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dennis100
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« 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
« Last Edit: May 03, 2017, 01:36:09 AM by dennis100 » Logged
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« Reply #1 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
« Last Edit: February 12, 2015, 11:29:59 PM by dennis100 » Logged
dennis100
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« Reply #2 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
« Last Edit: February 12, 2015, 11:30:30 PM by dennis100 » Logged
dennis100
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« Reply #3 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
« Last Edit: February 12, 2015, 11:30:52 PM by dennis100 » Logged
dennis100
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« Reply #4 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
« Last Edit: February 12, 2015, 11:31:21 PM by dennis100 » Logged
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« Reply #5 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
« Last Edit: February 12, 2015, 11:31:46 PM by dennis100 » Logged
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« Reply #6 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
« Last Edit: February 12, 2015, 11:32:06 PM by dennis100 » Logged
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« Reply #7 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
« Last Edit: February 12, 2015, 11:32:35 PM by dennis100 » Logged
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« Reply #8 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
« Last Edit: February 12, 2015, 11:33:32 PM by dennis100 » Logged
dennis100
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« Reply #9 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
« Last Edit: February 12, 2015, 11:34:12 PM by dennis100 » Logged
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« Reply #10 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
« Last Edit: February 12, 2015, 11:34:48 PM by dennis100 » Logged
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« Reply #11 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
« Last Edit: February 12, 2015, 11:35:24 PM by dennis100 » Logged
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« Reply #12 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
« Last Edit: February 12, 2015, 11:37:18 PM by dennis100 » Logged
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« Reply #13 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
« Last Edit: February 12, 2015, 11:38:12 PM by dennis100 » Logged
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« Reply #14 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
« Last Edit: February 12, 2015, 11:38:57 PM by dennis100 » Logged
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« Reply #15 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
« Last Edit: February 12, 2015, 11:39:55 PM by dennis100 » Logged
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« Reply #16 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
« Last Edit: February 12, 2015, 11:40:51 PM by dennis100 » Logged
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« Reply #17 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
« Last Edit: February 12, 2015, 11:41:40 PM by dennis100 » Logged
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« Reply #18 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
« Last Edit: February 12, 2015, 11:42:19 PM by dennis100 » Logged
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« Reply #19 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
« Last Edit: February 12, 2015, 11:43:00 PM by dennis100 » Logged
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« Reply #20 on: December 15, 2010, 08:18:06 AM »

Event
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« Reply #21 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
« Last Edit: February 12, 2015, 11:44:50 PM by dennis100 » Logged
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« Reply #22 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
« Last Edit: February 12, 2015, 11:45:47 PM by dennis100 » Logged
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« Reply #23 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
« Last Edit: February 12, 2015, 11:46:59 PM by dennis100 » Logged
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« Reply #24 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
« Last Edit: February 12, 2015, 11:47:44 PM by dennis100 » Logged
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« Reply #25 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
« Last Edit: February 12, 2015, 11:48:31 PM by dennis100 » Logged
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« Reply #26 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
« Last Edit: February 12, 2015, 11:49:07 PM by dennis100 » Logged
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« Reply #27 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
« Last Edit: February 12, 2015, 11:49:54 PM by dennis100 » Logged
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« Reply #28 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
« Last Edit: February 12, 2015, 11:50:29 PM by dennis100 » Logged
dennis100
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« Reply #29 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
« Last Edit: February 12, 2015, 11:51:12 PM by dennis100 » Logged
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