to the physical presence of the device and not from stimulation. The exact location of the pain was described as in the left anterior chest region. The explant surgery was for patient comfort and the patient's pain was relieved with removal. No programming or diagnostic history was provided. No causal or contributory programming or medication changes preceded the onset of the pain, and no patient manipulation or trauma occurred which is believed to have caused or contributed to the pain. In regards to the lack of efficacy, it was stated that this was per the patient and neurologist. No other information was provided.

Event Description
On (b)(6) 2013, it was reported that the patient had her generator explanted due to pain and the patient not gaining any seizure benefits from vns therapy. Product analysis on the explanted generator found that it was not at end of service. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the explanted lead found no performance issues. Inspection of the connector pin and ring connector identified what appears to be remnants of silicone adhesive on the exposed surface of the pin within 0. 022in from the o-ring and on the exposed surface of the ring at 0. 020in from the small o-ring and 0. 022in from the large o-ring. This is out of tolerance (max: 0. 015in); however, no adverse effect in the device performance was identified as a result of this condition. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Note that since the electrode array portion was not returned for analysis an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical and wear and explant related observations, no anomalies were identified in the returned lead portion. A review of the patient's programming history found that the patient had been programmed off and had periods of long off time durations originally implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3008992


Title: Re: Chest Pain
Post by: dennis100 on February 12, 2017, 09:38:25 AM
Model Number 102
Event Date 02/16/2013
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Analysis of the vns generator was completed. Proper functionality of the pulse generator and its ability to provide appropriate programmed output currents was verified. There was no dried body fluid/corrosion identified in the lead cavity or connector block, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. The explanted generator was returned for analysis on (b)(4) 2013, and analysis is pending.

Event Description
Reporter indicated a patient was having shocking sensations in the chest at the vns generator site and the lead site in the neck since (b)(6) 2013. The vns settings were adjusted and the shocking sensations resolved. On (b)(6) 2013, the patient reported still having random shocking sensations. The reporter suspects there may be a device issue with the vns. X-rays were reviewed by the manufacturer, but no generator views were provided. Partial views of the lead did not note any obvious anomalies. The patient has been referred for generator replacement and possible lead replacement surgery. A surgery date has not been set. The vns has not been disabled. Review of the device history records for both the vns generator and lead did not note any non-conformities, and both devices passed all final testing prior to distribution.

Event Description
An implant card was received to the manufacturer indicating the patient had vns generator replacement surgery on (b)(6) 2013 due to prophylactic reasons. Diagnostics with the resident lead and new vns generator were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023442


Title: Re: Chest Pain
Post by: dennis100 on February 14, 2017, 03:06:23 AM
Model Number 101
Event Date 02/20/2012
Event Type Injury
Event Description
Additional information was received from the patient's surgeon indicating that the patient started experiencing pain in (b)(6) 2012, following a motor vehicle accident. The discomfort was not associated with stimulation and was limited to the chest wall. The generator and lead were explanted on (b)(6) 2012, for patient comfort, not to preclude a serious injury. No diagnostic or programming history was provided as it was indicated that the patient's device had been off for many years following epilepsy surgery. The explanted lead and generator were returned to the manufacturer on (b)(6) 2012, however product analysis is not yet complete.

Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported, by an mri technician, that a patient's vns was not activated. The reporter also stated that the patient was scheduled to have the vns explanted because it had become uncomfortable for the patient. It is unclear if surgery has occurred to date, and attempts to obtain any additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2494398


Title: Re: Chest Pain
Post by: dennis100 on February 19, 2017, 02:40:15 AM
Model Number 102
Event Date 03/11/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear. Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear. Her generator site was hurting and her brain was foggy. The patient then visited the nurse practitioner on (b)(6) 2016. During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before. Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation. The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation. So the magnet pulse width was decreased down to be the same as normal stimulation. Diagnostics were performed and were within normal limits. X-rays were taken afterwards and no issues were observed. Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016). Since the shock with the magnet, patient felt that her heart would beat really fast. This happens about once a day at different times of the day and can last 10-30 min. This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse. She never had this happen before and there are no triggers that patient could find. Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.

Event Description
Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation. No known causes or contributory factors were present. Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation. The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation. Per the medical profession, there was no device migration as she could not perceive any movement of the generator. The pain in the chest was not due to presence of device or migration. Patient has had her generator replaced since then on (b)(6) 2016 and is doing well. The explanted device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549412


Title: Re: Chest Pain
Post by: dennis100 on February 21, 2017, 01:35:23 AM
Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
Rptr indicated that the pt had their vns device removed as it was no longer needed, and it was causing pain in her chest when she would roll over at night. Pt had a hemispheric lobotomy which corrected her epilepsy, meaning she no longer needed vns therapy. Attempts for further info regarding the pain the pt was experiencing have been unsuccessful to date. The explanted generator was returned to the mfr for analysis, but analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1643717


Title: Re: Chest Pain
Post by: dennis100 on February 21, 2017, 01:36:09 AM
Model Number 300-20
Event Date 02/19/2010
Event Type Malfunction
Event Description
Initial reported indicated that they interrogated a vns patient in clinic and attained high lead impedance on a system diagnostic test. There has been no reported trauma or injury preceding the patient's high impedance being noted. The patient did report chest pain with stimulation mid february that has resolved. The vns has been programmed off and the patient is being sent for full revision surgery. No date has been set at this time. The patient is being sent to have x-rays taken. Good faith attempts will be made to get a copy the x-rays for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1649081


Title: Re: Chest Pain
Post by: dennis100 on February 22, 2017, 02:47:16 AM
Model Number 300-20
Event Date 02/10/2010
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a serious injury or death.

Event Description
It was reported that the pt had generator replacement surgery due to end of service. Lead was not replaced at that time. Pt was then seen by neurologist and high impedance was noted on both system and normal mode diagnostics. Follow-up with surgeon reveals that high lead impedance was found at the time of generator replacement surgery. Pt is also experiencing some pain in her ear and chest which may be due to the lead fracture, per physician, but this cannot be confirmed. Pt's device was programmed off. X-rays were taken of the pt's device and reviewed by the manufacturer. Upon review, a lead fracture was visualized. No trauma or manipulation was reported. No casual or contributory programming or medication changes preceded the onset of the pain. Revision surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1634487


Title: Re: Chest Pain
Post by: dennis100 on February 25, 2017, 01:54:51 AM
Model Number 300-20
Event Date 10/31/2008
Event Type Malfunction
Event Description
The reporter indicated that a vns patient was experiencing pain over the generator site, and that prior to the event, the patient was in the process of lifting an excessive amount weight. Diagnostics were performed on the patient's ncp device and resulted in high impedance warning. X-rays of the patient's ncp device were reviewed by the manufacturer and revealed the presence of a gross lead discontinuity in the patient's chest region. Due to the severity of the patient's seizures without vns therapy, the treating physician opted leave the device programmed on and prescribed pain medication to compensate for the chest pain. Revision surgery occurred and the lead break was reportedly visualized by the explanting surgeon. The patient's chest pain has reportedly persisted post surgery, prompting the treating vns physician to decrease therapy settings. The patient's explanted ncp device was returned to the manufacturer, where it is currently awaiting analysis.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1295318


Title: Re: Chest Pain
Post by: dennis100 on March 02, 2017, 12:56:06 AM
Model Number 102
Event Date 10/21/2010
Event Type Injury
Manufacturer Narrative
Initial report inadvertently indicated the incorrect explant date as the generator had not been explanted at that time.

Event Description
Additional information was received indicating that the previous report that the patient's generator was replaced on (b)(6) 2010 is incorrect. It appears that at that time the generator was only repositioned. The generator has since been replaced on (b)(6) 2012 along with the vns lead as noted in manufacturer report # 1644487-2012-02147.

Event Description
It was reported that the patient was scheduled for vns generator replacement for an unknown reason. Follow-up with the surgeon found that the patient was experiencing discomfort in her chest and the generator had possibly migrated. The surgeon believes that the suture used to secure the vns generator may have failed. The neurologist indicated that the patient's discomfort was immediately resolved after the generator revision. No trauma or manipulation had been reported. Notes from the implant of the previous generator found that the vns generator was likely not secured to the fascia with a non-absorbable suture as recommended by the manufacturer. It was indicated that the generator was placed into a pocket that was closed using an absorbable suture. No device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956375


Title: Re: Chest Pain
Post by: dennis100 on March 04, 2017, 02:23:15 AM
Model Number 102
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2014, the patient reported that prior to vns device disablement due to pain in 2010, the patient was having pain in the chest due to protrusion. The pain was because the generator was right under her skin. The implanting surgeon repositioned the generator a few years prior to device disablement. No replacement was performed, as far as the patient knew. No further details were provided. Attempts were made for additional information from the physician; however, they were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3592636


Title: Re: Chest Pain
Post by: dennis100 on March 10, 2017, 06:59:04 AM
Model


Title: Re: Chest Pain
Post by: dennis100 on March 10, 2017, 06:59:40 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
The surgeon's office reported that the patient was experiencing pain at the generator site. The patient had slipped in the bathtub hitting her head and chest. After this incident the patient reported that there was a stabbing pain which radiated from around the site of her device in her neck and chest to her shoulder and down her left arm. The pain resolved when the device was disabled. Diagnostics were performed on the patient's generator after her fall and it was noted that the results were within normal limits. The patient then underwent generator replacement surgery. There was no noted reason to replace the lead at the time of the generator replacement and diagnostics were within normal limits with the new generator per the implant card. Information was then received that indicated the patient had undergone lead revision surgery 7 days after the generator was replaced due the pain at her lead site. No high impedance was seen and there was no lead discontinuity observed either. The explanted products were discarded. No product return is expected. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6358184


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:35:00 PM
Model Number 106
Device Problem No Known Device Problem
Event Date 02/22/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was in the hospital due to chest pains. The patient recently had a generator and lead replacement and her device had not yet been turned on. The manufacturer's device history records were reviewed. Both the lead and the generator passed all final quality inspections prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6416454


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:35:35 PM
Model Number 302-30
Device Problem High impedance
Event Date 11/12/2015
Event Type  Malfunction   
Event Description
It was reported that a patient felt a shocking pain in her left chest up into her neck. Diagnostics were performed, and high impedance was identified. X-rays were performed, but a lead break was not visualized. The patient was referred for revision surgery. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently left off that the patient did not feel stimulation and did not have voice alteration, which indicated that the patient was not receiving therapy due to the high impedance.
 
Event Description
The patient did not feel stimulation and did not have voice alteration, which indicated that the patient was not receiving therapy due to the high impedance. The physician temporarily disabled the generator on (b)(6) 2015 due to the high impedance. The patient had lead revision surgery on (b)(6) 2016 due to the shocking pain in the chest and high impedance. There was high impedance during pre-op. Generator diagnostics were performed to rule out the generator as the cause of the high impedance, and the results were within normal limits. After testing the generator, the original lead was inserted back into the generator to ensure the high impedance was not due to a connection issue, but the impedance was still high. The lead was replaced, which resolved the high impedance. The explanted lead was received on 01/12/2016. Analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5331002


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:36:08 PM
Model Number 101
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Event Description
It was reported by the physician that the patient had requested to have the vns explanted as it has reached end of service and it was bothering her. It was reported that the patient was experiencing an electric shock in her chest that spreads to her whole left arm and neck randomly. She had also complained of experiencing pain in her chest around her vns generator and neck when yawning. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

Event Description
Further follow up with the physician revealed that the explant would be for the patient's comfort. It was also reported that the generator battery is dead and that the patient's seizure control has not changed since the generator battery has died.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374516


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:36:46 PM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/24/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient¿s vns system was fully replaced. The reason for the lead replacement was not known at that time. The explanted generator and lead were received by the manufacturer for product analysis. Follow up with surgeon showed that the lead was replaced because of a break in the lead insulation was observed. Communication with the office of the treating surgeon showed that no diagnostics were performed on the generator pre-operatively. The patient previously experienced pain in the chest that the surgeon believed corresponded with stimulation to an unintended site from the breech in the insulation. The operative notes did not clarify what layer(s) of the lead tubing (inner vs. Outer) were abraded open. The surgeon also observed fluid in the lead. No mentions of abnormal lead impedance were present. The lead was explanted before an impedance measure was taken with a new generator. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process. No surface abnormalities were noted on this device or the internal printed circuit board. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 771 volts, confirming a battery end of service condition. Electrical tests results show that the pcb performed according to functional specifications. The internal device data revealed that 109. 662% of the battery had been consumed. Review of the internal data from the pulse generator showed no indications of abnormal impedance or other anomalies during the life of the device. There were no additional performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portion. The single piece was returned with the lead connector portion still attached to the pulse generator. Continuity checks performed between the setscrew and the attached lead portion verified that proper contact between the setscrew and the lead pin was present. The returned portion of the lead measured approximately 41. 9 cm in length. Setscrew marks seen on the connector pin provide further evidence that proper contact existed between the setscrew and the connector pin. The outer silicone tubing was abraded open at approximately 23. 3-25. 4 cm from the boot and appeared to be wear-related damage. No obvious damage to the inner tubing or the lead coils was noted at this location. The lead assembly had dried remnants of what appear to have once been body fluids inside the outer silicone tubing. Besides these noted observations, visual analysis showed only observations consistent with the explant procedure. During functional analysis, no discontinuities were identified within the returned lead portion. Note that since a portion of the lead - including the lead electrodes - was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6380540


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:37:16 PM
Model Number 103
Device Problem No Known Device Problem
Event Date 02/15/2017
Event Type Injury
Event Description
Clinic notes were received from a visit on (b)(6) 2017, reporting an increase in seizures, and the patient reports that they believe the seizures are related to the pain in the chest caused by the vns since the vns settings were increased. Clinic notes then report that the vns settings were decreased and the patient ¿tolerated this¿. Further notes were received indicating the device is in referral for replacement and he is having attacks often and is on medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6405019


Title: Re: Chest Pain
Post by: dennis100 on April 18, 2017, 01:37:55 PM
Model Number 106
Device Problem No Known Device Problem
Event Date 07/29/2016
Event Type Injury
Event Description
Additional information was received from the physician's office that the device was not protruding when it was checked but the patient felt that the device tilts out when she lies down and wanted to remove it. The surgery was solely based on patient's request and for patient comfort. Patient reported that she felt vns tilt out when she lies down and cause discomfort to her left shoulder. The patient had lots of other unrelated issues and just did not like how the device felt. Per the neurologist, the patient reported that she was having some chest pain and shortness of breath on (b)(6) 2016. The neurologist felt vns moving on (b)(6) 2016. The explanted generator has not been received to date and is suspected to have been discarded.

Manufacturer Narrative

Event Description
It was reported that the patient underwent explant surgery. Follow up indicated that the explant was due to difficulty breathing, protrusion of device when patient lies down, and discomfort to the left shoulder and down the side. Patient's device was last checked in (b)(6) 2016 and device diagnostics were normal with full battery. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374392


Title: Re: Chest Pain
Post by: dennis100 on April 20, 2017, 01:20:28 AM
Model Number 102
Event Date 03/03/2008
Event Type Injury
Event Description
It was reported that the vns pt had their vns generator and lead removed due to "shocking sensation. " additional info was received regarding the events that took place just prior to and during surgery. The shocking sensation was throughout the neck and chest area. The pt reported the shocking sensation continued, even after the device had been disabled. The pt is mentally retarded and this may have contributed to the report. There was no report of direct trauma to the area. X-rays were taken prior to surgery and revealed no visible lead discontinuities and the physician indicated that the strain relief bend and loop "looked good. " diagnostics were performed during surgery and revealed normal function. The explanted lead and generator have been returned to manufacturer and analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022606


Title: Re: Chest Pain
Post by: dennis100 on April 21, 2017, 03:49:17 AM
Model Number 101
Event Date 10/25/2007
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was experiencing chest pain when the device was on. Additionally, the physician reported that the patient was seen at the "clinic" and the pain was a level 10, and the patient also experienced "numbness tingling in hands". Three days later the patient continued to experience pain and presented at the emergency room believing it was due to vns therapy. At the emergency room, the patient was advised to tape the magnet over the device. The patient then reported that the magnet fell off and it caused sharp pain. Patient experienced breakthrough seizure from the er visit and medications were added. The following day, the treating physician saw the patient and the device was tested. Both normal and system diagnostics test results revealed normal device function. The device was turned off at the office visit. X-rays were sent to manufacturer for review. There were no obvious anomalies observed that could be contributing to the reported events. Attempts to obtain additional information have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959346


Title: Re: Chest Pain
Post by: dennis100 on April 21, 2017, 03:49:51 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated that a pt would have the vns generator and lead explanted. It was reported that the vns device "had stopped being beneficial" and the pt wanted to have the device removed due to discomfort caused by the generator in the pectoral region. It was reported that the "vagal nerve stimulator didn't seem to reduce her seizure disorder. " at an earlier date while receiving vns therapy, the physician's notes stated that the pt's epilepsy worsened and that most of the pt's seizures were of a "convulsive" type with as many as 5 to 10 seizures per month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=958445


Title: Re: Chest Pain
Post by: dennis100 on April 21, 2017, 03:50:29 AM
Model Number 102
Event Date 05/15/2009
Event Type Injury
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that a vns pt experienced an infection and was scheduled for wound debridement with the implanting surgeon. Additional info was received from a company indicating the surgeon was no longer going to see the pt for infection, but rather for discomfort in the chest area. Plans to move the generator to another location due to discomfort were made by the surgeon, but at the moment no additional info has been received to confirm the reported infection or the intervention taken. Good faith attempts to obtain additional info from the surgeon and the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1477008


Title: Re: Chest Pain
Post by: dennis100 on April 22, 2017, 01:17:01 AM
Model Number 102
Event Date 01/26/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns pt was experiencing a shocking sensation in the chest. The pt was seen by the physician due to the adverse event, and the device was disabled. Diagnostics performed following the onset of the event revealed normal device function. Further follow up with the physician revealed that the pt had a large dog jump onto the chest area and this event may have contributed to the reported shocking sensation in the chest. The pt subsequently had surgery where the generator was replaced. The explanted generator has been returned to manufacturer and analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1329156


Title: Re: Chest Pain
Post by: dennis100 on April 29, 2017, 01:15:47 AM
Model Number 102
Event Date 08/01/2003
Event Type Malfunction
Event Description
Reporter indicated that a vns pt was scheduled to undergo generator and lead revision surgery. Follow up after the surgery was performed revealed that only the generator was replaced. Follow up with the treating neurologist's office revealed that the pt had presented with high lead impedance since initial implantation. The pt was finally sent for surgery after painful stimulation in the chest worsened. During surgery, the generator was replaced and the high impedance resolved. This led the surgeon to determine that the lead connector pin was not fully inserted into the generator. Attempts for return of the explanted generator were unsuccessful as the explanting facility indicated that it was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022712


Title: Re: Chest Pain
Post by: dennis100 on May 04, 2017, 01:41:13 AM
Model Number 102
Event Date 07/12/2012
Event Type Injury
Event Description
It was reported by a nurse that a vns patient had a seizure and felt on her device. Following the fall, the device was working intermittently. X-rays were taken and there was no obvious lead disconnection or breakage. An exploratory surgery was performed on (b)(6) 2012, to disconnect and reconnect the lead, which solved the issue. Further information was received indicating that following the fall, the patient noticed tenderness / bruising over the device and she could felt the device was not working. The patient was seen in clinic on (b)(6) 2012 and it was noticed that the generator has migrated to the right. The patient had pain over the generator area and shoulder and had hematoma on the chest. There were no signs of infection (no redness, no swelling nor heat). It was reported that the patient's generator was regularly checked from 2012 to 2015 and no other issue noted. On (b)(6) 2015, the ifi indicator was detected and the device was replaced on (b)(6) 2016 due to the battery running down. Review of the available programming and diagnostic history showed normal diagnostic results through the adjusted date on (b)(6) 2014. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. The explanted device was not returned to the manufacturer for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5719870


Title: Re: Chest Pain
Post by: dennis100 on May 04, 2017, 01:42:15 AM
Model Number 302-20
Event Date 01/01/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. A pre-operative system diagnostic test showed high impedance (dc dc - 7). The replacement generator was first tested with the existing lead and system diagnostic results still showed high impedance (dc dc - 7). The surgeon then replaced the patient's lead and system diagnostic results showed lead impedance within normal limits. It was noted that the surgeon was unable to explant the electrodes of the lead due to scar tissue around the jugular vein. The patient's replacement device was not programmed on during the procedure. The explanted devices have not been returned to date. The patient stated that she began experiencing pain in her ear approximately six months prior to the initial report of the event. The pain had since moved to the chest and neck incisions sites. The patient was able to differentiate stimulation on-times and off-times and clarified that the pain was intermittent and did not only occur with stimulation on-times. No patient trauma was reported.

Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient had experienced a shocking sensation and the device was checked. The device was not programmed off after observing the high impedance. Clinic notes dated (b)(6) 2014 noted that the patient has experienced a shocking sensation on the left side of the neck for about the past 6 months. The notes indicate that the patient has parasthesias in the left neck radiating up to the left ear. The neurologist reported that the device was not at end of service and it was unknown if any patient manipulation or trauma occurred that could have contributed to the high impedance. The patient was referred to neurosurgeon. No known surgical intervention has been performed to date.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3971704


Title: Re: Chest Pain
Post by: dennis100 on May 05, 2017, 03:39:33 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/09/2017
Event Type Injury
Event Description
It was reported that the patient was referred for vns replacement due to the desire for a newer model of vns generator and the patient was complaining of feeling a shock when he lays on his left side. The clinic notes received indicated that the patient turned over while laying down and felt a shock all through the chest. It was stated that most of the time when the patient was laying down on his left side at night, it hurt. It was noted that the patient's care facility staff would not use the vns magnet anymore due to the physician stating it was dangerous. It was stated that the patient reported that his neck and chest hurt a couple times a day. The patient's neck hurts when flexed or extended and when the vns stimulates. It was later reported that the patient's replacement surgery was put on hold due to the patient having a brain mass that was unrelated to the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7172237


Title: Re: Chest Pain
Post by: dennis100 on May 06, 2017, 10:40:50 AM
Model Number 102
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was initially reported through clinic notes that the patient's vns is "sticking out" which requires the patient to wear a sports bra to stabilize it. Patient's grandmother stated that the patient has lost (b)(6) due to which her skin is pulling so thinly that the generator is surfacing causing her pain. Pt was referred to a plastic surgeon to help her with the issue. The plastic surgeon indicated that the vns generator is in the breast tissue and needs to be moved before he can do anything. He believed that once the vns is moved, it will stop the pain. No add'l info is received. Good faith attempts to obtain add'l info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894919


Title: Re: Chest Pain
Post by: dennis100 on May 06, 2017, 10:41:39 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 03/21/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the patient that she was having some shocking feelings that would come from the area of the vns generator. She explained that there is some brain tissue damage that was not there before during her er visit that she had for an unrelated issue. The patient noted there was a high possibility of stroke and she was wondering if this could be due to vns because it started with a shock of the neck on the left side where the implant was located, up the neck, down the arm, and then slowly down the leg. She explained she was having a hard time lifting her leg. The vns representative later reported the patient had complained of pain in the chest and she doesn't know why; however, it was explained that the pain had gone away. It was later reported by the physician's office that this is a very complicated case and he believes it goes way deeper than just vns. The generator was noted to be at end of service; however, the physician did not know if he would refer for a replacement due to the complexity of the case. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499043


Title: Re: Chest Pain
Post by: dennis100 on May 06, 2017, 10:43:30 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 03/13/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient experiences pain at the generator site when lying on left side, migration of the device and intermittent arrhythmia with stimulation. Patient mentioned that she hasn't ever been able to sleep on her left side because it causes some discomfort where the generator is located. It was described that it felt like her heart was "beating against the generator" even though she knew they weren't physically touching. She also mentioned that for about two weeks, she has felt like her heart was racing and pounding, which was intermittent and not with every stimulation. Then one day patient felt that her heart racing was more consistent with what felt like every stimulation on-time. Patient was told to go to er and the er physician instructed her to tape the magnet over her device to stop the stimulation, which appeared to resolve the issue. While in the er, it was confirmed that her heart rate (hr) was rising to about 105-110 beats per minute (bpm), but when the magnet was taped over, her hr dropped and remained about 80bpm. The patient then saw her neurologist and had the device turned off. The patient confirmed that diagnostics were performed as the physician told her it was functioning properly. It was then mentioned that she can move the generator around with her hand from her armpit to chest, which has been like this for some time. Per a nurse at the neurologist office, the first time patient reported about the heart beating against the device was on (b)(6) 2017. No known interventions were taken for the chest pain or migration and no known trauma or manipulation were involved. The patient underwent generator replacement and the explanted generator was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499756


Title: Re: Chest Pain
Post by: dennis100 on May 07, 2017, 01:56:13 AM
Model Number 302-20
Event Date 05/22/2014
Event Type Malfunction
Manufacturer Narrative
\device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the vns patient was having painful stimulation and an increase in seizures. System diagnostic results revealed high impedance. The patient¿s device was subsequently programmed off. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. The patient was in a car accident a few years ago and reported having pain in his chest and neck. The patient¿s device showed normal device function after the car accident until his recent office visit where high impedance was observed. The patient had up to five seizures per day prior to vns. The patient was doing well with vns and was almost seizure free with vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3881786


Title: Re: Chest Pain
Post by: dennis100 on May 08, 2017, 11:31:54 AM
Model Number 302-20
Event Type Malfunction
Event Description
Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. There were no observed product-related anomalies with the single returned lead portion. Radiographic examination of the connector pin (negative coil) and ring (positive coil) shows the ends of the coils at the crimp locations. Although not conclusive, it is believed that the coils were torn at crimp locations most likely at explant.

Event Description
It was reported that the vns patient was referred for surgery due to a depleted battery and lead break. It is unclear how the lead break was determined, but it was attributed to the patient¿s recent mammogram that damaged her device. The date of the mammogram is unknown. The patient presented with pain in her left chest and neck on (b)(6) 2014 following the issue with the mammogram. The patient did not experience any pain related to vns prior to the mammogram. The patient¿s device was disabled and the patient did not have symptoms since the device disablement. The patient stated that the generator had migrated further down towards the axilla aggravating the incision scars. The physician noted that the incision sites appeared normal. The patient¿s device did not show any issues with the device. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due damage from the mammogram. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Event Description
Information received on 05/17/2016 for file (b)(4) regarding the patient's post-op nerve damage, states that the patient did have a broken lead after mammogram and underwent a full replacement because of it which was previously reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4168428


Title: Re: Chest Pain
Post by: dennis100 on May 09, 2017, 01:25:28 AM
Model Number 102
Event Date 09/01/2014
Event Type Malfunction
Event Description
It was reported that the patient felt a painful event where the generator felt as though it had turned in her chest and since then, the patient has experienced more depressive episodes. The patient feels that the generator battery may be running low. The patient was given a name of a physician to have the device checked. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4162145


Title: Re: Chest Pain
Post by: dennis100 on May 11, 2017, 01:09:22 AM
Model Number 102
Event Date 01/10/2008
Event Type Malfunction
Event Description
The reporter indicated that the pts vns "off" time had spontaneously changed from 5 mins "off" time to 3 mins "off" time. Additionally, the reporter revealed that the pt was experiencing pain at the chest site. Further follow up the physician revealed that the pt's settings have been reset and the pt is " feeling fine".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992345


Title: Re: Chest Pain
Post by: dennis100 on May 11, 2017, 01:10:06 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated that pt had surgery to remove scar tissue at the generator chest incision site. The pt also had pain at the generator site. The generator was programmed off. Evaluation by a surgeon revealed that the incision site was well healed and could not find anything wrong with the device. Physician programmed device back on, and there have been no more reports of chest pain. Good faith attempts to obtain add'l info from the implanting surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989699


Title: Re: Chest Pain
Post by: dennis100 on May 12, 2017, 01:17:48 AM
Model Number 302-20
Event Date 09/22/2008
Event Type Malfunction
Event Description
Product analysis was completed on the returned generator. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes received on (b)(6) 2012, indicate that high impedance is still noted in this patient's vns system. The patient feels that the stimulator isn't working and feels that he is having headaches and neck discomfort as a result. The patient also reported pain on the left anterior chest- around the vns generator. In the clinic notes it was also mentioned that the patient was having seizures "all week long" the week of (b)(6) 2012. The device remains enabled. The patient has been referred for revision. Revision is likely, but has yet to occur.

Event Description
Reporter indicated the patient had vns lead and generator replacement surgery performed on (b)(6) 2013. Preoperative vns diagnostics still noted high lead impedance, and reinserting the lead pin into the new generator also resulted in high lead impedance, ruling out a lead pin issue and making a lead fracture more likely. An intraoperative x-ray was done and per the surgeon he could not clearly see any helical coils and did not believe the lead was even connected to the vagus nerve. During the removal of the old lead the surgeon stated there was a complete lead break that appeared close to where the anchor coil should be, but he did not see any helical coils. Diagnostics with the new lead and generator were within normal limits. An implant card was later received to the manufacturer indicating the vns system was replaced due to a lead discontinuity. The lead and generator were returned for analysis. A break of both the positive and negative lead coil was identified in electrode region of the returned lead. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Due to metal dissolution, mechanical distortion, and surface contamination the fracture mechanism of the coil cannot be determined. Scanning electron microscopy images of the secondary broken strand verified that a break has occurred. However due to mechanical distortion the fracture mechanism cannot be determined. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred have occurred at the coil end. Scanning electron microscopy images of the negative coil suggest a stress-induced fracture has occurred in at least two strands of the quadfilar coil and at one end of the strand segment. However, due to pitting, mechanical distortion (smoothed surfaces), and/or surface contamination a conclusive determination of the fracture cannot be made. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations, typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis of the generator is still pending.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Programming history, available in house was reviewed and it was revealed that high impedance was first noted on (b)(6) 2008. The manufacturing records for the lead were also reviewed and no anomalies were observed.

Event Description
Reporter indicated the patient has been having more complex-partial seizures that are above pre-vns baseline levels, and are believed to be due to the vns high lead impedance preventing therapy. Vns generator and lead replacement surgery is now planned, but has not occurred to date.

Event Description
It was reported that diagnostic testing resulted in high lead impedance during a vns pt's routine office visit. The physician also indicated the pt was having some neck discomfort. X-rays were sent to the mfr for review. No obvious lead discontinuities were observed. Good faith attempts to obtain additional info have been unsuccessful to date. Revision surgery is likely.

Manufacturer Narrative
Analysis of programming history was performed and the manufacturing records were reviewed. Review of manufacturing records did not reveal any anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213114


Title: Re: Chest Pain
Post by: dennis100 on May 12, 2017, 01:19:07 AM
Model Number 302-20
Event Date 07/16/2012
Event Type Injury
Manufacturer Narrative
Device failure is suspected but did not contribute to a death. Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

Event Description
Additional information was received from the patient that due to her growing since implant it had contributed or caused the lead to break.

Event Description
On (b)(6), 2012, it was reported that this vns patient was requesting vns explant due to ongoing left-sided pain. The patient was reportedly implanted in 2006 and described an ongoing tightness in her neck and left chest. The use of her left arm was limited due to the pain. The physician described the patient as having a "frozen shoulder" on her left side. The patient was referred for x-rays and explants consult. A battery life calculation on (b)(6) 2012 showed 7. 66 years to eri=yes. Clarification of implant date and attempts for additional information are underway.

Event Description
A physician's letter dated (b)(6) 2012 was received on (b)(6) 2012. The letter indicated that the patient has had relatively good seizure control. The device was unaesthetic to the patient. An eeg was performed but did not show clearly defined epileptiform features in the study. The patient requested that the device be removed. She believed that it was responsible for her left shoulder restricted range of motion. The patient had some tenderness at the long head of the bicipital tendon. The patient's mother believed that the patient had problems with progressive shoulder function associated with having a vagal nerve stimulator put into her left vagus nerve area. This contributed to some social isolation. The patient was scheduled for a battery replacement and repositioning. On (b)(6) 2012, the patient's surgeon reported that the patient had a break in her lead seen during surgery in (b)(6) 2012, so only the generator was explanted. The surgeon questioned whether the lead break was causing the patient pain. The patient was not reimplanted at this time. The explanted generator and portion of the lead was returned on (b)(6) 2013 and is currently undergoing product analysis.

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected but did not cause or contribute to a patient death.

Event Description
Clinic notes dated (b)(4) 2013 indicated that the patient presented for suture removal. The left chest wall incision and sutures were intact while the generator was absent. There was no erythema or swelling. Product analysis for the generator showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead product analysis showed that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2701479


Title: Re: Chest Pain
Post by: dennis100 on May 13, 2017, 03:37:08 AM
Model Number 300-20
Event Date 08/18/2008
Event Type Malfunction
Event Description
Reporter indicated a vns pt had experienced 4-5 intermittent shock-like sensations with no pattern in the upper chest and the reporter felt this may mean "there may be a frayed wire". All vns diagnostics tests were normal. Per the reporter, the pt will have vns lead and generator revision surgery in 2008.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1190779


Title: Re: Chest Pain
Post by: dennis100 on May 14, 2017, 01:11:50 AM
Model Number 102
Event Date 08/01/2008
Event Type Injury
Event Description
The pt reported the mfr consultant that they were having painful unpredictable stimulation. The pt was implanted in 2007. Over the course of a year, she lost a considerable amount of weight related to her medications and the generator had migrated as a result of that weight loss. The pt had been seizure free until one of her medications had been discontinued and the vns was adjusted in 2008. Shortly after that she started to gradually feel muscle soreness in her chest, and a burning sensation around her electrodes and some erratic stimulation. Diagnostics testing was within normal limits. The treating physician turned the device off for two weeks and the pt reported that muscle soreness continued but not the erratic stimulation. When generator was turned back on, it was ok for a day or so, but then erratic and painful stimulation started again. The pt has been having seizures but not above their pre vns seizure rate. It has been decided to schedule the pt for generator replacement to maintain their seizure control.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1148168


Title: Re: Chest Pain
Post by: dennis100 on May 14, 2017, 01:12:19 AM
Model Number 302-20
Event Date 07/29/2008
Event Type Malfunction
Event Description
It was reported to mfr that the vns pt was seen for a follow up visit, due to worsening depression over the last two weeks, and pain in the chest. The pt has denied any recent trauma, however, the patient mentioned that she mows the lawn, which is on a very steep incline and experienced the chest pain during this activity. Diagnostic testing was performed and revealed high lead impedance, end of service status set to no. The physician subsequently disabled the device. X-rays were sent to manufacturer to review, and a lead discontinuity was observed following the fourth tie-down after the strain relief loop in the neck region. Attempts to obtain additional information for the treating physician have been made, but have been unsuccessful to date.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Results: review of x-rays by the mfr revealed a gross lead discontinuity. Conclusions: device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172179


Title: Re: Chest Pain
Post by: dennis100 on May 14, 2017, 10:48:25 PM
Event Date 01/01/2008
Event Type Injury
Event Description
It was reported from a physician's office that they were scheduling a pt to have their vns generator moved related to pain that they were having in their nipple area. Unk if the surgery has occurred. Good faith attempts have been made for additional details from the site and thus far no further info has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1120667


Title: Re: Chest Pain
Post by: dennis100 on May 14, 2017, 10:49:46 PM
Event Date 07/06/2008
Event Type Injury
Event Description
It was reported that a vns patient was experiencing pain and twitching in the upper left chest not during stimulation. Diagnostic tests were performed and the results were within acceptable limits. The patient continued to feel this pain even after the device was programmed off and generator revision surgery was performed. The explanted generator was returned to the manufacturer and is currently awaiting analysis. An associate of the reporter diagnosed the event as a possible peripheral nerve event. In response to the continued pain event, the patient will undergo lead revision surgery within the month; a surgery date has not been finalized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1102492


Title: Re: Chest Pain
Post by: dennis100 on May 14, 2017, 10:50:22 PM
Model Number 102
Event Date 06/12/2008
Event Type Injury
Event Description
It was reported to mfr that the vns pt was experiencing pain in the chest at the generator site and pain in the left neck. The device had been disabled and the pain was constant and not associated with stimulation of the device. The pt subsequently had surgery where the generator was removed and the leads were left in place. The explanted generator has been returned to mfr and analysis is underway. Attempts to obtain additional info from the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1104290


Title: Re: Chest Pain
Post by: dennis100 on May 15, 2017, 12:53:12 AM
Model Number 102
Event Date 11/20/2009
Event Type  Injury   
Event Description
It was reported that a vns pt experienced an increase in seizures due to unk reason. Info from the treating neurologist revealed he was not able to interrogate the pt's generator and was referring the pt for generator replacement surgery. Further info was received in the form of clinic notes stating the pt was complaining of some chest discomfort while being examined by the treating neurologist in 2009. At the moment, it is unk if the discomfort was related to vns stimulation as good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552699



Title: Re: Chest Pain
Post by: dennis100 on May 15, 2017, 11:18:04 PM
Model Number 102
Event Date 05/12/2008
Event Type Injury
Event Description
It was reported that a vns patient desired to be explanted or have the device turned off as he found out that he has bipolar disorder. Patient also complained of chest pain and fatigue. Further follow up with the treating physician revealed that there was no report of chest pain during clinic visits. Fatigue was reported, but this was in the context of low mood, low motivation, and low interest, indicating that the patient experienced an increase in depression, relationship to pre-vns baseline unknown, and emotional changes. The physician stated that device function was checked, but did not offer specific results. Attempts to obtain additional info from the treating physician were made, but were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077466


Title: Re: Chest Pain
Post by: dennis100 on May 16, 2017, 01:04:30 AM
Model Number 102
Event Date 06/08/2008
Event Type Injury
Event Description
Reporter indicated a vns patient was experiencing chest pain and was hospitalized. Cardiac issues have been ruled out as a causative factor. The patient's magnet has been placed over the generator to temporarily disable to the vns therapy system. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1071606


Title: Re: Chest Pain
Post by: dennis100 on May 16, 2017, 01:05:04 AM
Model Number 300-20
Event Date 06/01/2008
Event Type Malfunction
Manufacturer Narrative
Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that system and normal mode diagnostic tests showed high lead impedance. It was reported that the patient had an "intense episode" of chest pain the previous weekend and the magnet was used to disable the device, an ice pack was placed on the patient's chest, and he was given a "mild angelgesic" due to the pain. The patient's caregiver reported that there was no trauma, patient manipulation or other interactions that could have caused or contributed to the event. X-rays were reviewed by the manufacturer and it was identified that the negative filter feedthrough was not intact. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1081940


Title: Re: Chest Pain
Post by: dennis100 on May 17, 2017, 11:28:48 PM
Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description 
It was initially reported that a patient had her device replaced because her previous device was causing some chest pain. Follow up with the patient's treating physician revealed that the pain the patient reported is a continuation of pain reported last year that occurred after the patient went through a metal detector at the airport; however, now intervention are being taken. The patient had her device replaced and has been doing very well since the surgery. The explanted device has been returned to the manufacturer for analysis and no performance or any other type of adverse conditions were found with the generator. The device performed according to specifications.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1241170


Title: Re: Chest Pain
Post by: dennis100 on May 17, 2017, 11:30:06 PM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description 
It was reported that the vns patient's device was explanted due to pain and that there were no plans for replacement. Follow-up revealed that the patient has experienced pain around the device in the neck and on the left side of the chest. The relationship of the pain event to vns therapy is unk at this time. Several therapies were tried to resolve the pain but were unsuccessful, therefore, the physician decided to explant the device as a last option. No specific device issues were reported. It was indicated that the patient's pain was constant and existent even when the generator was programmed to 0 ma. Both the lead and generator were explanted from the patient. Good faith attempts to obtain products for product analyses have been unsuccessful to date. It is unk at this time if the patient's pain event resolved after the vns device was explanted as the patient has not followed up with the neurologist since the explant.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1242941


Title: Re: Chest Pain
Post by: dennis100 on May 18, 2017, 01:07:52 AM
Model Number 102
Event Date 10/01/2008
Event Type  Injury   
Event Description 
It was reported that following a car wreck, a patient is experiencing headaches and chest pain with vns stimulation. Diagnostics testing shows vns to be functioning properly. However, the physician indicated revision surgery is likely. Good faith attempts to obtain additional information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1245979


Title: Re: Chest Pain
Post by: dennis100 on May 23, 2017, 01:45:59 AM
Model Number 102R
Event Date 04/01/2008
Event Type  Injury   
Event Description 
Initial reporter indicated the patient was scheduled for revision surgery. The patient had chest wall pain that was constant. The pain was being attributed to the position of the lead and generator. They had surgery to reposition the generator and leads. It is not known if the pain resolved after surgery.
 
Manufacturer Narrative 
A serious injury did occur, but did not cause or contribute to a patient death.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031159


Title: Re: Chest Pain
Post by: dennis100 on May 23, 2017, 01:46:58 AM
Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that patient had a "broken lead = short causing loe and left chest wall pain. Was sent to surgeon to repair it. " patient underwent generator and lead replacement. Three good faith attempts were made with this physician to obtain further information. No further information has been received. Explanted leads were discarded by hospital therefore product analysis cannot be performed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030358


Title: Re: Chest Pain
Post by: dennis100 on May 23, 2017, 01:48:53 AM
Model Number 102
Event Date 10/28/2007
Event Type  Injury   
Event Description 
Reporter indicated that a vns patient experienced chest pain at the pulse generator site. Stimulation was disabled and the pain was reported to persist. The treating physician does not know the cause of the pain. The patient will likely undergo generator revision surgery.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034314


Title: Re: Chest Pain
Post by: dennis100 on May 24, 2017, 02:26:15 AM
Model Number 101
Event Date 03/04/2008
Event Type  Injury   
Event Description 
Reporter indicated that the pt was experiencing pain at the chest site. The physician suspected that the generator had migrated. Diagnostic testing showed the device to be functioning properly. Further follow up with the site revealed that the pain only occurred when the pt's generator was palpated. X-rays were sent to the manufacturer for review. Placement of the generator seemed abnormal as it was not located just below the clavicle. Confirmation of the migration event could not be confirmed as no previous x-rays were available for comparison. Generator revision surgery is likely.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025106


Title: Re: Chest Pain
Post by: dennis100 on May 27, 2017, 06:59:45 AM
Model Number 106
Event Date 05/06/2016
Event Type Injury
Event Description
It was reported on 07/08/2016 that, that patient had surgery that day and because her generator had migrated. The generator was anchored securely with multiple stitches in hopes to prevent further vns pocket issues. Notes were received dated (b)(6) 2016 from intraoperative report. In the notes there is no mention of issues with vns and no mention of the type of suture used to secure the generator.

Event Description
Further information was received through operative notes dated on which the migration was corrected. The notes stated that the patient had surgery due to the mobility of the generator which has caused discomfort and concern for erosion of the generator through the skin. The patient had described the movement as flipping, and during the surgery, the generator was found to have flipped. It was noted that the silk suture used to anchor the generator had pulled out from the underlying tissue. The generator was repositioned. Scar tissue in the chest area was identified and the generator was anchored to this tissue. Additional silk sutures were passed through the scar tissue to the generator to provide more security. No further information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported on 05/20/2016 from the patient that her generator was just placed on (b)(6) 2016 and is now moving around in her chest. She can slide it back and forth and is causing a lot of pain along her scar line on her chest when she moves her arm. She stated it started about a week or two prior. Follow-up from the physician showed that there was no trauma or manipulation that may have caused the generator to move. It was stated that a non-absorbable suture was not used to secure the generator to the fascia during initial implantation. However, it was also stated that the patient previously had a model 103 which was replaced with the larger model 106 which required enlargement of the previous pocket thus causing the movement. The patient is planned for revision of the generator with plan for sub-muscular placement although this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5724621


Title: Re: Chest Pain
Post by: dennis100 on May 29, 2017, 03:32:14 AM
Event Date 05/12/2009
Event Type  Injury   
Event Description 
It was reported in scientific article "vagus nerve stimulation for depression: efficacy and safety in a european study," a vns therapy pt experienced angina pectoris. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative 
Schalaepfer, t. E. , (2008) vagus nerve stimulation for depression: efficacy and safety in a european study. Psychological medicine, 11.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1404936


Title: Re: Chest Pain
Post by: dennis100 on May 30, 2017, 02:22:16 AM
Model Number 302-20
Event Date 03/25/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that a vns pt was explanted of both generator and lead due to constant pain in left side of the face and left side of the chest at the generator site. Trauma was reported by the pt prior to experiencing pain and as the generator was programmed off the pain was relieved. Moreover, both the generator and lead were returned and analyzed by the mfr. Product analysis on the generator indicated there were no performance or any other type of adverse conditions found with the pulse generator as the pulse generator performed according to specs. However, product analysis on the lead revealed that the outer and inner silicone tubing appeared to be punctured. It is believed that this condition could have potentially contributed to the pt's pain event, but currently, the exact impact of this condition and when it occurred is unk.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485553


Title: Re: Chest Pain
Post by: dennis100 on May 31, 2017, 01:56:52 AM
Model Number 103
Event Date 02/23/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient's painful stimulation started following her generator being programmed back on in (b)(6) 2011. During stimulation, the patient experienced pain in left side of neck that proceeded to back of her head. She also noted more pain during magnet activation. She does; however, have seizure control. The patient's settings were provided and diagnostics were also run with ok results, however, no specifics were provided. The physician then lowered the patient's signal frequency to 20hz and pulse width to 250usec. The patient's magnet mode pulse width was also adjusted to 250usec. Diagnostics were repeated and tested ok. The patient was able to tolerate both normal stimulation and magnet stimulation following these adjustments and stated it was much better. The patient also complained of chest discomfort at generator site which the physician felt it was due to scar tissue and not stimulation related. The change in patient settings was performed for patient comfort, and no other interventions are planned at this time.

Event Description
It was reported that the patient was experiencing constant burning at her generator site as well as a shooting pain into the back of her head, hot flashes, and trouble breathing when her device would go off. This started following her recent replacement in (b)(6) 2011. The patient was told that this may be due to a lack of fatty tissue and possible scarring. The patient has been referred for a generator, and possible lead replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2351767


Title: Re: Chest Pain
Post by: dennis100 on June 02, 2017, 01:01:05 AM
Model Number 302-30
Event Date 07/28/2009
Event Type  Malfunction   
Event Description 
It was reported that a patient experienced pain and would grab the electrode and generator site every time the device activated stimulation. Further information was received from the medical professional stating that the patient's dc dc code dropped from 2 to 0 on system diagnostics. Additionally, the patient experienced an increase in seizures below pre-vns baseline which have not resolved by an increase in settings like they have done in the past. Based on clinical symptoms and the diagnostic history of the patient's device, the issue is possibly related to a short-circuit condition.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1491972


Title: Re: Chest Pain
Post by: dennis100 on June 07, 2017, 12:25:40 AM
Model Number 102
Event Date 01/21/2010
Event Type Injury
Event Description
It was reported that a vns patient experienced constant pain at the chest generator area after having a seizure. Follow up with the treating neurologist indicated the patient fell and hit her chest on vinyl floor and on the edge of the bathtub which resulted in soft tissue injury. Furthermore, the patient's device was turned off because it was causing pain around the site and surgical intervention is planned to remove the generator because of pain. At the moment surgery is likely and is awaiting patient confirmation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615461


Title: Re: Chest Pain
Post by: dennis100 on June 09, 2017, 01:13:48 AM
Model Number 103
Device Problem No Information
Event Date 01/01/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
A physician reported that a patient underwent a full replacement surgery due to pain in the chest and neck. The physician indicated that the device had not been working for a few months prior to the replacement. The system diagnostic test showed normal values and patient had an emg-based test that showed good values. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600631


Title: Re: Chest Pain
Post by: dennis100 on June 09, 2017, 03:59:15 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/14/2017
Event Type Injury
Event Description
It was reported that a generator pocket revision surgery was scheduled for the patient. The patient reported that she felt like there was a little movement within the pocket, so the physician planned to perform exploratory surgery. Follow up with the office of the surgeon showed that the generator movement was first noted by him in an office visit. Review of the operative report from the patient¿s previous generator implant surgery did not show a reference to the generator being sutured within the pocket. In the consult appointment, the surgeon noted that the generator did have some mobility within pocket and moved slightly to the left. It was assessed that the generator was causing left chest and arm pain via physical irritation to the pectoralis and biceps muscles. The patient and caregiver requested the surgeon to move the generator medially. Surgery to reposition the generator was completed as planned. In this surgery, the surgeon placed a non-absorbable suture to secure the generator within the pocket. No additional pertinent information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572484


Title: Re: Chest Pain
Post by: dennis100 on June 13, 2017, 04:00:40 AM
Model Number 302-20
Event Date 03/01/2010
Event Type  Malfunction   
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description 
It was reported to manufacturer that the vns pt had a sudden increase in seizure frequency, above the pre-vns baseline, and a "burning sensation" at the generator site in the chest. The pt had x-rays taken to assess the continuity and placement of the vns device, which were sent to manufacturer for review. Review of the x-rays revealed that the lead connector pin appeared to be fully inserted inside the connector block, and no lead discontinuities were observed on the portion of the lead that could be assessed. Further follow up with the treating neurologist revealed that a system diagnostic test was preformed, which revealed high lead impedance, dcdc = 7, end of service status was set to no. The device was disabled following the observation of high lead impedance. There was no report of any pt manipulation or trauma to the device site. The last time the pt was seen by the neurologist was in (b)(6) 2009, where diagnostic testing revealed normal device function at that time. The pt will be referred to a surgery for a consultation, and revision surgery is likely to occur.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662860


Title: Re: Chest Pain
Post by: dennis100 on July 01, 2017, 01:22:02 AM
Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
On (b)(6) 2011, additional information was received when the physician whom the patient reported that she was seeing stated that she is not one of his patients. The physician further stated that he does not know what physician the patient is seeing. Since it is unknown what physician the patient is seeing, no further follow-up can be made regarding the patient's adverse events.

Event Description
On (b)(6) 2011 additional information was received when the vns patient reported that about a year ago she reported that she was having pain in her chest. The patient has just now made an appointment with her physician concerning this event. The patient then reported that her pain is not really in her chest anymore and is more near her sides. (b)(6) attempts for additional information will be made to the physician. When further information is received, it will be reported.

Event Description
It was initially reported by the pt that she has not had her device checked at all since implant. She had her vns placed about 7 years ago. She has not been seen by any physician as she has moved to (b)(4). She stated that recently she is not been able to feel her stimulation at all and her seizure intensity has increased. Pt was referred to a treating physician in her area. Good faith attempts have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830842


Title: Re: Chest Pain
Post by: dennis100 on July 02, 2017, 01:56:45 AM
Model Number 104
Event Date 08/26/2010
Event Type Injury
Event Description
Reporter indicated a vns pt was to have the vns explanted due to pain in the left chest with movement. The pt later had the vns explanted. The vns was removed to prevent further discomfort for the pt in the future. Attempts for return of the explanted devices are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846188


Title: Re: Chest Pain
Post by: dennis100 on July 05, 2017, 12:31:07 AM
Model Number 103
Event Date 09/01/2010
Event Type Injury
Event Description
It was initially reported by the pt that when she was walking into a casino, she experienced a painful stimulation in her chest area. There were no believed security detectors when she entered the door. The pain was said to have eventually went away and then over the weekend after she got home she began experiencing painful stimulation every min. Her husband took her to er at one facility and was later transferred to another er facility. The pt was disabled at that time and told to f/u with her treating neurologist. The pt later requested that her pcp refer her for explant of the device due to the painful stimulation she was experiencing. Two weeks prior to the report, the pt had an increase in her settings, but the pain didn't show up until a few days prior to the report. There has been no known trauma or manipulation to the device. The pt did go through airport security and was patted down at that time. A search performed in the mfr's programming history database indicates that the last known diagnostics performed on (b)(6) 2010 were within normal limits. During the explant surgery, the surgeon indicated that the leads were twisted due to pt manipulation. It appeared that the pt flipped generator over and over again. The lead was straight, then twisted, then straight again. The explanted lead portions and pulse generator have been returned to the mfr, but has yet to be completed on the pulse generator. Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete eval could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908004


Title: Re: Chest Pain
Post by: dennis100 on July 05, 2017, 12:31:54 AM
Model Number 302-20
Event Date 10/21/2010
Event Type Malfunction
Event Description
It was initially reported by hospital that pt had their generator and portion of the lead removed due to a lead fracture. The lead fracture was visualized on an x-ray (not made available to the manufacturer). Pt was experiencing burning sensation in chest and neck prior to generator and lead explant. The burning sensation resolved once the vns was turned off. The lead and generator have been returned to the manufacturer. Product analysis has been planned but has not occurred. Good faith attempts to gain more info have been unsuccessful to date.

Manufacturer Narrative
Analysis of programming history. Device failure suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908703


Title: Re: Chest Pain
Post by: dennis100 on July 06, 2017, 05:13:01 AM
Model Number 102
Event Date 11/11/2010
Event Type Injury
Event Description
Additional information was received on (b)(6) 2011 when clinic notes from the patient's physician were received. In the clinic notes dated (b)(6) 2011, the patient reported that not only had the generator become infected, but the lead also became infected and he had to have the lead explanted as well and go on more antibiotics. He reported that the infection was a (b)(6). Since the explant he reported that he has been having some dizziness and is unstable with ringing in his ears and dots in his vision and sometimes feel like he is going to black out. He also reports pain under his left axilla that goes down across his chest and stomach. Clinic notes dated (b)(6) 2011 revealed that the patient wants a vns re-implanted. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

Event Description
Reporter indicated that his vns generator was explanted due to infection at the generator site in the chest, and the vns lead was left intact. The pt is currently on antibiotics for the infection. All attempts to the treating surgeon for further info have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
On (b)(6) 2011, additional information was received when the physician's assistant reported that the lead infection was first noticed on (b)(6) 2010 when the patient's family noticed a knot on the left side of neck and chest. The patient was told to go to the hospital for evaluation and the lead was removed around (b)(6) 2011. The patient was given iv antibiotics. The patient's family reported that the patient had had (b)(6). No patient manipulation or trauma had occurred that was believed to have caused or contributed to the infection. The physician's assistant did not know if it was the same infection as the infection at the generator site. He also was not aware that the patient was having any pain but said that it was probably related to the surgery and infection.

Event Description
Additional information was received on (b)(6) 2011 when the manufactures consultant reported that the patient had a neck exploration surgery that day to determine whether or not the patient would be reimplanted with vns. The surgeon decided not to implant a new vns system as he found that the vagus nerve was adhered with scar tissue to the internal jugular. The surgeon stated that he did not think it was possible to dissect the vagus from the internal jugular without damaging the internal jugular.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943766


Title: Re: Chest Pain
Post by: dennis100 on July 07, 2017, 03:21:43 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568


Title: Re: Chest Pain
Post by: dennis100 on July 07, 2017, 11:29:14 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that the patient was complaining of pain around the vns in the chest and left shoulder. The pain occurred when the left chest area was touched. The patient was referred to a surgeon for further evaluation, including a ct of the left chest, an emg, and x-rays of the ribs without a possible cause for pain shown. There was no infection or any problems seen in the left chest. The patient was subsequently referred for explant surgery with relation to the tenderness over the left armpit and vns chest site. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
Device evaluated: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6653715


Title: Re: Chest Pain
Post by: dennis100 on July 14, 2017, 03:54:19 AM
Model Number UNKNOWN
Event Date 12/30/2010
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns patient's generator had migrated and was resting in the neck region. The patient also complained of pain at the incision site on her chest and neck where the generator had moved. The neurologist also suspected infection and elected to leave the vns device turned off. Patient was referred to er for evaluation. Further follow up with patient's neurologist have been unsuccessful to date. Further follow up with patient's implanting surgeon revealed that patient reported to him about pain at the incision and possible infection at the generator site while he was on vacation on (b)(6) 2010. The neurosurgeon's colleague examined the patient but didn't see any migration or leakage. After the neurosurgeon came back from vacation, he examined the patient twice and noticed that the incision was opened about 4mm. He suspected patient manipulation even though patient denied it. There was also a small leakage from the generator site and the surgeon contributed it to the serum from sub-fascia. As a precautionary measurement, he prescribed antibiotics and pain medications. No cultures were taken from the wound site by the neurosurgeon. The surgeon saw the patient on (b)(6) 2011 and reported to the manufacturer that the device had not moved and there is no infection. He also mentioned that he used non-absorbable sutures to fixate the device to fascia. Good faith attempts to obtain generator and lead product information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1976036


Title: Re: Chest Pain
Post by: dennis100 on July 15, 2017, 09:55:52 AM
Model Number 302-30
Event Date 08/03/2007
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a vns patient developed left vocal cord paralysis due to initial vns implant surgery performed on (b)(6) 2007. The patient had a silastic implant in the left vocal cord performed in 2008, and recently had this replaced with a gore-tex implant. The patient also had left vocal cord medialization surgery performed on (b)(6) 2010. The patient can now project her voice and speaking is not as tiring, and her voice has much improved but is still hoarse. The patient has excellent mobility currently with both vocal cords, with complete glottic closure. The patient's vns was disabled on (b)(6) 2009, due to neck pain, and the generator and most of the lead was explanted on (b)(6) 2010, due to pain in the chest (reported previously via mdr # 1644487-2010-02741). All attempts for return of the explanted lead and generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953677


Title: Re: Chest Pain
Post by: dennis100 on July 16, 2017, 07:10:36 AM
Model Number 302-20
Event Date 11/21/2010
Event Type  Malfunction   
Event Description
It was reported by a nurse that high lead impedance (>10000 low output current, 0ma) was received while performing diagnostics on a vns patient. The nurse indicated that about a month ago, the patient was hit in the chest with a basketball and after which reported some intense painful stimulation in the chest area for a few minutes, but did go away. Then, two days prior to the report of high impedance, the shocking happened again. There have been no other changes with the patient, except for one seizure that the nurse is attributing to recent strep throat. X-rays were taken and no anomalies were seen by the nurse. The device was disabled due to the high impedance and the patient was referred for replacement surgery. Additional information was received from a company representative indicating the patient underwent lead replacement surgery due to high lead impedance. Diagnostics were performed after the lead revision and all were within normal limits, but specifics were not immediately available. The company representative indicated that both him and the surgeon looked at the lead and it was not apparent as what caused the high impedance. The explanted lead was returned to the manufacturer and is currently undergoing analysis. At the moment, the direct cause of the high lead impedance is unknown as it could be related to trauma.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2007128


Title: Re: Chest Pain
Post by: dennis100 on July 18, 2017, 04:52:45 AM
Model Number 102
Event Date 03/16/2010
Event Type  Injury   
Event Description
It was reported by a neurosurgeon that a vns pt had her device removed due to pain at her incision sites, i. E. , chest and neck region. The neurosurgeon attributed pt's pain to presence of the device since turning off the device did not resolve pt's pain. No medication changes occurred prior to pt's pain and neurosurgeon increased the therapeutic level of the generator on (b)(6) 2010, by 0. 25ma. Mfr received the explanted generator and lead and product analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979717


Title: Re: Chest Pain
Post by: dennis100 on July 18, 2017, 08:53:34 AM
Model Number 302-20
Event Date 10/03/2012
Event Type  Injury   
Event Description
On (b)(6) 2013 the patient underwent generator replacement. It was reported that the lead was fine. The explanted generator could not be returned to the manufacturer as the hospital does not return explanted products.

Event Description
On (b)(6) 2012 it was reported that the vns b patient is in the emergency room due to electrical shocks in her chest; pain from vns. The patient was referred for a revision surgery due to the painful stimulation. It was later reported that the painful stimulation was first observed on (b)(6) 2012. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the painful stimulation. It was reported that both system and normal mode diagnostic tests were performed which showed the device to be functioning properly as they came back "ok. " the device is currently programmed off. The revision surgery is for patient comfort. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was seen that day by a vns treating physician and the patient's mother had informed the physician that the device had been disabled in october because the device was at near end of service and the patient was having painful stimulation in her neck and had been referred for a full revision surgery because he believed that something may be wrong with her lead. No diagnostics were performed on the (b)(6) 2013 visit because the device was disabled and they did not want to bring the painful stimulation back with diagnostics. The physician's rational in referring the patient for a full revision was because the battery was depleted anyways and he believed something was wrong with the lead which was causing the painful stimulation. Clinic notes dated (b)(6) 2013 were received which indicated that the vns battery is depleted causing an increase in seizures. The patient was referred for a full revision surgery. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Brand name; common device name; model #, serial #, lot #, expiration date; device manufacture date; corrected data: additional information was received which changes the product that the initial report was submitted on.

Event Description
Additional information was received on (b)(4) 2013 when clinic notes were received. The clinic notes dated (b)(6) 2012 indicated that the patient has had no chest pain, cough, or throat irritation. The vns appears to be in place without surrounding redness, swelling, increased warmth, or tenderness. The clinic notes state that the patient's headache resolved with change in vns settings and patient not able to tolerate >1. 0ma output current. The patient's last seizure was on (b)(6) 2011 with no recurrence. The clinic notes dated (b)(6) 2012 indicate that for the last 4 days, the patient complains of intermittent pain starting on the right side of the chest along the vns and radiating into the right side of the neck that is severe and occurring on a frequent basis. The patient states that it is every five minutes and on for 21 seconds. The patient has had no recurrent seizures. No obvious injuries or neck injuries. Her x-rays were reported as unremarkable and no obvious notable break along the wires to suggest a short. The physician stated that the left-sided chest and neck pain are most likely related to the vns. The patient's vns was interrogated and appeared to be working "essentially unremarkable. " the lead impedance was ok with no signs of end of service and a dcdc of 2. The patient's device was disabled and the patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was later reported that the patient has clinical depression and symptoms are worsening as well as seizures. The patient's device had been disabled in the er prior to this.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2808655


Title: Re: Chest Pain
Post by: dennis100 on July 24, 2017, 01:15:25 AM
Model Number 102
Event Date 03/26/2011
Event Type  Malfunction   
Event Description
A physician reported that a vns pt was experiencing some tingling numbness around her generator site and the pt wanted the device disabled. There had been no reported trauma recently. A company rep was able to visit with the pt and found the pt to have high impedance. Furthermore, the pt occasionally had painful stimulation in her chest, but she now did not want the device to be disabled. The pt did not have a neurologist at the time. The pt underwent a revision surgery. The surgeon opened up the pt's chest site and noticed the setscrew was loose. The surgeon tightened the screw and ran system diagnostic tests and received within normal limit results. The surgeon prophylactically replaced the generator and all diagnostics were again within normal limits. The pt was reported to be "fine" post surgery. Furthermore, an update indicated that the physician felt the pt's tingling numbness was related to the setscrew's looseness. Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092180


Title: Re: Chest Pain
Post by: dennis100 on July 27, 2017, 05:24:39 AM
Model Number 102
Event Date 02/18/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when it was reported that the patient would like to have her vns tested. The patient was dismissed by her last physician and none of the other physicians were willing to see her. The patient was given contact information for additional physicians in her area.
 
Event Description
Additional information was received stating that the vns patient had not felt stimulation from her device for quite some time and wants to have the device replaced or removed. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator was completed. The generator could not be interrogated at two orientations, but was successfully interrogated once the programming wand was repositioned. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output current showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.
 
Event Description
It was reported by a vns patient that she was having painful stimulation in her neck and chest since her stress test on (b)(6) 2011. The patient said she was also having a loss of appetite with headaches during the stimulation. She alleged that her device was failing. However, her psychiatrist performed system and normal diagnostics which showed the device was within normal limits, dcdc=2, eos=no and dcdc=5, eos=no, respectively. The patient's current settings were 2/20/500/30/5; however, the doctor decreased the output current to 1. 75 ma. The psychiatrist did not want to disable the device because the patient was receiving efficacy. She called manufacturer again on (b)(6) 2011 and stated that her device was failing. She wanted her device removed. She was told to contact her physician; however, she stated that the physician will no longer see her and threatened to commit suicide over the phone. She was offered to be transferred to crisis help line or call 911 which she declined. Manufacturer contacted the treating physician and he stated that patient has had suicidal ideations before but has never followed through. The treating psychiatrist stated that patient's depression and threats of self harm had increased over the last month. The physician didn't feel the patient's issues were related to the vns therapy or the result of a malfunction, just that her disease condition was so severe that it didn't respond to the vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055651


Title: Re: Chest Pain
Post by: dennis100 on July 29, 2017, 05:40:32 AM
Model Number 103
Event Date 12/01/2010
Event Type  Malfunction   
Event Description
It was reported by the pt that she was experiencing a burning sensation around her generator site and that she was concerned that there may be a "short in the machine". The pain/burning started following her 3rd generator replacement surgery. The pain was reported as occurring every now and then and was said to not be related to stimulation. The physician had recently performed diagnostics on the device and everything was "working fine". The pt also reported that the physician reduced her signal frequency. The pt reported no recent trauma and would not use her magnet to disable the generator as she felt that the pain/burning was not related to stimulation. Add'l info was received from the treating neurologist indicating that he also believed the device was malfunctioning because the pt was experiencing pain at her generator site. The physician also reported that system and normal mode diagnostic test results indicated that the lead impedance and output status were ok. He indicated that the pain/burning was intermittent, occurring daily, and not associated with stimulation. The pain was occurring in the upper left chest, at the incision site, and was worsened with touch. X-rays have been scheduled, however it is unclear when or if they will be returned to the mfr for review. The pt's generator is still on. However, it was recommended that the device be disabled if the physician feels that it is malfunctioning. The pt may be referred for revision surgery. Current settings are: (b)(6) 2011 - output current: 2. 25 ma, signal frequency: 15 hz, pulse width: 500 usec, on time: 30 seconds, off time: 3 minutes, magnet output current: 2. 5 ma, magnet pulse width: 750 usec, magnet on time: 60 seconds.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107779


Title: Re: Chest Pain
Post by: dennis100 on August 03, 2017, 01:36:03 AM
Model Number 102
Event Date 06/02/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 the vns pt reported to the case manager that she had felt poorly and that her chest and neck were real swollen and painful so she went to the hospital and it was discovered that she had a post op infection of her incisions. The pt said that she was unclear of the dates when this occurred but that she thinks she was in the hospital from about (b)(6) 2011 to (b)(6) 2011. The physician later reported that the pt had no infection; that she was admitted for a different medical complaint. No further info regarding the medical complaint was provided. He said that the pt has normal post op results. Good faith attempts for info regarding why the pt was hospitalized; specifically its relationship to vns, have been to no avail thus far. If additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2167116


Title: Re: Chest Pain
Post by: dennis100 on August 04, 2017, 06:23:00 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 06/23/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient was complaining of pain and numbness in the chest wall around the site of the generator. The physician believed that the patient's generator may have "loosened up". Clinic notes indicated that the patient had woken up and began to feel pain at the apex of the generator. He also felt numbness around the generator site that extended to the left side of his lower neck. The physician noted erythema at the left chest and neck. The physician believed that there may have been a dislodgement of the vns generator. The patient's system diagnostics were within normal levels with impedance at 2804 ohms. Approximately 6 months prior, the patient had had a physical alteration with his brother and his chest was hit, and the patient had been worried that the generator was damaged. Impedance was within normal limits. The patient was referred for replacement. On a fax from the physician, it appeared that the patient was referred for surgery to preclude a serious injury and for patient comfort. He indicated that trauma to the vns during the patient's fight with his brother was the believed cause of the migration. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6753210


Title: Re: Chest Pain
Post by: dennis100 on August 04, 2017, 06:23:50 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient began experiencing intermittent pain at the neck site in the neck in 2014. The patient has since reported in 2017 pain in her neck and in her chest and armpit area too, and wants the battery explanted. Clinic notes for surgical referral provided that the patient is requesting vns to be removed as she is having pain at the site of vns implantation up into her neck. The device has been off since 2015 she states she is unable to move her left arm above her chin level. The notes provided they were unable to palpate chest wall to check for vns placement due to pain as the patient moves away and refuses further examination. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695815


Title: Re: Chest Pain
Post by: dennis100 on August 04, 2017, 08:42:42 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/03/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via clinic notes that the patient experienced painful stimulation at the throat and chest sites with magnet stimulation. She did not feel the pain during normal stimulations. The physician adjusted the magnet mode output current. System diagnostics were within normal limits. The patient's device was at ifi=no, but the physician believed that the battery was low and referred the patient for generator replacement surgery due to the painful stimulation and low battery. The physician reported that the patient did not specify when the painful stimulation started, but she had been having the tolerability issues since the physician started seeing the patient. The physician reported that the surgery was being done due to low battery, as system diagnostics were done and impedance was within normal limits. However, the physician stated that the surgery was also being done to preclude a serious injury. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727266


Title: Re: Chest Pain
Post by: dennis100 on August 04, 2017, 08:43:20 AM
Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported via the nurse that the patient had been experiencing voice alteration for a year, but that it had not been discussed since diagnostics were all ok and the patient had stated that the voice alteration was more of a constant rather than occurring with stimulation. The issue first began in (b)(6) 2012. The patient's settings were decreased from output current of 1. 75 to 1. 5ma and magnet output current of 2 to 1. 75ma. Per the notes, the system test resulted in dcdc 2 and normal mode was a dcdc 3. The patient was also referred to an ear nose - throat doctor (ent), dr. (b)(6), who did tests and found that there was extra weakness in her voice when the stimulation was present. The patient was seen again (b)(6) 2012, during which the settings were decreased again (output current from 1. 5 to 1. 25ma, magnet from 1. 75 to 1. 5ma). The patient reported doing a bit better. System diagnostics resulted in dcdc 2, normal mode was dcdc 3. The patient was seen (b)(6) 2012, and settings were decreased again (output current from 1. 25 to 1ma, magnet from 1. 5 to 1. 25ma). System diagnostics resulted in dcdc 1 and normal mode diagnostics resulted in dcdc 3. (b)(6) 2013, the patient was seen and settings were not changed. This time, system diagnostics resulted in dcdc 0. In (b)(6) 2013, system diagnostics were dcdc 0 again, and patient reported the dysphonia was better and her ability to speak was ok. The patient was last seen (b)(6) 2013 and was still improving. System diagnostics resulted in dcdc 1. The ent took x-rays and it had seemed that everything was intact. However, due to the dcdc of 0, the physician stated she was considering having the patient's device replaced. It was noted that along with the decrease in settings, the patient began having an increase in seizures. However, the physician was unsure if the increased seizure frequency was related to vns or not. The increase in seizures was not above pre-vns baseline leves. The patient's device was disabled and the patient is still experiencing chest and neck discomfort. Additional follow up indicated the patient was seen again on (b)(6) 2013 and was having more seizures that were not above pre-vns baseline levels. There were no contributory external factors, physical status, medications, etc. No recent changes were made. The patient was presented still experiencing voice dypshonia. Last time the patient was in, her voice was better for about 2-3 weeks, but now it is worse and she has discomfort in the chest area up to the electrodes that feels like it travels throughout the vns system. The patient has reportedly always complained of pain around the electrode site the last year or two but it has become more pronounced. The patient has been monitored for a year and the site has been watching the dcdc code drop from 3 to 0; however, the diagnostics never showed low or high. The patient mentioned that it "doesn't come on and of like it used to" in a way that the stimulation does not feel the same. The dysphonia is what brought the site to notice this initially. The patient was feeling the dysphonia/stimulation in one specific area in the neck which used to make the patient's voice low but now yesterday, the patient presented with her voice really high pitched. The physician said at that point that there is "something going on" and questioned if there could be an issue with the vns. Initially, they thought it could have been related to non-neurological events, co-morbid conditions. However, they all resolved and now they have determined it's related to vns. They do not want the patient to go through this anymore, so they have referred her for surgery and she will likely have a full revision. The office event sent the patient for psychiatric evaluations to rule psychiatric reasons out and ruled the events to be related to vns for the last year. Additionally during a routine clinic visit for general follow-up when she was being seen every 3-6 months, the office sent the patient to an ent immediately to perform swallowing tests. The ent determined there was weakening of the vocal cord (not paralysis) from implant of vns but when vns is stimulation, they attribute the dysphonia to the stimulation. The ent told neurology that the dysphonia is probably related to the stimulation. The patient was diagnosed in the beginning of 2012 or mid-2012. The patient did not want to stop vns because she had such a good benefit with vns. The dysphonia got better for 2-3 weeks then kicked back. The patient relies heavily on the magnet for seizures/auras, and she began feeling a lot more of voice change along with pain/discomfort along the vns system (chest/neck areas). No x-rays being taken at this time as they are referring the patient for surgery irregardless. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3347530


Title: Re: Chest Pain
Post by: dennis100 on August 06, 2017, 01:45:14 AM
Model Number 302-30
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt had gone through a metal detector and was swiped with the wand multiple times while going through a security check point. She woke up the following day with pain at the electrode site and went to see her physician. Diagnostics were within normal limits and there was nothing found wrong. The pain has continued and the pt has been referred for a surgical eval. Good faith attempts for more info have been unsuccessful to date.
 
Event Description
Reporter indicated the patient was seen in the office on (b)(6) 2012. The vns settings were adjusted which resolved the painful stimulation in the chest and neck, and the patient was having no discomfort by the end of the visit. The vns is reported to be working properly. The vns had previously been disabled temporarily in 2011 due to the painful stimulation.
 
Event Description
Additional information was received that indicated that the patient is not going to have surgery at this time. Diagnostics were run at a recent appointment and were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229149


Title: Re: Chest Pain
Post by: dennis100 on August 06, 2017, 01:45:47 AM
Model Number 300-20
Event Date 07/15/2011
Event Type  Malfunction   
Event Description
It was reported to the mfr via an implant card that a vns pt underwent both generator and lead replacement due to a lead break. Further info was received from the area representative indicating that the pt had reported pain in the chest area. The surgeon opened the pt to have a look at the pain and saw liquid inside the electrodes. A full revision was then planned and the pt was explanted. Additional info was received from the pt's treating physician indicating that the pt introduced himself in their outpatient department in (b)(6), telling he suffered from increasing pains in the subcutaneous pectoral area. Wounds were non-irritating as well as the wound on his throat and the conduction lines of the stimulator lead. The skin on the subcutaneous pectoral implantation area was hard showing the indication of scarring. After further discussion with other physicians, it was decided to operate on the pt. The physician described "there was a subtle preparation of the lead of the vagus nerve stimulator, showing that the case around the lead was damaged and there is liquid between the silicone case and he lead. " at the moment it was indicated that the lead was discarded but the generator will be returned to the mfr. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245743



Title: Re: Chest Pain
Post by: dennis100 on August 06, 2017, 01:46:52 AM
Model Number 302-20
Event Date 07/29/2011
Event Type  Malfunction   
Event Description
It was reported by the pt's physician that the vns was uncomfortable when the vns stimulated, and her settings had been the same for some time. Upon interrogation, the doctor found the lead impedance to be high, greater than 10 kohms. Diagnostic testing showed the output current to be low. The pt later had a lead replacement surgery. X-rays had not been taken of the device prior to surgery. Also, there was no known trauma or manipulation, and the device hurt the pt in the upper chest and clavicle area when it stimulated. Attempts for further info have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2258033


Title: Re: Chest Pain
Post by: dennis100 on August 07, 2017, 03:32:29 AM
Model Number 102
Event Date 05/04/2011
Event Type  Injury   
Manufacturer Narrative
(b)(6). The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.
 
Event Description
Additional information was received on (b)(6) 2011 when the explanted generator was returned for product analysis that was completed on (b)(6) 2011. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Manufacturer Narrative

Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing pain in their chest with stimulation. The patient said the pain is sharp and is at the incision location of the generator site. The patient was also reported to be experiencing sleep apnea. The patient was recently evaluated by an ear, nose, and throat physician who discovered that the patient has paralysis of the left vocal cord in the median position which is causing the patient dyspnea and coughing. The patient says that the vns does help with seizures and that if the vns is off she will have grand mal seizures. A 14-system review of the patient's systems was done by the physician and the patient was found to have asthma. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. The physician reported that if the patient's symptoms persist, it may be necessary to explore and possibly replace the generator as she gets benefit from a functioning system. Clinic notes dated (b)(6) 2011 report that the patient has had an increase in seizure frequency over the past few months. The patient has also noticed an increased pain in her left chest in the area of the generator pocket. Diagnostics were performed which revealed no malfunction; specifics were not provided. The physician reported that given the patient's pain in her chest, as well as decreased efficacy within the past 3 months, he is referring the patient for prophylactic battery replacement. Additional clinic notes were received from the physician dated (b)(6) 2011 which revealed that the patient was having an increase in spells. The patient went to the epilepsy monitoring unit and these were non-epileptic. The patient also feels that her asthma has worsened. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. A battery life calculation was performed with the patient's programming history and it revealed negative years until eri = yes. The patient went for battery replacement surgery on (b)(6) 2011. The manufacture's consultant reported that she has the explanted generator and will be sending it back for product analysis but it has not yet been received. When additional information has been received, it will be reported.
 
Manufacturer Narrative
The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits. The manufacturer's consultant reported that she made good faith attempts to obtain additional information from the physician concerning the patient's adverse events. The physician reported that the patient is doing well after the generator replacement and that all the patient's issues have resolved except for her pre-existing conditions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2212668


Title: Re: Chest Pain
Post by: dennis100 on August 08, 2017, 02:25:21 AM
Event Date 07/13/2011
Event Type  Injury   
Event Description
It was reported by a physician to a company representative that some time ago a vns pt experienced a mild chest infection and developed some chest pain. Vns switched off and the chest pain resolved; vns was switched back on again after the chest infection had cleared up and now no pain experienced. Additional info was received from a company representative indicating that no additional interventions were taken for the infection. There was no trauma or manipulation to the device that could have caused or contributed to the reported infection. Moreover, the reported pain was not a cause of programming vns or medication changes. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2210496


Title: Re: Chest Pain
Post by: dennis100 on August 09, 2017, 06:11:04 AM
Model Number 300-30
Event Date 07/08/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2011, when product analysis was completed on the explanted lead. The green negative electrode, a portion of the white positive and green negative electrode quadfilar coils, and a portion of the anchor tether helical were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 8 mm portion the end of the white positive electrode quadfilar coil appeared to be melted. Scanning electron microscopy was performed and the area was identified as having the appearance of being melted, with re-solidified material. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device; however since portions of the lead were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. What appeared to be remnants of dried body fluids were observed inside the inner silicone tubes, in some areas. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress. Puncture marks were observed on the inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and the quadfilar coils appeared to be kinked. Tool marks were observed on the marked connector inner silicone tubing. The marks penetrated the insulation and three of the marked quadfilar coil strands appeared to have been cut in half. The gouge and puncture marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. The torn appearance of the electrode bifurcation and kinked quadfilar coil most likely occurred due to manipulation of the lead during the explant procedure. Product analysis on the explanted generator was completed on (b)(4) 2011. The device performed according to functional specifications and no eri flags were observed during testing. The device was continuously monitored for 26. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The consultant reported that he would meet with the physician in september 2011 and would find out how the patient is doing since the full revision surgery. When additional information is received, it will be reported.
 
Event Description
On (b)(6) 2011, a vns treating physician reported that he saw the vns pt on (b)(6) 2011 and the pt was complaining of painful stimulation in the chest area, above the clavicle. The physician did evoked potential monitoring and noticed a break down of skin where the pt was complaining of pain. It appeared that stimulation was stopping at the clavicle where the skin was breaking down. The physician had three sets of x-ray taken and fluoroscopy performed all of which will not be sent to the mfr for review. The physician reported that the x-ray did not show any lead breaks. The pt's device was disabled and the painful stimulation resolved. The pt was then scheduled for a full revision surgery. The pt is a swimmer and does do butterfly stroke, but no trauma or manipulation was reported. The physician believes that the lead is frayed and did not want to perform any diagnostics because the pt was in pain. The consultant requested that diagnostics then be performed prior to surgery when the pt is under anesthesia. The consultant was unable to attend the pt's full revision surgery on (b)(6) 2011; therefore, the operating room circulating nurse reported that she would have either the neuro-tech who normally does the vns programming in the operating room to call the consultant once the system and normal mode diagnostics were run prior to the pt's revision surgery. The consultant never received a call so it was unk at this time whether diagnostics were indeed performed. The consultant is scheduled to meet with the surgeon at a later date. The lead impedance was reported to be ok after the surgery. The explanted product was returned for product analysis on (b)(6) 2011, which has not yet been completed. The pt's programming history was reviewed which revealed that the pt's last system diagnostic test was performed on november 10, 2010 which showed output = ok/lead impedance = ok/dcdc = 1/eri = no. The pt's settings on (b)(6) 2010 were output - 2ma/frequency = 20 hz/pulse width = 250 usec/on time - 21 sec/off time = 3 min/magnet output = 2. 75 ma/magnet pulse width = 250 usec/magnet on time = 60 sec. A battery life calculation was performed with the programming history available which revealed 6. 91 years until eri = yes. When add'l info is received, it will be reported.
 
Manufacturer Narrative
Method: analysis of programming history.
 
Event Description
The patient's father wrote a book describing the patient's epilepsy. The book described the painful stimulation that occurred in (b)(6) 2011. The book reported the electrical charge was leaving the stimulator properly. It was stopping right where [the patient] was feeling the shock. There was also a description of a red mark on the shoulder, near where the painful stimulation was occurring. The red mark on his shoulder was described as directly over the path of the wire that was hooked up to his stimulator. The patient's physician reportedly turned the device off due to the painful stimulation.
 
Event Description
On (b)(6) 2011, additional information was received when the physician reported that the patient has been doing well with no painful stimulation since replacement surgery.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201312


Title: Re: Chest Pain
Post by: dennis100 on August 09, 2017, 06:11:51 AM
Model Number 102
Event Date 07/12/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician reported that the vns pt was experiencing pain in the chest breast area secondary to vns and had a mild seizure that she went to the er for. The pt's vns was difficult to interrogate due to the generator located deep in the breast tissue. The pt was referred for prophylactic battery replacement and repositioning of the vns. The pt's programming history was reviewed and a battery life calculation was performed with the programming history available which revealed 0. 97 years until eri = yes. Good faith attempts for additional info from the physician have been to no avail thus far. Although surgery is likely, it has not yet occurred. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193846


Title: Re: Chest Pain
Post by: dennis100 on August 09, 2017, 06:12:29 AM
Model Number 102
Event Date 07/04/2011
Event Type  Injury   
Event Description
It was reported by the patient's speech pathologist that the patient had "severe oral dysphagia"; the patient also reportedly coughed what she ate. The patient had been admitted to the hospital for aspiration pneumonia, confirmed with a barium test. The mother believed that some of the issues could coincide with a fall the patient experienced. The mother later indicated that the patient was "seriously ill. " the patient was admitted to the hospital for chest pains, which was later diagnosed as pneumonia with aspiration into the lungs. The patient's muscles in her throat had weakened. Consequently, when she swallows, the matter goes into the wrong pipe, causing aspiration into the lungs. The patient's mother stated she had searched and saw that the vns may be causing some of these issues. The patient may have a tube placed due to the issues she is having. Later information from the patient's speech pathologist indicated that the patient's swallowing problems were the same when the device was on and off. The therapist stated she could not state whether the device was causing the swallowing issues, just that the issues were not made worse with stimulation. The mother again told the manufacturer of her daughter's issues. She stated that she could not say the vns was the cause of the problem, but that it could be a cause. The patient recently was not able to stand, was lethargic, and her head was going to one side. Also, the patient was not able to find objects 6 inches in front of her. Additional information from the patient's parents showed that for the past two years, the patient had had problems with choking, aspiration, fainting, low blood pressure, and pneumonia. They had initially believed these issues were due to ongoing dental issues, but after research on vns, they had conducted on their own, the vns may cause these issues. The father of the patient stated the settings had been decreased by 0. 25 ma every month, but they were afraid to disable the vns. The patient's last known settings and diagnostics show proper device function. Attempts for further information have been unsuccessful to date.
 
Event Description
It was noted by the patient's family that they had declined to replace the vns, once it had reached normal end of service, due to the dysphagia the patient experienced in 2011. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196460


Title: Re: Chest Pain
Post by: dennis100 on August 14, 2017, 03:05:30 AM
Model Number 102
Event Date 08/17/2011
Event Type  Injury   
Event Description
Reporter indicated a patient was experiencing severe pain at the vns generator site in the chest that was not related to stimulation. The patient did not want to stop vns stimulation. A referral to a surgeon was made, but no surgery date has been set as the surgeon ordered ct scans of the neck and neck. Surgery appears possible. A battery life analysis performed by the manufacturer yielded 4. 79 years remaining; generator end of service is not suspected. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had vns generator repositioning surgery performed on (b)(6) 2012. Since the vns generator was repositioned, the patient's pain has decreased significantly. The patient has been released from surgery back to the care of his neurologist.
 
Event Description
Reporter indicated the patient's vns was disabled on (b)(6) 2011 to evaluate for seizures. Replacement of the vns generator is not currently planned. The reporter does not know what to attribute the pain to. The pain was also occurring in the left upper extremity and jaw as well as the generator site. The patient's pain did improve somewhat with lowering the vns settings, but the response varies by appointment date.
 
Event Description
On (b)(6), 2011, a vns implanting surgeon's nurse reported that the vns pt was having their generator replaced due to increased seizures. The pt's programming history was reviewed and based on the pt's last setting of output=2. 75ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec, the battery longevity tables revealed that the battery should last approximately around 2. 8 yrs from date of implant until eos. Although surgery is likely, it has not yet occurred. Good faith attempts for additional info from the physician regarding the pt's increased seizures have been unsuccessful thus far. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246510


Title: Re: Chest Pain
Post by: dennis100 on August 29, 2017, 01:58:48 AM
Model Number 103
Event Date 10/01/2011
Event Type  Malfunction   
Event Description
Additional information was received that indicated that the product analysis was completed on the generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative

Event Description
Additional information was received regarding the patient. A response was received from the physician, but did not have any information about the increase in seizures. The patient reported "shooting pain" into her chest that was occurring intermittently. The generator was programmed to 0 ma and later had the magnet placed over the generator to ensure it was disabled, but the pain still occurred with both adjustments. X-rays were taken but there were no lead breaks or damage to the lead seen. The generator was turned back on and she could feel stimulation and said it felt the same as the pain she experiencing with the generator turned off. There was no trauma or manipulation to the area. The patient had a generator replacement and the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not occurred to date.
 
Event Description
It was initially reported in clinic notes that the patient has been having an increase in seizure frequency, unknown if above or below pre-vns baseline. It is unclear if this is related to vns since the physician was discussing all the stressors in the patient life when it was mentioned. It was also reported that the patient was experiencing shocking pain that does no correlate with the stimulation cycles. The painful stimulation is in her left chest and neck. Turning the generator to an output of 0 ma did not stop the pain but placing the magnet over the generator reported to stop the pain. X-rays were taken that did not show any lead breaks or kinks in the lead. The x-rays were not provided to the manufacturer for evaluation. Diagnostics were within normal limits. The patient was sent to a surgeon for evaluation. It is unknown what the plan forward will be in regards to the painful stimulation. (b)(4) attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2375484


Title: Re: Chest Pain
Post by: dennis100 on August 31, 2017, 02:30:44 AM
Model Number 300-20
Device Problem Mechanical issue
Event Date 11/07/2011
Event Type  Malfunction   
Event Description
Follow-up from the physician¿s office was received (b)(6) 2016 and provided that the vns was still programmed off. The pain was not suspected to be due to the vns, but pain was experienced on the same side as the vns when the dbs goes off. It was decided to remove the device due to the continued complaint from the patient, even though vns was not expected to have been causing the pain. The generator and the entire lead were removed on (b)(6) 2016, and it was stated the patient has not complained regarding the pain since explant. The explanted generator and lead was received for analysis, which is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the generator. The device output signal was monitored while placed in a simulated body temperature environment. Results showed no signs of variation in the output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The diagnostics were as expected for the programmed parameters. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 989 volts and was not at end-of-service. The downloaded data revealed that 23. 935% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned lead. Abraded openings were noted on the outer silicone tubing. The reported lead fracture was not verified within the returned lead portion. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the patient is scheduled to have the device removed. No known surgery has occurred to-date.
 
Event Description
Additional information was received on (b)(6) 2011, when it was discovered that the patient had a surgery consultation on (b)(6) 2011. The patient's device was disabled because the patient was still feeling painful stimulation in the chest area. Although surgery is likely, it has not yet occurred.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns patient was seen by them yesterday and a high impedance warning message came up when the patient was interrogated. The physician turned the patient up from an output of 1. 5 ma to 2. 5 ma and the patient was complaining of feeling painful stimulation in the neck at the electrodes. He turned the patient back down to 1. 5 ma and the patient no longer felt any painful stimulation. The manufacturer's consultant visited the physician's office and the patient came in again for evaluation. The patient's generator was interrogated again and the high impedance warning message was again received. A system diagnostics test was performed which showed lead impedance=high/impedance value >10,000ohms/ifi=no. The patient is still receiving stimulation however and is at output = 1. 5ma/frequency = 30hz/pulse width = 250usec/on time = 30sec/off time = 3min/magnet output = 1. 5ma/magnet on time = 60sec/magnet pulse width = 500usec. They know the patient is still getting some stimulation since the patient's voice fluctuates with stimulation; this is normal for the patient. The manufacturer's consultant stated that x-rays would be taken and sent to the manufacturer for review. The patient was reported not to be feeling any pain whatsoever. The physician decided to leave the patient programmed on despite the manufacturer's recommendation to turn it off. The patient is being referred for revision surgery. It was also reported that the patient wants to have brain surgery independent of vns. The patient's x-rays were received by the manufacturer and during the x-ray review, whether the lead wires were intact at the connector pin could only be confirmed for one of the lead pins, the other was unable to be assessed due to poor contrast of the x-ray image. The lead pins could be visualized past the connector blocks and therefore appeared to be fully inserted. Based on the x-ray received, no gross lead discontinuities or sharp angles appear to be present. However, an unpronounced lead fracture cannot be ruled out. Using the battery longevity tables, with the patient's settings the patient has about 10 years left until end of service with his battery. Although revision surgery is likely, it has not yet occurred.
 
Event Description
It was later reported by a medical professional that the patient experiences periodic neck pain when his dbs device is turned on. The dbs was turned off and symptoms resolved. It was stated the patient elected not to revise the device. No known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355453


Title: Re: Chest Pain
Post by: dennis100 on September 02, 2017, 02:15:56 AM
Model Number 102
Event Date 10/27/2011
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2011, that the pt was admitted to the emergency room due to status epilepticus. The neurologist went to the hospital to interrogate the generator, but the battery was dead. The pt had generator replacement surgery due to battery depletion. The neurologist reported that the generator was at eri=yes and was unable to be interrogated. However, no troubleshooting was performed. No programming settings were provided by the neurologist, as the generator was reported dead prior to the generator replacement, so no programming changes were completely recently. The company rep reported that the neurologist attributed the pt's hospitalization to the generator being at end of service. As a result, they immediately scheduled replacement to get the generator changed. The generator was returned to the mfr for analysis. The generator product analysis was completed, and the results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The reported allegation of "end of service" was not duplicated in the pa lab. No eri flags were observed during eval. The pulse generator module performed according to functional specs. However, it was noted that the generator did not interrogate at two orientations at approx 135 and 315 degrees. Clinic notes were later received which revealed that the pt's increased seizures occurred in a different town and was not being treated by her usual physician. The pt's seizure frequency with vns was one to two seizures per week as generalized-tonic seizures lasting one to two minutes. However on (b)(6) 2011, the pt had at least three seizures back to back for at least two hours and had pain in the chest/neck area. She also reported headache during stimulation. She told the staff at the home that vns was continually firing. The magnet reportedly did not stop the vns. The pt was taken to the er in an ambulance which did not have a vns programming system. The pt was given diazepam which stopped the pain and twitching. The pt was transferred via ambulance to another hospital and during that time, she had pain and twitching again, so they stopped at another hospital because her pain was so bad. In the er, she still had pain and also had convulsions that involved both lower extremities. Another vns physician attempted to interrogate her device in the hospital multiple times and was unsuccessful. Dr. (b)(6) stated that indicated that the battery was depleted, as it is unusual for pt to be in so much pain if battery is depleted. The notes stated that a lead fracture is possible, so x-rays would be obtained and will get a ct to rule our brain abnormalities. Although the possibility of a lead fracture was mentioned in the notes, the pt's lead were not replaced. F/u revealed that there were no programming or medication changes that preceded this onset and there was also no trauma prior to the painful and erratic stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2427383


Title: Re: Chest Pain
Post by: dennis100 on September 03, 2017, 01:28:05 AM
Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns implanting surgeon's nurse reported that the vns patient was complaining of pain in the left axillary/pectoral area and stating that the vns moves occasionally. The patient has had physical therapy to see if it would help with the discomfort but it did not. The patient was going to have surgery to either reposition or replace the battery. The nurse stated that the patient first reported the pain on (b)(6) 2011. The patient had surgery on (b)(6) 2012 and the surgeon just repositioned the generator and did not replace it. The operation notes from the surgery reveal that the patient has been experiencing this pain at the generator site over the past several months. The pain was exacerbated by movement at her shoulder. The surgeon stated that x-rays showed no evidence of malposition or break in the wire and that diagnostics show no evidence of functional problems. Because of the pain, the patient underwent reposition of the generator. After the generator was repositioned, diagnostics were still within normal limits. Attempts for additional information from the surgeon were made but no further information has been received to date. The implanted product information has been requested from the hospital but has not been received.
 
Manufacturer Narrative
Additional information was received regarding the product information therefore updating the information reported on the initial report.
 
Event Description
On (b)(6) 2012 the patient's implanted product information was received from the medical records department of the hospital the patient was implanted in.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2468877



Title: Re: Chest Pain
Post by: dennis100 on September 05, 2017, 02:09:30 AM
Model Number 102R
Event Date 01/05/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Product analysis of the generator and lead was completed. No anomalies were noted with the generator, and the generator performed per specifications. Analysis of the lead noted abraded inner and outer tubing. The full lead product analysis was reported via mdr #1644487-2012-00930.
 
Event Description
Reporter indicated a patient was having intermittent pain at the vns generator site, and the generator had migrated medially in the chest. The pain was not noted during activity but more when resting. The patient has had no trauma. The patient had the generator previously repositioned and resutured to the fascia for comfort due to migration on (b)(6) 2009. The patient was referred to the surgeon who did the previous generator repositioning surgery, but the surgeon stated he felt the vns lead was frayed and did not want to perform surgery. It is unknown why the surgeon believes the lead is frayed, as vns diagnostics are within normal limits. The patient now has been tentatively scheduled for vns generator replacement surgery with a smaller generator on (b)(6) 2012 with the same surgeon, and a possible prophylactic lead replacement due to the age of the lead (over 12 years old). It is not known if the surgery is planned to preclude a serious injury or is for patient comfort. Attempts for additional information are in progress.
 
Event Description
Reporter indicated the patient had vns generator and lead replacement surgery on (b)(6) 2012. The vns lead was replaced prophylactically due to being frayed, even though vns diagnostics were within normal limits prior to the surgery. The explanted generator and lead have been returned and are pending analysis. The paperwork included with the explants indicated the "outer tubing disrupted" on the lead, and "generator migration about to protrude through skin" for the generator. An implant card was also received to the manufacturer indicating the replacement was due to "adverse event - generator migrated & about to erode thru skin. Old lead had disrupted outer sheath. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2453737


Title: Re: Chest Pain
Post by: dennis100 on September 08, 2017, 02:49:15 AM
Model Number 304-20
Event Date 10/16/2012
Event Type Malfunction
Event Description
Patient with vagal nerve stimulator and lead had complaints of electric like shock above the stimulator and over the pectoral region. It was suspected that the lead was malfunctioning and lead replacement was indicated. During the surgery, the stimulator was removed and tested and was functioning properly. The lead was inspected and fluid was observed within the sheath of the lead. The lead was removed except from the vagal nerve. A new lead was implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2839290


Title: Re: Chest Pain
Post by: dennis100 on September 08, 2017, 11:37:35 AM
Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".
 
Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.
 
Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.
 
Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236


Title: Re: Chest Pain
Post by: dennis100 on September 09, 2017, 12:56:53 AM
Model Number 102
Event Date 01/01/2016
Event Type  Injury   
Event Description
It was reported that the patient has been having some issues with her vns generator. The generator is now reported to be moving in the chest wall and is protruding and rotating causing her significant discomfort. There was no known trauma that may have caused the device to rotate/protrude. The physician reported that this migration began >6 months ago. The patient is planned for full device explant but the explant has not occurred to date.
 
Event Description
Operative notes from (b)(6) 2007 were received on 08/02/2016. Notes state that the generator was inserted into the subcutaneous pocket on the left upper anterior chest and was sutured to the pectoralis fascia with a 3-0 silk suture (non-absorbable suture). No surgical intervention has occurred to date.
 
Event Description
Operative notes were received on 09/13/2016 for the patient's surgery on (b)(6) 2016. The patient had a full device explant on (b)(6) 2016. The reason stated was painful hardware with vns. Notes state the device was not effective for her and it became painful for her. The explanted device was discarded and will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5826374


Title: Re: Chest Pain
Post by: dennis100 on September 09, 2017, 12:57:45 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 07/08/2013
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device. (b)(4).
 
Event Description
It was reported that since initial vns implant surgery, the patient had been experiencing pain in his left chest, shoulder, and neck when lifting weights or objects over 40 pounds. The pain did not correlate with vns stimulation and would subside after rest. The patient also reported that he felt his lead had migrated overtime and he experienced a lead pulling sensation that was described as bothersome. Follow up with the treating physician revealed that x-rays had been reviewed by the physician that showed the lead was intact. At the time the physician was uncertain if the lead migration was due to the patient¿s weight lifting. No interventions were known to have occurred or been planned at the time of the initial report. It was reported several years later that the patient was requesting to have the vns lead and generator explanted due to the previously reported discomfort. A review of device history records revealed that the generator passed quality control inspection prior to distribution. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6767888


Title: Re: Chest Pain
Post by: dennis100 on September 20, 2017, 01:41:55 AM
Model Number 101
Event Date 01/01/2005
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The explanted vns generator was returned along with a portion of the patient's vns lead. A returned product form was received that indicated the reason for return was patient no longer needs. Analysis of the generator found the generator to be at end of service with a battery voltage of 0. 47 volts. Otherwise, the generator performed to specifications and no anomalies were found. A large portion of the lead was not returned for analysis. Dried body fluids were observed inside the outer tubing however no openings were observed other than those made during the explant procedure. Otherwise, no anomalies were found.
 
Event Description
It was reported that the patient was having his vns explanted as it had been off for 7 years following a motor vehicle accident and being seizure free. The site indicated the vns was 'non-working' and 'irritating' the patient since it was no longer needed. Follow-up with the surgeon's office found that the 'irritation' is referring to pain in the left pectoral related to the presence of the device. Since the patient has been has been seizure free for so long, the physician feels that it is okay to explant the vns. The site indicated the 'not working' began following the motor vehicle accident however what was meant by 'not working' could not be clarified. It was indicated that the patient previously had the vns tested and found that it was 'not working. ' surgery to explant the patient's vns has occurred. Attempts for the return of the explanted generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2655520


Title: Re: Chest Pain
Post by: dennis100 on September 30, 2017, 12:52:37 AM
Model Number 103
Event Date 10/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the explanted generator would be returned for product analysis. The explanted generator was received for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information as received on (b)(6) 2013 when it was reported that the vns patient underwent generator replacement surgery on (b)(6) 2013. It was also reported that high impedance was observed after the generator was replaced (reported on mfr. Report # 1644487-2013-00472). It was reported that the explanted generator could not be returned to the manufacturer for product analysis as the hospital requires a signed release from the patient, however they usually discard it.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012 clinic notes were received dated (b)(6) 2012 which indicated that the patient has been complaining of intermittent chest wall pain overlying the vns for the last two weeks. The pain was non-radiating and intermittent in nature. Interrogation of the vns was attempted but a message was received that indicated "vbat less than eos threshold" and the generator is not supplying stimulation. The physician reported that the vns is not working properly at this time so the patient would be referred for battery replacement due to end of service. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
Additional information was received on (b)(6) 2012 when clinic notes were received dated (b)(6) 2012. The clinic notes indicate that he patient has one grand mal seizure per week and has jerking through the day that is getting worse. The patient's mother reported that the vns has been turned up as much as possible but the magnet doesn't seem to be working. Recently the patient has had neurologic regression with both cognitive and motor regression. The vns was noted to be at end of life and the patient was referred for replacement of the vns. Good faith attempts for further information from the physician have been unsuccessful. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(4) 2013 product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the pulse-disabled by the pulse generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 855 volts, verifying an eos condition. With the exception for capacitor c4 out of specification, the post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. This is not expected to have an adverse effect on battery longevity. The cause for the out of specification capacitor, c4, (v cpu) value is likely associated with component aging. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870716


Title: Re: Chest Pain
Post by: dennis100 on October 01, 2017, 12:38:34 AM
Model Number 103
Event Date 11/06/2012
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2012 that the patient was seen for follow up and high impedance was observed, 10,000 ohms. The patient was not in pain, but it was noted that she had a recent fall due to a seizure. X-rays were sent to the manufacturer for review. The generator and the lead can be visualized. The connector pin does not appear to be fully inserted as it cannot be visualized past the second connector block. The generator seems to be placed in a normal position and the feedthru wire appears to be intact. The lead was visualized routed from the generator towards the left neck. A portion of the lead appears to be behind the generator and therefore cannot be assessed. There appears to be no fractures, discontinuities or any sharp angles present in the lead, and the lead wire appear intact at the connector pin. Based on the x-ray images provided, an exact cause for the report of high impedance could not be confirmed however the lead pin did not appear fully inserted into the generator. Additional information was then received indicating that prior to the observed high impedance; the physicians had noticed an increase in her seizure frequency, but there was no noted trauma or manipulation. Additionally the patient had started to experience pain in her left chest near the generator a few weeks prior. Per the physician, the high impedance was first noted on (b)(6) 2012 and the device was disabled at that time. Surgery occurred on (b)(6) 2012. The generator was replaced, however, it was indicated that the issue appeared to be with pin insertion as following re-insertion, the diagnostics were within normal limits.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records did not reveal any anomalies.
 
Event Description
Attempts for the return of the generator have been unsuccessful to date. A review of the design manufacturing records of the patient's implanted generator was performed on (b)(6) 2013 and no non-conformances were observed.
 
Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were also observed on the pulse generator header, which indicated that the pulse generator may have been exposed to an electro-cautery tool during the explant procedure. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing and monitoring indicated the device was operating properly. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Additional information was received on (b)(4) 2013 when the explanted generator was returned for product analysis. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862989


Title: Re: Chest Pain
Post by: dennis100 on October 01, 2017, 12:39:15 AM
Model Number 102
Event Date 11/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled to have his vns removed. Clinic notes dated (b)(6) 2012, indicated that the patient was experiencing pain on the left side of his chest and numbness at his incision site. Additionally it was indicated that the patient was never doing "well" until the generator was turned off. Since that time he has not had any more seizures. The patient was referred for generator explant due to the pain. Attempts for additional information are in progress.
 
Event Description
It was reported on (b)(6) 2012 that the patient had his generator and lead explanted on (b)(6) 2012. The patient was not re-implanted. The explanted products were returned to the manufacturer on (b)(4) 2012 and product analysis is currently in progress and has not been completed at this time.
 
Event Description
Product analysis on the generator was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications, and during the product analysis there were no anomalies found with the pulse generator. Pa on the lead was completed on (b)(6) 2013. Note that since the lead's electrode and anchor tether helix were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. However no obvious point of entrance was noted other than the identified tubing openings related to the explant procedure. No discontinuities were identified during the analysis. Other than typical wear and explant related observation, no anomalies were identified in the returned lead portion. A review of available programming history revealed no anomalies. The last available interrogation date was (b)(6) 2011. At that time the generator was enabled and diagnostics were within normal limits. Follow up performed with the treating surgeon was performed however he was unable to provide additional information as he indicated that the patient was evaluated by a neurologist and he was just asked to remove the device. Follow up performed with the last known treating neurologist was performed and it was indicated that they had not seen the patient since (b)(6) 2011. The pain and numbness had not been reported to his office; however he did indicate that the patient had been experiencing hoarseness since (b)(6) 2011. The neurologist did indicate that the patient had fallen off his bike in (b)(6) 2011, but he was unsure if this had contributed to the event. No other information was provided, and attempts to determine a more recent physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862854



Title: Re: Chest Pain
Post by: dennis100 on October 01, 2017, 12:39:56 AM
Model Number 102R
Event Date 11/12/2012
Event Type  Injury   
Event Description
Additional information was received that the explanted generator will not be returned to the manufacturer for evaluation. The hospital does not return explanted product to the manufacturer as it is too much work.
 
Event Description
On (b)(6) 2012, it was reported that this vns patient was scheduled for repositioning of her generator. The device was poking the patient she lay down, so the surgeon was going to reposition it. Clinic notes dated (b)(6) 2012, indicated that the patient vns was causing pressure and pain in the chest with certain body positions. The generator was palpated in the left upper chest and was noted to be protruding when lying on the right side. The vns was controlling seizures. On (b)(6) 2012, the patient underwent surgery. The operative notes indicated that the generator was in a capsule. The capsule was carefully opened and the generator was extracted. There was no anchoring suture on the generator. The pocket was expanded, the generator was anchored, and the pocket was closed. After closing, the generator was interrogated and device diagnostics were returned in acceptable range. Follow-up with the physician showed that the patient presented with pain but could not assess if the surgery was due to patient comfort or to preclude a serious injury.
 
Manufacturer Narrative

Event Description
Additional information was received that the pain was since the repositioning surgery and it was not related to stimulation. It was unknown it was related to surgery or presence of the device. It was also unknown if the patient¿s recent generator replacement was for patient comfort or to prevent a serious injury but the referral was related to the pain. Good faith attempts for product return are in process.
 
Event Description
Additional information was received that the patient is going back for surgery due to complaint of discomfort in the surgical area. It is unknown what will be done until surgery is completed and it has not been confirmed surgery occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2868384



Title: Re: Chest Pain
Post by: dennis100 on October 04, 2017, 01:17:33 AM
Model Number 102
Event Date 02/04/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 the patient's mother reported that the patient has been complaining of chest pain at the generator site for the past two days. The physician then referred the patient for a vns replacement. On (b)(6) 2013 it was reported that the patient recently started feeling erratic stimulation and pain at the chest. The nurse didn't think that the pain was related to the device issue reported so the patient was referred to the emergency room for evaluation. It was reported that it was still unclear what the physician's belief of a lead issue is. Pain and erratic stimulation captured on mfr. Report # 1644487-2013-00526. The physician later reported that the pain has been going on for several months but it is unknown when the erratic stimulation was first observed. No causal or contributory programming or medication changes precede the onset of the erratic stimulation or pain. No patient manipulation or trauma occur that is believed to have caused/contributed to the events. Pain and erratic stimulation captured on mfr. Report # 1644487-2013-00526. The physician again mentioned that the device was unable to be interrogated. The physician stated that surgery is pending. The physician stated that the pain is not related to vns. X-ray reviews dated (b)(6) 2011 and (b)(6) 2013 from the radiology department were received which indicate that the patient has had chest pain. X-ray reviews dated (b)(6) 2010 indicate again that the patient has chest pain but "probable pneumonia" was indicated. Clinic notes dated (b)(6) 2013 were received which indicated that the patient's device could not be interrogated. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was that day and the generator could not be interrogated. The physician's programming system was reported to be working fine on other patients. It was also stated that the patient is not feeling stimulation. The physician indicated that he believes there is a lead issue and had x-rays taken (lead issue reported on mfr. Report # 1644487-2013-00526), but the x-rays appeared normal. Clinic notes dated (b)(6) 2013 were received that indicated the patient's generator could not be communicated with. The patient was referred for surgery. A battery life calculation was performed which showed 0 years remaining until eri=yes. A copy of the patient's a/p and lateral neck and chest x-rays were received for review. The lead pin appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, no anomalies were observed that could be contributing to the reported events. However, a portion of the lead behind the generator could not be visualized. The physician later indicated that the failure to program could possibly be due to eos or a lead issue (lead issue reported on mfr. Report # 1644487-2013-00526). The physician indicated that he believes there may be a lead issue due to the lack of feeling stimulation. The patient has not felt stimulation for several weeks. No causal or contributory programming or medication changes precede the onset of the stimulation not being perceived and no patient manipulation or trauma occur that is believed to have caused/contributed to the stimulation not being perceived. The patient was seen again on (b)(6) 2013 but the physician did not try and interrogate the vns again. The manufacturer's consultant stated that the physician just suspects that there is a lead issue, has a "gut feeling", and also thinks so because the patient cannot perceive stimulation (lead issue reported on mfr. Report # 1644487-2013-00526). Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient underwent generator replacement surgery that day. The explanted generator could not be returned for product analysis since it was discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2979668


Title: Re: Chest Pain
Post by: dennis100 on October 06, 2017, 02:47:21 AM
Model Number 104
Device Problem Premature end-of-life indicator
Event Date 09/06/2016
Event Type  Malfunction   
Event Description
It was reported that this patient was having a prophylactic generator replacement. The physician noted that the battery is now at ~20%, even though it was last replaced 15 months ago, and would like evaluation as to why the battery ran down so rapidly. The clinic notes also indicate that the patient had chest pain near the generator site. The device history record of the generator was reviewed, and there is no evidence to suggest that the battery of the device depleted more quickly than expected, and there were no unresolved non-conformances were found. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6901167


Title: Re: Chest Pain
Post by: dennis100 on October 06, 2017, 10:18:25 AM
Model Number 302-20
Device Problem Fracture
Event Date 03/01/2017
Event Type  Malfunction   
Event Description
A patient underwent surgery to resolve painful and erratic stimulation in the neck and chest that began in (b)(6) 2017. The device had previously been programmed off after the patient complained that the pain sensation intensified with greater output currents. Diagnostics for the device were within the normal limits. The surgery was for patient comfort and was not required to preclude a serious injury. The generator was explanted during surgery 5 months later. Generator diagnostics were performed independent of the lead during surgery and revealed no anomalies with the performance of the generator. The existing lead was examined for obvious damage, and a company representative identified a hairline crack near the connector boot of the lead. The lead reportedly became more pronounced when the lead was twisted. The lead appeared to have been cut during a previous surgery, but the surgeon could not confirm the cause of the fracture. The surgeon and company representative believed that the lead fracture was the likely cause of the painful stimulation. The surgeon elected to repair the lead using adhesive. The now-repaired lead was connected to a new generator, and diagnostics returned results within the normal limits. The device was programmed on, and the patient reported feeling the stimulation at multiple parameter sets; however, the sensation of stimulation was no longer painful to the patient. The explanted generator was not returned to the manufacturer. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6840804


Title: Re: Chest Pain
Post by: dennis100 on October 06, 2017, 10:19:08 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 08/16/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6858790


Title: Re: Chest Pain
Post by: dennis100 on October 10, 2017, 03:04:29 AM
Model Number 103
Event Date 01/30/2013
Event Type Injury
Manufacturer Narrative
Adverse event or product problem, corrected data: previously submitted mdr stated that the event was reportable as a both a malfunction and an adverse event; however, this should have been reportable as an adverse event only. This report is being submitted to correct this data. Type of reportable event, corrected data: previously submitted mdr stated that the event was reportable as a malfunction; however, this should have been reportable as a serious injury. This report is being submitted to correct this data.

Event Description
Product analysis was performed. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2013, it was reported that this vns patient's device was disabled two weeks prior due to pain at the chest. The pain resolved with the device being disabled, and the surgeon believed that there was a malfunction with the generator. The patient was referred for generator revision. It was reported that the physician did not see anything in x-rays (not provided for review) and that all diagnostics were okay. The surgeon wanted to revise the generator to see if it made a difference. X-rays were received for review. The generator is visible the upper left chest, close to the shoulder. It cannot be verified that the connector pin is fully inserted in the connector block. Feedthru wires appear intact. Lead appears to be present behind the generator. Lead wires appear intact at the connector pin. Follow-up with the surgeon and physician showed that the patient was experiencing painful stimulation (occurring with on times). The device was disabled, and the pain ceased; however, the patient experienced an increase in seizures due to loss of therapy. The surgeon stated that he intended to revise the generator because he didn't know what was wrong. He stated that diagnostics were all okay. The physician indicated that the patient experienced painful stimulation even at very low output currents and a pulsewidth of 130 usec. The generator was revised on (b)(6) 2013. The generator has not been received to date.

Manufacturer Narrative

Event Description
The generator was returned on (b)(4) 2013 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3078704


Title: Re: Chest Pain
Post by: dennis100 on October 11, 2017, 02:35:11 AM
Model Number 102
Event Date 03/11/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the vns patient underwent generator replacement that day. The explanted generator could not be returned as it was discarded by the hospital.

Event Description
It was reported that the patient was putting on her pantyhose the morning of (b)(6) 2013 and heard a "crack" at the generator site and says that it now feels like it is stimulating over and over. The nurse in the er noted that they performed x-rays and didn't see anything of concern. The manufacturing records for the generator were reviewed and device met all specifications prior to distribution. The manufacturer's consultant stated that he performed system diagnostics on the patient and there was no high lead impedance. The physician later reported that no causal or contributory programming or medication changes precede the onset of the event and no patient manipulation or trauma occur that is believed to have caused/contributed to the event. The only intervention being taken is to replace the vns generator. Clinic notes dated (b)(6) 2013 were received which indicated that he patient has begun to have some pain around the generator site in the left chest. The patient denied any specific injury. There have been no other orthopedic issues or fractures noted. The vns generator has veen felt to be in need of replacement. The patient stated that she at times will have palpitations. The patient was tender to palpation mainly about the superior margins of the battery. There was no erythema or inflammation noted. Diagnostics were noted to be within normal limits and the patient's settings were output=1ma/frequency=30hz/pulse width=500usec/on time=21sec/off time=1. 8min. It was noted that the "battery function appears to be good presently. " good faith attempts for further information have been unsuccessful. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3037196


Title: Re: Chest Pain
Post by: dennis100 on October 13, 2017, 12:55:53 AM
Model Number 102
Event Date 04/16/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that this patient had falls a couple of days ago which caused the device to move. The device was checked and was ¿not working. ¿ x-rays were taken which showed that the device had moved. Clinic notes dated (b)(6) 2013 indicated that this patient was seen due to a recent fall on the left side of the chest and soon after noticed that her device was displaced. The patient began to have chest pain and was uncomfortable. The patient did not experience any obvious unpleased side effects with stimulation. The device was interrogated, and settings were provided. A diagnostic test was performed in which there appeared to be a problem in output current. The output delivered was 1 ma but was expected to have 1. 75 ma but there was no evidence of impedance problems. The physician¿s impression was that the device was malfunctioning, and the patient was referred for revision. A voicemail form the patient indicated similar events. Follow-up with the physician showed that the patient was experiencing extremely painful stimulation at the generator and electrode site. The patient was previously programmed to an output current of 1. 75 ma, but the stimulation had to be reduced to 1. 0 ma to alleviate symptoms; however, reducing the output current caused the patient to have an increase in seizures due to the loss of therapy. The patient was prescribed medications to control seizures as she was previously seizure free. The patient was referred for surgery because it was believed that there was a device malfunction. Diagnostics were performed and returned within normal limits. It was also stated that there was pain due to the generator moving in the chest. Surgery is likely but has not taken place.

Event Description
An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2013. The lead impedance was marked as "ok". It was reported that the explanting facility does not returned explanted devices so the device will not be returned for analysis.

Event Description
On (b)(6) 2013, this vns patient reported that she was seen by her physician on (b)(6) 2013. The patient had a wound abscess from another surgery that prevented her from being able to undergo generator revision. The patient also stated that she had a seizures one month earlier and several emergency room visits, not related to vns. The patient stated that her seizures had been increasing for about two weeks to seizures almost every day to every other day because her device was not working. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119262


Title: Re: Chest Pain
Post by: dennis100 on October 13, 2017, 11:12:16 PM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
On (b)(6) 2013, the patient underwent generator revision. Pre-operative and post-implant diagnostics were within normal limits, and the old generator was at eos=yes. The patient¿s device was programmed to intended settings after implant. An implant received on (b)(6) 2013 indicated that the reason for revision was eos. The generator was returned on (b)(6) 2013 and is pending analysis.

Manufacturer Narrative

Event Description
It was initially reported that the patient was experiencing pain in localized to the neck and extending to the generator site. The patient was being referred for surgery. Surgery is likely but has not occurred to date. Clinic noted were received that indicated that there was side of the chest pain from the vns. Follow-up indicated that there was no reported manipulation or trauma and the relationship of the pain to vns was unknown. It was also unknown the reason for surgery or if it was even related to the pain since the nurse was unable to locate the referral notes. No further information was known or provided.

Manufacturer Narrative

Event Description
Product analysis was performed on the explanted generator. An open can measurement of the battery voltage confirmed that the eri flag had been properly set. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a ¿partially depleted battery¿ condition. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. With the exception of the eri parameter (eri flag was set to ¿yes¿ due to a low battery condition), the device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144577


Title: Re: Chest Pain
Post by: dennis100 on October 13, 2017, 11:13:27 PM
Model Number 300-30
Event Date 05/20/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the generator and lead which were explanted (b)(6) 2013 to a lead discontinuity and painful stimulation. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. An abraded opening was identified in the outer silicone tubing at the lead body. The lead assembly has remnants of what appear to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
On (b)(6) 2013 it was reported that the vns patient had a prophylactic generator replacement on (b)(6) 2013. The patient reported painful stimulation was occurring prior to the replacement. The old generator was interrogated prior to removal and lead impedance was ok, with a dcdc of 0. The new generator was implanted and lead impedance was ¿ok¿ with a reading of 1500 ohms. During replacement, the current lead was observed by surgeon to have fluid inside it. X-rays were performed prior to surgery and no lead break was observed. The patient was programmed to prior settings per surgeon. It was later reported that there is an issue with the lead so the patient¿s lead will also be replaced. The patient underwent a full revision surgery on (b)(6) 2013. Device diagnostics and lead impedance were ¿ok¿. It was stated that the painful stimulation occurred in the left chest and the full revision surgery on june 10, 2013 was intervention for the painful stimulation. Attempts were made for the return of the explanted products but they have not been received to date. No further information has been received from the physician despite request for additional information.

Event Description
On (b)(6) 2013, the generator that was prophylactically explanted on (b)(6), 2013 was returned for product analysis. Product analysis is still underway and has not yet been completed.

Event Description
On (b)(4) 2013 the lead and generator that were explanted on (b)(6) 2013 due to a lead discontinuity and painful stimulation were returned for product analysis. Product analysis on these is still underway and has not yet been completed. On (b)(4) 2013 product analysis was completed on the generator that was explanted on (b)(6) 2013. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications and the product analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3170202


Title: Re: Chest Pain
Post by: dennis100 on October 13, 2017, 11:14:53 PM
Model Number 102
Event Date 05/01/2013
Event Type Injury
Event Description
The patient had generator replacement surgery on (b)(6) 2013. The device was not near end of service. The generator was received by the manufacturer for analysis. However, analysis has not been completed to date. The return product form indicated the reason for replacement as end of service (battery depletion).

Event Description
Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative

Event Description
The treating physician¿s medical assistant reported that the patient¿s device was possibly nearing end of service. The patient was implanted since 2005 and was recently experiencing an increase in seizures. The company representative attended the patient¿s follow-up appointment on (b)(6) 2013, which revealed that normal mode and system diagnostics are within normal limits. The patient is complaining of erratic stimulation and pain where the battery is located. The patient thinks she may have fallen and hit the battery as it protrudes from her chest a bit. Therefore, the patient is opting for a prophylactic generator replacement. Clinic notes dated (b)(6) 2013, indicated that the patient had experienced some increase in seizures, especially at night. The husband counted approximately 15-20 at night. She usually has seizures at night, although infrequently during the day. The impression listed in the notes indicated that the patient¿s complex seizure disorder with secondary generalization was somewhat ¿poorly controlled. ¿ the vns output current was increased on this visit. Clinic notes dated (b)(6) 2013, reported that the patient has more seizures with menstrual periods (catamenial seizures), and even though the patient was weaning her anti-seizure medication, now because of the increase in frequency of seizures with menstrual cycle, the anti-seizure medication was increased. The patient's vns output currents were increased. Clinic notes dated (b)(6) 2013, reported that the patient was doing relatively well with seizure control now in increasing anti-seizure medication slowly and gradually. The only difficulty that she had was a partial simple seizure with her menstrual cycle, about a week before her period she has seizures. The patient¿s vns current was decreased from 2. 5ma to 2. 25ma on this date. Although surgery is likely, it has not occurred to date. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
The initial report inadvertently did not report the report of the patient's generator protrusion.

Event Description
The company representative attended the patient¿s appointment on (b)(6) 2013 in which the patient was complaining of erratic stimulation and pain where the battery is. It is unknown when these events first occurred and it is unclear what the believed cause of the erratic stimulation and pain at the generator site is, per the physician. No causal or contributory programming or medication changes precede the onset of the erratic stimulation and pain at the generator site. The patient thinks she might have fallen and hit the battery as it protrudes from her chest a little bit. The patient¿s fall is not believed to be contributing to the patient¿s feeling of erratic stimulation and pain at the generator site. She is opting for a prophylactic battery change to preclude serious injury. The generator is not showing near end of service condition. The relationship of the patient¿s recent increased seizures to vns is unclear as the patient has had vns for many years. Although generator replacement is planned, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3177095


Title: Re: Chest Pain
Post by: dennis100 on October 16, 2017, 01:18:30 AM
Model Number 102
Event Date 11/19/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient¿s device was temporarily disabled on (b)(6) 2012 due to the patient experiencing coughing with stimulation and chest pain. The coughing was resolved with the device disablement, but the patient continued to experience the chest pain, which was found to be related to trauma from the patient¿s large dog jumping on his chest. The patient¿s mother later requested that the device be turned back on as the patient¿s depression was increasing with the loss of therapy. It was noted that this increase was below pre-vns baseline levels. Follow up with the clinic confirmed that the patient started to have an increase in depression which led to suicidal thoughts during this time. Per the physician, the patient's increase in depression and subsequent suicidality was believed to be related to the loss of therapy as the patient was medication-free while using the vns. The patient was put back on medications until the vns therapy could be increased back to efficacious levels. No additional information was provided. On (b)(6) 2013, the patient reported that the depression he had experienced during this time had increased further than what was originally reported. He stated that after the device was turned back on he began to experience a cough again and the settings were decreased from the previous settings to help with tolerability. It was reported that no new medication changes or medical interventions took place prior to the increased depression and no additional trauma or manipulation was suspected. The patient also stated that he could feel stimulation at one point; however, at some unknown date, he stopped being able to feel the stimulation. On (b)(6) 2013, the patient reported that his depression was ¿raging out of control¿. A nurse from the clinic reported the day before that the patient¿s settings had changed abruptly over the past week and they were trying to rule out vns problems; however, they were not sure if the vns was working. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3183001


Title: Re: Chest Pain
Post by: dennis100 on October 18, 2017, 01:02:35 AM
Model Number 102
Device Problem No Information
Event Date 07/19/2013
Event Type Injury
Event Description
On (b)(6) 2015 clinic notes were received. Clinic notes dated (b)(6) 2014 indicate that the vns was unable to be interrogated and the patient was referred for generator replacement. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
Patient underwent generator replacement (b)(6) 2015. The explanting facility's policy does not allow returns and they discard the devices after surgery. Therefore, the explanted generator is not available for analysis.

Event Description
Clinic notes received on 10/23/2015 and dated 10/15/2015 state that he is having a seizure everyday. Replacement surgery is likely but still has not been completed to date.
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 were received which indicates that the patient is getting more seizures recently. Per the notes, the patient screams, then falls to the ground. Additionally, the patient has chest pain. Notes dated (b)(6) 2013 indicate the patient's vagus nerve stimulator on the chest is bothering him. The notes state that it is painful and tender in the left mid chest area. The patient was last checked a year prior per the notes; however, clinic notes dated (b)(6), 2012 were also received. These notes state that the patient complains of sharp pain near the implanted vns. It was stated that the device was supposed to be taken out for unknown reason; however, surgery has not occurred.

Event Description
Clinic notes dated (b)(6) 2014 were received. The notes stated that the patient had been having more seizures for the past month: the patient's mother passed away three months earlier, and since then, the patient was having more seizures. Two nights earlier the patient had five grand mal seizures lasting two minutes each and one hour apart.

Event Description
Follow up with the physician's office found that the patient was experiencing a lot of pain. The patient was implanted with the vns for six years and had been in pain for six years. The relationship of the patient's increased seizures to baseline was that the seizures had increased more. The patient is having the generator explanted because of the increased seizure frequency, pain, and lack of efficacy. The patient had medication changes, but it was not the cause of the increased seizures, per the nurse. The physician did not know why the seizures increased, but stated that the vns did not do anything. The patient has only one seizure type. No other information was provided.

Event Description
It was reported that the patient has experienced an increase in seizures over the past three weeks. It was reported that the physician feels that the increase in seizures is related to a lack of vns therapy. It was reported that the generator was at eos - yes in (b)(6) 2014. It was reported that the patient wanted to wait before having the generator replaced because he wasn't sure if vns was doing him any good. It was reported that the pain the patient experienced was related to the presence of the device because it happened when the patient was sleeping and rolled over on it. Generator replacement surgery is planned, but has not occurred to date.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 note that the patient's seizures decreased after vns settings were increased in (b)(6) 2013. It was noted that the patient has experienced four seizures the previous week and that the family agrees to replace the generator. It was noted that the vns was checked electronically and that the battery is dead. The patient was referred to surgery. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3297246


Title: Re: Chest Pain
Post by: dennis100 on October 18, 2017, 01:03:28 AM
Model Number 101
Event Date 10/13/2009
Event Type Injury
Event Description
Reporter indicated a vns therapy patient was complaining of painful stimulation in the chest incision when lying down, which caused her to cough. The patient was admitted and a pacemaker magnet was taped over the device to turn it off. The patient followed up with her treating physician and diagnostics were within normal limits. After diagnostics, the physician disabled the recurring stimulation, but the magnet mode stimulation was left active to allow stimulation during seizures. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1530570


Title: Re: Chest Pain
Post by: dennis100 on October 20, 2017, 12:32:02 AM
Model Number 101
Event Date 08/02/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was discovered that the patient underwent explant of the vns on (b)(6) 2013. The explanted vns has not been returned to the manufacturer for product analysis to date. Good faith attempts for further information from the physician were made but no additional information has been received to date.

Manufacturer Narrative

Event Description
It was reported that the explanting facility automatically discards products that are over three weeks explanted. The explanted device has been discarded and will not be returned for analysis.

Event Description
On (b)(6) 2013, it was reported that there was suspected migration of the generator. The migration was first observed on (b)(6) 2013. The patient saw the physician on (b)(6) 2013. The patient's device was disabled and the patient was referred for surgery. The suspected migration was not due to trauma or migration, and the cause is unknown. X-rays have been taken and diagnostics showed everything was ok with a dcdc = 2. Clinic notes dated (b)(6) 2013 indicate the patient came into the clinic with shocking pain to the vns site. Per the x-ray, the device is situated over the left fourth anterior rib and extends up at least to the left c7 level. The patient still has pain to the left chest wall, but finds it difficult to describe. She states it is like a muscle cramp and a vibration. It is intermittent and sometimes exacerbated by her movements. Attempts are underway for additional information; however, no additional information has been received. Surgery is likely, but has not occurred to date. Additionally, it was noted that the explant may be due to the patient no longer needing vns therapy as she is seizure free. The patient was prescribed licoderm and told to apply the patch to intact skin for painful area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3335694


Title: Re: Chest Pain
Post by: dennis100 on October 21, 2017, 01:48:30 AM
Model Number 302-20
Device Problem High impedance
Event Date 03/22/2013
Event Type  Malfunction   
Event Description
X-rays were received for review. The generator was visualized in the patient's left chest. The angle of the film prevents full assessment of the interface, but the angle of the lead pin to the generator can indicates the lead is likely adequately inserted. The integrity of the filter feed-thru wires was able to be visualized. Some of the lead was visualized behind the generator. Strain relief was unable to be observed due to what appears to be a break in the lead near the top of the lead body. Patient manipulation has potentially caused the lead to be pulled away from the electrode site. One tie-down is found behind the positive electrode. Due to the angle of the x-ray, it is difficult to assess if the tie-down is placed as specified per labeling. Per cyberonics¿ labeling proper strain relief should include a 3cm strain relief bend that should begin at least 1cm below the anchor tether, and the bend should be secured parallel to the anchor tether. A large strain relief loop should then be formed and secured with an additional tie-down. The strain relief loop should allow for full neck movement. It appears that the patient was a ¿twiddler¿ and has manipulated the lead to break at the top of the lead body; likely twisting the lead near the site of the generator, and pulling the lead away from the electrode site, causing the lead to collect along the side and behind the generator. Multiple twisted lead loops are noted next to the generator. Based on the x-ray images provided, the most likely cause of the high lead impedance observed by the physician is the gross lead discontinuity and sharp bends of the lead wire found. Surgery is likely but not scheduled at this time.

Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

Event Description
Clinic notes were received indicating that the patient had pain at the generator site prior to replacement surgery. During the procedure, the surgeon noted that the patient's lead was twisted and may have been causing the pain.

Event Description
It was reported that the patient underwent generator and lead replacement on (b)(6) 2013. It was reported that the lead was in a knot and would be returned for analysis in pieces. The generator was returned to manufacturer for analysis on 10/23/2013; however, the lead was not returned. Analysis of the generator was completed on 11/07/2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(4) 2013 clinic notes dated (b)(6) 2013 were received that indicated the patient had two larger seizures in church on (b)(6)2013 and then 3-4 shorter ones in the car on the way to the ¿ed¿. It was stated that in the past when he has been more emotional, or upset, then he will be set off into a seizure. It was stated that the patient¿s seizures have changed over time; they used to be in clusters and now they are sporadic. He used to have episodes of zoning off, with or without stiffness. He still has a lot of spacing off, but it was stated that it was difficult to determine if he is just ignoring people or truly having seizures. It was stated that currently he is having 1-2 seizures per day. The clinic notes mention that it is unclear whether he ever had a good trial of the vns and the physician said that if they replace it, it may be that ¿he will just not put up with it again, and may have just as bad an experience as he had previously¿. The patient¿s mother however stated that she is willing to have the vns replaced. The physician indicated that he will start him on rapid cycling but at very low amplitudes and will increase the amplitude slowly in the hope that he will tolerate this approach better. Although surgery is likely, it has not occurred to date.

Event Description
It was reported that the patient's device had previously been programmed off for a sleep study on (b)(6) 2012. The patient was noted to have sleep apnea. This is addressed in medwatch number: 1644487-2013-01565. No surgery scheduled at this time until further work up with their surgeon. The patient's parents are interested in giving vns therapy another try. Per clinic notes dated ((b)(6) 2013) the patient's absence seizures during the day have decreased. They are rarely seeing a seizure during the day. He has been intractable to many medications with side effects to several meds, and he continues to have frequent seizures.

Event Description
A vns patient was seen in clinic on (b)(6) 2013 and their device was programmed on and testing performed. It was noted that the patient had high lead impedance over 10,000 ohms. The patient was referred for a surgical consult. No x-rays were taken. Their device was programmed back off. It was unknown what the cause of the lead issue was but the patient was having an increase in seizures since the previous device disablement so that was thought to be the cause. Possible a seizure event caused a lead break. During the time of their increased seizures they were not receiving any vns therapy as their device had been programmed off for several months. The patient's device had previously been programmed off on (b)(6) 2012 related to a sleep study and not turned back on. No surgery is planned at this time.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3072665


Title: Re: Chest Pain
Post by: dennis100 on October 23, 2017, 01:05:38 AM
Model Number 302-20
Event Date 12/15/2010
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
During review of the patient's programming history available in the manufacturer's database, it was identified that low impedance was observed for patient's device. Patient's vns was finally disabled on (b)(6) 2012. Patient underwent full explant of lead and generator on (b)(6) 2013. Surgical notes indicate that the patient was not receiving benefit from vns due to low impedance and that the patient experienced pain in the chest. During the surgery, the surgeon observed that there was a fracture in the electrodes which were coiled up around the generator. The cervical incision was also opened but there were no electrodes remaining there. The explanted products are suspected to be discarded by the explant facility after 30 days from explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4922893


Title: Re: Chest Pain
Post by: dennis100 on October 23, 2017, 01:06:21 AM
Model Number 103
Event Date 08/15/2009
Event Type Injury
Event Description
It was reported that the pt was hospitalized, due to pain at the generator incision site on the chest. The pt was recently implanted, and no changes have been made to her programmed settings. The physician plans on monitoring the pt for now, and there are no plans to take any interventions. Info in the complaint form indicated that device diagnostics were performed in 2009, however, the complete results were not recorded. Good faith attempts to obtain additional info from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1495358


Title: Re: Chest Pain
Post by: dennis100 on October 23, 2017, 01:07:18 AM
Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002


Title: Re: Chest Pain
Post by: dennis100 on October 24, 2017, 01:29:10 AM
Event Date 11/16/2009
Event Type Injury
Event Description
Additional information was received stating that the vns patient¿s lead was not replaced during the procedure on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostic results showed lead impedance within normal limits (impedance value - 3459 ohms). The patient¿s replacement device was programmed back on previous device settings.

Event Description
Analysis of the generator was completed on 07/10/2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes dated (b)(6) 2013 stated that this vns patient recently relapsed and began to have spells of confusion several times each day. The patient was seen on (b)(6) 2013. When the patient was seen on (b)(6) 2013, she had return to her baseline neurological status. Apart from the complex partial seizure with awareness and confusion impairments, there were no other positives in the patent¿s review of systems. The patient complained of pain at the generator site due to the sagging nature of the device related to the site of implant. The patient wanted breast augmentation and evaluation of the implant site. The device was interrogated, and the settings had been recently adjusted on (b)(6) 2013 to abort seizures. The patient was now doing well. The patient¿s condition was stable. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that device diagnostics were within normal limits. Clinic notes dated (b)(6) 2014 note that the patient has experienced issues with the position of the device over the last several months and now complained of pain related to stimulation of the device. At times the patient states the pain is not tolerable. The notes indicate that the patient's seizure frequency is much improved due to the device itself. The patient complains about pain in the neck at the site of the device. The patient also complains that pain in the left side of the chest is close to the device. It was noted that the generator seems to be hanging and it makes her more uncomfortable. The patient has tenderness at the site of the generator and also in the neck where the lead is placed. The notes indicate that the pain is intensified with magnet use. It was noted that the problem appears to be due to the suspension of the device. Device settings were adjusted and the patient was referred for an appointment with a neurosurgeon. The patient underwent generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
On (b)(6) 2014, it was reported that the patient was referred for breast implant surgery as she has no breast tissue to attach the device to. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3537553


Title: Re: Chest Pain
Post by: dennis100 on October 24, 2017, 01:30:25 AM
Model Number 102
Event Date 11/27/2013
Event Type Injury
Event Description
Although the reported allegation of chest pain at the generator site and pain with stimulation cannot be evaluated in the product analysis laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. However, the cored septum may have been a contributing factor. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the septum anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. Attempts were made for additional information; however, they were unsuccessful. No additional information has been received.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent generator explant due to pain and the patient no longer wanting the device. The lead was not removed. The generator was returned on (b)(6) 2013 and is pending analysis. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531374


Title: Re: Chest Pain
Post by: dennis100 on October 25, 2017, 02:23:40 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316


Title: Re: Chest Pain
Post by: dennis100 on October 29, 2017, 03:10:03 AM
Model Number 103
Event Date 01/23/2010
Event Type Injury
Event Description
It was reported that a patient experienced an increase in seizure activity and was admitted to the hospital due to chest pain. The hospital discharge summary indicated negative troponin and ekg changes. The patient's settings were increased and approximately 1 week later, the patient experienced a choking sensation that started in mid sternum to the throat. The patient finds it difficult to breath when this would occur and stated the symptoms were episodic; however, there did not appear to be any regular interval between the symptoms. The choking sensation would last for a few minutes then subside. The patient was taking prilosec for these symptoms which helped, but they did not completely resolve. The patient would still experience a mild choking sensation. The patient was instructed to place the magnet over the device to stop stimulation and this resulted in the symptoms resolving. The physician determined that the events appear to be related to the device and has programmed the device off to see if the symptoms would resolve. The patient does not have a history of gerd, heartburn, or reflux prior to this event. There were no medication changes made prior to the onset of the event. The patient came back into the office a few months later and the settings were slowly increased. There were no issues. The physician plans on monitoring the patient and not taking any additional interventions at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1650538


Title: Re: Chest Pain
Post by: dennis100 on November 05, 2017, 02:54:05 AM
Model Number 100
Event Date 01/10/2000
Event Type Injury
Event Description
Review of the patient's programming history revealed the device was disabled on (b)(6) 2000.

Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date reported on the initial report.

Event Description
It was reported that the vns patient¿s device was disabled approximately about 10 years ago because it is made her heart feel funny; attempts for additional relevant information have been unsuccessful to date.

Event Description
Clinic notes were received dated (b)(6) 2014 that indicate the vns device has been turned off since shortly after being placed due to what the patient describes as intolerance of the device. Over the last year she occasional feels a pulling sensation over her left anterior chest at the site of the stimulator. It aches at those moments. Over the last year, she has noticed this sensation three or four times, all being while laying on her left side except once while sitting up. The last time was one month ago. The clinic notes state that she has no cardiac condition of any type.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3978460


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:03:49 AM
Model Number 103
Device Problem No Known Device Problem
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by the patient that he was unable to find a physician to address the issues he was having with the vns. The patient reported that he has had 52 outbreak seizures with the vns and a maximum dosage of keppra, though no timeline was provided. The patient reported severe pain in the chest, upper back, and middle back. The company representative followed up with the patient who was asking for physicians who could prescribe pain medication. The patient told the company representative that physicians would not see him and were sending him certified letters. It was reported that the patient was referred for vns replacement surgery. Follow up with the patient's last known treating neurologist revealed that they did not see the patient anymore and had not in a while. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949980


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:05:57 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type Injury
Event Description
It was reported through clinic notes that this patient had chest pain over the location of the vns module. The patient's pain was described as a 5 out of an unknown limit. The notes also indicated that the patient would be referred to surgery for vns location assessment. Follow-up from the doctor indicated that the patient's pain was related to both vns stimulation and presence of the device. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6988762


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:07:20 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 08/02/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960601


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:08:40 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type Injury
Event Description
Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949677


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:09:54 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 09/20/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245


Title: Re: Chest Pain
Post by: dennis100 on November 11, 2017, 04:11:05 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/04/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that this patient was in the er complaining of continual shocking in her neck from the vns, the patient's device¿s output current was lowered, and diagnostics tests were performed and were within normal limits. The patient was noted to be seizure and medication free where she was previously on 9 medications. The patient had a fall recently, and the pain was said to originate in the generator site and radiates into the neck, jaw and face area. The pain felt continuous in the chest and neck areas. During the appointment with the nurse, it was observed that the patient had an irregular/fast heart rate that was concerning to the nurse. The patient¿s device was disabled and the pain subsided along with the heart rate issues. The patient was said to still be sore despite no stimulation. An ekg was taken, and was said to be normal, and the patient may be referred for revision due to the issue. The nurse was concerned there was a device malfunction due to the recent events, but diagnostics were within normal limits. Additional information was received that the patient previously was having 10 seizures a day before vns, and was on 9 medications, and after vns she had been completely seizure free. The device was disabled by her nurse practitioner, and the patient had 4 seizures that following night. The patient therefore went back to the er where the doctor was skeptical if they were actual seizures or not, as the patient is in a perpetual state of hysteria. Due to the patient¿s reported seizures, the device was programmed back on. Additional information was received from the patient's provider. They mentioned that the patient feels stimulation all the time, but the device is only going off every 5 minutes, so the doctor is not sure what the patient is feeling. The magnet was used at night during one of the patient's seizures, and the patient woke up in pain. The provider doesn't know if the pain is real or what exactly is going on. The doctor thinks the patient could possibly be getting down to the end of her battery life, even though she recognized it was okay according to system diagnostics. The neurologist from their clinic believes the patient is having pseudo-seizures, because the patient is very anxious. The patient mentioned being very light headed and dizzy and almost passed out before seeing the nurse practitioner (np) at the clinic. The patient was said to have sinus arrhythmia prior to having the vns implanted. The nurse was able to hear some heart irregularities that she couldn't identify when the vns was on. When the vns was disabled, and they were monitoring the patient, it was noted that no cardiac issues came up; therefore the nurse believes that the vns may have exacerbated some of the patient's heart issues. The patient's heart rate rose to about 110bpm at one point, but the nurse believes this to be from the patient's anxiety and previous heart condition. The nurse mentioned she did not know where the pain is coming from, or why, because the device looks okay, according to diagnostics. The nurse also mentioned that she palpated the patient's chest and neck, and the patient did not have any pain or soreness. Diagnostics were run when the patient was in many different positions and all diagnostics were within normal limits. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6942048


Title: Re: Chest Pain
Post by: dennis100 on November 15, 2017, 02:52:08 AM
Model Number 103
Event Date 02/25/2015
Event Type Injury
Manufacturer Narrative
X-rays showed that the vns was not in place.

Event Description
It was reported that the patient was seen on (b)(6) 2015 and the postoperative wounds appeared normal. The reason for the visit was noted to be chest pain with vns stimulation. X-rays showed that the vns was no in place and could be causing the chest pain. An exam by another physician identified that the surgical sites looked good and there was some excoriation of skin of the end of the left chest incision. The patient was seen by the neurologist who concluded the incisions were healing well. The patient had no longer experienced any chest pains. Device diagnostics were within normal limits.

Event Description
Initially, it was reported that the patient was experiencing problems with incisions following vns implant. It was reported that the patient had been seen in the emergency room twice with chest pain. It was also reported that device migration was noted. Further follow-up with the physician identified that the patient was doing great and the incisions were healing. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that both the neurosurgeon and neurologist spoke with the er physician and informed him that the device position was normal and that it had not moved from it's original implant site. No known interventions occurred for the reported chest pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632705


Title: Re: Chest Pain
Post by: dennis100 on November 15, 2017, 02:53:37 AM
Model Number 302-20
Device Problem Fracture
Event Date 02/18/2015
Event Type Malfunction
Event Description
The mother reported after onset of high impedance that the patient experiences pain to the throat and chest exclusively with magnet use. No additional relevant information has been received to date.

Manufacturer Narrative

Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not report this information. The supplemental report #1 inadvertently did not report the updated conclusions.

Event Description
It was reported that device diagnostics resulted in high impedance (8497 ohms). X-rays were performed and sent to manufacturer for review. The patient was referred for surgery. Review of x-rays did not identify any gross discontinuities with the vns system. There was a portion of the lead that was unable to be seen. The patient's mother reported that device diagnostics on the visit prior to (b)(6) 2015 were within normal limits. It was reported that the device was not programmed off after observing the high impedance because the physician did not want to patient's seizures to return. The patient's mother reported that there was no known trauma or patient manipulation that may have caused or contribute to the high impedance. A second set of x-rays were received by manufacturer. Review of the second set of x-rays did not identify any obvious discontinuities with the vns system. The presence of a micro-fracture in the lead could not be ruled out. No known surgical interventions have been performed to date.

Event Description
It was reported that the patient underwent surgery on (b)(6) 2015. During the surgery, a new generator was connected to the existing lead and high impedance (>10,000 ohms) was observed. The surgeon attempts exploration of the neck incision to dissect the lead electrodes from the vagus nerve; however, the surgeon encountered scar tissue and the patient's mother asked that the surgeon stop the procedure. The original lead was left in place with no generator implanted. There are currently no plans to undergo lead replacement at a later date. The explanted generator was received for analysis on 03/26/2015 and the generator that was not implanted was disposed of by the hospital. The surgeon attributed the scar tissue to the presence of the vns lead. Analysis of the generator was completed on 04/14/2015. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4600770


Title: Re: Chest Pain
Post by: dennis100 on November 17, 2017, 04:00:44 AM
Model Number 103
Event Date 01/12/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
Additional information was received that the patient's vns device was programmed by a different physician on (b)(6) 2015 to the settings observed on (b)(6) 2015. It was noted that the pulse width had been decreased from 250 to 130.

Event Description
It was reported that the patient experienced pain and chest discomfort with vns stimulation when magnet was swiped. Interrogation of the generator showed that the patient¿s magnet mode output current was set higher (3. 0 ma) than what was previously programmed (2. 75 ma). The pulse width and the normal mode on time were also changed. The physician questioned about the possibility of vns settings automatically changed without the physician programming the device. The patient also mentioned that no other physician changed the vns settings. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702201


Title: Re: Chest Pain
Post by: dennis100 on November 18, 2017, 02:48:25 AM
Model Number 102
Event Date 03/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
The explanted generator was received for analysis which was completed on 02/14/2017. The device output signal was monitored for more than 24-hours in a simulated body temperature environment. Results showed no variation in the output signal and demonstrated the expected level of output current for the entire monitoring period. The diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative

Event Description
Generator replacement surgery occurred. The explanted device has not been received by the manufacturer to-date.

Event Description
It was reported that the patient complained of left shoulder and neck pain with vns stimulation on-times. The pain originated in the shoulder. Chest x-rays were ordered and the patient was referred for generator replacement. Good faith attempts for additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

Event Description
Clinic notes reported that at the patient's visit on (b)(6) 2015 the patient was experiencing pain with vns stimulation. As a result, vns settings were decreased. At the next appointment with neurosurgery on (b)(6) 2015, the device was disabled to assess what was causing the painful stimulation. After the device was disabled, the sternal pain resolved. No additional relevant information has been received to date.

Event Description
It was reported that the patient was referred for full vns replacement. No known surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4668220


Title: Re: Chest Pain
Post by: dennis100 on November 20, 2017, 03:51:09 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 03/15/2015
Event Type Injury
Manufacturer Narrative
Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.

Event Description
Additional information was received which indicated that the generator and lead were explanted on (b)(6) 2015. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The nurse that initially reported the event provided additional information. The "heart problems" started on (b)(6) 2015. The patient had cough, shortness of breath, and chest tightness. Due to the chest tightness, she went to the er and was diagnoses with hyperkalemia, which she interpreted as a heart attack. This was not related to vns and no interventions were taken. The nurse also indicated that there was no actual arrhythmia. She stated that she does not think vns was causing any cardiac issues. She is not sure why the patient had pain, but the pain continued with the device off. The patient still complains of pain with the device removed.

Event Description
Product analysis was completed for the lead. There was no evidence to suggest an anomaly with the returned portion of the device. Since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed for the generator. There were no performance conditions found with the pulse generator. There was a device issue found which was unrelated to the reported adverse event. This issue will be reported in mfr. Report # 1644487-2015-05884.

Event Description
The patient's device was explanted on (b)(6) 2015. The explanted device has not been returned to date.

Event Description
It was reported that the vns patient was having unspecified cardiac issues and was referred for surgery to explant the device. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4876988


Title: Re: Chest Pain
Post by: dennis100 on November 22, 2017, 03:58:52 AM
Model Number 105
Device Problems Inappropriate shock; Device displays error message
Event Date 06/23/2015
Event Type Malfunction
Event Description
The surgeon reported that the patient picked through the skin to access the lead and cut the lead. It was reported that the surgeon will not likely see the patient again.

Event Description
It was reported that the patient was scheduled for surgery, but later reported that the surgery had been cancelled and postponed until further notice due to the drug abuse by the patient. Clinic notes dated (b)(6) 2015 note that the patient was see in the emergency department and when no neurologists were available the patient cut the protruding lead wire out herself. The patient noted since first noticing the wire she was being shocked 24/7. It was reported that due to the patient's non-compliance the surgeon will no longer see the patient. The patient will need to be seen by another surgeon. The patient continues to complain of painful stimulation. Clinic notes dated (b)(6) 2016 note that the physician called the patient to explain why he was uncomfortable redoing the vns. The patient had positive drug screens within a week and failed to have a third done a month later. The patient dug into the electrodes under her chest wall skin, pulled the electrode out and cut it off. The patient continued to complain of shocking in the neck and the left side of her chest, even when the generator was programmed off. The surgeon indicated that he does not feel she will be happy after replacing the unit and electrodes, even if the generator is relocated to her suprascapular area where she can no longer dig at the electrodes.

Event Description
It was reported that the patient was having a lot of trouble with the battery. The patient reported that she was seen by the physician two weeks prior at which time the generator battery showed as "dead". The patient also reported that the physician lowered the device settings. The patient reported that she feels that she is being electrocuted constantly which began approximately a week and a half prior. The patient placed the magnet over the generator to disable stimulation; however, reported that she was still able to feel stimulation. The patient's neurologist wants to replace the generator due to the patient complaining of erratic stimulation. The patient was seen by the surgeon and it was reported that device diagnostics were within normal limits and the device was not at end of service. It was reported that the pain is limited to the patient's chest. The patient's generator was programmed off which did not resolve the patient's pain. The patient indicated that when she presses on the lead at the generator site the patient resolves. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient was scheduled for surgery; however, was unable to undergo surgery due to testing positive for meth and marijuana during pre-operative testing and anesthesia cannot be done. It was reported that is it unknown whether or not the surgeon will reschedule the surgery.

Event Description
The physician reported that the cause of the electrocution sensation is unknown since the event occurs without device stimulation. It was reported that the patient was scheduled for vns replacement. It was reported that the patient feels the shocking when she presses on the lead and this resolves the pain. Clinic notes dated (b)(6) 2015 note that the patient is having problems with the vns shocking her non-stop. Clinic notes dated (b)(6) 2105 note that the vns is still shocking the patient on the lowest setting. It was noted that the plan is to move the generator to the left scapular area. Surgery is planned, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949640


Title: Re: Chest Pain
Post by: dennis100 on November 22, 2017, 04:00:22 AM
Model Number 302-20
Device Problem Corrosion
Event Date 05/29/2015
Event Type Malfunction
Event Description
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of pain was previously reported in manufacturer report # 1644487-2015-04809.

Event Description
A user facility medwatch (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient. Per surgeon's note, there was corrosion on the inside of the lead.

Manufacturer Narrative

Event Description
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on (b)(4) 2015. Analysis is underway but has not been completed to date.

Event Description
Additional information was received from the explant facility that the explanted products will not be returned.

Manufacturer Narrative
This information was previously and inadvertently reported in mfr. Report # 1644487-2015-04809.

Event Description
During a surgery for migration of the generator (reported in manufacturer report # 1644487-2015-04809), the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead. The explanted device is expected to be returned but has not yet been received by the manufacturer.

Manufacturer Narrative
Product analysis results was inadvertently left out of the previous correction mdr. Device available for evaluation?, corrected data: yes. If yes, returned to manufacturer on (mo/day/yr), corrected data: (b)(4) 2015, the product received date was inadvertently not reported in the previous correction mdr. Evaluation codes (refer to coding manual) , corrected data: product evaluation codes were inadvertently left out of the previous correction mdr.

Event Description
Analysis of the returned portion of the lead was completed. The abraded opening and incision mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the complaint of corrosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808424


Title: Re: Chest Pain
Post by: dennis100 on November 22, 2017, 04:01:51 AM
Model Number 102
Device Problems High impedance; Migration of device or device component
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.

Manufacturer Narrative

Event Description
It was reported the hospital was able to find the explanted generator. The explanted generator was received by the manufacturer on 08/14/2015. Analysis is underway, but has not been completed to date. The explanted lead is captured in mfr. Report # 1644487-2015-04810.

Event Description
Additional information was received from the explant facility that the explanted products will not be returned.

Event Description
A user facility medwatch report (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient.

Event Description
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of corrosion on the lead was previously reported in manufacturer report # 1644487-2015-04810.

Manufacturer Narrative
Describe event or problem; corrected data: the information regarding the return of the lead was originally and inadvertently reported in mfr. Report # 1644487-2015-04809, supplemental report #03.

Event Description
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on 08/14/2015. Analysis is underway but has not been completed to date. New information was also received stating the voice hoarseness the patient experienced was sometimes caused by stimulation.

Manufacturer Narrative
The supplemental 04 mfr report was stated to be 09/13/2014. This was mistakenly reported and the actual date was 09/13/2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808411


Title: Re: Chest Pain
Post by: dennis100 on November 22, 2017, 04:02:40 AM
Model Number 104
Event Date 03/13/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient experienced pain is in chest area with vns stimulation after vns dosing appointment on (b)(6) 2015. Device was interrogated and diagnostics ran in multiple positions: sitting, arm raised, arm extended. It is unknown if the pain is related to stimulation as there is minimal time between stimulation period (patient';s settings are 21 sec on and 0. 5 min off). The physician did not want to turn off vns due to patient';s worsening of seizure frequency. The increase in seizures is being correlated to the chest pain. The physician lowered output current to 2. 5ma and pulse width to 250 usec. Chest and neck x-rays were ordered and patient was started on new medication. The patient's generator was subsequently checked again on (b)(6) 2015 at the surgical consult. Diagnostics were run on patient in 4 different positions and lead impedance came back ok every time. After reviewing x-rays, the surgeon attributed her pain to just normal pain and discomfort from the replacement surgery. No interventions were planned and patient was told to contact surgeon if there is an increase in pain. No further information was received regarding the patient¿s increase in seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4819553


Title: Re: Chest Pain
Post by: dennis100 on November 22, 2017, 04:03:38 AM
Model Number 104
Event Date 04/01/2015
Event Type Injury
Event Description
It was originally reported that the patient was experiencing pain in the neck at the site of the electrodes and in the chest at the site of the generator. The generator was programmed off on (b)(6) 2015. It was reported that the patient underwent surgery to replace the generator on (b)(6) 2015. Pre-operation diagnostic results were checked on the original generator and lead and the results were within normal range. Once the new generator was attached to the original lead, diagnostics were checked and impedance was above normal range. The pin of the original lead was reinserted into the generator and during this process the lead broke. The broken lead is reported under mfr. Report # 1644487-2015-04830. It was noted by the surgeons that the original placement of the lead was not well done and seemed "tight" (no slack) before the lead finally broke. Due to the lead break, a full revision was performed and diagnostics were run and the results were within acceptable ranges. The generator and lead have not been received to date.

Manufacturer Narrative
Conclusions; corrected data: the code was incorrectly reported on the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4816140


Title: Re: Chest Pain
Post by: dennis100 on November 23, 2017, 02:39:59 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 07/09/2015
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2015, the physician reported that the patient¿s pain was first observed approximately in 2009 after the patient¿s generator replacement and was due to the location of the generator. The lead impedance was normal and settings were unchanged. The patient¿s surgery was for patient comfort.

Event Description
It was reported that the patient was scheduled for surgery to reposition the generator for an unknown reason. Good faith attempts for further information from the physician have been unsuccessful.

Event Description
It was later reported by the physician on (b)(6) 2015 that the patient's vns was repositioned due to discomfort and that there was no device malfunction. Diagnostics showed normal impedance and there had been no change in settings. It was reported that the patient had her generator repositioned on (b)(6) 2015 and the surgeon repositioned it again on (b)(6) 2015 due to continued complaint of chest pain. Good faith attempts for further information from the physician regarding the patient's pain were unsuccessful.

Event Description
It was reported that the patient underwent repositioning of the vns generator on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924676


Title: Re: Chest Pain
Post by: dennis100 on November 28, 2017, 02:54:25 AM
Model Number 103
Event Date 08/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received dated 09/01/2015 which indicate that the patient had her vns implanted in 2011 and hasn't had it checked since then. The patient was complaining that device has migrated in her left chest wall and is causing pain in area. The patient said that she was stretching a couple of weeks ago and heard something " pop". She went to the er and was told she has an "air pocket around generator site". The patient was referred to a surgeon for evaluation. Although surgery is likely, it has not occurred to date. The physician believes the air pocket is just the normal generator pocket larger due to the migration. No diagnostics are available.

Event Description
On 2/22/16 it was reported that the patient was seen on (b)(6) 2016 for a consult and that the surgeon will replace the patient's generator. It was noted that the patient has been keeping the magnet taped to the device. The patient underwent generator replacement on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5107586


Title: Re: Chest Pain
Post by: dennis100 on November 29, 2017, 02:00:04 AM
Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type Injury
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.

Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394


Title: Re: Chest Pain
Post by: dennis100 on November 29, 2017, 02:01:19 AM
Model Number 105
Device Problem No Information
Event Date 04/20/2015
Event Type Injury
Manufacturer Narrative
Describe event or problem, corrected data: analysis of the generator was completed on 12/22/2015. Previous supplemental mdr #2 was submitted prior to the completion of the generator analysis on 12/22/2015.

Event Description
During patient's first follow up appointment after vns implant surgery on (b)(6) 2015, bruising was observed around the generator incision site. No physical trauma is suspected to have occurred to the site. Patient was sent for labs and was referred to a surgeon for second opinion. The patient's bruising was reported to be abnormal and the cause was unclear. It was also reported that the patient had a (b)(6) infection prior to this implant surgery in the chest area and so the patient was referred for a second consult. On (b)(6) 2015, swelling was observed near the incision site but there was no redness or warmth. No interventions were taken and patient was asked to follow up in a few weeks. Additional information was received that the patient has a seroma around the generator pocket, pain in the chest and some significant bruising. Patient is to undergo a generator pocket revision surgery but no known surgical interventions has occurred to date.

Event Description
A pocket revision was planned for the seroma but patient underwent full explant on (b)(6) 2015 due to infection on the generator side. Patient was given antibiotics and neurologist was informed to increase medications. The explanted devices are expected to be returned but have not been received. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description
Analysis was completed for the generator and lead. In the (b)(4) lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Furthermore, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 002 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The outer silicone tubing has an abraded opening. Other than the above mentioned observation and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
The generator and lead were received on 12/01/2015. Analysis is underway but has not been completed.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5092193


Title: Re: Chest Pain
Post by: dennis100 on November 30, 2017, 02:28:40 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 08/24/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the er due to painful stimulation at the chest vns generator site. System diagnostics were run and were within normal limits including impedance which was 1888 ohms. It was reported that the patient had a sternal rub the day before and the pain has been occurring since then. Settings were reported as 1/75/20/500/60/1. 8, 2/60/500. The device was then disabled.

Event Description
Additional information was received that the patient saw his neurologist one day following the er visit. The neurologist adjusted the vns settings, which reportedly resolved the patient's pain. The physician believed the pain was simply related to normal vns stimulation. The setting adjustment was reportedly performed for patient comfort, not to preclude a serious injury. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5082511


Title: Re: Chest Pain
Post by: dennis100 on December 02, 2017, 02:17:38 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/10/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported on (b)(6) 2015 that the patient began experiencing discomfort in the chest that day or the day prior. She was being seen by her primary care physician on (b)(6) 2015. The patient's vns device was checked a couple days prior, and everything was reportedly okay. The patient was undergoing blood work to confirm that this was not cardiac in nature, but it was initially not clear on the relationship to vns. Upon follow-up, the treating neurology nurse practitioner reported that the patient had a myocardial infarction. Attempts to the patient's primary care physician have been unsuccessful to date. The nurse practitioner was unable to provide further information. No additional relevant information has been received to date.

Event Description
It was reported that the patient has a "leaky heart valve" which is believed to be unrelated to vns per the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5154890


Title: Re: Chest Pain
Post by: dennis100 on December 04, 2017, 02:03:33 AM
Event Date 09/10/2015
Event Type Injury
Manufacturer Narrative

Event Description
An adverse event paper reports two unidentified children experienced "recurrent episodes of severe pain that occurred during vns stimulation but independent of volitional vns magnet mode stimulation. " it was noted that these episodes abated after the vns magnet function was disabled. Neither patients had seen significant decreased in seizures with vns therapy. No recent changes had been made prior to symptom onset. Both reported acute onset of repeated episodes of sudden, brief, paralyzing pain centered around the generator and radiating to the chest and neck. No consistent correlation with electronics usage or patient activity. The device programmed off and the pain resolved. One patient was programmed back on and pain recurred. Five months following vns magnet deactivation neither patient had experienced a return of the pain episodes. The patient whose device was not programmed back on is reported in mfr. Report # 1644487-2015-06025.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5128906


Title: Re: Chest Pain
Post by: dennis100 on December 06, 2017, 03:11:34 AM
Model Number 103
Device Problems Migration of device or device component; No Known Device Problem
Event Date 12/04/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table. The patient reported that her generator migrated up towards her collarbone. The company representative saw that the generator was in a position that is commonly placed by surgeons. The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck. Diagnostics were performed, which were within normal limits. X-rays were performed, and they showed that the generator was situated near the left armpit of the patient. The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators. The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays. The location of the bruise is where the patient claimed that the generator was prior to the fall. The patient was referred for revision surgery to ensure the correct placement of the generator. No surgical intervention has occurred to date. Attempts for further information were unsuccessful to date.

Event Description
Clinic notes were received for the patient's appointment with the physician. The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm. The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months. The patient also could feel the generator moving towards the axilla. The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration. The physician referred the patient for surgery to get a new generator and fix the migration. No surgical intervention has occurred to date.

Event Description
The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall. Pocket revision surgery was planned due to the migration of the generator. However, the patient saw her neurologist again instead of going to see the surgeon. The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

Event Description
The patient had generator replacement surgery due to migration/pain. The device was explanted by the hospital. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5337448


Title: Re: Chest Pain
Post by: dennis100 on December 07, 2017, 03:00:17 AM
Model Number 103
Device Problem Device inoperable
Event Date 11/10/2015
Event Type Malfunction
Event Description
It was reported the patient had generator replacement surgery on (b)(6) 2015 due to generator battery depletion. It was noted the generator was unable to be interrogated prior to surgery. The explanted generator has not been received by the manufacturer to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that the patient underwent generator repositioning due to patient discomfort on (b)(6) 2015. The generator was turned off before surgery and upon post-op when the device was programmed back on, the generator stated it was at near end of service. The consultant discussed with the surgeon how electrocautery used during surgery could have depleted the battery. System diagnostics said lead impedance of ok. Generator was left at pre-op settings of 1. 75ma/30sec/1. 1min. The patient's primary neurologist would be contacted regarding a battery change. Although surgery is likely, it has not occurred to date. Further information was received which indicated the surgery was for patient comfort. No causal or contributory programming or medication changes precede the onset of the pain. The pain was confirmed to be in the chest area. No patient manipulation or trauma occurred. The pain was first observed around (b)(6) 2015. The patient's mother stated that the surgeon removed scar tissue and moved the generator "under the muscle" which improved and resolved the pain.

Event Description
The explanted generator was received by the manufacturer for analysis. Product analysis found that the reported failure to program was not replicated in the lab. The generator was able to be interrogated at all multiple orientation adjacent to the programming wand. The battery voltage observed did not meet the threshold for eos (end of service). It was also noted the septum of the generator was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The generator's output signal was monitored in the product analysis lab for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The reported premature end of life was not duplicated in the product analysis lab. The final electrical test showed and ifi = no condition (intensified follow-up indicator). The vns programming history database showed no parameters available for the generator. A battery life calculation was performed using the "as received" parameters and estimated the generator had approximately 4. 7 years remaining until neos = yes condition (near end of service). There were no performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270817


Title: Re: Chest Pain
Post by: dennis100 on December 07, 2017, 03:01:20 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
A patient reported that he has been experiencing painful stimulation in his chest and side, and an increase in seizure activity, following being in a coma for 3 days (coma was stated to be due to a grand mal seizure). The patient was subsequently seen by a new treating neurologist in (b)(6) 2016 and it was reported that the patient's vns system showed a normal lead impedance and battery status. Vns device parameters were adjusted to address the reported painful stimulation. A review of available programming and diagnostic history revealed no anomalies.

Event Description
Multiple requests for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5399489


Title: Re: Chest Pain
Post by: dennis100 on December 08, 2017, 04:14:12 AM
Model Number 103
Device Problem Degraded
Event Date 05/27/2015
Event Type Injury
Event Description
Additional information was received that the patient was scheduled for vns explant surgery. The surgery has not occurred to date. No additional pertinent information has been received to date.

Event Description
It was reported that the patient was experiencing daily chest pain and thus wanted the vns explanted the treating neurologist wanted to begin the process of referring the patient for explant. Additional information was received that the pain has been occurring daily since (b)(6) 2015. The vns was disabled on (b)(6) 2015. The cause for the pain was believed to be the presence of the device. No known interventions were planned or scheduled at the time, other than the device disablement. Additional information was received that the patient was being scheduled for vns explant surgery due to the daily chest pains and associated shortness of breath. The patient's vns settings and diagnostics were reported to be as intended and within normal limits.

Event Description
Product analysis was completed for the returned generator. There were no performance or any other type of adverse conditions found. Besides explant related observations, visual examination did not observe surface anomalies on the generator. The septum was not cored, eliminating that as a possible path for current. No anomalies were detected from the internal device data. Both interrogation and system diagnostic tests were performed and were within normal limits. The generator showed no signs of variation in the output signal in 24-hour simulated monitoring and demonstrated the expected level of output current. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. No additional pertinent information has been received to date.

Manufacturer Narrative

Event Description
It was reported that the patient's generator explant surgery was completed. The explanted generator was returned to the manufacturer and is currently undergoing product analysis. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5353601


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2017, 12:25:17 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported from the patient¿s grandmother that the patient has had multiple adverse events that she believes are related to vns therapy. She stated that the adverse events first began after the device was implanted in 2015. She reported increase in heartbeat and chest pain (patient is non-verbal and it was stated that she grabs at her chest). It was also reported that the device was disabled about two months ago but the issues persisted. She has not seen the neurologist lately but she reported that the patient has been hospitalized multiple times due to the heartbeat problems. Per the primary care physician that the patient was seeing, there was no arrhythmia to detect or report. This physician does not believe that the patient's reported adverse events are related to vns therapy since they have persisted past the disablement two months prior. However, it's not clear if there was never an arrhythmia or just not one at that appointment. Follow-up was also made to the patient¿s neurologist. The patient had not been seen in the office since (b)(6) 2016 and at that time the device was programmed on except autostim was off. The patient has not been seen back since. Therefore the office has no comments currently on the reported issues. The sales rep then noted that while he was in the office, the np noted that the patient was currently at sacred heart hospital complaining of heart issues. The patient was seen later on (b)(6) 2017 by the neurologist¿s nurse. The vns settings were turned down. Attempts were made for more information but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7026660


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2017, 12:26:04 AM
Model Number 102R
Device Problem Detachment of device component
Event Date 10/23/2017
Event Type Malfunction
Event Description
It was reported that the patient was having difficulty with his vns causing pain and some erratic readings. The neurologist notified the surgeon and they wanted him to be seen urgently and possibly have surgery. The patient¿s generator was explanted. Further information was provided that the explanted generator appeared to be ¿split in two. ¿ from images provided it appears that the header on the generator was detached. It was also stated that the patient had felt infrequent stimulation. Impedance prior to surgery was stated to be within normal limits. Regarding the initial report of pain, it was stated that the pain was infrequent, and felt as if he could hardly feel stimulation and all of sudden felt higher stimulation. The pain was felt at the left chest just under the clavicle. The ¿erratic readings¿ report was referring to the patient¿s infrequent stimulation. The 4000-5000 ohms impedance was verified to be from system diagnostics. The physician believes that the detachment of the header occurred prior to surgery, most likely believed to be due to day to day activity as the patient has lived a ¿hard¿ life. The explant generator has not been received for analysis to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7039508


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2017, 12:26:55 AM
Model Number 302-20
Device Problem No Known Device Problem
Event Date 10/17/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was complaining of sternal pain with stimulation. However, the vns settings were lowered in steps and eventually disabled with no relief. The vns was programmed back on. The patient was referred for prophylactic vns generator replacement. Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest. Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine. Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted. The patient was then referred for full vns replacement surgery per the clinic notes. The patient underwent only vns generator replacement surgery. The explanted generator was received by the manufacturer and is pending product analysis. It was later reported that the patient was still experiencing pain after the vns generator replacement surgery. The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again. The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck. It was noted that the incision from the generator replacement surgery was well healed. There was no indication of damage on the lead during the vns generator replacement surgery. However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7030468


Title: Re: Chest Pain
Post by: dennis100 on December 09, 2017, 02:31:21 AM
Model Number 104
Device Problem Fracture
Event Date 02/11/2015
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient had an infection following generator replacement and that the patient would undergo generator replacement the next day due to the infection. During the generator replacement surgery a lead fracture was also identified. The lead fracture is reported in mfr. Report # 1644487-2015-04270. Both the generator and lead were explanted as the physician did not plan to perform both lead and generator replacement. The patient has been admitted to the hospital and is being followed by infectious disease and will undergo device reimplant once cleared by infectious disease. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Product analysis has been completed for the generator and lead. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was completed on 03/30/2015. No obvious anomalies were noted with the returned lead portion that was not attributed to the explant procedure. Analysis of the lead is reported and captured in mfg report #: 644487-2015-04270.
 
Manufacturer Narrative
Suspect device udi: (b)(4). This information was inadvertently left off of initial mfr. Report.
 
Event Description
Clinic notes dated (b)(6) 2015 reported that the patient's incisions were healing well, and that the vns system was intended to be replaced after approval from the treating physician. The clinic notes indicated that the incision still had seepage. Cultures were taken and showed (b)(6), with the infection thought to be limited to the generator pocket. The patient was treated with iv antibiotics. Clinic notes dated on (b)(6) 2015 reported that the incision had healed, and that re-implantation would be scheduled. The patient was seen by an infectious disease specialist on (b)(6) 2015 where it was noted there was an increase in erythema and pain at the left chest incision where the leads were clipped. The site at the generator was reported to be doing well. It was then reported by the surgeon on a visit on (b)(6) 2015 that the remaining lead would be removed due to the remaining infection. The remaining portion of the lead was removed on (b)(6) 2015. The device was discarded and is not available to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638165


Title: Re: Chest Pain
Post by: dennis100 on December 10, 2017, 02:02:09 AM
Model Number 102
Event Date 06/01/2015
Event Type Death
Manufacturer Narrative

Event Description
Clinic notes were received regarding the patient's reason for admission to the hospital and her death. It was noted the patient was admitted to the hospital on (b)(6) 2015 and discharged on (b)(6) 2015. It was noted that the day before she was admitted, she was on the toilet and fell to her side, injured her left ribs, but the staff did not think too much about it because she did not really complain. But, as time went on, she started complaining more of shoulder pain, breast pain, and lateral chest pain, so they brought her into the e. R. Where 2 fractured ribs on the left anterolateral side were found. It was felt by the physician that the patient should be admitted so that they could observe her. The patient was admitted and had no problems over the weekend. On monday morning, the physician was told the patient had an arrest. He discussed with the physician on call and the nurse and it was explained that around 3 am the patient had some nausea and abdominal pain. They provided the patient with zofran and then when they went to check on her again, she had vomited and it was noticed she has some pudding around her mouth. At that time, she was just staring and then just "went out. " a sternal rub was performed and a code was called, but they were unsuccessful. It was decided the patient most likely aspirated and an autopsy was not performed.

Event Description
It was reported by the company representative that the patient had passed away. An obituary search provided the date of the patient's death, but no cause of death was provided. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5463400


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2017, 02:11:19 AM
Model Number 103
Event Date 03/01/2016
Event Type Injury
Event Description
The generator was originally reported to have been discarded, but it was later received by the manufacturer for analysis. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters.

Event Description
The neurologist's office indicated that the chest pain and arm paralysis are not related to the vns and indicated that the device is not extruding but that it was protruding the skin. The skin is intact and the patient was only referred to the surgeon.

Manufacturer Narrative
(b)(4).

Event Description
The surgeon indicated that the patient was sent for a ct scan with and without contrast and has not returned. No additional relevant information has been received to date.

Event Description
The patient was referred for generator replacement surgery as she was still experiencing burning/throbbing at the generator site that extended into the upper left arm due to the positioning of the device. The physician stated that the symptoms were helped with prescription pain medication. The patient had generator replacement surgery. The explanted generator was discarded by the hospital. Therefore, no analysis could be performed.

Event Description
It was reported that the patient contacted the surgeon complaining of irritation at the generator site. The patient reported an inability to move the left arm and that the generator is extruding from the site. Infection was ruled out. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5574939


Title: Re: Chest Pain
Post by: dennis100 on December 16, 2017, 02:12:46 AM
Model Number 102
Event Date 03/12/2016
Event Type Death
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.

Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.

Manufacturer Narrative

Event Description
The explanted devices were received for analysis on 05/02/2016. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator is underway and has not been completed to date.

Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.

Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).

Event Description
In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the (b)(4) lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549413


Title: Re: Chest Pain
Post by: dennis100 on December 20, 2017, 08:44:26 AM
Model Number 101
Event Date 04/17/2009
Event Type Injury
Event Description
Pt has had an implanted vagus nerve stimulator initially placed in 2000. It was used successfully and helped improve seizure control initially. A few years ago, pt had an mri with transmit and receive head coil and vns device was turned off before the test, as required. When this author tried to turn device back on after the mri, he complaint of pain and was more sensitive to vagus stimulation in general. Multiple attempts over time were not successful in getting his vns settings back to premri settings. He did however, continue to use the vns at lower settings with fair control of seizures. In 2009, this author received a phone call from pt, stating that he had throat pain and dysphagia each evening lasting about 3 hours for the preceding four days. He was seen by his epileptologist that day and vns was turned off with relief of pain and dysphagia. Pt had recalled that he had received diathermy treatments from a physical therapist at least on two known dates - the same month prior to original date, for treatment of plantar fasciitis. Pt states that he was not aware that the treatment involved diathermy and didn't recall the warning about diathermy and vns until original date. Further information obtained by dr. Reveals that patient noted some intermittent pain near the vns site after the first diathermy treatment. Over the past 1. 5 weeks at night, right after taking his bedtime pills, he would develop pain in upper chest and neck on left in the region of his vagus nerve stimulator. Then pain would last 1-2 hours, described as sharp, pulsating pain in left neck and upper chest. He also noted some increased voice hoarseness for a few days and increased coughing after taking pills. Pt was sent to the emergency room the same day, xrays of neck done and patient examined. No other complications were found. He was also seen by ent specialist in early the following month - no evidence of vocal cord paralysis found. Seizures worsened without the vns. Seizures used to be considered minor by patient, but without vns, seizures increased in frequency and were more intense. He would awaken from sleep 2 to 3 hours after onset with a startle with a change in breathing, feeling of anxiety, funny feeling in stomach. This could last 45 minutes intermittently before he would fall asleep. During remainder of night, sleep would have restless quality and he would awaken frequently with stomach feeling off. He would also feel more fatigued during day, requiring frequent rests, generalized weakness, and seizures occuring during daytime naps. Frequency of seizures increased to 1 to 3 times per day, on average of 5 to 6 times per week. Since vagus nerve stimulator was 9 years old and possibly contributing to the above symptoms, surgery was done the same month, to replace the vns generator. During surgery, system diagnostics were done with patient under anesthesia with results within normal limits. Device was removed -model 101, and upon visual examination by the neurosurgeon, one of the two screws -the one corresponding to the positive sign- was very loose and there was fluid within the cavity of where the lead contact should be going. A new vagus nerve stimulator was implanted - model 102r. The patient tolerated the procedure well. In the recovery room, the vagus nerve stimulator was turned on to very low settings. This did not trigger pain or other symptoms. Patient has since reported that sleep and seizures have improved in past 2 days.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386564


Title: Re: Chest Pain
Post by: dennis100 on December 21, 2017, 03:21:21 AM
Model Number 103
Event Date 07/08/2014
Event Type Injury
Event Description
Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events remains unknown. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3970627


Title: Re: Chest Pain
Post by: dennis100 on December 28, 2017, 03:26:16 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2016
Event Type  Injury   
Event Description
It was reported by a patient¿s provider that the patient had recently fell and was having some discomfort so he went to the er. Device settings were checked and found to the same. Since the fall, the generator had migrated significantly downward. A call was received from the patient¿s caregiver also reporting that the generator had migrated to the sternum. He reported that the lead is now visible through the skin. He stated that his son has always had voice alteration with the device, but it now seems worse. He has since seen a surgeon about performing a revision surgery. It was also stated he was going to have his vocal cords checked to evaluate for any potential damage that may have occurred with the shifting of the generator and lead. Clinic notes were received from a visit to the surgeon on (b)(6) 2017 for replacement referral. The notes provide that the patient was seen at the ed for pain surrounding his vns battery. X-rays were done and labs did not reveal any sign of infection, so he was discharged home. He returned again to the ed. He did not feel his vns activate for several hours. His vns was found to be working appropriately. The battery was in an uncomfortable position for him, and was at the very superior aspect of the sternum. The skin overlying the battery and nearby lead is thin. He feels significant discomfort when lying down or on his side. He is concerned that the battery moves, but it was reported the battery has always been in this approximate position. He said it may have even been a little higher in the neck right after surgery. He has hoarseness to his voice constantly, and the patient denies any hoarseness prior to surgery. The battery is slightly mobile, but not more than expected. The skin overlying this area is thin but intact. Palpation and manipulation of the battery causes some pain. X-rays reviewed showed the vns generator overlying the superior aspect of the sternum. The lead is in an expected location. There is no evidence of fracture. It was provided the vns is in an unusual position. It was stated that the vns is functioning properly in the current location, but that it is not in the most common site for generator placement and is causing the pain. It was stated they are concerned the patient may have vocal cord paralysis from injury to the recurrent laryngeal nerve. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Suspect medical device lot#, corrected data: the lot# was inadvertently not provided in the initial report.
 
Event Description
Generator replacement surgery occurred. The explant facility does not return devices to the manufacturer and the explanted device has not been received by the manufacturer to-date.
 
Event Description
Follow-up from the physician on (b)(6) 2017 provided that the patient claims ¿being back to normal¿ and does have a vns now. The patient¿s mother claims that replacement of vns fixed the problem. Diagnostics were reported to be ok.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309855


Title: Re: Chest Pain
Post by: dennis100 on December 29, 2017, 02:23:55 AM
Model Number 103
Event Date 07/19/2012
Event Type Injury
Manufacturer Narrative
Review of programming history.

Event Description
The explanted generator and a portion of lead were returned to the manufacturer on 04/29/2016. Analysis of the returned generator indicated that the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). This was successfully verified in the product analysis lab. The battery shows an ifi=no condition. The data in the diag accum diagaccumconsumed memory locations revealed that 9. 140% of the battery had been consumed. Measured battery voltage and consumed capacity parameters are as expected. There were no performance or any other type of adverse conditions found with the pulse generator. The returned portion of the lead containing the manufacturing id tag was not returned thus the model and the serial number of the returned lead portion cannot be verified. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

Event Description
Further information was received indicating that the patient underwent generator explant surgery on (b)(6) 2014. As reported by the nurse, the device was explanted due to the following reasons: "device failed to demonstrate any benefit as regards seizure improvement, and patient's suspicion that nocturnal seizures may have been made worse". It was reported that no replacement was performed. The return of the explanted generator is expected but it has not been received to date.

Event Description
On (b)(6) 2012, it was reported that this patient's seizure activity had changed: the patient was beginning to experience nocturnal seizures when the device was programmed on. When the device was disabled, the events stopped. The patient believed that vns was affected seizure activity. The device was to be disabled on (b)(6) 2012. The patient had previously been experiencing chest pain. The device was disabled when the chest pain was initially reported, and the patient did not experience additional chest pain. Once the device was programmed back on, the pain returned. The chest pain was first observed on (b)(6) 2012. The pain was not believed to be related to vns. An ecg did show changes but there were no changes in pulse. The pain was not limited to the generator site. A cardiology appointment was scheduled, but the event was not believed to be related to vns. Systems diagnostics from (b)(6) 2012 indicated 2421 ohms. The chest pain began coincided with a settings increase to 0. 50 ma. The pulsewidth was lowered to 250 usec. The device remained on until (b)(6) 2012, at which point, the output current was 1. 0 ma. At this time, the patient began to complain of worsening nocturnal seizures. Looking back, her seizures had become troublesome at 0. 5ma, but the patient's settings were increased with the hope of settling the seizures. On (b)(6) 2012, the patient disabled the device with the magnet and requested that the device be programmed off. The device was disabled for a month, and the patient reported that she did not have any seizures (nocturnal) and she had not had any chest pain. On (b)(6) 2012, the device was programmed on to 0. 5 ma. On (b)(6) 2012, the patient reported that the night seizures had returned and that she had experienced one episode of chest pain. The device was disabled. The patient's seizures were reportedly back to pre-vns.

Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently provided an incomplet event description.

Event Description
Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. The explanted generator and a portion of lead were returned to the manufacturer on 04/29/2016. Analysis of the returned generator indicated that the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). This was successfully verified in the product analysis lab. The battery shows an ifi=no condition. The data in the diagaccum consumed memory locations revealed that 9. 140% of the battery had been consumed. Measured battery voltage and consumed capacity parameters are as expected. There were no performance or any other type of adverse conditions found with the pulse generator. The returned portion of the lead containing the manufacturing id tag was not returned thus the model and the serial number of the returned lead portion cannot be verified. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2893543


Title: Re: Chest Pain
Post by: dennis100 on December 29, 2017, 02:25:24 AM
Model Number 103
Event Date 01/01/2016
Event Type Malfunction
Event Description
It was later reported that the patient passed away from a drug overdose. During follow-up with the physician it was reported that the patient had a long history of being non-compliant and was suffering from other issues that were not related to vns. The physician suspected that the reported symptoms and issues with her vns were likely more related to the patient's "extracurricular activities" rather than vns therapy.

Event Description
It was reported that the patient attempted to disable the vns device by taping the magnet over the generator however the device did not disable. The patient's magnet placement has not been observed by the physician to ensure that it is sufficient to disable the generator. The most recent lead impedance was reportedly normal. No additional relevant information has been received to date.

Manufacturer Narrative

Event Description
It was reported that the generator had been programmed off by the physician after the patient was unable to disable the device with the magnet. The reason for the device being programmed off was due to the patient experiencing chest pain, painful stimulation and an increase in seizures. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5945770


Title: Re: Chest Pain
Post by: dennis100 on December 29, 2017, 02:26:35 AM
Model Number 106
Event Date 07/08/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient's generator was programmed off due to the intermittent high impedance, and the patient was referred to the surgeon for possible explant surgery. No surgical intervention has occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient that recently had generator replacement surgery ((b)(6) 2016) had high impedance about a month prior to the report (>10000ohms). The patient was then referred for surgery, but the surgeon performed diagnostics and no high impedance was present. The patient was referred back to the neurologist, and the impedance was 2200ohms and 3000ohms upon diagnostics. The patient then started to feel intermittent pain at the generator site. The patient was then referred to another surgeon. No surgical intervention has occurred to date.

Event Description
The patient had a consult with a different surgeon, and it was believed that the lead pin was not fully inserted. The patient was experiencing painful stimulation in the chest and neck, trouble swallowing, and more voice alteration than he previously experienced. X-rays were performed. There were ap and lateral chest and neck x-rays from (b)(6) 2016. The x-rays showed that the lead pin was not fully inserted into the connector block, as the connector pin could not be visualized past the connector block. The generator was placed in the left chest per labeling, and the feedthru wires appeared intact at the connector block. No gross fractures were identified with the provided images. No sharp angles were noted. Additionally, a portion of the lead was identified to pass behind the generator and an assessment could not be made on this portion of the lead. There were no noticeable differences between the x-rays taken on (b)(6) 2016. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965583


Title: Re: Chest Pain
Post by: dennis100 on December 29, 2017, 02:27:40 AM
Model Number 106
Event Date 08/12/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient had her vns generator explanted on (b)(6) 2016. The explanted generator has not been returned to the manufacturer to date. Follow up communication with the explanting surgeon determined that, in his medical opinion, there was no indication of an underlying infection or site reaction. He believed the patient perceived the device as being uncomfortable. The surgical intervention taken was not to preclude a serious injury. There was no trauma or other external factors that were contributing to the reported symptoms. No additional pertinent information has been received to date.

Event Description
The explanted generator was reported to have been discarded following the explant surgery. No additional pertinent information has been received to date.

Event Description
Additional information received showed that the patient had her vns removed due to pain from the size of the generator. Clinic notes showed that the device had also migrated from its original implant location prior to removal. No additional pertinent information has been received to date.

Event Description
It was reported that the patient was experiencing pain where her vns implant is in the chest and down her left arm. The vns generator was also reportedly protruding from her skin. She had passed out at the time this started, and she was also experiencing a low-grade fever. Follow up with the surgeon's office showed that the patient came in for an appointment, and surgery was planned to remove her vns. It was reported that this was upon patient request on not wanting the vns anymore. However, insufficient information was given on what role the reported symptoms had in the decision to explant the device. Surgical intervention has not occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5939462


Title: Re: Chest Pain
Post by: dennis100 on December 31, 2017, 03:08:20 AM
Model Number 106
Event Date 07/01/2016
Event Type Injury
Event Description
It was reported that the patient was experiencing a lead pulling sensation which appeared related to the previously migration of the generator. Therefore the physician intended to perform another repositioning surgery where the generator pocket would be moved to the right side of the patient's chest. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

Event Description
It was reported that the patient was planned for a generator revision and that the placement of the generator would be moved. Additional information from the physician's office indicated that the reason for the revision was the generator had migrated medially and inferiorly and was causing pain and discomfort to the patient's sternum. The surgery was being done to preclude patient injury. The migration began spontaneously, and the physician had used tichron 30 non-absorbable sutures to anchor the generator in the initial surgery before the migration. Additional relevant information has not been received to date.

Manufacturer Narrative
(b)(4).

Event Description
Additional information was received on 10/28/2016. Per the physician, the repositioning was being done because the generator was rubbing against the patient's manubrium and not being done to preclude serious injury. Information was also received from a company representative on 11/01/2016. He stated that the patient felt that stimulation was being triggered when raising her left arm due to the device migration and has shortness of breath and coughs because of this. Before the revision surgery, the patient saw her physician and the physician lowered the output current to 1. 0ma. The change was noted as to have been done for the shortness of breath and cough. The frequency was noted as 15hz, the pulse width as 250 micro seconds, and the off time as 1. 1 min. The patient only had 5 autostimulations in the last 102 days prior to the visit. System diagnostics were noted as normal. It is known that stimulation cannot be triggered by the patient's hand or arm movement unless the patient is using a magnet to trigger magnet activation. The device was repositioned on (b)(6) 2016. No additional relevant information has been received to date.

Event Description
It was found out that the patient was in a car crash which is suspected to be the cause of the migration of the device. The adverse events previously reported are stated to have been occurring for some time which predated the accident. Therefore those events appear to be unrelated to the accident and migration of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6063772


Title: Re: Chest Pain
Post by: dennis100 on January 01, 2018, 02:59:30 AM
Model Number 106
Event Date 08/12/2016
Event Type Injury
Event Description
It was reported the patient had undergone vns explant surgery on (b)(6) 2016 for "discomfort". No additional relevant information was received. It is noted that the hospital will not return explanted devices per protocol. Attempts for additional relevant information has been unsuccessful to date.

Manufacturer Narrative
(b)(4).

Event Description
It was later reported by the physician's office that the patient was having pain due to the presence of the device. The patient had been complaining of a pulling sensation on the neck, as well as chest, clavicle, and neck pain. It was noted the explant surgery was for patient comfort only and not to preclude a serious injury. No recent diagnostic results were obtained from the physician; however, the implant card from the patient's initial implant on (b)(6) 2016 showed the diagnostics were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6047619


Title: Re: Chest Pain
Post by: dennis100 on January 04, 2018, 02:37:35 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/25/2017
Event Type Death
Event Description
Follow-up from the hospital where the patient expired provided that the patient presented to the er from hospice. She presented with respiratory distress. She was experiencing respiratory difficulty which was new for her and she was complaining of chest pain that had a bradycardia episode, developing to a heart attack. The patient declined into respiratory failure, agonal respirations, and eventually cardiopulmonary arrest.

Event Description
It was reported by a physician that a vns patient was deceased. The patient passed away at a hospital, and was a resident of a group home facility. An online obituary found the patient had died (b)(6) 2017. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6362787


Title: Re: Chest Pain
Post by: dennis100 on January 05, 2018, 04:51:10 AM
Model Number 302-20
Device Problem No Known Device Problem
Event Date 09/11/2017
Event Type Injury
Event Description
It was reported that the patient is still experiencing shocking sensations in her chest near the generator incision of her newly implanted generator. Patient said that midnight on (b)(6) 2017, night of surgery, it started bothering her. Surgeon thought that this may be when the local wore off. She saw the physician the next day and she confirmed that the pain the patient reported was close to her off time which was 1. 1 minutes. Lead replacement was completed (b)(6) 2017. It was noted that diagnostics were within normal limits prior to replacing the lead and that the lead replacement was for patient comfort. The explanted lead was not available for return. Additional information was received on that the reason for the lead replacement was due to the pain to ensure that the current was not escaping the leads and there was no lead issue. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7106875


Title: Re: Chest Pain
Post by: dennis100 on January 06, 2018, 05:08:00 AM
Model Number 302-20
Device Problem Fracture
Event Date 11/09/2017
Event Type Malfunction
Event Description
It was reported that high impedance was observed on the patient's device. It was also stated that the patient experiences pain during stimulation at times in the neck and chest. The patient was referred for consult with the surgeon however no surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7081841


Title: Re: Chest Pain
Post by: dennis100 on January 06, 2018, 05:08:46 AM
Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7134281


Title: Re: Chest Pain
Post by: dennis100 on January 06, 2018, 05:09:35 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 05/20/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient's third vns device was explanted due to it causing tremendous pain in her chest and she states she opted to have the device completely removed, device and wires on the vagal nerve. She states when the device was removed it was dead (nonfunctioning). It was reported that several times, the patient would tell the physician that it was incorrectly firing. She states they would check the device and it was working, but the settings on the device were not the same as what was set. Eventually the third device had to be removed. Based on programming history, there is no indication that the settings were set to anything other than intended settings. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7135032


Title: Re: Chest Pain
Post by: dennis100 on January 08, 2018, 03:03:01 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 05/14/2013
Event Type Injury
Manufacturer Narrative

Event Description
A review of the available programming history was performed and showed that the patient's device showed good diagnostic results in (b)(6) 2013.

Event Description
A patient called reporting that her device had been moving around in her chest and causing her pain. The pain was reportedly continual since the patient's device was implanted. The patient wanted to have surgery to try and resolve these issues. Follow-up with the surgeon who implanted the patient's device was performed and it was verified that a non-absorbable suture was used to secure the generator to the patient's chest. A review of the device history record for the implanted generator verified that it had passed all quality inspections prior to release for distribution. No further relevant information has been received to date and no known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6314319


Title: Re: Chest Pain
Post by: dennis100 on January 11, 2018, 02:38:49 AM
Model Number 102
Event Date 09/05/2007
Event Type Malfunction
Event Description
Reporter indicated the patient has experienced "life changing side effects" from the vns therapy system. The "patient reports a number of non-specific complaints including not feeling well, blood pressure fluctuation, intermittent chest pain, having been in the hospital on several occasions, including receiving a coronary stent. The patient also states the device has not helped his seizure disorder. " the patient elected to have the vns therapy system explanted. Good faith attempts are being made to obtain additional information, but have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959423


Title: Re: Chest Pain
Post by: dennis100 on January 13, 2018, 01:44:56 AM
Model Number 102
Event Date 08/26/2008
Event Type Injury
Event Description
Reporter indicated a vns therapy patient's vns was explanted in 2008. The reason for the explant was due to no improvement of seizures and discomfort at chest region. Also the patient reported she could feel battery moving and feels electric sensation going up her neck at times. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1412506


Title: Re: Chest Pain
Post by: dennis100 on January 15, 2018, 02:57:10 AM
Model Number 104
Event Date 07/19/2013
Event Type Injury
Event Description
It was reported that the patient has been experiencing an increase in seizures over the past few days since generator replacement surgery. It was reported that the patient experienced continuous grand mal seizures causing the patient to be hospitalized for several days. It was reported that the physician does not know what's causing the increase in seizures. Diagnostics at time of generator replacement were reported to be within normal limits. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received that the patient had gone to the emergency room due to shortness of breath and chest discomfort not related to vns and then began having an increase in seizures. Ct and lab tests were normal. The patient had more seizures on (b)(6) 2013 and the suspects the patient was in and out of status epilepticus. The patient was then admitted to the hospital and found to have a significant hyponatremic state from the seizures. The patient is back on medications after the hospitalization and is doing better. The physician believes that the cause of the seizures was from not taking adequate seizure medication and they did not suspect a vns was the cause. There were no programming/medication changes that preceded either increased seizures before or after surgery. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3289839


Title: Re: Chest Pain
Post by: dennis100 on January 15, 2018, 02:57:49 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported by the mother of the vns pt that the pt began experiencing sleep apnea, ambulation difficulties, painful stimulation in the chest, dizziness, flushing in the face, dyspepsia, and increase in seizures above baseline about 3-4 years ago but was unsure of their relationship to vns. Attempts to further info from the pt's physician have been unsuccessful to date. No device failure is suspected. It has been noted that surgery to replace the pt's generator prophylactically is possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2052676


Title: Re: Chest Pain
Post by: dennis100 on January 18, 2018, 02:53:06 AM
Model Number 303-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369


Title: Re: Chest Pain
Post by: dennis100 on January 20, 2018, 02:51:52 AM
Model Number 102
Event D