VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on April 05, 2011, 01:56:43 AM



Title: Misc. Respiratory
Post by: dennis100 on April 05, 2011, 01:56:43 AM
Event Date 12/01/2000
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Late report due to administrative error.

Event Description
Reporter indicated that patient was asleep and woke up and couldn't breathe for about 8 seconds.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=334672


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 01:57:22 AM
Event Date 03/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Patient indicated that has been experiencing shortness of breath while lying down and almost asleep.

Manufacturer Narrative
The physician stated the pt's shortness of breath was not clinically significant. No pulmonary tests were performed. The device settings had not been adjusted and the pt feels that the symptoms have resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=327796


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 01:58:02 AM
Event Date 02/23/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Rptr indicated that pt complained of being unable to sleep due to the vns sensation. The pt complained that the sensation was positional and that in certain positions the pt would feel pain in throat, temple, and forearm "like being hit with a rock". Pt states that the pt is unable to sleep if lies on right side due to the pain in throat and shortness of breath. Pt reported to be experiencing dysesthesias in left hand and pain around the site of surgery which is constant but increases with stimulation when lies on right side. This pain radiates to ear and at times to left temporal region. Pt has also complained of increase in seizures since activation. Device programmed to off 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=328089


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 01:58:50 AM
Event Date 05/18/2001
Event Type Malfunction
Event Description
The patient experienced gagging, coughing and choking. Reporter indicated that microprocessor had reset. The physician said that he originally set the device to 0. 25ma.

Manufacturer Narrative
Programming history was reviewed. Programming history revealed that after the pt was programmed to receive 0. 25 ma of therapy, the pt code was programmed for the first time. When the pt code is programmed, it automatically sets the output current to 0. 0 ma. The pt left the office. Upon return at the next visit, the device was interrogated. The parameters reported 0. 0 ma of output current just as would be expected per physician's manual for the model 250 ncp programming software. Interrogating the device as the last step of any programming session is addressed in device labeling and was not followed in ths case. The event did not contribute to loss of therapy that could have contributed to an adverse event since this was the pt's first visit and there was not enough time for the pt to get accustomed to the possible benefit of vns therapy before going home that day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=337995


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:00:21 AM
Event Date 02/24/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt experienced respiratory arrest 3 days post-implant.

Manufacturer Narrative
Code: mfg records reviewed. Code: review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Device was programmed to on during implant surgery. Ncp system labeling states that the ncp system should not be programmed to on for at least 14 days after the initial or replacement implantation. Further investigation revealed that the pancreatitis was due to a viral illness and not related to the vns. The cause of the respiratory arrest remains unknown. The physicians do not believe the vns contributed to the respiratory arrest. The device remains programmed to on and the pt is tolerating the stimulation without any complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=323861


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:01:02 AM
Event Date 05/19/2001
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Further investigation revealed that the device has been helping control the pt's seizures and that the pt has been a lot more alert. Attempts to obtain add'l info have been unsuccessful.

Event Description
Reporter indicated that pt developed continuous stridor and was hospitalized in 2001. During the hospitalization, a tracheostomy was placed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=342440


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:01:45 AM
Event Date 06/01/2001
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Method: manufacturing records reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that approx 1 1/2 weeks after parameter increase, pt started grabbing neck, gritting teeth, coughing and gagging, for 30 seconds every five minutes. It got to the point where the pt would throw up. Pt was taken to the emergency room in 2001 because the pain was so severe. Pt went to the emergency room again 3 days later and was admitted to the hosp. Pt was seen by the physician the next day and the device was programmed to off. Pt was discharged from hosp the following day. Pt was again seen by physician one week later. Device has not been programmed back to on. Pt reported to be doing well. Physician plans to keep pt on current dilantin and sonogram dosages. Further investigation revealed that the pt is still experiencing pain at the neck incision site eventhough the device is programmed to off, but the pain is minor as compared to when the device was programmed to on. The pt is still coughing; however, the pt is not vomiting anymore. It was reported that the vns has not helped the pt much with seizure control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355953


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:02:23 AM
Event Date 05/01/2001
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that she had heard that there have been several deaths at one of their developmentally delayed centers over the previous months including some patients with vns. Reporter reiterated that the physician involved did not believe that any of the deaths of the vns patients were related to the vns and that many of those patients had experienced problems in the past due to their illness. Further investigation revealed that there were 2 vns patients who had passed away. Patient aspirated their food resulting in respiratory problems and being put on a ventilator. They were unable to wean the pt off the ventilator.

Manufacturer Narrative
Physician indicated believed relationship between vns and cause of death to be not related. Manufacturing records reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Manufacturer Narrative
Programming history was reviewed. No anomalies in the programming history were found that would affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=353700


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:03:09 AM
Event Date 08/14/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient had a breakthrough seizure and programmed settings were increased in 2001. Later it was discovered that patient had stopped taking the pt's tegretol. Pt complained of anxiety and shortness of breath. The following month, programmed settings were decreased. Patient has since been seen in the emergency room several times complaining of anxiety. A complete cardio workup and x-rays were negative and patient is not pregnant. The device was programmed to off 2 weeks later per the patient's request. The physician ran a lead test and the impedance was fine - eri (elective replacement indicator) flag was "no". Physician plans to keep device programmed to off for 4-5 weeks. Patient plans to see the pt's primary care physician for anxiety medications. Neurologist does not believe that the event is related to the vns.

Manufacturer Narrative
Follow up with both the pt and the physician indicated that the pt's shortness of breath resolved after device was programmed to off. The pt reported that she believed that the vns made her bladder infection worse. The pt reported that the shortness of breath and pain in her back and stomach that she experienced was after a parameter increase. Pt also reported that the device migrates and causes chest pain. Physician reported that the pt is very inconsistent in her descriptions of her health condition and skips many of her appointments. The physcian does not believe that the vns caused the pt's bladder infection. The pt's device was programmed back in 2001 at a lower setting. At the 9/01 office visit, the physician noted that there appeared to be a problem with the stimulator surgical pocket with the pt reporting that she can feel the stimulator moving in and out of the pocket either up toward the clavicle or the sternum which creates discomfort as well as anxiety for her. A surgical revision was performed to create a new pocket and the pt has not complained of any other side effects since the revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=352293


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:03:57 AM
Event Date 08/06/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient has recently begun coughing badly and vomiting when stimulated. When magnet is placed over device to temporarily turn device off, the symptoms stop. Programmed settings were reduced but symptoms continued. Device was programmed to off in 2001. Further investigation revealed that family member stated that pt began coughing as far back as 4 months before, but it was first believed that it was related to allergies. Physician plans to leave device programmed to off for atleast a month and then attempt to turn it back on and ramp up slowly instead of every 2 weeks. Patient reported to have received excellent benefit from the device in controlling the pt's seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=352299


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 02:06:03 AM
Event Date 07/26/2001
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Further investigation revealed that none of the pt's symptoms have resolved since programming the device to off. Physician plans to program the ncp system to on, however, no date is set at this time.

Manufacturer Narrative
Manufacturing records reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that patient's device was programmed to off in 2001 at the families request due to the following symptoms: increased periphal edema, excesive coughing, difficulty swallowing, neck and muscle pain, weight gain, low grade fever, hiccuping, difficulty with breathing and shortness of breath, choking sensation, facial flushing, heartrate and rhythm changes. Physician is unsure whether the symptoms are related to the vns. Patient's family does not believe that the device has helped with seizure control since implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=351106


Title: Re: Respiratory
Post by: oreo on April 05, 2011, 10:21:17 AM
Although I mostly tolerate the several crummy side effects I have from VNS, I realize how blessed I am after reading all the work you do to show the devastating effects so many experience.


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 01:23:56 PM
I'm on a mission oreo. This device is killing innocent people who's only mistake was listening to their doctor and trusting the FDA. It's time for those idiots at the CDRH to take action.


Title: Re: Respiratory
Post by: dennis100 on April 05, 2011, 01:25:12 PM
Event Date 07/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that since implant, patient's voice is gone and they experienced an awful cough, chokes on fluids, and has shortness of breath. It was reported that patient was seen by the ear, nose and throat who diagnosed left vocal cord paralysis. Further investigation revealed that the device was not turned on at implant. The device was programmed to on in mid-august 2001 and remains at 0. 25ma output current. Patient reported that they did not want to program the device to off to give the vocal cord paralysis a chance to resolve because pt is already having some seizure reduction.

Manufacturer Narrative
This report is a duplicate of a previously submitted report. This event was previously reported under mfr. Report number 1644487-2001-00522.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=363399


Title: Re: Respiratory
Post by: dennis100 on April 06, 2011, 06:11:44 AM
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Rptr indicated that pt has a problem with choking at times. It was reported that the pt's pulse width was changed but that did not help the situation. The pt reports that as a result of the choking sensation, the pt doesn't swallow when eating until the pt can feel the cycle stop. Investigation was unable to determine the severity of the dysphagia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=361810


Title: Re: Respiratory
Post by: dennis100 on April 06, 2011, 10:33:23 PM
Event


Title: Re: Respiratory
Post by: dennis100 on April 07, 2011, 09:46:10 AM
Event Date 01/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
The physician stated that a decrease in the programmed parameters improved the apnea, but not the dyspnea. A sleep study on 11/7/01 concluded that the pt still had mild dyspnea and apnea. The physician stated that the pt's device is programmed to the most effective settings for her. The pt had her tonsils and adenoids removed in 12/01 in an attempt to decrease the chances of obstruction when she sleeps. On 1/13/01 the pt's family member indicated that the pt was not 100% better, but had "marked/significant improvement in breathing and a decrease in snoring" following the surgery to remove their tonsils and adenoids. The pt doesn't have another appointment scheduled with the neurologist.

Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that when she sleeps closely with the patient, she feels like she is picking up some of the electrical current from the vns. These events were described as lasting for approximately 20-30 seconds, occurring once or twice per week, and without any pain or discomfort. Additionally, reporter indicated a concern that the device may be "misfiring". Occasionally she would witness the patient making a strange noise and a "jeering" movement. Following these episodes, the device will stimulate. These episodes commenced in 2000 and are infrequent (once every three months). These episodes last 30-40 seconds. Reporter indicated that she is uncertain if these may be seizures. It was reported that there were no unusual environmental hazards present. Further investigation revealed that the reporter no longer believed that the device was "misfiring"; however, some irregular night breathing was reported. These different breathing patterns began in 2001. It was reported that the patient changes medication dosages and frequencies very often and is currently on four anti-convulsive drugs. It was reported that since the vns implant, the patient has had mild seizure control, but is more aware and alert than before the implant. Physician reported that the patient developed irregular breathing after patient had a prolonged seizure that was probably related to an inadvertent elevated lamictal administration. Physician indicated that he did not believe that the vns was the cause of the irregular breathing. An ent reviewed the patient's sleep tapes and concluded that there were periods of apnea throughout the night when the patient was asleep. The device was temporarily programmed to off and the patient's breathing returned back to normal, but patient had an increase in seizures and developed dyspnea. The device was programmed back to on with parameter adjustments in hopes of maintaining seizure control without further breathing difficulties.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=356058


Title: Re: Respiratory
Post by: dennis100 on April 11, 2011, 12:27:21 AM
Event Date 06/13/2000
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Rptr indicated that on event date, pt had a violent 18 minute seizure. The magnet was used at the onset of the seizure. The pt vomited and aspirated into their lungs resulting in adult respiratory distress. Pt was hospitalized for three months. Pt spent the first month in neuro-critical care, the second month in the respiratory unit being weaned off of the ventilator, and the third month in therapy to regain strength and weight pt had lost. Also while in the hosp, the pt developed a bleeding ulcer and needed 6 units of blood. In 2000, just 6 weeks after being home, the exact same seizure pattern occurred. The magnet was again used at seizure onset. The pt again vomited and aspirated, but a vacu-aide suction machine was used and eliminated a great deal from entering the lungs. Pt was again hospitalized for another 6 weeks and placed on a ventilator. The physician decreased the device output current to 0. 75 the following month while pt was still in hosp. The magnet has not been used at seizure onset. There have been no more incidents of this nature. There have been many seizures, but no life-threatening aspiration.

Manufacturer Narrative
Method: mfg records were reviewed. Results not review of the mfg records did not identify any anomalies or abnormalities that would have an adverse effect on device performance. Two written requests and three phone calls were made to gather further info; however, the info was not rec'd.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355868


Title: Re: Respiratory
Post by: dennis100 on April 12, 2011, 04:30:36 AM
Event Date 04/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt did not experience an increase in seizures as initially reported. It was reported that the pt did not experience any changes in seizures with vns therapy. Further follow-up also revealed that the pt did not have dysphagia as initially reported. The pt has had difficulty clearing secretions since birth and this did not change with vns therapy. The ncp system was programmed to off on 5/9/2002. The pt does not have any plans to explant the ncp system at this time. H. 6. Results: device labeling lists dyspnea as a potential adverse event that may result from stimulation. H. 6. Conclusions: pt's mother reported that the dyspna resolved by itself without any changes in the device parameters.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and bipolar lead revealed no anomalies that could have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3, date event.

Event Description
In the process of contacting the pt to inform pt that generator may be nearing end of service, it was discovered that the pt was experiencing symptoms of dyspnea, dysphagia, and an increase in seizures. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=397658


Title: Re: Respiratory
Post by: dennis100 on April 12, 2011, 04:31:38 AM
Event Date 01/01/2001
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. Death certificate listed the cause of death as respiratory failure, due to (or a consequence of) status epilepticus, due to (or a consequence of) lennox-gastaut. The death certificate listed the manner of death was listed as natural.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
In the process of contacting the pt to inform them that their generator may be nearing end of svc, it was discovered that the pt had expired. The cause and exact date of death are unk at this time. Attempts to obtain add'l info have been unsuccessful to date. The pt's family member would not give any details regarding the pt death. Follow-up with pt's last known physician revealed that she was no longer the pt's treating neurologist at the time of death. Last known physician reported that she believed that the pt had been hospitalized for status epilepticus and that during the pt's hospitalization, pt's family members decided to withdraw life support and pt died. It is unk whether the pt's ncp system was explanted. There is no allegation of device deficiency. There is no indication that the vns therapy caused or contributed to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=390523


Title: Re: Respiratory
Post by: dennis100 on May 05, 2011, 03:39:00 AM
Event Date 03/01/2002
Event Type Injury
Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Pt reported that they had an increase in seizure activity. It was reported that there have been some recent changes to their medication regimen and that pt has a low sodium level. The pt reported that pt feels like they have more of an awareness of their seizures. The pt reported that they had eeg monitoring to prove that pt is now having generalized instead of partial seizures. Further follow up revealed that the pt went in for telemetry monitoring because of an increase in seizures. The pt reported that when they would have seizures, use of the magnet would decrease the duration of the seizure. The pt reported they were an in-patient for 8 days during the testing. During the hospital stay, their sodium level decreased. The pt's trileptal prescription was changed to dilantin (600 mg po bid) in 2002. The pt reported that they used their magnet so often during the hospital stay that their voice was hoarse. Device programmed parameters were reduced in hopes of helping their voice recover. The pt was discharged from the hospital the following day. On the next day the pt experienced blurred vision, tachycardia, and trouble breathing. The pt was seen in the emergency room and was prescribed diastat. The er physician attributed the pt's symptoms to the sudden change to dilantin. Their dilantin dosage was reduced to 400mg on that day. It was later reported that the pt was hospitalized again 13 days later because they were experiencing a flurry of seizures. The physician did not make any further changes to the vns programmed parameters. Attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative
The pt was released from the hosp in 2002. No parameters were changed during the stay. The physician told the pt their symptoms were psychological. The physician reported to the pt that the tachycardia and trouble breathing were related to stress and the position they sleep in. Chaning sleep positions resolved these symptoms and the pt did not have any further problems. The pt did not follow up with the physician after being discharged from the hosp. The pt followed up with another neurologist one week later and had their parameters adjusted. 2 days later they had an spisode of status and was hospitalized. During this hospitalization, the treating physician changed their medications (stopped dilantin and gabitril). The pt was released 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=388523


Title: Re: Respiratory
Post by: dennis100 on May 05, 2011, 03:39:42 AM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt had actual vocal cord swelling by endoscopy and evidenced by stridor clinically. The physician assumed that the device programmed parameters may have been too aggressive and reduced normal mode output current to 0. 75ma and magnet mode output current to 1. 00ma. It was reported that the pt was initially fine after the parameter reduction, but that 2 months later the pt was again showing some stridor again. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=387323


Title: Re: Respiratory
Post by: dennis100 on July 07, 2011, 02:49:18 AM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt started having very mild spells with just "gasping" (no convulsions). Previously the pt's arms and legs would extend out and pt would convulse when having a seizure. The pt had 3 very severe seizures in 2002. No injuries were reported. 3 days later, the pt had 4 very severe seizures and 5 mild seizures about 3-4 mins in between. The physician reduced the device output current from 3. 5 ma to 2. 5 ma 2 days later. 2 days later, the pt had 9 mild seizures. The physician programmed the pt's device to off the following day. That night, the pt started having very severe seizures. Pt was taken to the emergency room. The dr prescribed 5mg of diastat (a valim suppository), but the pt's family member were not able to get the prescription filled. 2 days later, the pt had 1 medium seizure that lasted about 2 minutes and 15 seconds. During six days, the pt didn't have any seizures at all. In 02/02 the pt had 4 severe seizures which continued to the following day. The next day, the pt went in for an appointment and the stimulation output current was turned up to 1. 0ma. The physician prescribed 15mg of diastat. The pt had 16 mild seizures on this day. The following, the pt took 15mg of diastat and didn't have any seizures following this. The next day, the device was set to 30 sec on, 5 mins off. The pt had small seizures every 5 mins. When the horsehsoe magnet was used it slowed the frequency of the seizures to 15 mins - 45 mins apart (most were 25-35 mins in between). The following day, the block magnet was used. The pt had many small seizures throughout the night at 5 min intervals that the block magnet did not stop. No magnet was used at all. The pt was given 15mg of diastat and pt continued having seizures. The block magnet was used again and the pt was still having seizures. Following all of this, the pt's family member took pt to see the physician again (date unknown). The physician ran a lead test which resulted in ok lead impedance, indicating proper device function. The pt's family member is in the process of changing physician's. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the patient's device was turned off on 02/12/2002. The patient was last seen by the physician on 03/19/2002 and was much improved. The patient's device has not been returned back on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=385294


Title: Re: Respiratory
Post by: dennis100 on July 07, 2011, 02:50:16 AM
Event Date 02/12/2002
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the pt was explanted after complaining of "electrical shocks".

Manufacturer Narrative
Device manufacturing records were reviewed. Device programming history was reviewed. Review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. Review of programming history did not reveal any anomalies that would have an adverse effect on device performance. Lead test results were within normal limits, indicating proper device function. Eri (elective replacement indicator) was no, indicating that the generator was not at end of service.

Event Description
Reporter indicated that patient complained of erratic and painful stimulation. When this occurred the patient would become pale and short of breath. The physician ran two lead tests one of which resulted in a "fault" and one that resulted in "okay" readings. The physician did not report what the eri (elective replacement indicator) flag was. The physician programmed the patient's device to off which relieved their discomfort. Further follow-up revealed that the patient also complained to their surgeon of chest pain, tightness in chest and a pinching and pulling sensation. The surgeon did not believe that these symptoms were related to the vns since the device had been programmed to off. The patient was seen in the emergency room and reportedly had a negative cardiac work-up. The patient's neurologist plans device replacement due to suspected malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=382808


Title: Re: Respiratory
Post by: dennis100 on July 07, 2011, 02:51:06 AM
Event Date 09/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Physician indicated that the reported events of shortness of bret and tachycardia are now resoved; however, dr did not state how the event was resolved. Device programming history was reviewed. Review of device manufacturing records did not reveal any anomalies nor abnormalities.

Manufacturer Narrative
Further follow-up revealed that the pt experienced an increase in seizures following a parameter change in 2/2002. The pt's mother reported that she is unsure whether this change is due to the pt's parameter change or due to the pt's seizure disorder as the pt has had periods like these in the past. The pt's mother dose not feel like the increase in seizures is not manageable.

Manufacturer Narrative
Dyspnea and heart rate and rhythm changes are listed as potential adverse events in the labeling for these products. The following dates are estimated. Only the month/year is known: b,3. , date of event.

Event Description
The reporter indicated that since the vns reporter has experienced shortness of breath associated with minimal exertion (i. E. Walking fast). The patient also experiences tachycardia during these events. The patient's heart rate will raise to 120 bpm from a resting rate of 80 bpm. It was reported that the patient had a very high energy level and a good deal of stamina prior to the implant. The patient's oxygen saturation was checked and resulted in normal and all pulmonary testing that has been done has also been normal. The patient reportedly does not notice any relationship between these symtpoms and the cycling of the vns. Patient also reported that the medications have not been changed. Patient stated that patient was having good seizure control until the last parameter adjustment. Subsequent to this adjustment, patient's seizures have increased, but are still below baseline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=380159


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:25:40 PM
Event Date 01/22/2001
Event Type Injury
Patient Outcome Life Threatening; Disability Other
Event Description
In 2001 rptr had a vagus nerve implanted for control of epilepsy. When rptr came out of the surgery rptr had a paralyzed left vocal cord, no sense of smell, or taste, deep inner ear nerve pain and head aches constantly. Has had their air intake and has to sit up in bed so not to aspirate. They cannot do a thing, rptr has to deal with this the rest of life. The drs could not turn the device on because of rptr's problem. They took the vagus nerve stimulator out 8 mos later. Rptr does not know if it was caused by the device or not, but others should be told before they make the decision to have the surgery and end up like the rptr. Such a device should be looked into.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=380583


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:26:15 PM
Event Date 10/24/2001
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that pt was found "with breathing standstill and stopped heart functions, successful reanimation". Device was turned off in 2001. Further follow-up indicated that the pt suffered from pneumonia that was untreatable. Pt was last seen at the physician's office 6 days ago.

Manufacturer Narrative
Reviewed manufacturing records. Review of manufacturing records did not reveal any anomalies that would have had adverse effect on device performance. Physician indicated that the ncp system was not related to the cause of death.

Manufacturer Narrative
Physician was not willing to provide copy of death certificate. It was reported that the pt had taken all anti-epileptic medications available at one time or another. Pt was implanted on 9/4/01. Pt was found not breathing on the morning of 9/6/01. Pt's device was programmed to off on 9/14/2001. Pt was last seen by phsyician on 10/18/2001. Pt expired on 10/24/2001 due to complications from untreatable pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=377400


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:26:50 PM
Event Date 01/01/1999
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Reviewed mfg records. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Pt said that pt has had vocal cord paralysis for 2. 5 years. Also, the pt wanted the device implanted under pt's armpit and the surgeon implanted the device in pt's chest area. When pt woke up from surgery, pt had no voice and could not breathe. Pt has been to an ent a few times and the ent said that the right vocal cord is compensating. No intervention was taken by the ent. Pt's device has been turned on and off multiple times in the past 2. 5 years, but pt received best seizure control when it was off. An attmept has been made to obtain add'l info via federal express letter to physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=377656


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:27:29 PM
Event Date 02/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Late report due to administrative error. Method: device mfg records were reviewed. Results: review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

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: Respiratory
Post by: dennis100 on July 16, 2011, 02:28:04 PM
Event Date 10/01/2001
Event Type Injury
Patient Outcome Required Intervention; Life Threatening
Manufacturer Narrative
Device mfg records were reviewed. Review of device mfg records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Rptr indicated that in 2001, the pt was unable to swipe magnet prior to onset of grand mal seizure. As a result, the pt had a drop attack and 911 was called. When the pt stopped breathing, the attending emt began to revive the pt and bruised the pt at the generator site. The pt immediately saw the physician. The physician ran diagnostic tests on the device which indicated that the device was functioning properly. Device programmed parameters were increased a few weeks following the event. It was reported that the pt has fully recovered. Investigation to date has been unable to determine why the pt was not able to activate magnet mode stimulation on the day of the event. Four attempts have been made to obtain add'l info with no reponse to date (2 via telephone conversation with nurse at site, 1 via us mail to physician, 1 via telephone message to site).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=376577


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:28:43 PM
Event


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:29:20 PM
Event Date 04/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
In the process of contacting the pt to notify pt that pt's device may be nearing end of service, it was reported that when the pt is asleep and snoring pt experiences episodes of severe dyspnea that last for 3 to 4 minutes. These episodes began after the pt's device was programmed to off for x-rays and then programmed back to on. Further f/u with pt's last known physician revealed that the pt was experiencing difficulty breathing, but the physician could not clinically diagnose that pt was asthmatic. The pt was tested and asthma was ruled-out. Physician could not provide an answer regarding whether or not he believed that the vns contributed to the pt's condition. Vns re-implant for end of service is not scheduled at this time as the pt will undergo brain surgery in 2002. Attempts to obtain add'l info have been unsuccessful to date.

Event Description
Further follow-up revealed that the pt was explanted due to end of service. It was also reported that the pt underwent brain surgery and was "cured".

Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3 date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=408870


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:30:21 PM
Event Date 05/17/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt experienced a 5-hour episode of status which required hospitalization and a reduction in device settings. It was reported that the pt initially experienced a dramatic decrease in seizures with the vns, but increases to device settings seemed to worsen the pt's seizure activity. The pt's generator was programmed to on approximately one week post-implant to the following settings: 0. 50ma output current, 30 seconds on, 5 minutes off. Two minutes later, the programmed settings were increased to 1. 0 ma output current, 4 minutes off (on time remained the same). With the next parameter increase to following parameters: 2. 0ma output current; 45 seconds on; 2 minutes off, the pt experienced a day of clusters and their seizures worsened to the point of the status episode. At the last device settings (2. 0ma output current), it was noted that the pt coughed constantly, was short of breath, and experienced horseness. At the time of hospitalization, the device output current was reduced to 1. 25ma. Since this parameter reduction, the pt did not experience any further seizures for at least 2 days. The pt denies any traumatic brain injury and states that there were no medication changes during the time of the reported event. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off after experiencing coughing and hoarseness shortly after implant. It was reported that after a period of time the device was programmed back to on wihtout any further problems. It was reported that the patient is having great seizure control.

Manufacturer Narrative
Conclusion: device labeling states that "pt's whose seizures are well controlled at follow-up should not have their settings changed unless they experience uncomfortable side effects. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=401108


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:31:26 PM
Event


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:32:10 PM
Event Date 03/07/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. H. 6. Results: review of manufacturing records revealed no anomalies that would have adverse; effect device performance.

Manufacturer Narrative
Further follow-up revealed that the pt never reported any problems or dissatisfaction with his ncp system to the physician. H. 6. Physician indicated that the relationship between the ncp system and cause of death were not related.

Event Description
Reporter indicated that patient had passed away. The patient presented to the emergency room for evaluation of new onset dyspnea that occurred with reclining throughout the evening before this presentation. Patient had a long history of seizures, hypertension and a long history of cigarette use (one and one-half packs per day). After referral to the hospital emergency room, patient was noted to be hypoxemic by o2 saturations and received oxygen with improvement. Initial laboratory analysis was done in addition to chest x-ray, echocardiogram and venous doppler of the lower extremities (results unknown). Initial therapy was recommended regarding patient's obstructive airway disease. In follow up, the respiratory therapist was checking on patient. Patient was trying to sit up on the side of the stretcher to urinate when patient complained of severe precordial discomfort and turned blue from the waist up. Patient was subsequently noted to have a barely palpable pulse at 30 and was not breathing. Cpr was begun. Despite prolonged cpr and acls protocol, patient was pronounced dead. Physician indicated that the death seemed natural, but the precise reason for sudden decline is unknown. A provisional diagnosis of acute cardiopulmonary arrest was made. No autopsy was performed and death certificate is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418940


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:33:10 PM
Model Number 100
Event Type Death
Patient Outcome Death;
Event Description
In the process of updating device tracking info, it was discovered that the pt had passed away. The pt's last known physician was contacted in an attempt to obtain the name of the pt's new physician since the last known physician had relocated. The cause and date of death is unknown at this time. The pt was seen by last known physician in 3/2000. Last known physician suspects that the pt died of natural causes and does not know whether an autopsy was performed.

Manufacturer Narrative
The report is incomplete because the pt's last known physician is no longer practicing at the same facility. Attempts to obtain additional info from physicians remaining at the facility have been unsuccessful to date. The pt's treating physician at the time of death is unk at this time. Request for a copy of the death certificate is pending with the state dept of health. H. 6 method: device mfg records were reviewed. Results: review of mfg records for both the pulse generator and the bipolar revealed no anomalies that would adversely affect device performance.

Manufacturer Narrative
Further follow-up revealed that the death certificate listed the cause of death as cardiorespiratory arrest, due to (or a consequence of) suspected hypoxia and acidosis, due to (or a consequence of) possible hypoventilation secondary to tracheostomy. The manner of death was listed as natural.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The physician described the circumstances of death as: the patient developed respiratory progressive distress and appeared in a septic state. H. 6: physician indicated that there was no relationship between the ncp system and cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418941


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:33:47 PM
Event Date 06/26/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Conclusions: there is no evidence at this time that the ncp system caused or contributed to the reported event.

Event Description
In the process of contacting the patient to notify them that their device may be nearing end of service, it was discovered that the patient had passed away. Autopsy report attributes cause of death to sepsis and respiratory failure with multi-organ damages including hepatic central lobular necrosis, adrenal necrosis, acute tubular necrosis, and diffuse pulmonary intra-alveolar interstitial fibrosis. There is no evidence at this time that the ncp system caused or contributed to the reported event. Further investigation revealed that the patient was hospitalized from 05/02 until the date of their death. The patient was taken to the emergency room by their mother in 05/02 for a sore throat, difficulty breathing, "making sounds" (stridor) for three days intermittently. The patient was intubated in the emergency room, during which a mass completely obstructing the left main stem bronchus was visualized and biopsies of the mass were performed with follow-up laser therapy. The patient aspirated during this initial procedure. Post-operatively, patient's respiratory status declined. Patient was subsequently reintubated and the mass was debulked to ventilate the left lung with rigid bronchoscopy. Once the rigid bronchoscope was withdrawn, attempt to reintubate the patient was unsuccessful and an emergent cricothyroidotomy was performed. Possibly one of the internal jugular veins and the esophagus were partially lacerated in the event. During the procedure, the patient developed bradycardia, asystole and ventricular tachycardia requiring electrical defibrillation to restore sinus rhythm. Patient was subsequently transferred to the intensive care unit. The transbronchial biopsies of the left main stem bronchus mass done during this hospital admission was determined to be from a squamous papilloma with severe dysplasia. The patient's hospital course gradually worsened with adult respiratory distress syndrome, sepsis, and intractable seizures. Although patient's multiple blood cultures continued to be negative for organism, their urine and respiratory sputum samples grew enterobacter cloacae and candida albicans. Patient developed bilateral pneumothoraces and chest tubes were placed. The patient also developed a deep venous thrombosis in the left common femoral vein as determined by doppler ultrasound and was given anticoagulant prophylaxis. Patient's respiratory status continued to deteriorate and their family decided to change code status to no code. The patient suffered cardiopulmonary arrest and was pronounced dead in the hospital 5 weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418268


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:34:23 PM
Event Date 08/15/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6: cause of death reported as respiratory failure as a result of many multi-system organ failures and high co-morbidity. Physician indicated that the ncp system was not related to the cause of death.

Event Description
Reporter indicated that vns pt had passed away due to repiratory failure. The pt reportedly suffered from many multi-system organ failures and had a high co-morbidity. Further investigation revealed that the pt was last seen by the last known treating physician in 07/2002. The pt was receiving vns therapy at the time of death and their condition had not changed. It was revealed that an autopsy was performed but attempts to contact the last known physician have not been successful to date. The device was not explanted and is subsequently not available for an analysis. The pt had a history of being worked up for resective epilepsy surgery but had never undergone such surgery. Physician indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=416474


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:35:09 PM
Event Date 07/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
The report is incomplete due to the anonymous nature of the reported event.

Event Description
Reporter indicated that when programmed device settings are increased, the pt experiences pain and difficulty in breathing. It was also reported that the pt experiences extreme voice alteration at higher device settings. When the pt squats or bends over, they reportedly begins breathing hard and then cannot breathe at all. Investigation to date has been unable to determine the severity of the reported symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=416425


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:35:53 PM
Event Date 06/05/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Review of mfg records revealed no anomalies that would adversely effect device performance.

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: Respiratory
Post by: dennis100 on July 16, 2011, 02:37:01 PM
Event Date 11/27/1999
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the pt developed respiratory and cardiac arrest following a seizure. The physician indicated that the pt did not have efficay with vns therapy. H. 6. Conclusions: physician indicated that the relationship between the ncp system and cause of death was not related.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that could have an adverse effect on device performance.

Event Description
In the process of contacting the patient to notify that the device may be nearing end of service, it was discovered that the patient had passed away. Exact date and cause of death are unknown at this time. There is no evidence that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that the patient developed respiratory and cardiac arrest following a seizure. The physician indicated that the patient did not have efficacy with vns therapy. H. 6 physician indicated that the relationship between the ncp system and cause of death was not related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414511


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:37:37 PM
Event Date 07/28/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6-device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that could have and adverse effect on device performance.

Event Description
Reporter indicated that the pt had passed away and that the cause of death was hypoxia. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414552


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:38:30 PM
Event Date 07/20/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6: device manufacturing records were reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Physician indicated that the ncp system was not related to the reported event.

Event Description
Reporter indicated that vns pt had passed away. Certificate of death lists respiratory arrest as the immediate cause of death, due to or as a consequence of mitochondrial disorder of oxidative phosphorylation, due to or as a result of epilepsy. No autopsy was performed. Physician indicated that the pt died of respiratory arrest during the night and there was no seizure associated. Physician indicated that the ncp system was not related to the cause of death. The pt reportedly experienced a >50% reduction in seizures with the vns therapy. Return of explanted product for analysis is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=412627


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:39:31 PM
Event Date 06/07/2001
Event Type Death
Patient Outcome Death;
Event Description
In the process of notifying the pt that their device may be nearing end of service, it was discovered that the pt had passed away. The cause of death is unk at this time. There is no evidence that the ncp system caused or contributed to the reported event. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies that would have an adverse on device performance.

Manufacturer Narrative
Corrected dat: h. 10. - the paragraph in follow-up 01 referenced the wrong year. See correction below. Further follow-up revealed that the pt was admitted to the hosp on 5/15/2001, in respiratory distress with a temperature of 103 degrees fahrenheit. The pt was intubated and put on a ventilator which they were unable to wean. The pt aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. On 6/5/2001, the pt aspirated again and had a lower gi bleed. The family decided to withdraw care and the pt died on 6/7/2001. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia.

Manufacturer Narrative
Further follow-up revealed that the pt was admitted to the hospital in 2002, in respiratory distress with a temperature of 103 degrees fahrenheit. The pt was intubated and put on a ventilator which they were unable to wean. The pt aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. In 2002, the pt aspirated again and had a lower gi bleed. The family decided to withdraw care and the pt died in 2002. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia. H. 6. Physician indicated that the relationship between the ncp system and cause of death were not related.

Manufacturer Narrative
Further follow-up revealed that the patient was admitted to the hospital in 2001, in respiratory distress with a temperature of 103 degrees fahrenheit. The patient was intubated and put on ventilator which they were unable to wean, the patient aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. In 06/2001, the patient aspirated again and had a lower gi bleed. The family decided to withdraw care and the patient died two days later. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411200


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:40:13 PM
Event Date 05/17/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6 method: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Conclusions: per death certificate, immediate cause of death listed as "cerebral edema", due to or as a consequence of seizures that were due to or a consequence of ventriculo-peritoneal shunt malfunction.

Event Description
In the process of contacting the pt to notify them that their device may be nearing end of service, it was discovered that the pt had passed away. The pt was reportedly seizure-free from january 2000 to may 2000. In 2000, the pt was admitted to the hospital for break-through seizures with fever. The pt had been in their normal stage of health until earlier that morning. The pt was admitted and was observed overnight and was hemodynamically stable, but did not wake up; pt remained very sleepy. The following morning, the pt was noticed to have mental status change and was unresponsive in respiratory failure. Pt began experiencing abnormal breathing and was taken to the operating room for a vp shunt revision. After the vp shunt revision, the pt was started on rocephin and nafcillin, but mental status did not improve. Two days later, the pt remained in a deep coma and was unresponsive to painful stimuli. An apnea test was performed and the pt was apneic for seven minutes. A neurologic exam was done twice, and the pt was pronounced dead by brain death criteria. The pt reportedly developed massive cerebral edema and died. The pt's parent stated that they feel the vns is partially responsible for the pt's death; however, they did not state why they feel that way. The death certificate stated the cause of death as cerebral edema along with seizures and a ventriculo-peritoneal shunt malfunction as consequences of death. The pt was taking phenobarbitol, but it had been discontinued. The pt was currently prescribed 45mg of topirmate. No autopsy was performed and the lead and generator were not explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411250


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:41:15 PM
Event Date 06/18/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt has been experiencing shortness of breath and sometimes stops breathing during the night. The pt reported that she has had trouble sleeping since having their device programmed to on. The pt also reported that they have been experiencing pain at the generator site for since 2002. The physician's office indicated that th ept has not been seen by the physician one month ago. During office visit 2 months ago the pt denied having chest pain, shortness of breath, fever and chills and was doing well. The pt has not contacted the physician's office concerning any problems since being seen 2 months later.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that pt began to experience episodes of dyspnea, during which they would lose conciousness due to shortness of breath. The pt started a new medication (klonipin) at approx the same time that the episodes of dyspnea began. The shortness of breath has reportedly resolved. Further follow-up with pt's neurologist revealed that the pt had not been in contact with their office since the last visit in 5/2002. The pt has an appointment scheduled for 8/2002 at which time the neurologist will address the reported event.

Manufacturer Narrative
Further follow-up revealed the pt is doing well. Device labeling lists dyspnea as a potential adverse event that may result from stimulation. Physician indicated that the reported events have resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411401


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:42:16 PM
Event Date 07/01/2000
Event Type Injury
Patient Outcome Life Threatening;
Event Description
When the vns was first implanted, the patient had very marked problems with swallowing on the following regular cycle device settings: 30 seconds on, and 5 minutes off. The treating physician quickly ramped the device settings up to rapid cycling which markedly improved the swallowing problems at that time. Over the past year, the patient has complained of occasional intermittent episodes of choking where they have indicated that it is difficult to breathe. This does not coincide with eating or swallowing and there are no obvious triggers. The first episode seemed to follow a severe respiratory infection. The patient has other significant neurological problems with bilateral perisylvian polymicrogyria and a very severe facial palatal paresis. Physician is unclear about the relationship of the vns to the most recent events that the patient is experiencing because they did not have these problems pre-vns, but they did not begin until after vns had been implanted for some time. Device diagnostic testing was within normal limits, indicating that the device is functioning properly.

Manufacturer Narrative
Further follow-up revealed that the pt has had a good response from vns therapy. The pt has not had any major seizures since being implanted with the ncp system. Device diagnostic testing was within normal limits and eri (electvie replacement indicator) flag was no, indicating that the device was not at end of service. Device settings are currently set to 7 seconds on and 18 seconds off.

Manufacturer Narrative
Report is incomplete because the physician was out of the country for a period of time and was not available. Recent attempts to contact the physician through international distributor have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=424174


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:42:57 PM
Event Date 09/09/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that pt was found dead in their bed by their family three days post-vns implant. It was reported that the pt had some 'breathing problems' after the surgery. The pt's family reported that the evening before their death, the pt appeared fine and they did not suspect any problems. Autopsy report is not complete, but it was reported that the cause of death was pulmonary edema. It was also reported that the vns was programmed to on the day of implant surgery and was on at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=421693


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:43:35 PM
Event Date 08/14/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that the pt had passed away. The pt was admitted into the hospital in 2002 with multiple medical problems and was a dnr (do not resuscitate). The cause of pt's death was listed as respiratory failure. The reporting physician did not have full details on the event as pt was out of town and another doctor was covering for them.

Manufacturer Narrative
The report is incomplete because the treating physician has been out of town and unable to respond to requests for add'l info to date. Method: device mfg records were reviewed. Results: review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=420624


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:44:21 PM
Event Date 11/28/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
The magnet was used at the onset of a seizure and the patient indicated that their chest and throat hurt and then the patient became cyanotic. This reportedly occurred on two occasions. The patinet's programmed parameters were changed and the magnet had been used daily since then without incident. The magnet was tested before leaving the physician's office at the time that the adjustment in parameters was made, also without incident. Physician advised patient not to use magnet until manufacturer completes a review of the reported information. Physician is considering reducing the magnet pulse width to a more tolerable setting. No device malfunction is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435937


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:45:10 PM
Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Disability
Manufacturer Narrative
Further follow-up revealed that the physician indicated that the pt's condition is "stable".

Event Description
Reporter indicated that the patient has been "heaving" and feels like there is something wrong with their lungs. The patient is asthmatic, but reports that their family doctor indicated that the heaving is not related to their asthma. Further follow-up revealed that the patient had an episode on 12/10/02 where pt woke up and couldn't breathe. The patient reported that this started about 9 years ago and happens about once a year. The patient has been implanted with the ncp system since 1991. The patient was seen by a laryngologist in 12/02 and was diagnosed with paradoxical vocal cord dysfunction. The laryngologist is considering using botox as a treatment.

Manufacturer Narrative
Report is incomplete because no response to manufacturer's requests for additional information has been received to date from physician. H. 6. Results: the ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435868


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:46:18 PM
Event Date 11/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6: device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. The ncp system labeling lists aspiration (fluid in the lungs) and dysphagia (difficulty swallowing) as potential adverse events possibly associated with surgery or stimulation. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that the pt had been choking excessively due to stimulation. The pt's device was turned off using the magnet. The pt was seen by physician in 12/02 and the physician told the pt's parent that the lead was detached from the generator. The physician indicated that the lead had migrated to the center of the pt's neck causing the pt to choke. The pt's parent indicated that they could see the lead in the pt's neck when the pt leaned their head back. The physician planned on removing the ncp system in 2002, but the pt developed aspiration pneumonia in 12/02; therefore, the surgery was cancelled. Physician indicated that the aspiration pneumonia was caused by the choking from the ncp system. The pt was given oral antibiotics for the aspirtion pneumonia and the pt's device was programmed to off. Surgery to remove the ncp system is planned for 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435492


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:47:14 PM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt has experienced wheezing following device parameter increase. Reporter also indicated that the pt has experienced a decrease in seizures. The physician indicated that the wheezing was due to the device parameter increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432862


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:47:59 PM
Event Date 11/14/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt reported that she is "not doing very well. " the pt also reported that she has intermittent swelling in her neck, a sore throat, shortness of breath, and that she as experienced no change in her seizures.

Manufacturer Narrative
H6 results: ncp system labeling lists hoarseness, choking sensation and pain as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt was experiencing pronounced hoarseness/choking sensation and pain at implant incision site. The pt went to the emergency room in 2002 due to the aforementioned symptoms. Device diagnostic testing at follow-up office visit was within normal limits, indicating proper device function. Device output current was reduced on 11/18/2002 from 0. 50ma to 0. 25ma. The pt reports that pt no longer experiences the reported symptoms following the reduction in device output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432873


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:48:43 PM
Event Date 11/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
It was initially reported that the pt's device was programmed to stimulate every minute. The physician has since reprogrammed the pt's device to stimulate every five minutes (normal device settings). H. 6. Device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that patient was experiencing a choking and shocking sensation down their neck. It was reported that the device was programmed to off. The patient reportedly experienced 8 grand mal seizures and was hospitalized. The device was programmed back to on, but the patient reports that patient is again experiencing the shocking feeling and continues to have difficulty breathing.

Manufacturer Narrative
Report is incomplete due to the anonymous nature of the reported event. H. 6 results: ncp system labeling lists dyspnea, dysphagia, and painful stimulation as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432509


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:49:55 PM
Event Date 01/01/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. : ncp system labeling lists choking sensation as a potential adverse event possibly associated with surgery or stimulation.

Event Description
In the process of contacting the patient to notify them that their device may be nearing end of service, it was discovered that the patient's ncp system was explanted due to choking sensation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=430127


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:50:49 PM
Event Date 10/04/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Conclusions: physician indicated that the ncp system was not related to the cause of death.

Event Description
In the process of contacting the pt's physician to notify them that their pt's device may be nearing end of service, it was discovered that the pt had passed away. Circumstances of death are described by physician as sepsis and/or respiratory compromise. It was reported that the pt's seizure frequency/intensity was greatly decreased with vns therapy, but that as the pt's health was failing, their seizures increased. The pt was receiving vns therapy at the time of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=429237


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:51:36 PM
Event Date 10/01/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The physician reported that the patient experienced a great than 50% reduction in seizures. H. 6. Conclusions: physician indicated that the hcp system was not related to the cause of death.

Manufacturer Narrative
Further follow-up revealed that the death certificate listed the cause of death as postictal apnea, due to (or a consequence of) life long seizure disorder. The death certificate listed the cause of death as natural.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The dr reported tha the pt experienced a > 50% reduction in seizures. Dr indicated that the ncp system was not related to the cause of death.

Event Description
Vns pt had passed away. Exact date and cause of death are unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. H. 6. Results: review of mfg records revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=428344


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:53:09 PM
Event Date 10/16/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Results: the labeling for the ncp pulse generator states that the safety and efficacy of vns therapy has not been established for patients with a history of respiratory diseases or disorders, including dyspnea and asthma. Conclusions: it was reported that the physician did not attribute the death of the patient to vns therapy.

Event Description
Reporter indicated that patient was hospitalized following an asthma attack. The patient had been remodeling their home approximately one week prior to the hospitalization and was around a lot of dust. Further investigation revealed that while in the hospital, the patient became brain dead and was put on a ventilator. The following day, the patient died. An autopsy was not performed. It was reported that the cause of death was respiratory arrest. Patient received a greater than 50% reduction in seizure auras with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=427963


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:53:52 PM
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: Respiratory
Post by: dennis100 on July 16, 2011, 02:54:45 PM
Event Date 01/01/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Reporter indicated that the patient underwent generator replacement surgery in 2001. The patient's new generator was activated in 4/2001. During the patient's office visit in 6/2001, the device parameters were increased. The physician's notes from this visit state that the patient has had a 50% decrease in seizures and is currently taking topamax and neurontin. The physician's notes from the patient's next office visit (8/2001) indicate that the patient was better with the vns; their alertness was better and patient was talking more. Physician's notes from the patient's visit in 10/2001 state that the patient is having briefer post-ictal spells. The patient was weaned off their neurontin as of 9/2001 and continues to take depakote. The patient was started on a weaning program to eventually stop the topomax. The patient was started on dilantin and changed the patient's medication from tegretol to tegretol xr. The patient was next seen in 01/2002. The patient reported that they had been seen by another physician who turned off the vns in 11/2001, due to dysphagia and gagging. The patient's tegretol xr was discontinued. Following these changes the patient was able to swallow liquids better and also began to gain weight. The device remains off and the patient is scheduled to see their neurologist for follow-up in 11/2002.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426455


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:57:01 PM
Event Date 12/01/2001
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
H. 6. Method: device programming history was reviewed. Results: review of programming history revealed no anomalies. Physician indicated that the patient had pseudo-seizures. It was reported that the patient has an additional diagnosis of mental illness and that it is a contributing factor in their treatment and symptoms. Conclusion: physician indicated that the vns treatment is not related to the patient's reported symptoms.

Event Description
Reporter indicated that after the patient had their ovaries and uterus removed, they started havine an increase in seizures and stopped breathing in some of the seizures. The patient's device was programmed to off on 02/18/2002 at their request and was later explanted. It was reported that the patient's seizurs were stress related and that since explant, the patient no longer has grand mal seizures and is no longer taking any medications. The patient was referred for evaluation of pseudo seizure activity along with evaluation of symptoms and medication titration.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=445448


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:57:33 PM
Event Date 09/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Physician's notes from the (latest) office visit state the following: neurologic: neurologically intact. Appearance: well nourished, well developed, in no acute distress. Chest: lungs clear to auscultation. Cardiovascular: normal s1, s2, no rubs, murmurs or gallops. Abdomen: bowel sounds normal. No distended. Soft. No tenderness or masses. Diagnosis: s/p vns implant, chronic generalized seizures and r/o tegretol toxicity. The pt was to return for a visit in 1 month blood work. The pt was told to see their surgeon for the neck swelling.

Event Description
During the process of a post-implant follow up call with the pt, the mfr's representative learned that the pt is experiencing the following problems: edema in their throat, enlarged veins in their chest area, discomfort in their arm including numbness and tingling, tightness in their chest, and device migration. Further info revealed that during the pt's follow-up visit with their physician, they complained of breakthrough seizures, bowel incontinence, trouble breathing and rash. The pt reported that they were coughing up "yellowish/blood tinged matter. " during subsequent follow-up visits, the pt complained of headaches, ringing in their ears and chronic pain. On the office visit in 2002, the pt indicated that the vns is working well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=443116


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:58:23 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt's device is still programmed off and the pt is doing well. Physician reported that it was very unlikely that the reported event was related to vns therapy.

Manufacturer Narrative
H. 6. Code 100: ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with stimulation. Additionally, labeling cautions that pts with obstructive sleep apnea may have an increase in apneic events during stimulation. Mfr recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of gsa.

Event Description
Pt was hospitalized for respiratory failure and is reportedly on a ventilator. The pt's ncp system was programmed to off upon hospitalization. One week prior to hospitalization, there were no complaints of breathing problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=442843


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:59:13 PM
Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete due to anonymous nature of reported event. No response to request for add'l info has been received to date.

Event Description
Reporter indicated that pt is experiencing spasms of the vocal cords and larynx and that breathing is very difficult. Investigation to date has been unable to determine the severity of the breathing difficulty.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=440519


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 02:59:51 PM
Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H6 results: ncp system labeling lists of dyspepsia (indigestion) and dyspnea (difficulty breathing, shortness of breath) as potential adverse events possibly associated with stimulation. Conclusions: physician indicated that the pt's symptoms are not related to the vns.

Event Description
Pt was experiencing shortness of breath and is having trouble swallowing, though their seizure control with vns therapy has been very good. Further follow-up revealed that the pt was hospitalized for treatment of gerd (gastric esophageal reflux disease). Physician indicated that the pt's condition was not related to the vns. Investigation to date has been unable to determine whether the pt was diagnosed with gerd prior to vns implant and whether or not the vns therapy has exacerbated this condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=437035


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:01:03 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has experienced heavy breathing since vns implant. Investigation to date has been unable to determine the severity of the breathing problem. It was also reported that the pt is experiencing vision changes and is unable to sleep at night. Additionally, the pt reports "a draining feeling around video cameras and microwaves".

Manufacturer Narrative
Further follow-up revealed that the pt had dyspnea, insomnia and vision problems prior to having ncp system implanted. Physician also indicated that the pt's imagination made her think that there was interference with the ncp system from microwaves. H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar revealed no anomalies that would adversely effect device performance.

Manufacturer Narrative
Report is incomplete because attempts to obtain add'l info from treating physicians have been unsuccessful to date. No response has been rec'd to mfr's requests for add'l info. H. 6. : vns therapy labeling lists dyspnea and insomia as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=457738


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:01:46 PM
Event Date 03/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info from treating neurologist have been unsuccessful to date. No response has been received to manufacturer's requests for additional info.

Event Description
Reporter indicated that pt was seen in emergency room for respiratory distress and was in a coma. The pt was intubated and placed on a ventilator. Investigation to date has been unable to determine whether the event was related to the vns therapy or system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=457748


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:02:32 PM
Event Date 12/01/1998
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
Reporter indicated that patient's ncp system was explanted due to sleep apnea. Further follow-up revealed that in 2003 during surgical consult for ncp system explant, the patient indicated that they felt as if their throat was closing down with stimulation, but that they had tolerated it because they had been doing well regarding their seizures with the vns therapy. The patient indicated that their symptoms had worsened and their programmed parameters were gradually reduced to the point that the device had been programmed to off since 2002. The patient indicated that the closing of their throat had improved since programming the device to off. Additionally, the patient indicated that they had a sensation of food getting stuck in their esophagus when they eat which was also worse when the device was prgrammed to on. As of 2003, the patient had reportedly had no seizures in the past two or three months. The patient reported that their breathing was better since programming the device to off. The patient had reportedly requested removal of the ncp system for difficulty swallowing. Neurosurgeon indicated that he was unsure whether the ncp system was involved in the patient's swallowing problem and requested a gi work-up and a swallowing study to look for dysmotility and possible diverticulum prior to explant surgery for clarification of the patient's swallowing problem. Investigation to date has been unable to determine whether the aforementioned tests were performed. The patient's ncp system was explanted.

Manufacturer Narrative
Further follow-up revealed that the pt reported difficulty with cpap machine prior to explant. Physician contributes the ncp system to the pt's sleep apnea.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=456797


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:03:35 PM
Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because attempt to obtain additional info has been unsuccessful to date. No response has been received to manufacturer's request for additional info from treating neurologist. H. 6. : ncp system labeling lists dyspnea as a potential adverse event possibly associated with stimulation.

Event Description
Reporter indicated that pt has been experiencing shortness of breath for approximately 3 months that has become severe. It was reported that the shortness of breath began around the same time that the pt discontinued one of their anti-epileptic medications (mysolin). An adjustment in programmed parameters was made in an effort to alleviate the shortness of breath that resulted in an increase in seizure activity. The history of the device adjustments are as follows: 2002: reduced output from 1. 5 to 1. 25 ma. Pt was only having 1-2 auras at this time. 2003: output current remained the same, the frequency was increased from 20 to 30 hz. The pt had 2 auras during the time from the previous visit to this visit. The following month no changes in parameters. Had only two auras since last visit. The following month. The pt has had 6 seizures since the last visit. Treating neurologist indicated that device output current would be increased back to 1. 5ma in a effort regain seizure control. Further follow-up revealed that the pt's shortness of breath was lasting for up to 40 minutes and resulted in at least one trip to the hospital emergency room. Treating neurologist plans to reduce output current back to 1. 25ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=456828


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:04:10 PM
Event Date 03/17/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6: vns therapy labeling lists dyspnea and heart rate/rhythm changes as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:04:55 PM
Event Date 08/06/2000
Event Type Death
Patient Outcome Death;
Event Description
In the process of contacting the pt's physician to notify pt that the pt's device may be nearing end of service, it was discovered that the pt had passed away. Exact cause of death is unk at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as respiratory arrest, due to (or a consequence of) aspiration pneumonia, due to (or a consequence of) seizure disorder, profound mental retardation was listed as another significant condition contribution to death but not resulting in the underlying cause. The manner of death was listed as natural.

Manufacturer Narrative
Report is incomplete because last known neurologist had reportedly not seen the pt since october 1998. The pt was seen in january 2000 by a neurosurgeon that is no longer at the same facility and may have retired. Implanting facility reportedly had no record of the pt's product info (model and s/n's).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=451890


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:05:36 PM
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: Respiratory
Post by: dennis100 on July 16, 2011, 03:06:30 PM
Event Date 01/08/2003
Event Type Death
Patient Outcome Death;
Event Description
Vns patient had passed away. It was reported that the patient had various co-morbidities and died of natural causes. The exact cause of death is unknown at this time. No autopsy was performed and the ncp system was not explanted. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that the pt complained of abdomial pain and increasing somnolence was noted several days prior to death. Progressive hypopnea occurred resulting in respiratory arrest. The pt was last seen by the physician in 2003. The physician indicated that the ncp system was not related to the cause of death.

Manufacturer Narrative
Report is incomplete because attempt to obtain additional information from physician has been unsuccessful to date. H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448112


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:07:19 PM
Event Date 06/14/2002
Event Type Malfunction
Manufacturer Narrative
H6 method: device mfg records were reviewed. Results: review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of mfg records for the pulse generator revealed that the device was approximately one year past labeled expiration date at the time of implant.

Event Description
Reporter indicated that patient's device is not stimulating at programmed intervals. The patient reported that when the device is stimulating, the voice becomes very low and extremely hoarse and pt experiences a shortness of breath. It was reported that the device on time was programmed at 30 seconds and that the off time was programmed to 5 minutes, but that the patient has gone for as long as 20 minutes without the feeling of stimulation. The patient's generator was approximately one year past labeled expiration date at the time of implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=449138


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:08:09 PM
Event Date 01/14/2003
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. Vns therapy labeling lists neck pain, facial paralysis/paresis and dyspnea as potential adverse events possibly associated with surgery or stimulation.

Event Description
Pt is experiencing loss of sensation in neck from chin down with partial facial paralysis. Additionally, the pt complains of pain, stiffness and limited range of motion in neck along with shortness of breath and difficulty breathing. The pt has reportedly benefited from the vns therapy. Pt's neurosurgeon will reportedly not see the pt again due to repeated threats from the pt regarding the condition of their surgical scars. Neurosurgeon indicated that there was no relationship between the pt's symptoms and the vns. Additonally, the neurosurgeon indicated that the pt had a low tolerance to pain and was addicted to narcotics. Further follow-up with neurologist indicated plans to increase device frequency from 10 back to 20, increase pulse width from 130 to 250, leave output current the same to allow the pt to become accustomed to the therapy and bring pt back in two weeks to progress device setting increases along algorithm. The pt is reportedly doing much better and reports that their incisions are healing very well now.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448068


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:08:55 PM
Event Date 01/01/2003
Event Type Malfunction
Manufacturer Narrative
Further follow-up revealed that the pt's condition has not improved and that the pt is still on assisted breathing at home. Physician indicated that the pt underwent resuscitation efforts due to their respiratory problems which may have contributed to the suspected lead break. The pt is currently 4mg, and prilosec 40mg. The physician indicated that the pt is in no condition to perform revision surgery and doesn't know when or if this will ever be possibility.

Manufacturer Narrative
H6: device mfg records were reviewed. Available device programming history was reviewed. X-rays were reviewed. H6: review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect performance. Limited device programming history was reviewed and was inconclusive in determining a time frame in which the suspected lead break may have occurred. High lead impedance condition was confirmed. Review of x-rays revealed no discontinuities in the ncp system.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of service. Further follow-up revealed that pt had an increase in seizures since the high impedance incident, but that the increase was not above their pre-vns baseline frequency. Pt is hospitalized for a respiratory infection and their condition was reported as "not good". Medical opinion was that the increase in seizures was due to lack of vns therapy due to suspected lead break as well as pt's health condition. Chest x-ray did not reveal any discontinuities in the ncp system. Lead replacement surgery will be scheduled if pt becomes well enough to undergo the surgery. There have been no medication changes, no change in the device settings and no environmental stimuli (stress, family issues, etc. ) that could be contributing to the seizure increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=447350


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:09:39 PM
Model Number 100
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
No response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Ncp system labeling states that patients with obstructive sleep apnea (osa) may have an increase in apneic events during stimulation. Manufacturer recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
In the process of contacting the patient's physician to notify them that the patient's device may be nearing end of service, it was discovered that the patient's device had been programmed to off due to unrelated apnea. The patient's medications had also been decreased. Treating neurologist planned to restart vns therapy once the patient's other medical issues were resolved. Further follow-up revealed that the patient had many medical problems including several apnea. Most forms of treatment (including vns therapy) were withheld and the patient eventually became better. The patient's family has chosen not to have the same combinations of treatment (including vns therapy) resumed for fear of a repeated episode. Treating neurologist does not believe that the apnea was related to the vns, but does not want to retry the vns to confirm. Investigation to date has been able to determine the severity of the apnea and whether or not the event was related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=469157


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:10:27 PM
Event Date 05/05/2003
Event Type Malfunction
Manufacturer Narrative
The pt's problems with their first model 101 generator were previously reported to the fda. A voluntary medwatch was also submitted to the fda by the pt's family member. Further follow-up revealed that the same leads have been implanted since 1996. Device was activated and parameters were obtained and found to be normal (appropriate parameters). The pt's device is currently activated. Review of mfg records for the pulse generator revealed no anomalies that would adversely affect device performance. Labeling for the ncp system includes the following: "pts should exercise reasonable caution in avoiding devices that generate a strong electric or magnetic field. " "based on testing to date, cellular phones have no effect on pulse generator operation. Unlike an implanted pacemaker or defibrillator, the pulse generator does not sense physiologic signals. " ". Because of their higher energy levels, sources such as transmitting antennas may interfere with the ncp system. It is suggested that the pulse generator be moved away from equipment--typically at least six feet (1. 8 meters)--that may be causing interference. " "strong magnets, hair clippers, vibrators, loudspeaker magnets, and other similar electrical or electro-mechanical devices, which may have a strong static or pulsing magentic field, can cause accidental magnet activation. Pts should be cautioned to keep such devices away for the pulse generator, typically at least six inches (15 centimeters) away. ".

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:11:04 PM
Event Date 05/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. : ncp system labeling lists dyspnea and dysphagia as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt's device was programmed to off due to shortness of breath. Pt initially reported episodes of shortness of breath approximately one week after a parameter increase. Follow-up with treating neurologist revealed that the pt had problem with allergies and that the shortness of breath was not related to the vns. Device output current was reduced from 2. 0ma to 1. 75ma at that time. Device output current was reduced further three days later (from 1. 75ma to 1. 50ma along with a reduction in pulse width (from 250 to 130) as the pt continued to complain of shortness of breath, mostly in the middle of the night. It was later reported that the pt's device was programmed to off due to approximately 50 spells of shortness of breath in the last month. The pt had reportedly experienced spells of gasping, shortness of breath, feeling of breath being taken away and a choking feeling. These symptoms were occurring mostly at night, but had begun to occur during the day as well. It was reported that the pt had no upper respiratory or allergy symptoms at the time that the device was programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468498


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:11:37 PM
Event Date 08/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Treating neurologist has not seen the pt for 6 months and was not aware of the pt's symptoms. H. 6. Ncp system labeling lists dyspnea and worsening of asthma/bronchitis as potential adverse events possibly associated with surgery or stimulation. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use/indications" section of the manual or in patients with history of respiratory diseases or disorders, including dyspnea and asthma.

Event Description
Vns patient has experienced shortness of breath since approximately four months after generator replacement surgery for end of service. The patient has reportedly been diagnosed with dyspnea by family physician and was prescibed advair and combivent. The patient reports that these medications are not working very well and that they still get short of breath at night. Family physician reports that the patient is doing well and that symptoms are not related to the vns, but that the patient suffers from allergies and asthma. The patient has not been seen by their neurologist for approximately 6 months but is scheduled for a follow-up visit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=467648


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:12:17 PM
Event Date 05/30/2003
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Vns therapy system labeling lists painful or irregular stimulation and dyspnea as potential adverse events possibly associated with surgery or stimulation. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adersely affect device performance.

Event Description
Vns patient was hospitalized for six days due to a seizure that lasted for two hours. The patient reported feeling very shaky and light headed and indicated that device stimulation was painful and made them short of breath. The patient has reportedly been experiencing a lot of physical problems and is unsure whether they are stress-related or a result of discontinuing them depakote. It was reported that the patient has been experiencing continuous headaches since vns implant and had discontinued depakote to see if it was the cause of headaches. The headaches did not resolve after discontinuing the depakote. The patient had recently moved to a different state and had not yet been seen by their new neurologist. It was reported that the patient was scheduled to undergo a 3-day video eeg monitoring session.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=467657


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:13:09 PM
Event Date 05/07/2003
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as acute respiratory failure, due to (or as a consequence of) anoxic encephalopathy, due to (or as a consequence of) chronic seizure disorder. The manner of death was listed as natural.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

Event Description
In the process of contacting the pt to notify them their device may be nearing end of service, it was discovered that the pt had passed away. Exact cause of death is unk at this time, but the treating neurologist reportedly believes that the death was seizure-related. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=467392


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:13:45 PM
Event Date 04/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
No response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Vns therapy system labeling lists increased coughing and dysphagia as potential adverse events possibly associated with surgery or stimulation.

Event Description
Vns patient has expierienced two episodes of coughing that resulted in choking. It was reported that the "strangling feeling" that the patient experiences during these episodes seems to coincide with stimulation. The patient is reportedly experiencing a greatly reduced number of seizures with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=467442


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:14:29 PM
Event Date 05/15/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt has been experiencing severe symptomatic bradycardia believed to be related to the vns therapy. Prior to the bradycardia event, device parameters were reduced due to coughing with stimulation. The pt's generator was programmed to off with plans to perform a cardiac workup. Further follow-up revealed that revision surgery was scheduled to reposition the lead electrodes on the vagus nerve. The pt had reportedly experienced shortness of breath with the episodes of bradycardia and even had one episode that sounded like a brief cardiac arrest as described to treating neurologist by the pt's spouse. The pt indicated that the bradycardia events coincide with stimulation. The pt has reportedly had improvement in seizure control with the vns therapy.

Manufacturer Narrative
H. 6. Vns therapy labeling lists increased coughing and dyspnea as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=466314


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:15:06 PM
Event Date 04/22/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain add'l info have been unsuccessful to date. Treating neurologist indicated that the pt's chart was kept in a separate building and would take some time to retrieve. Vns therapy system labeling lists pain, dyspnea and heart rate and rhythm changes as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:16:41 PM
Event Date 05/01/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Vns therapy system labeling lists dysphagia as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was hospitalized for three days due to severe headache and feeling of choking. The patient's device was programmed to off. Further follow-up revealed that the patient is currently doing well with the device programmed back to on. Treating neurologist indicated that the patient's symptoms were not related to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=464881


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:17:21 PM
Event Date 01/15/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. Treating neurologist asked the manufacturer not to call him again regarding the pt as he did not believe that the pt's symptoms were caused by the vns therapy. H. 6. : ncp system labeling lists dysphagia and vomiting as potential adverse events possibly associated with surgery or stimulation. Ncp system labeling cautions that pts with obstructive sleep apnea (osa) may have an increase in apneic events during stimulation. Manufacturer recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Reporter indicated that vns pt has been experiencing continual choking sensation, vomitting and dry heaves. It was also reported that the pt's sleep apnea has worsened since vns implant. It was reported that the pt had very good seizure control initially, but pt is now reports that their seizures have worsened at night. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up revealed that the pt described the choking sensation as feeling "like someone is pressing their finger down over their trachea" and that this is because the surgeon cut their trachea. Pt was seen by treating neurologist who does ot believe that the pt's sleep apnea has worsened with the vns therapy. The pt's normal mode stimulation was programmed to off (0ma), but their magnet mode stimulation remains activated. An additional sleep study is planned. The pt reported that pt was "all better" after having the normal mode output current programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461848


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:18:40 PM
Event Date 04/18/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date. No response has been received to manufacturer's requests for additional information from treating neurologist. H. 6: the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with patient onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns patient had a sudden increase in seizure activity and was seen in the emergency room three days later. The patient was hospitalized and was initially placed on an intermittent positive pressure ventilator. The patient was eventually taken off of the ventilator. Device diagnostic testing was within normal limits, indicating proper device function. The device output current was increased to 1. 50ma. Further follow-up revealed that the patient was hospitalized again approximately two weeks later and experienced a two-hour episode of bradycardia and a drop in blood pressure due to unknown cause. The patient has reportedly always had a lot of seizures and was not doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461858


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:19:32 PM
Event Date 04/24/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been received to manufacturer's requests for additional info from treating neurologist. H. 6. : vns therapy labeling lists dysphagia (difficulty swallowing) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the day after vns implant surgery, the pt was choking each time pt drank water.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461893


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:20:38 PM
Event Date 09/27/2001
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because an attempt to obtain additional info has been unsuccessful to date. No response has been received to manufacturer's request for additional info from treating neurologist. H. 6. : device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Manufacturer Narrative
Further follow-up revealed that the patient died while pt was an inpatient at the hospital. The death certificate listed the immediate cause of death as respiratory failure, due to (or as a consequence of) pneumonia, due to (or as a consequence of) poor lung status, due to (or as a consequence of) cerebral palsy. The manner of death was listed as natural.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. Physician indicated that patient experienced no change in seizure control with vns therapy. The patient was seen by the physician one month prior to death. H. 6. Physician indicated that the ncp system was not related to the cause of death.

Event Description
In the process of contacting the pt's physician to notify him that the pt's device may be nearing end of service, it was discovered that the pt had passed away. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=460752


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:22:05 PM
Event Date 04/25/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date. No response has been received to manufacturer's request for additional information from treating neurologist. H. 6: vns therapy system lableling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:23:03 PM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was scheduled for explant for unknown reason after less than one year of service. Further follow-up revealed that the patient had experienced an increase in seizures "by 20 times" after vns implant and has subsequently required 22 emergency room visits for seizure activity. The patient also reported constant worsening of asthma, shortness of breath, and burning in the throat. The patient's device was programmed to off five days prior to explant. Device diagnostic testing on day of explant was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. X-rays on day of explant surgery revealed that the location of the lead was inconsistent with normal vns lead placement. There were no tie-downs used, the lead was in disarray, not aligned in the normal parallel orientation, and was located lower than normal. It was reported that the lead electrodes were not wrapped around the vagus nerve. Poor implant technique at time of initial implant is suspected.

Manufacturer Narrative
H. 6. Continuity check using a multimeter was performed. Visual exam revealed that the negative lead coil is exposed forming a loop at approx 0. 5cm past the anchor tether. Continuity check did not identify any other discontinuities on the portions of the lead returned. A conclusive determination could not be made whether the coil was exposed or not during the implant life of the device. The condition of the lead is consistent with conditions that exist after the explant procedure.

Manufacturer Narrative
Ncp system labeling lists worsening of asthma/bronchitis, dyspnea and laryngeal irritation as potential adverse events possibly associated with surgery or stimulation. Additionally, ncp system labeling lists improper surgical implantation, including not using the tie-downs, as an event that can shorten the life expectancy of the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461860


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:25:11 PM
Event Date 01/01/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as cardio pulmonary arrest, due to (or as a consequence of) cardiac arrhythmia.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been received to manufacturer's requests for additional info from neurologist. H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that vns pt had passed away. Exact date and cause of death are unk at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=460588


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:26:07 PM
Event Date 05/01/2001
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Pt's generator was explanted because the pt was having trouble breathing. The pt was re-implanted with a new generator and was reportedly doing well with their seizure control following generator replacement surgery. No further episodes of dyspnea with the replacement generator were reported until 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=458871


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:27:02 PM
Event Date 04/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:27:41 PM
Event Date 03/11/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Vns therapy labeling lists worsening of asthma and bronchitis as a potential adverse event possibly associated with surgery or stimulation. Additionally, vns therapy labeling states that the safety and efficacy of this therapy have not been systematically established in pts with history of respiratory diseases or disorders, including dyspnea and asthma.

Event Description
Vns pt had an asthma attack and was hospitalized. The pt was given prednisone and was discharged. The pt is reportedly still taking medications to control the breathing. It was also reported that the pt's device was inadvertently programmed to on as a result of an interrupted lead test during implant surgery. The pt's first follow-up visit after surgery was 13 days after discharge at which time it was discovered that the device output current was set to 1. 0ma. The output current was reprogrammed to 0. 25ma during this visit, but the pt reportedly had intense seizures during the time that the generator was programmed to 1. 0ma output current. The pt is reportedly doing better with both breathing and their seizures since the reduction in output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=458807


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:28:25 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Ncp system labeling lists choking sensation as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was seen in hospital emergency room due to choking. The patient's device was programmed to off at the time of the emergency room visit due to the choking. There are no plans to reactivate the device as the patient reportedly did not seem to benefit from the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481342


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:28:59 PM
Event Date 07/19/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist. H. 6. Vns therapy system labeling lists worsening of asthma and bronchitis as a potential adverse event possibly associated with surgery or stimulation. Additionally, labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use / indications" section of the manual or in patients with history of respiratory diseases or disorders, including dyspnea and asthma.

Event Description
Reporter indicated that asthmatic vns patient has been experiencing difficulty breathing since implant. The patient reportedly was experiencing discomfort following parameter increase. Neurologist planned to reduce device pulse width setting and monitor the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481352


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:29:48 PM
Event Date 01/31/2003
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist. Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. H. 6. Device manufacturing records were reviewed. Vns therapy labeling lists infection, dysphagia, dyspnea, choking sensation and device migration/extrusion as potential adverse events possibly associated with surgery or stimulation. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:30:21 PM
Event Date 07/21/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. H6: vns therapy labeling lists dyspnea and increased coughing as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt was experiencing severe shortness of breath. The pt reportedly felt as if pt was going to have a seizure and swiped the device with the magnet. The pt then began to cough severely with shortness of breath which did not resolve when the coughing stopped. The pt went to the hosp emergency room at which time ekg, chest x-ray and h&p (history and physical) did not show any abnormalities. The pt was seen by the neurologist the following day at which time the device settings were adjusted (specifics unknown) and the symptoms subsided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479849


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:31:16 PM
Event Date 07/01/2003
Event Type Malfunction
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt has been experiencing as many as 6 seizures a day after being seizure free for approx 15 weeks. It was reported that the increase in seizures is above the pt's pre-vns baseline seizure frequency. The magnet is reportedly no longer effective in stopping the pt's seizures. The physician checked the magnet results and found that the magnet is functioning. The pt reportedly experiences difficulty breathing and gets "worn out" following device parameter changes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476255


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:32:16 PM
Event Date 06/01/2003
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H. 6. The ncp system labeling lists voice alteration (hoarseness), dyspnea (difficulty breathing, shortness of breath) and worsening of asthma and bronchitis as potential adverse events possibly associated with surgery or stimulation. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use/indications" section of the manual or in pts with history of respiratory diseases or disorders, including dyspnea and asthma.

Event Description
The pt has unilateral laryngospasms and unilateral vocal cord paralysis. The pt began experiencing voice problems and intermittent diffculty breathing) the pt has reportedly experienced asthma "all summer". The pt reported that they have used the magnet to stop the symptoms, but that it only helped some. The hoarseness reportedly appeared following a decrease in device settings. Physician indicated that the pt is with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=474985


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:32:49 PM
Model Number 102
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation. H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use / indications" section of the manual or in pts with history of respiratory diseases or disorders, including dyspnea and asthma.

Event Description
The pt has been experiencing breathing problems. It was reported that the pt was given a stress test and after being on a treadmill for 6 minutes, a sonogram was done on the pt's heart. The results were inconclusive. Further follow-up revealed that prior to the vns implant, the pt experienced shortness of breath with their anxiety disorder. The physician reported the shortness of breath is probably not related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=474988


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:33:31 PM
Event Date 06/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for add'l info from treating neurologist. H. 6. Ncp system labeling lists heart rate and rhythm changes as a potential adverse event possibly associated with surgery or stimulation. The following dates are estimated. Only the month/year is known. B. 3, date of event.

Event Description
Reporter indicated that vns pt was hospitalized due to bradycardia. It was reported that the pt uses a bipap machine at home and that they became unresponsive and was taken to the hosp. The pt was reportedly placed on a ventilator, not for the oxygen but for the pressure. The pt's heart rate was in the 40's at this time. Ekg reviewed by a cardiologist reportedly indicated that the pt had a sinusbrady rhythm and the cardiologist believed that it was due to the vns. The pt's neurologist does not believe that this condition is related to the vns therapy. There had been no increases in vns therapy settings for over a year.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=473271


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:34:09 PM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea (difficulty breathing or shortness of breath) as a potential adverse event possibly associated with surgery or stimulation. The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Pt's device was programmed to off approx 10 mos post-implant because the vns therapy reportedly worsened their pre-existing breathing problems. The pt had no improvement in seizure frequency with the vns therapy. The pt plans to have the device explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=473298


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:34:51 PM
Event Date 04/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date. No response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. : ncp system labeling lists dyspnea and weight change as potential adverse events possibly associated with surgery or stimulation.

Event Description
In the process of contacting the patient to notify then that their device may be nearing end of service, it was discovered that the patient's device was programmed to off due to extreme shortness of breath and excessive weight loss. The patient had reportedly lost 18 pounds in a two-week period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=470046


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:35:27 PM
Event Date 09/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because treating neurologist indicated that it was their office policy not to release any pt info unless the pt signed a release. H. 6. Vns therapy system labeling lists weight change, vomiting and choking sensation as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt has lost approx 15 pounds in one month following vns implant and that they had recently experienced an episode of choking and vomiting while they were eating. It was reported that following a reduction in device pulse width setting, the pt still does not have a good appetite and pt is supplementing their diet with ensure in the evenings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493017


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:36:05 PM
Event Date 09/12/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Vns therapy system labeling lists dyspnea and pharyngitis as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:37:13 PM
Event Date 01/01/2000
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
In the process of contacting the patient's neurologist to notify him that the patient's device may be nearing end of service, it was discovered that the patient had experienced an increase in seizures over a one year period with the vns therapy. The patient had 160 seizures in the year prior to vns implant and 390 seizures in the year after vns implant. The patient's device was subsequently programmed to off approximately 15 months post-implant and was programmed back to on 20 months later. Various medication changes were made during this time. Treating neurologist is attempting to adjust device settings for favorable seizure control and continues medication changes. 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 service. It was reported that during the time of the increased seizures, the patient's post-ictal state was better and their appetite, sleep pattern and behavior were unchanged. Stimulation was gradually reduced over a period of one month prior to programming the device to off. It was reported that the patient had less frequent but more intense seizure without the vns therapy. It was also reported that during the time that the generator was programmed to off, the patient had several episodes of suddenly becoming unresponsive. There was a question of whether there was no heart rate or respiratory effort during these episodes, but by the time caregivers obtained a stethoscope, the patient was reportedly breathing and their heart rate had recovered. The patient was seen by a cardiologist who indicated that the patient was having syncope, but that since patient was a do not resusciate, no further workup was warranted. Caregivers are seeking second cardiac opinion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=487256


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:37:55 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because device tracking information was not forwarded to manufacturer. Additionally, no response has been received to manufacturer's requests for additional information from treating neurologist. It was reported that the patient has not been seen by their neurologist for a while. H. 6. : the vns therapy system labeling lists choking sensation and dyspnea as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that patient's seizures seem to be getting worse since vns implant. It was reported that the patient has been set to the lowest settings since implant and that when increases in programmed parameters are attempted, the patient feels "strangled" and has trouble breathing. The patient also reports headache pain that they believe is related to the vns. Investigation to date has been unable to determine whether the patient has experienced an increase in seizures above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=487259


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:38:58 PM
Event Date 05/23/2003
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Vns therapy labeling lists dyspnea, hiccuping, weight change, voice alteration, and left vocal cord paralysis as potential adverse events possibly associated with surgery or stimulation.

Event Description
Vns patient is experiencing constant voice alteration that worsens with stimulation and that the patient has lost 27 pounds since vns implant. The patient's family member believes that the weight loss is due to a recent medicaton reduction. The patient is also experiencing shortness of breath during stimulation and hiccups a lot since implant. Investigation to date has been unable to determine whether vocal cord paralysis has been diagnosed. Additionally, the contributing factor and severity of the patient's weight loss has not been determined.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=485430


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:39:42 PM
Event Date 09/14/2003
Event Type Malfunction
Event Description
Vns pt experienced a hard nocturnal seizure during which it is suspected that the pt's lead was broken. Pt awoke in the middle of the night realizing that they had experienced a hard seizure and was toward the postictal end of the episode. The pt developed a choking sensation in their throat when they tried to initiate magnet mode stimulation that was so severe, that they were not able to breathe or to turn their head or neck. This lasted for several seconds and eventually abated. Since that time, the pt reports that they intermittently experience muscle spasms in the side of their neck and throat with stimulation which are uncomfortable and sometimes make it difficult for them to breathe. Additionally, if this happens while the pt is chewing a piece of food, they have to stop because they cannot swallow. The pt has reported an increase in frequency of their "little seizures" which had been under relatively good control up to that point. Subsequent device diagnsotic testing resulted in high lead impedance reading (dc dc code 7 and limit), indicating possible device malfunction. Following adjustments to programmed parameters, the pt continued to have intermittent laryngeal spasms with stimulation and treating neurologist also noticed occasional sternocleidal mastoid muscle twitching. The pt underwent lead replacment surgery after which device diagnostic testing was within normal limits, indicating proper device function. The pt has not regained seizure control to date despite programmed parameter adjustments and increases in their anti-epileptic drug regimen. Neurlogist plans to perform a partially sleep deprived eeg with anterior temporal montages if seizures do not come under better control. Additionaly, neurologist is considering changing the pt's primary anticonvulsant medication. The pt indicated that the pain in their neck and ear was not quite as severe as it had been.

Manufacturer Narrative
Report is incomplete because device tracking info was not supplied to mfr.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=485238


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:40:18 PM
Event Date 08/15/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Vns patient had difficulty breathing and swallowing post-implant. It was initially believed that the patient's symptoms were due to intubation and anesthesia during implant surgery and that they would get better over time. The patient continued to complain of difficulty breathing and swallowing, so spouse took them to the hospital emergency room at which time the on-call ent indicated that the patient had a sluggish vocal cord, perhaps related to the anesthesia during implant surgery. The patient was prescribed a steroid dose pack. The patient was reportedly doing fine while on the medication, but the symptoms returned upon completion of the steroid dose pack. Ent later reported that the patient had acid reflux which is causing their swallowing problem and difficulty breathing. Further follow-up revealed that the patient is doing well but still has a little difficulty with their throat. The patient was reportedly told that this was either due to anesthesia or surgery. The patient reports that they still has a little soreness in their chest but that the surgeon indicted that the surgeon indicated that this was to be expected.

Manufacturer Narrative
No response has been received to manufacturer's request for additional information from treating neurosurgeon. H. 6. Vns therapy system labeling lists dyspnea and dysphagia as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484520


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:41:00 PM
Event Date 06/26/2003
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H6: ncp system labeling lists increased coughing and dyspnea as potential adverse events possibly associated with surgery or stimulation. Vns therapy system labeling cautions not to program the vns therapy system to an on or periodic stimulation treatment for at least 14 days after the initial or replacement implantation. Failure to observe this precaution may result in pt discomfort or adverse events. Additionally, labeling states that during the first few weeks after implantation, the pt should be seen to confirm wound healing and proper pulse generator operation. The pulse generator's output current for both the magnet and the programmed stimulation must be 0. 0 ma for the first 14 days after implantation. Additionally, device labeling cautions that the safety of this therapy has not been systematically established for pts experiencing bradycardia or asystole during vns therapy system implantation.

Event Description
Reporter indicated that vns pt had to be intubated after the device was programmed to on the same day as implant due to bradycardia and coughing that led to respiratory distress. The pt was reportedly in the recovery room when the device was programmed to on at 2. 0ma output current. The device was immediately programmed to off. Stimulation was initiated at a later date to 0. 50ma output current without further incident. Implanting surgeon indicated that pt's previous device was set to 3. 25ma output current but may not have been delivering that amount due to end of service. Surgeon believes that the bradycardia was a result of the high setting of the new device being too much for the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=482427


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:41:47 PM
Event Date 06/17/2002
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. H. 6. Ncp system labeling states that the helical electrodes and anchor tether should be coiled around the nerve, beginning with the electrode that is farthest from the lead bifurcation (with green suture embedded in the helical material). This electrode should be nearest (proximal to) the pt's head. To maximize system performance and minimize possible mechanical damage to the nerve or lead, pay careful attention to electrode placement. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolecscents over 12 years of age with partial onset seizures that are refractory to antiepilpetic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that pt has had more trouble swallowing since vns implant which is thought to have been due to damage of the vagus nerve from the surgery and not due to stimulation. It was reported that the vns therapy does not seem to be helping the pt's seizure control even after being programmed to high settings over the past year, although sometimes when the pt's device is swiped with the magnet during an aura, the seizures do not occur. It was reported that there have been many changes in the pt's medication regimen as well. Diastat is reportedly used for every seizure because some of them last for 20 -30 minutes at a time. The pt is also coughing more and does not eat as well as she used to since vns implant surgery. Additionally, x-rays revealed that the lead electrodes were inverted on the vagus nerve at implant. Investigation to date has been unable to determine whether the pt's dysphagia is a result of nerve damage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481897


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:42:35 PM
Model Number 102
Event Type Malfunction
Event Description
Reporter indicated that vns pt was scheduled for revision surgery due to device migration. X-rays reviewed by physician revealed that there does not appear to be sufficient slack in the lead wires and that the generator may have migrated towards the pt's back. The pt had previously reported a decrease in seizure activity but was experiencing burning pain, a sensation of shortness of breath and sometmes nausea with stimulation approximately two months prior. The pt's generator was implanted in axillary area but the device was in the normal place, so the pocket is larger than most pts'. Neurosurgeon indicated that it would take the pt longer to heal than most pts due to the fact that he had to go through more muscle and tissue to get the device implanted. The pt reported severe pain and tenderness in left axillary and left upper chest area after washing the car. There was no report of drainage, bruising or signs of infection at that time. Treating neurosurgeon felt at that time that the pt's pain was a result of normal postoperative healing. The pt was seen by treating neurologist approximately two weeks later at which time, lead test had to be interrupted due to excruciating pain in the pt's left arm. X-rays at that time revealed that the device appeared to be intact and that the generator had not moved. The pt reported severe left arm pain approximately every 40 minutes throughout the night on that same day. The pt was seen again by neurologist the next day at which time the device was interrogated and reprogrammed to prescribed parameters. The pt reportedly tolerated the settings well and was no longer experiencing difficulty breathing or nausea with stimulation. Treating neurologist indicated that the aforementioned events had resolved and that the pt was fine. It was later reported that the pt was scheduled for revision surgery due to possible device migration. The original surgery date was cancelled by the pt due to a problem with their children. A new surgery date has not yet been scheduled. Additionally, it was reported that the pt had severe seizure activity the day after vns implant surgery with injuries to the left upper chest after chin/head dropped. Excessive device migration could cause a lead break resulting in loss of therapy. Investigation to date has been unable to determine whether the generator was properly secured during the initial implant procedure or whether the system may have been damaged during the seizure that the pt experienced the day after implant surgery.

Manufacturer Narrative
H6: vns therapy system labeling lists device migration, pain, dyspnea and nausea as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481899


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:43:25 PM
Event Date 12/05/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6 vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient had an "unusual reaction" at office visit during parameter adjustment. It was reported that following an increase in programmed parameters, the patient "put on a big production" acting very strange and indicating that patient could not breathe. Treating neurologist described that patient as borderline psychotic and reportedly did believe that patient was a good candidate for the vns therapy because they were so psychotic. The patient's device was programmed to off and the patient was referred to their regular neurologist for follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=503894


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:44:03 PM
Event Date 10/28/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Manufacturer periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Manufacturer became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by manufacturer. Death certificate indicates that the pt died while hospitalized. Immediate cause of death is listed as respiratory arrest for 20 minutes duration due to anoxic brain damage and status epilepticus (both for 6 days duration). No autopsy was performed. There is no evidence that the ncp 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=503617


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:44:52 PM
Event Date 02/23/2003
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Ncp system labeling cautions that patients with obstructive sleep apnea (osa) may have increase apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Manufacturer periodically compares device tracking information to the social security death index for the purpose of updating device tracking data. Manfacturer became aware of patient death during this process and evaluated available information against currect procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional information regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by manufacturer. Death certificate indicates that patient died while hospitalized. Immediate cause of death is listed as acute respiratory distress syndrome (12 hours duration) secondary to sepsis and aspiration pneumonia both of 24 hours duration. Patient underwent uvulopharyngopalatoplasty with tonsillectomy four days prior to death. No autopsy was performed. There is no evidence that the ncp 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 on contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=503623


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:45:33 PM
Event Date 11/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and abolescents with partial onset seizures that are refractory to antepileptic medications. Vns therapy system labeling cautions that pts with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Reporter indicated that vns pt experienced an increase in seizures and abnormal breathing at night since an increase in programmed parameters approximately two weeks prior. It was reported that the increase in seizures was not above pre-vns baseline frequency and could possibly be attributed to a cold that the pt had a few weeks ago. The pt reportedly has difficulty breathing and stops breathing for short periods. The pt's family member, who is a physician, used a pulse oximeter on the pt at night and noted that their oxygen saturation fell from 97% to 90% and their heart rate increased from 82 beats per minute to 92 beats per minute. Treating neurologist indicated that the pt experienced an increase in lethargy and an increase in seizures, especially at night. It was reported that the pt experienced stridor during sleep with stimulation and that their oxygen saturation was 90% during these episodes. It was reported that the pt's overall health condition was worsening and that the pt was experiencing sleep apnea. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up revealed that the pt's condition had improved after a reduction in programmed device settings and changes to their drug regimen. The pt has experienced no further episodes of stridor and their seizure episodes have decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=503250


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:46:29 PM
Event Date 04/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6 the vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 03:47:03 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: Respiratory
Post by: dennis100 on July 16, 2011, 03:47:36 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.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist. H. 6. Device manufacturing records were reviewed. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

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


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:48:08 PM
Event Date 02/28/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient has requested that the device be explanted. The patient has reportedly experienced shortness of breath since implant and has not benefited from the vns therapy.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=499589


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:51:09 PM
Model Number 102
Event Date 10/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
Pt's seizures had increased from pre-vns seizure rate following an increase in device output current from 0. 75ma to 1. 0ma. Further follow-up revealed that treating neurologist did not believe that the increase in seizures was above the pt's pre-vns baseline frequency. It was reported that the pt first complained of a burning and choking sensation with stimulation after an increase in device output current from 0. 50ma to 0. 75ma. The burning became more intense when output current was increased to 1. 0ma and when the pt uses their magnet (1. 25ma output current) to initiate magnet mode stimulation. The pt has reportedly required immediate attention due to a severe seizure during which they experienced several hematomas and bruising.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=499989


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:51:45 PM
Event Date 10/01/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Patient awoke with choking sensation, neck pain and shortness of breath. The magnet was placed over the device to temporarily stop stimulation, but the patient's symptoms continued for an hour. The patient was taken to the hospital emergency room at which time 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. Further follow-up revealed that the event resolved after 12 hours with the magnet in place over the device, temporarily stopping stimulation. Investigation to date has been unable to determine the cause of the patient's symptoms.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Ncp system labeling lists dysphagia, dyspnea and neck pain as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=498095


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:52:26 PM
Event Date 05/15/2002
Event Type Death
Patient Outcome Death;
Event Description
Manufacturer became aware of patient death and evaluated available information against current procedures. The event did not meet mdr reporting criteria per manufacturer's current. In an effort to obtain additional information regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by manufacturer. Cause of death is listed as respiratory insufficiency and acute pulmonary edema secondary to probable seizure. No autopsy was performed. There is no evidence that the ncp 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 patient's death, it cannot be definitively ruled out as a factor.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=497000


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:53:39 PM
Event Date 10/06/2003
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. The pt was hospitalized two days post-implant due to other multiple comorbidities and died while hospitalized. It was reported that stimulation had not been initiated and that the event was not related to the vns. Certificate of death lists immediate cause of death as respiratory failure secondary to aspiration and altered mental status. Autopsy results are pending. The device was not explanted. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=497200


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:55:19 PM
Event Date 10/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient had developed a lung infection and increased shortness of breath. It was reported that the patient was currently taking oxygen for these problems. Investigation to date has been unable to rule out the vns as a contributing factor.

Manufacturer Narrative
Further follow-up revealed that the pt continues to take oxygen. The pt's device was programmed to off to assess the pt's status without the ncp system; however, no change was noted. Neurologist does not feel that the ncp system is related to the reported events. Neurologist indicated that it could be an age related medical condition that coincided with vns therapy.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Ncp system labeling lists dyspnea (shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=495266


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:56:00 PM
Event Date 10/09/2003
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Vns therapy system labeling lists voice alteration (hoarseness), dysphagia (difficulty swallowing), dyspnea (difficulty breathing, shortness of breath) and dizziness as potential adverse events possibly associated with surgery or stimulation.

Event Description
Vns patient was experiencing hoarseness, dysphagia, dyspnea and dizziness three days post-implant. Stimulation had not yet been initiated at time of in initial report. Treating neurosurgeon indicated that all symptoms except for dizziness were probably due to intubation and post-operative swelling and that the dizziness may be atrributed to low blood pressure. Further follow-up with epileptologist revealed that the patient's throat is scarred. The patient continued to complain of hoarseness after stimulation was initiated but has not yet been diagnosed with vocal cord paralysis. Epileptologist plans to refer the patient for evaluation by an ent if symptoms persist at time of next office visit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=494761


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:56:40 PM
Event Date 05/01/2003
Event Type Malfunction
Event Description
Reporter indicated that vns patient underwent lead replacement surgery due to a broken lead. It was reported that the patient did not experience any adverse events after stimulation was initiated but that patient was later wrestling and may have damamged the lead. The patient did not experience any adverse events after the wrestling incident. A few weeks after the wrestling incident the patient fell on some rocks while fishing and subsequently experienced a burning sensation in the throat while stimulation was present. It was reported that the patient experienced shortness of breath and a choking sensation when the device stopped stimulating. X-rays reviewed by treating neurologist did not reveal any discontinuities in the vns therapy system although it had been previously reported that x-rays revealed a lead break. The patient was implanted with a larger electrode lead as the implanting surgeon felt that the smaller electrode lead might be constricting the nerve causing the patient's pain with stimulation. The patient is reportedly doing well with no adverse events following lead replacement surgery.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=495342


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:57:45 PM
Event Date 12/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H6 vns therapy system labeling list worsening of asthma and bronchitis as a potential adverse event possibly associated with surgery or stimulation. H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of respiratory diseases or disorders, including dyspnea and asthma. The following dates are estimated. Only the month/year is known: b. 3. , date of event.

Event Description
Reporter indicated than vns pt has complained of exacerbation of asthma since implant, but that treating neurosurgeon indicated that the symptoms were not related to the vns. Further follow-up treating neurologist revealed that the pt complained of chest tightness, feeling winded and difficulty taking a full breath at office visit one month post-implant. Lung sounds were normal with no wheezing. Neurologist indicated that the pt's breathing difficulties were possibly related to the vns. Pt's primary care physician prescribed an advair disc. The pt has been referred to a pulmonologist for eval of astham and pulmonary function. Neurologist prescribed a medrol dose pack to help chest tightness and reduced programmed device signal frequency and pulse width.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=508859


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:58:23 PM
Event Date 12/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced an episode of apnea associated with a seizure. It was reported that pt had never experienced apnea with a seizure pre-vns implant and that apnea was not a typical part of the pt's seizure pattern. Further follow-up with treating neurologist indicated that the pt was doing fine. Neurologist indicated that the event was possibly related to the vns therapy system. No intervention is planned at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=508386


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:59:02 PM
Event Date 12/23/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient was experiencing shortness of breath with stimulation and constant hoarseness. The symptoms subsided when the patient placed their magnet over the device to temporarily discontinue stimulation. The patient plans to follow-up with their neurologist.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. H. 6 vns therapy system labeling lists voice alteration (hoarseness) and dyspnea as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=507589


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 03:59:46 PM
Event Date 10/09/2002
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evalauted available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate lists immediate cause of death as respiratory insufficiency secondary to pulmonary congestion and edema with aspiration and probable seizure. Autopsy results were considered in determining the cause of death. There is no evidence that the ncp 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 patient's death, it cannot be definitively ruled out as a factor.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=507048


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:00:48 PM
Event Date 12/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was seen in hospital emergency room due to seizures. Further follow-up revealed that the patient began to experience blackout episodes and totally lose consciouness. It was reported that the patient sometimes stopped breathing during these episodes. During one of these episodes, the pt's family member swiped the device with the magnet and the pt reportedly regained consciousness. The pt was seen in the hospital emergency room at which time the er physician reportedly indicated that the pt's medicaion levels were toxic. The pt's tegretol and dilantin were discontinued at that time. At subsequent follow-up visit with treating neurologist, the pt's medication were restarted, valium was added to their drug regimen and the device magnet mode output current was increased. Before the increase in magnet mode output current, it had been programmed to the same stimulation level as the normal mode output current. Treating neurologist indicated that the device was functioning properly at that time. These adjustments reportedly worked well for the pt for approx two weeks, after which the episodes recurred and the pt was again seen in the hospital emergency room. Drug levels were reportedly not toxic at the time of the second emergency visit. The pt's family member is unhappy with the pt's current neurologist and has scheduled follow-up with a new neurologist who reportedly plans to perform an eeg.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=504875


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:01:26 PM
Model Number 300-20
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H. 6. Ncp system labeling lists left vocal cord paralysis, dysphagia as potential adverse events possible associated with surgery or stimulation. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt was experiencing problems with vocal cord paralysis and difficulty breathing. It was reported that the breathing difficulty was a long-term problem and was no worse than usual. X-rays revealed that the lead electrodes were implanted in an inverted configuration. The pt is reportedly receiving good seizure control with the vns therapy. Further follow-up revealed that the pt had never experienced vocal cord paralysis or difficulty swallowing prior to vns implant. The pt's family member plans to take the pt to an ent for evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=513261


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:02:08 PM
Event Date 01/03/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The patient died in their residence. Death certificate listed the immediate cause of death as respiratory arrest, due to (or as a consequence of) seizure disorder. The manner of death was listed as natural.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for add'l info from treating physician. H6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. H6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=511340


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:03:16 PM
Event Date 12/31/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt went to the hosp er due to an episode of dyspnea. The pt felt as if their throat was closing and that pt was short of breath. Er physician reportedly indicated that the pt had a "bacterial sore throat" and that the pt's throat was swollen and slightly red. The pt was given a penicillin shot and prescribed a one-week course of antibiotics. The pt's temperature was 103 degrees f. The pt is better now and there is no redness at the incision sites.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=510062


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:04:31 PM
Event Date 03/21/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. Additionally, device labeling cautions that patients with chronic obstructive pulmonary disease may have an increased risk of dyspnea. The safety and efficacy of vns therapy have not been systematically established for patients with history of respiratory disease or disorders, including dyspnea and asthma.

Event Description
The pt began to experience intermittent dyspnea of moderate severity approximately 3 weeks post-implant, mainly at night. Medications were added to the patient's drug regimen at first report of dyspnea and at other times throughout the course of treatment. The pt was hospitalized due to dyspnea approximately 3 months after onset. Approximately two months after hospitalization, the dyspnea had reportedly resolved. Treating physicians indicated that the dyspnea was not related to implantation or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=510235


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:06:02 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Device manufacturing records were reviewed. H. 6. Ncp system labeling lists dyspnea (difficulty breathing, shortness of breath), dysphagia (difficulty swallowing) and facial paralysis, paresis as potential adverse events associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 04:07:03 PM
Event Date 02/27/2004
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
H. 6. : device manufacturing records were reviewed. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance.

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: Respiratory
Post by: dennis100 on July 16, 2011, 04:07:55 PM
Event Date 02/26/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been reviewed to manufacuturer's request for additional information from treating neurologist. H. 6. : ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) and increased coughing as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt experienced coughing and shortness of breath after initiating magnet mode stimulation. It was reported that device normal mode output current was programmed to off in 2003 since the pt underwent surgery (type unknown) and that this was the first time that pt had initiated magnet mode stimulation. The pt reportedly felt as if pt was about to have a seizure and wiped the device with the magnet. Magnet mode stimulation reportedly aborted the seizure. Treating neurologist plans to reduct magnet mode output current setting.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517922


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:08:52 PM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt was making "sucking noises when pt breathes. " it was reported that the pt is experiencing significant seizure control with the vns therapy. Device off time was increased from 5 to 15 minutes, after which the pt's condition is reporteldy improving each day.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517781


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:09:37 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because pt reported that they are not currently seeing a neurologist because their previous neurologist moved out of state. Attempts to obtain additional information from neurologist's previous office have been unsuccessful because no pt records were found. The ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt's device was programmed to off several months ago due to severe shortness of breath. It was reported that the pt plans to make an appointment soon with a neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=516759


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:10:26 PM
Event Date 02/16/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt was hospitalized in intensive care unit due to respiratory problems. It was reported that the pt started to get a cold and that the next day, their oxygen level was decreased to the point that pt was hospitalized. The pt reportedly did not have to be intubated and was doing better the next day. Ct scan is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=516493


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:11:22 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Report is incomplete because the pt is now being seen by a different neurologist who was not aware of the ent diagnosis. The pt has not contacted their current neurologist regarding the issue of vocal cord paralysis. H. 6. Vns therapy system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation. Review of device programming history revealed that the pt's device was not programmed to an excessive output current during the period that pt began experiencing problems with choking and throat irritation with stimulation. Data from 09/01 through 05/02 revealed a gradual increase in normal mode output current from 0. 5ma to 1. 5ma during that time.

Event Description
Reporter indicated that vns pt was recently diagnosed with vocal cord paralysis by an ent. It was reported that the pt was seen by an ent for evaluaton due to a sore throat. Reporter indicated that approx two years prior, treating neurologist at that time increased device output current to a high level. After the increase in device output current, the pt reportedly began having problems with choking and throat irritation with stimulation. Device output current was subsequently reduced and the pt got a little better. Review of available device programming history does not show an excessive increase in normal mode output current at that time. Treating neurologist indicated that the pt was last seen in their office approx 4 months ago, at which time there seemed to be nothing wrong with the pt's voice. It was reported that at the time of the pt's last appointment, the pt apparently had a psychotic episode in the waiting room during which pt was screaming and yelling at the other pts in the waiting area. Local law enforcement subdued the pt with stun guns and pt was committed to a psychiatric facility. The pt's device remains programmed to on and no intervention is planned at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=516504


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:12:09 PM
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.

Manufacturer Narrative
H. 6. : ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

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


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:12:51 PM
Event Date 10/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The pulse generator operated within specification. No evidence of malfunction was identified. The pulse generator met electrical test specifications. The condition of the bipolar lead was consistent with conditions that exist after the explant procedure. No discontinuities were identified. H. 6. Ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) and choking sensation as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that depression study pt intermittently experienced severe dyspnea/feeling of choking with stimulation. Adjustments were made to device settings. The dyspnea became continuous, requiring additional adjustments to device settings and eventual adjustments to medication dosages after which the dyspnea resolved. The pt was later explanted due to a pain/inflammation in right arm that was reportedly not due to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515399


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:13:39 PM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolesecents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
The pt experienced an increase in seizures. The increase in seizures occurred when the vns output was increased. The pt had strep throat which might have contributed to the increase in seizures. The pt experienced shortness of breath and had swallowing problems. These problems resolved when the vns output was decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=523050


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:14:39 PM
Event Date 01/01/2004
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. : review of manufacturing records for the generator revealed no anomalies that would adversely effect device performance. H. 6. : the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. The vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt had passed away. Treating neurologist indicated that the cause of death was respiratory failure. The pt reportedly passed away while hospitalized. No autopsy was performed. It was reported that the pt experienced a >25% reduction in seizures with the vns therapy and that the pt was receiving therapy at the time of death. There is no evidence at this time that the vns therapy system caused or contributed to the reported event. Treating neurologist indicated that the vns therapy system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=509875


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:15:18 PM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 04:15:57 PM
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Vns therapy labeling lists dysphagia and dyspnea as potential adverse events associated with surgery. Events reported are most likely related to the implantation procedure.

Event Description
Reporter indicated that the patient was implanted a week ago and has been complaining that "his epiglottis won't close, he is experiencing pain in the lead area, and he has difficulty breathing. " the patient's device was not turned on yet and was confirmed to be programmed at 0 ma. The physician believes that "there was significant manipulation on the vagus nerve during the implantation procedure. " this could have "resulted in swelling and irritation of the vagus nerve. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841393


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:16:39 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because initial reporter would not provide patient or product info to mfr without patient consent. H. 6. : vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was experiencing difficulty breathing and that testing had been done that resulted in a diagnosis that the left side of the patient's diaphragm was not working properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522033


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:17:38 PM
Event Date 03/10/2004
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the pt was admitted to the icu following vns implant surgery. The pt reportedly went into respiratory arrest leading to icu admittance. Implanting surgeon indicated that during the implant surgery, there was a lot of scar tissue present and that it appeared that the pt had prior surgeries. It was reported that the vns implant surgery was difficult due to the patient's anatomy and the pt had to be intubated several times. The pt continues to experience constant hoarseness and swallowing problems. The pt has been referred to an ent due to suspected vocal cord paralysis. It was also reported that the pt has paresthesia affecting their chin and collar bone area.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520496


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:18:15 PM
Model Number 102
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. The ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that treating neurologist decreased several settings because the pt reportedly has a breathing problem. Investigation to date has been unable to determine the severity of the breathing problem or whether the breathing problem was a pre-existing condition. It was reported that the pt did not benefit from the vns therapy and that their device had been programmed to off. The reason the device was programmed to off is not known. The device was recently programmed back to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520197


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:18:55 PM
Event Date 10/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspena, neck pain, incision site pain, dizziness, increased coughipng, insomnia and tinnitus as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 04:19:38 PM
Event Date 03/08/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because initial reporter did not know patient's name and indicated that they would not be able to provide it even if they did have it. H. 6. Vns therapy system labeling lists dysphagia and increased coughing as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that patient coughed and choked on their saliva because of the vns stimulation and an ambulance was called.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=519541


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:20:19 PM
Event


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:21:40 PM
Event Date 05/18/2004
Event Type Death
Patient Outcome Death;
Event Description
Further follow-up revealed that the patient experienced a >25% reduction in seizures with vns therapy. Last known treating epileptologist indicated that he had not seen the patient recently, but that he does not believe that the ncp system was realted to the cause of death.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating epileptologist. H. 6. Device manufacturing records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that vns pt had passed away. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Event Description
Further follow-up revealed that no autopsy was performed. Hospice care manager listed the cause of death as "chronic" respiratory failure/pneumonia". Nursing home director indicated that approximately 1 month prior to death the patient became very sick and was rushed to the hospital. The patient was then admitted to the hospital and stayed until death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=529892


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:22:20 PM
Event Date 03/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns pt experienced problems with vomiting following an increase in programmed device output current from 0. 75ma to 1. 0ma. Programmed device settings were decreased, after which the pt was reportedly vomiting less but refusing to eat due to gagging. The pt was also more irritable following the parameter reduction. Treating neurologist indicated that the event was possibly related to the vns. The pt has history of chronic pancreatitis, but has not had any problems with the pancreatitis for approximately one year. The pancreatitis was reportedly ruled out as a factor. It was reported that it is difficult to pinpoint exactly what is wrong with the pt as pt is non-verbal. Neurologist believes that device stimulation may be causing the pt to gag; therefore causing pt to not want to eat. It was also reported that the pt recently had what is believed to be a viral infection not related to the vns. Neurologist plans to see the pt for follow-up in one month to see if the decrease in device settings helps symptoms.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists dysphagia (difficulty swallowing) and vomiting as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=528244


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:23:05 PM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling list increased coughing and dyspnea as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt has been experiencing a "tickle in their throat" that turns into a cough which leads to severe shortness of breath. It was reported that the pt has had to call an ambulance during these episodes due to respiratory distress. Treating neurologist indicates that the event is related to the vns. Programmed device settings have been reduced and the pt reportedly still coughs but the coughing has decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=525926


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:23:46 PM
Model Number 100
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling lists increased coughing and dysphagia as potential adverse events possible associated with surgery or stimulation.

Event Description
Reporter indicated that pt's device was programmed to off and was explanted approximately 13 months later due to coughing and choking with the vns therapy. Device diagnostic testing was within normal limits, indicating proper device function. Adjustments to device settings did not alleviate the pt's symptoms. It was reported that the symptoms resolved after the device was programmed to off and that the pt had never received efficacy with the vns therapy. The pt reportedly had paranoid ideations regarding the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=525997


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:24:47 PM
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt was experiencing stridor with stimulation. It was reported that before vns implant, the pt had a thyroidectomy along with subsequent unilateral vocal cord paralysis as a result. The pt developed stridor with stimulation after vns implant. The pt's device has been programmed to off because of the stridor.

Manufacturer Narrative
Report is incomplete because initial reporter could not recall the name of the pt. When asked for additional info about the event, treating neurosurgeon indicated that he had no documentation in any of his records regarding stridor for vns pts under his care. Investigation to date has been unable to determine whether this report is a duplication of a previously filed report for a pt with similar issues under the care of the same physician. Reference initial medwatch report number 1644487-2004-000411.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=526058


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:25:29 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. H. 6. Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. H. 6. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that vns pt experienced an episode of difficult breathing. At the time of the episode, the pt was being threatened by a man who was reportedly pushing the pt near the area where the generator is implanted. The pt startled and could not catch their breath unitl such time that the magnet was placed over the device to temporarily discontinue stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=525377


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:27:27 PM
Event Date 09/25/2003
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Report is incomplete because device tracking info has not yet been recieved by mfr. H. 6. Vns therapy system labeling lists left hemidiaphrapm paralysis, voice alteration (hoarseness), increased coughing and dyspnea as potential adverse event associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was diagnosed by pulmonolgist with left hemidiaphragmatic paralysis as confirmed under fluorosocpy. It was reported that no paralysis was noted with repeat fluorosocpy after device was programmed to off. Pulmonologist indicated that the paralysis was related to the vns implant procedure and stimulation, but treating neurologist indicates that the paralysis is not continuous as evidenced by absence of paralysis when stimulator was programmed to off. It was reported that after vns implant, the patient developed a cough and difficulty breathing. These symptoms did not subside when the device was programmed to off. Pulmonologist has recommended explant of the vns therapy system, but the patient does not want explant because patient has experienced significant efficacy with the vns therapy. Treating neurologist to repeat fluorosocpy with device programmed to on and to temporarily discontinue stimulation with use of the magnet during the test to see if any changes are noted in the paralysis. Additionally, neurologist plans to consult with an ent physician because the patient's voice sounds "funny".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=524901


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:28:50 PM
Event Date 09/12/2003
Event Type Injury
Patient Outcome Life Threatening; Disability Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist. H. 5. Vns therapy system labeling lists voice alteration, left vocal cord paralysis and dyspnea as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt experienced voice alteration and shortness of breath approx one month post-implant. Approx three weeks later, the pt was doing fine and that their symptoms were getting better. Treating neurologist indicated that the pt's voice problems were unrelated to the vns. Further follow-up with the pt five months later revealed that the pt was expeirencing severe shortness of breath. The pt had reportedly been seen by neurologist for shortness of breath and was referred to ent for evaluation. Ent reportedly indicated that there may be some vocal cord damage. It was reported that the pt discontinued stimulation due to the shortness of breath.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=524209


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:29:25 PM
Event Date 08/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns pt's device was programmed to off due to stridor. The pt reportedly experienced extreme coughing with device stimulation. Prior to programming the device to off, the pt's device was programmed to very long cycling (15 min off and 5 secs on) due to the coughing. Over several months, treating neurologist was able to increase the duty cycle to only 5 mins off and to 30 secs on, but the pt's family member felt that the pt still coughed intermittently and had shortness of breath with any kind of physical exertion. Eval by primary care physician did not reveal any other medical reasons for the pt's symptoms and there was no improvement in their seizures with the vns therapy. The pt's device remained at low settings (0. 25ma output current) because the pt had stridorous breathing at night and the device was eventually programmed to off.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists increased cough and dyspnea (difficulty breathing, shortness of breath) as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=541524


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:30:11 PM
Event Date 07/27/2004
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dizziness as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt has complained of feeling light-headed and dizzy during stimulation since a recent increase in programmed device output current. It was reported that the pt passed out and fell as a result of the dizziness. Additionally, the pt reports moderate wheezing with stimulation ever since stimulation was initiated. The wheezing reportedly occurs particularly when the pt is leaning to one side. Treating neurologist indicated that the pt is doing fine and that the events are not related to the vns therapy. Neurologist indicated that the events are "positional" and coincidental and that forward bending the straining at the time of stimulation was a possible cause. No intervention is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=540912


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:31:04 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because treating physician refused to provide manufacturer with pt name until it is confirmed that the vns is causing the pt's apnea. H. 6. Vns therapy system labeling cautions that pts with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa. Additionally, vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapuetic brain surgery.

Event Description
Reporter indicated that vns pt underwent a sleep study, which resulted in a diagnosis of "nonobstructive apnea". It was reported that the pt has apnea of 30 seconds every 5 minutes (every time the device stimulates). The pt was reportedly scheduled for follow-up with physician to see if the problem is vns-related. Treating physician reportedly believes that the vns is causing the apnea, but could not be sure until another study was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=540917


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:31:43 PM
Event Date 07/01/2004
Event Type Death
Patient Outcome Death; Required Intervention
Event Description
Vns pt developed epiglottitis and subsequently received a tracheostomy tube. Treating neurologist reportedly did not believe that the epiglottitis was caused by the vns therapy system. Further follow-up revealed that the pt recoved from the epiglottitis, but that they later died. Cause of death is not known at this time. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices and revealed no anomalies that would adversely effect device performance. There is no evidence at this time the vns system caused or contributed to the reported event.

Manufacturer Narrative
Report is incomplete because treating neurosurgeon cited hipaa regulations as reason that additional pt and/or product info would not be provided to device mfr. H. 6. Treating neurologist indicated that he was "99% sure" that the vns did not contribute to either the epiglottitis or the pt's death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=541155


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:32:29 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's requests for add'l info from treating neurologist (via fax x2).

Event Description
Reporter indicates that vns pt has recently experienced two episodes of stridor during which the pt seemed like they couldn't get enough air. Both episodes occurred since the last increase in device output current. Treating neurologist questioned whether the episodes of stridor could be related to stimulation of the recurrent laryngeal nerves and requested copies of articles regarding vns therapy and laryngeal function after implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=539408


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:33:11 PM
Event Date 06/17/2004
Event Type Death
Patient Outcome Death;
Event Description
The reporter indicated that the pt expired during the night due to "respiratory tract closing" while sleeping. The physician indicated that the pt's family member reported that the breath holding during seizures seemed to be the cause of death. Due to insurance issues, the pt had not gone to the neurologist for two years. The pt did not receive efficacy from the vagus nerve therapy. The treating neurologist indicated that the ncp system was not related to the pt's death. An autopsy was not performed. The ncp system was not explanted. There is no evidence that the ncp system caused or contributed to the pt's death. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=538748


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:34:06 PM
Event Date 06/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns system labeling lists dysphagia as a potential adverse event possibly associated with surgery or stimulation. Report is incomplete because attempts (1 fax, 1 phone call) to obtain additional information from physician have been unsuccessful to date.

Event Description
The reporter indicated that the pt choked twice while eating. The pt is reportedly only eating carnation instant breakfast due to the choking problem.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=539177


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:34:53 PM
Event Date 06/18/2004
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the vns therapy system was programmed to off at the pt's request because they were experiencing shortness of breath. The pt reported that the shortness of breath was interfering with their outside activities. Further follow-up with the physician concluded that the device stimulation was possibly related to the reported shortness of breath. No further adverse events were reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=537088


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:35:43 PM
Event Date 05/26/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that following the implant of the vns therapy system, vns pt experienced several small seizures, then a grand mal and was subsequently put on a respirator for three days. It was reported that the pt was hospitalized for five days due to the event. It was also reported that the device has not yet been programmed to on.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional info from physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=536800


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:36:19 PM
Event Date 04/01/2004
Event Type Injury
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating epileptologist. H. 6. Vns therapy system labeling lists increased coughing, choking sensation and dyspnea (difficulty breathing, shortness of breath) as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt was seen in hosp e. R. On two occasions due to choking sensation. The pt reports that their epileptologist told them that the neck incision site was not healing correctly and that they feel a small knot in their neck in an area that is close to their wind pipe. The pt reports that when they touch this area, they begin coughing and feeling a choking sensation. Treating epileptologist reportedly decreased programmed output current and plans to monitor the pt to see if the decrease in parameters alleviates the situation. The pt began experiencing an increase in coughing and shortness of breath in the first month following vns implant after treating epileptologist increased programmed parameters 4 times within that first month. The pt also has been taken off of depakote and tegretol and is now taking carbatrol and keppra. Additionally, the pt's phenobarbitol level has recently been decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=534360


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:37:45 PM
Event Date 04/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt was experiencing intermittent shortness of breath with stimulation. The pt had previously experienced flu-like symptoms and some shortness of breath several weeks earlier, but was now also having pain at the generator site. The pt is reportedly experiencing good efficacy with the vns therapy and there is no redness or swelling noted at the generator site. Device diagnostic testing was within normal limits, indicating proper device function. Review of x-rays revealed no obvious discontinuities in the ncp system. The pt reports no recent injury or trauma that may have damaged the ncp system but did indicate lifting heavy objects while on the job. Programmed output current was reduced from 1. 25ma to 1. 0ma. Further follow-up revealed that treating epileptologist referred pt to neurosurgeon for replacement of the entire ncp system.

Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532686


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:38:59 PM
Event Date 05/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Vns therapy labeling lists infection, dyspnea and formation of fibrous tisuse/pockets of fluid as potential adverse events possibly associated with surgery or stimulation. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that vns pt developed an infection at the generator site and that the neck site was later red and swollen. The pt reportedly presented to hospital emergency room due to the infection at the generator site at which time the pt was air-lifted to a critical care facility. The pt was reportedly admitted and treated with a course of iv antibiotics. Treating physicians reportedly attempted to drain the site on two occasions. Treating neurologist indicated that the pt did not have an infection and was not hospitalized, but was seen in emergency room for dehydration that caused shortness of breath. Neurologist reports that the pt was hydrated and sent home with the issue resolved. Treating neurosurgeon indicated that he was unsure whether the generator site was infected or whether a seroma had developed at the generator site.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532816


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:39:56 PM
Event Date 08/23/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Vns therapy system labeling lists ataxia, dyspnea, hoarseness, insomnia, increased coughing, muscle twitching, nausea, pain, paresthesia, laryngeal spasms, vomiting, device migration, dysphagia, dizziness, ear pain, facial flushing, heart rate/rhythm changes, irritablility, low grade fever, muscle pain, neck pain, painful or irregular stimulation, tinnitus, sore/painful throat, stomach discomfort, tooth pain, weight change, worsening of asthma/bronchitis and worsening of cardiac abnormalities as potential adverse events possibly associated with surgery or stimulation. H. 6. Treating neurologist indicated that pt has pre-existing medical conditions (asthma, depression, migraine headaches, history of multiple dental problems requiring root canals and extractions that may have contributed to some of their symptoms.

Event Description
Reporter indicated that the pt requested vns therapy system explant due to numerous side effects, including a visit to hospital emergency room for an episode of status. Vascular surgeon indicated that the pt was seen by a new neurologist for chronic pain and that the new neurologist discontinued all of the patient's seizure medications. The new neurologist reportedly started the pt on medications for migraine headaches. Vascular surgeon reported that the pt presented to the er with status epilepticus a few days after the seizure medications were discontinued. The pt has reported ataxia, dyspnea, hoarseness, insomnia, coughing, muscle twitching, nausea, pain, paresthesia, laryngeal spasms, vomiting, difficulty swallowing, dizziness, ear pain, flushing, heart rate/rhythm changes, irritablity, low-grade fever, muscle pain, neck pain, painful stimulation, device migration, sore/painful throat, stomach discomfort, tooth pain, weight change, worsening of asthma/bronchitis, worsening of cardiac abnormalities and tinnitus to their neurologist. The pt has also reported an increase in stress to their neurologist. 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 service. The pt reports that the vns therapy does not seem to have helped their seizure control. Neurologist indicated that the incision from implant surgery had healed nicely and that there were no signs of infection. The device reportedly appears intact and in the normal position. Neurologist indicated that he was not sure if all of the patient's symptoms were truly due to the device. The device was programmed to off and was explanted two months later. Neurologist indicated that the pt had frequent medical complaints prior to vns implant. Additionally, neurologist indicated that there was no apparent ataxia, the patient's breathing problems were related to their asthma, there was no evidence that the pt was suffering from insomnia, the pt experienced increased coughing with magnet activation only, the pt experienced nausea at the time that stimulation was first initiated, there was no evidence of device migration, there was no evidence of heart rate/rhythm changes, the pt experienced irritability prior to vns implant, there was no evidence of low-grade fever, the pt experienced neck pain prior to vns implant, there was no evidence of irregular device stimulation, there was no significant weight change-the pt had gained 2 pounds since vns implant, there was no evidence of worsening of asthma/bronchitis or cardiac abnormalities.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=546976


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:41:09 PM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Ncp system labeling lists low-grade fever as a potential adverse event possibly associated with surgery or stimulation. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. Ncp system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Reporter indicated that a sleep study revealed that vns pt experienced 200 episodes of 20-second obstructive apneas during a 400 minute study. The pt is also reportedly experiencing more hypopneas. It was reported that the pt also experiences apnea during the day and that it was determined that use of bi-pap machine was not enough to treat this condition. It was reported that before vns implant, physicians indicated to the patient's family member that the pt needed a tracheostomy, but the pt has not undergone one to date. Additionally, it was reported that when the pt was first implanted with the vns, there were problems with their temperature regulation. The patient's temperature reportedly runs between 93-94 f, but "shot up" to 108 f when pt implanted with the vns. Treating neurologist indicated that the temperature increase occurred approximately 3-4 months post-op and that he was not sure whether it was related to the vns. A repeat sleep study has been performed with the vns programmed to off in an attempt to determine whether device stimulation is exacerbating the patient's pre-existing apnea. 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 patient's fever or whether the vns therapy is exacerbating the patient's pre-existing apnea.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=547018


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:41:38 PM
Event Date 08/24/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
This event is currently under investigation. Report is incomplete because no response has been received manufacturer's request for additional information from treating neurologist. Vns therapy system labeling lists heart rate/rhythm changes and dyspnea (shortness of breath) as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt began experiencing shortness of breath and increased heart rate during stimulation the day after in increase in programmed parameters. The pt planned to follow-up with their neurologist, but was in the process of being transferred to the care of a new neurologist because their current neurologist is relocating to another state.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545559


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:42:11 PM
Event Date 05/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Device likely caused the dyspnea event. Dyspnea is an anticipated adverse event with vns therapy. H. 6. Vns system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the pt was having trouble breathing and is coughing. It was also reported that the pt's previous generator was removed for a period of time before getting their current device. During that time, the pt's breathing problems resolved. Further info revealed that during the pt's implant surgery, the surgeon accidentally hit the jugular vein when he was removing the old lead. Because of the difficulty in removing the old leads, the surgeon placed the new electrodes over the old electrodes. Since the surgery, the pt has been having breathing problems. The pt's device was activated immediately following the surgery. It was reported that the physician does not believe that the pt's breathing difficulties are related to vns therapy. It was reported that placing the magnet of the vns device to inactivate does alleviate the breathing problems. Vns device settings were increased and the pt has been seizure free. A pulmonary consult is planned. The physician indicated that the breathing difficulty is not related to the surgery but could be related to the stimulation. It was further reported that the pt has approximately 20 seizures a day. The pt feels like there is a lump in their throat and feels like they can't take a good breath. The pt denies chest pain, cough, sputum, wheezing, abdominal pain, nausea, or vomiting. Device off time settings were changed from 1. 8 seconds to 5. 0 seconds, and the pt was observed for ten minues. The pt felt better and felt that their respiration was improved. Their voice was observed to be stronger. The same day that the pt's device settings were changed, the pt presented back at the physician's office because pt had three breakthrough seizures. The settings were then changed back to the previous values. The pt was getting used to the higher parameters and would prefer the breathing difficulty rather than having the seizures. The pt tolerated the change in parameters without difficulty.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545205


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:42:47 PM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurosurgeon. This event is currently under investigation. H. 6. The vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the pt underwent ncp system explanted due to difficulty breahing. It was reported that the device stimulation was making it hard for the pt to breathe and that the device was programmed to off a couple of months prior to the explant surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545208


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:44:08 PM
Event Date 08/16/2004
Event Type Malfunction
Patient Outcome Hospitalization;
Manufacturer Narrative
Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Report is incomplete because the patient does not have a current treating neurologist and they are in the process of finding one. The previous neurologist was contacted and he reports that he is no longer seeing this patient due to insurance reasons. H6: vns therapy system lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation. The event is currently under investigation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 04:45:01 PM
Event Date 08/25/2004
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Manufacturer Narrative
This event is currently under investigation. H. 6. Vns therapy labeling lists dyspnea (difficulty breathing, shortness of breath) and left vocal cord parplysis as potential adverse events possibly associated with surgery or stimulation.

Event Description
The reporter indicated that the pt was being hospitalized because pt was found to have moderate respiratory distress and stridor. The pt's voice does not appear to be hoarse. Further follow-up revealed that the pt was hospitalized for further testing and observation. The pt reported that over the last month, pt has had more difficulty with their breathing. Over the last couple of days, the breathing has become even more difficult and it is "noisy. " the pt has not lost weight or had any recent trauma. The pt was examined by a pulmonologist and he noted some upper airway audible/stridorous breathing. The flow volume loop was consistent with an upper airway obstruction. The pt denied pain, dysphagia or dysphonia. The results concluded that the pt has moderate respiratory distress, with a stridorous breathing. The pt normal with regard to nutrition and development. The pt's ability to communicate is normal and pt does not appear hoarse. Examination of the larynx revealed an upper airway obstruction at the glottic level, secondary to a functional vocal cord disorder/vocal cord paresis bilaterally. The pt's primary care physician recommended that the pt continue to work with the speech pathologist. The physician indicated that intermittently, the pt has a tendency to adduct the vocal cords but with relaxation, pt is able to abduct these vocal cords and breathe comfortable. The possibility of a direct laryngoscopy under general anesthesia to rule out any other reasons for the vocal cord disorder may be considered. The pt's seizures are well controlled with vns therapy. The pt's treating neurologist reported that the breathing problem is not related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545277


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:45:47 PM
Event Date 08/21/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the us, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Treating neurologist indicated that the event was not related to the vns therapy system.

Event Description
Vns pt was hospitalized due to breathing problems. It was reported that the pt was having 52-60 shallow breaths per minute. It was also reported that the device seemed to be sending "jolts" to the pt's stomach during stimulation on cycles. Treating neurologist indicated that the event only occurred one time and that it was respiratory-related. The pt reportedly had severe respiratory problems before vns implant. The pt is reportedly doing fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=544661


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:46:23 PM
Event Date 08/17/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away due to pneumonia. Further follow-up revealed that the pt was hospitalized and was experiencing tachypnea and tachycardia. The physician reported that the pt's symptoms were not seizure related. An autopsy was reportedly performed. The physician indicated that the vns therapy was not related to the pt's death. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543854


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:47:01 PM
Event Date 07/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that vns patient was diagnosed with left vocal cord paralysis. It was reported that the pt previously experienced voice alteration but that it had worsened. Treating neurologist indicated that the pt was also experiencing choking-like asthma and that pt believed that the events were related to the vns therapy. Neurologist indicated that he did not believe that the events were related to implant surgery because they occurred some time after vns implant. Programmed parameters were decreased in an effort to let the vocal cord heal. Further follow-up revealed that the pt's voice was improving, but that the right vocal cord was compensating for the left vocal cord paralysis.

Manufacturer Narrative
H. 6. Ncp system labeling lists voice alteration (hoarseness), left vocal cord paralysis and dyspnea as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=544959


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:47:41 PM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Reprort incomplete because no response has been received to mfr's requests for additional info from treating neurologist. H. 6. Ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) and stomach discomfort as potential adverse events possibly associated with stimulation.

Event Description
In the process of contacting the pt for notification that their generator may be nearing end of service, it was discovered that the pt is plagued with various health problems that pt believes are related to the vns therapy, including shortness of breath, bouts of pneumonia and gastrointestinal problems. The pt was hospitalized and on life support approx six months ago, presumably due to the aforementioned health problems. The pt thought that their device was programmed to off over a year ago. But had recently swiped the device with the magnet and felt stimulation along with shortness of breath. The pt plans to follow-up with neurologist for device interrogation to determine whether or not the device is programmed to off. It is possible that the normal mode output current was programmed to off, but that the magnet mode output current is still programed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543136


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:48:16 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. The following dates are estimated. Only the year is known: b. 3. Date of event.

Event Description
Reporter indicated that 80% of the pt's airways are collapsed due to the vns therapy. The pt is very athletic and physically active and reports that during stimulation, it becomes very difficult for pt to breath. The pt reported that they never experienced breathing problems before vns implant. Treating physician adjusted programmed parameters and recommended that the pt use the magnet to temporarily discontinue stimulation during periods of physical activity. The pt was reportedly doing better at follow-up visit with neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=541903


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:48:46 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Ncp system labeling lists dyspnea (shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
In the process of contacting the pt's neurologist to inform him that the pt's device may be nearing end of service, it was discovered that the pt's device had been programmed to off due to shortness of breath. The pt was scheduled for generator replacement surgery, but the surgery was cancelled because device normal mode output current was programmed to off approximately one month prior to date of surgery due to shortness of breath. Treating neurologist plans to "see how pt does" with the device programmed to off and to re-evaluate the pt at a later date. 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=551143


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 04:49:32 PM
Model Number 102
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2). H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory of antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Repeated initiation of magnet mode stimulation made the pt gag, vomit and become unresponsive to the point that pt turned blue. The patient's family member reported that family member had been instructed by treating neurologist to swipe the patient's device repeatedly with the magnet 4 or 5 times without waiting in between swipes when the pt had a seizure. The family member reported that family member has refused to do this anymore because of the patient's reported response to this type of magnet mode activation. The patient's family member reported that it took the pt nearly 1 hour to recover from the incident. 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=549083


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:13:23 PM
Event Date 09/13/2004
Event Type Malfunction
Manufacturer Narrative
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 whether the device was functioning properly.

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: Respiratory
Post by: dennis100 on July 16, 2011, 10:15:11 PM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Further follow-up revealed that the pt is experiencing a shocking sensation with device stimulation. The pt's family member indicated that the pt has been experiencing drop attacks and that there has been some improvement in the pt's seizure control. The pt's family member also reported that the pt use to be verbal prior to vns therapy and that now they are non-verbal and only speak when the device is "shocking" them.

Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. Neurologist indicated that he believed that the symptoms that the pt had been experiencing were not related to the vns stimulation.

Event Description
Reporter indicated that vns pt was experiencing episodes of sudden falls with device stimulation, during which pt extends their upper extremities and bends forward before falling backward. There is no loss of consciousness during these episodes. The pt's family member had previously reported that the vns therapy was helping with the pt's seizure control, but that approximately 32 months post-implant, the pt began experiencing episodes where pt threw their arms in front and was short of breath approximately once per day. There had been no changes in programmed parameters for approximately six months prior to the onset of these episodes. After approximately six months, the episodes reportedly became more frequent. The pt's family member did not think that these episodes were seizures, but reported that treating neurologist did believe that they were seizures. Further follow-up with treating neurologist indicated that it was unknown whether the events were related to the vns therapy, but that no intervention was planned at that time. No serious injury was reported at that time. Three months later, treating neurologist contacted device manufacturer, indicating that the pt's family member reported that several times per day, the pt "puts their arms out and falls back" during device stimulation. Neurologist indicated that he did not believe that the events were seizures. Both normal mode and magnet mode output currents were decreased. Further follow-up revealed that the pt's device had been programmed to off per their family member's request. It was initially reported that the pt did not experience any more of the reported episodes after the device was programmed to off and that the pt's family member planned to pursue explant of the ncp system. Approximatley one week later it was reported that the pt had been experiencing drop attacks, during which pt fell forward or backward occasionally. Neurologist ordered an eeg and prescribed a small dose of klonopin. Neurologist indicated that if the pt continued to have these seizures, he would probably program the pt's device back to on. Neurologist indicated that he believed that the symptoms that the pt had been experiencing were not related to the vns stimulation.

Event Description
Further follow-up reveaqled that the patient's device was again programmed to off. It was reported that the patient has been referred for x-rays. Neurosurgeon believes that the patient's problems are likely caused by disease progression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=561981


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:17:33 PM
Model Number 101
Event Type Malfunction
Event Description
An explanted pulse generator was returned to device manufacturer after only 20 months of service, indicating possible device malfunction or adverse event. Further follow-up revealed that the patient underwent generator replacement surgery due to high lead impedance test result (dc-dc code 7) during previous device diagnostic testing, indicating possible device malfunction. The generator had reportedly "twisted" in the patient's body and the patient was experiencing a choking feeling with a feeling of a lump in the throat that caused patient to gasp for air. The patient complained of intermittent chest pains that worsened approximately one month prior to generator replacement surgery. The device was subsequently programmed to off four days before generator replacement surgery. Treating epileptologist indicated that the patient's spells of intermittent chest pain and gasping for air were non-epileptic events. These symptoms have reportedly not resolved and the patient has been referred to psychiatric evaluation. Review of x-rays by treating physician did not reveal any abnormalities. Treating epileptologist indicated that the cause of the device migration was unknown and that the generator had slipped out of the pocket. The patient is reportedly doing well following generator replacement surgery; however, investigation to date has been unable to determine whether generator replacement surgery resolved the high lead impedance condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612187


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:18:15 PM
Event Date 11/15/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
Vns patient was hospitalized with difficulty breathing, shortnes of breath, sleep apnea,vomiting and dizziness. There had reportedly been no recent medication changes or changes to programmed parameters. The events reportedly began after the patient experienced a seizure that caused their eyes to rollup in their head. During the seizure, the patient was not breathing well and was "out of it". This type of seizur reportedly happened several more times during the day and was more severe at night. Further follow-up with treating neurologist revealed that the reported events had completely resolved. Neurologist indicated that the events were not related to the vns therapy, although the patient did not have problems with dyspnea or apnea prior to vns implant. Neurologist indicated that the events were beleived to be related to pseudoseizure. No intervention is planned.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea, vomiting and dizziness as potential adverse events possibly associated with surgery or stimulation. H. 6. Vns therapy system labeling cautions that patient with obstructive sleep apnea (osa) may have increased apneic events during stimulations. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=559456


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:19:03 PM
Event Date 11/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist (via fax x2). H. 6: vns therapy system labeling lists increased coughing, insomnia, aspiration, choking sensation and dysphagia as potential adverse events possibly associated with surgery or stimulation. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns patient was hospitalized because they "almost arrested". It was reported that since vns implant, the patient had been "coughing from abnormal secretations when sitting" and that they had "no muscular power". The patient was reportedly choking and drooling and was having difficulty sleeping. The patient was reportedly"gray in apperance". The patient's device was programmed to off, after which the patient's condition improved. There are no plans to program the device back to on at this time. 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=558595


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:19:46 PM
Event Date 10/15/2004
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. H. 6. Treating neurologist indicated that the event was not related to the vns therapy system.

Event Description
Reporter indicated that vns pt had passed away. Treating neurologist indicated that the cause of death was respiratory problems. Three days prior to death, the pt underwent generator replacement surgery due to end of service. It was reported that the pt experienced a >25% reduction in seizures with the vns therapy and that pt was receiving therapy at the time of death. The pt had reportedly experienced an increase in seizure activity in the month prior to generator replacement surgery. Treating neurologist indicated that the pt had pneumonia at the time of death and that pt had a history of repeated pneumonias with respiratory compromise. The pt's family reportedly chose not to treat or to resuscitate. Reference previous medwatch report 1644487-2004-00803 for respiratory problems. Intraoperative device diagnostic testing at time of generator replacement surgery was within normal limits, indicating proper device function. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=555163


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:20:33 PM
Event Date 09/14/2004
Event Type Injury
Patient Outcome Life Threatening; Disability
Manufacturer Narrative
H. 6. Vns therapy system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Vns pt was diagnosed with left vocal cord paralysis and they were seen in hosp emergency room approx one month post-implant with difficulty breathing due to vocal cord spasm. Treating neurologist reported that the event was not related to the vns therapy but that it was related to the implant surgery. The pt reportedly believes that their voice is better during stimulation on cycles. The pt is being followed by an ent for treatment of the vocal cord paralysis. 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=553811


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:21:36 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Explanting surgeon indicated that the original lead electrodes appeared to have been placed too low on the vagus nerve, possibly interfering with the laryngeal nerve.

Event Description
Pt's lead was replaced due to dysphagia. It was reported that the pt was experiencing neck pain and choking sensations, but that parameter adjustments prior to lead replacement did help alleviate the pt's symptoms. During generator replacement surgery for end of service, the surgeon noted that the original lead electrodes seemed to be placed too low on the vagus nerve, possibly interfering with the laryngeal nerve. The lead was also replaced. The electrodes of the new lead were positioned higher on the vagus nerve. The pt reports no further episodes of choking or neck pain since ncp system replacement surgery. Concomitant device was returned and analyzed. External visual inspection of the explanted pulse generator revealed no signs of decomposition, wear, uneven edges, corrosion or any other condition that would affect device performance. The pulse generator met electrical test specifications, and the elective replacement indicator was no, indicating that the generator had not reached end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=553631


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:22:18 PM
Event Date 01/11/2005
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists voice alteration (hoarseness), increased coughing, aspiration and left vocal cord paralysis as potential adverse events possibly associated with surgery or stimulation. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pt's with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that pt's voice was very hoarse two weeks post-implant and that the pt coughs a lot while talking to the point that pt becomes breathless. Stimulation had not yet been initiated. It was reported that implanting surgeon may have taken a little longer than usual to attach the lead electrodes to the vagus nerve during initial implant surgery. Further follow-up with treating neurologist revealed that the pt's condition had not improved almost one month post-implant and that pt continued to cough excessively with possible aspiration. Additionally, the pt was diagnosed with dense left vocal cord paralysis by an ent. The pt has reported started speech therapy to strengthen the vocal cord.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=575744


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:23:07 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) and stomach discomfort as potential adverse events possibly associated with surgery or stimulation.

Event Description
Since vns implant, the patient has experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient experience 1 seizure per week before vns implant and now has up to 3 seizures per week. Treating neurologist reportedly believed that the programmed output current may have been too high and subsequently reduced it, after which the patient experienced shortness of breath. The patient also reports that since the decrease in output current setting, patient has pain in their stomach, described as a feeling as if "someone is kicking patient in the stomach and knocking the wind out of them. Additionally, the patient reports that swiping the device with the magnet does not abort or reduce their seizures and that more magnet activations are showing up on device history than patient claims to have initiated. Treating neurologist has reduced device pulse width setting and referred the patient to their family physician as patient does not believe that the events are related to the vns. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up with treating neurologist revealed that the patient is doing better, but that neurologist now believes that the reported events might possibly be related to the vns. 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 increase in seizure activity

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=574720


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:24:25 PM
Event Date 01/15/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Patient's generator was programmed to off so that the patient could undergo an mri/pet scan. Upon completion of the tests, there were no staff available at the hospital to program the device back to on. Treating physician at that time reportedly indicated that "it would be fine" for the patient's device to be programmed back to on by their local physician and that pt was not sure if the vns therapy was really helping the patient that much. The patient's family member was concerned about leaving the device programmed to off and stopped at another facility on the way home to see if the implanting surgeon could program the device back to on, but that facility also did not have staff available to program the patient's device. Upon arriving home, the patient's family member contacted their neurologist who also indicated that it would be fine to wait until they could come to his office after the weekend to program the device to on and went on to say that vns patients sustained therapeutic effects of the device for several days after it was programmed to off. One or two days later, the patient reportedly experienced "the worst seizure pt has ever had" and was transported by air to the hospital where pt had undergone the mri/pet scan a few days before. The patient's generator was programmed back to on by an intern taking instruction over the phone about programming. The patient's zonegran dosage was increased from 50mg per day to 150mg per day. The patient was discharged to home and is reportedly doing well. Further follow-up with the patient's family member revealed that the patient had experienced four seizures over the past three months during which pt stopped breathing and use of diastat was required. The patient reportedly did not experience these types of seizures before vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=572947


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:25:47 PM
Event Date 10/25/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6 the vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potenital adverse event possibly associated with surgery or stimulation.

Event Description
The pt had been hospitalized due to shortness of breath. It was reported that the pt has been experiencing shortness of breath since vns implant and the shortness of breath was constant. Neurologist indicated that the pt is doing better with bronchodilators and that the shortness of breath may possibly be due to device stimulation or implant surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=566962


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:27:34 PM
Event Date 12/01/2004
Event Type Injury
Patient Outcome Hospitalization; Life Threatening Disability Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt was diagnosed with bilateral vocal cord paralysis. The pt was reportedly hospitalized for seizure monitoring, but was reportedly receiving efficacy from the vns therapy. It was reported that while hospitalized, the pt's vocal cords collapsed against their trachea and a tube had to be inserted for pt to breathe. There had reportedly been no recent injury or trauma to the pt's neck area. Treating neurologist had changed the pt's anti-epileptic medication from depakote to dilantin during their hospital stay. The pt's device was programmed to off. Treating physician indicated that pt did not believe that the vns caused the paralysis since the pt was asymptomatic until approximately three weeks ago as well as it being a bilateral case as opposed to a left unilateral paralysis. A cause of the vocal cord paralysis has not yet been determined and the pt has been referred to an otolaryngologist for further evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=565166


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:28:48 PM
Event Date 04/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient has been experiencing an increase in seizure activity, shortness of breath, increased respiration, increased heart rate, left ear pain and increased sallvation for a couple of months. It was also reported that the patient has been scheduled for an echocardiogram and holter monitor. Approximately 5 months ago, the patient fell on their back. X-rays were taken and reviewed. No abnormalities regarding the vns system were noted on the x-ray review. Device diagnostic testing was within normal limits, indication proper device function. It was further reported that there were medication changes in the patient's lamictal and depakote during this time. Investigation to day has been unable to determine whether the vns is a contributing factor to the increased heart rate or whether the increase in seizure activity was above pre-vns baseline frequency as no response has been received to manufacturer's request for additonal information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621159


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:29:50 PM
Event Date 11/23/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt could not tolerate a normal mode output current setting >0. 25ma. It was reported that when normal mode output current was increased from 0. 50ma to 0. 50ma, the pt experienced excessive choking sensation with significant throat pain and extreme coughing. A reduction in the pulse width setting did not alleviate the pt's symptoms. Review of x-rays revealed that the lead electrodes were placed directly above the clavicle, which is lower than the recommended placement in device labeling. Revision surgery is planned.

Event Description
Further follow-up revealed that the pt underwent revision surgery to change the position of the lead electrodes. Treating physician indicated that the pt still complains of pain with device stimulation and that the pt is experiencing an increase in anxiety concerning the event. Treating physician believes that the vns therapy system and surgery are related to the reported event.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists increased coughing, pharyngitis and dysphagia as potential adverse events possibly associated with surgery or stimulation. H. 6. Vns therapy system labeling states that the recommended stimulation site is a 3-cm section of the vagus nerve, approximately half-way up between the clavicle and the mastoid process, where it is clear of branches (below where the superior and inferior cervical cardiac branches separate from the vagus nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=596436


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:30:47 PM
Event Date 06/19/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Pt hospitalized for medical complication of cancer treatment (gi bleed; infection, respiratory distress. ) has longstanding epilepsy and his vns had the current lowered before his radiation therapy. Had negative bronchoscopy in 06/2005. Two days later, pt had typical complex partial seizure and used the vns magnet for the 266th time. In the immediate postictal period pt went limp and pale and had apnea while seated. Duration may have been 20-30secs. Parents have never seen this before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=748697


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:31:50 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up (discharge summay dated 2004) revealed that the pt originally received the vns system so that he coul reduce the medications he was taking. The vns did not appear to help, and the pt reportedly began to have recurring and more-frequent events. The pt reported that 80% of the seizures are without warming and 20% are preceded by the sensation of jejavu. The pt feels "generally not right" and has difficulty breathing. He will suddenly stop what he is doing and become pale. His lips will turn blue and he will fall from standing. He denies any convusions. The episodes last 20-30 seconds, sometimes accompanied by brief myoclonus and followed by postictal confusion of 1-20 minutes. There is frequent urinay incontinence but rarely bowel incontinence. The pt was admitted to the impatient monitoring svc to better identify and classify his events for the initial evaluatio of possible surgical intervention. The pt was placed on continuous video-eeg monitoring. He had normal waking background alpha frequency of 11 hz with normal drowsiness and sleep stages identified. The pt had normal, if any, identifable interictal epileptiform discharges. He had several clinical events recorded. The pt had an event where he went from his prior sinus heart rate to a progressive bradycardia,culminating in a 15-second pause that was followed by generalized flattering of the eeg background, followed by some generalized delta events. After this event a cardiology consult was obtained. This was the event that prompted the initial medwatch report. There was concern that the vns system may have contributed to the event, therefore, the vns device was deactivated. Because the pt had the vns device for quite sometime before the asystole event, it was felt by the epilepsy svc to be exceedingly unlikely that the vns device contributed to the episode of asystole. Following the initial event, the pt had several more events, though none were accompanied by significant asystole. It was reported that the episode of asystole may have been triggered by a subtle seizure activity involving the frontal lobe, and there was no way to guarantee that this would not recur. The vns device was not turned back on at this point and it is unk if the vns device is presently activated.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was experiencing episodes of asystole. The cause of the episodes is unknown. The patient was subsequently implanted with a pacemaker. The patient's vns therapy system was programmed to off prior to the pacemaker implant surgery and was programmed to on at certain points during the pacemaker implant surgery to assess whether the vns therapy affected the pacemaker sensing capabilities. When the pacemaker leads were implanted and connected to monitoring equipment, the vns therapy system was programmed to on at 1. 0ma output current. There were no changes to the monitoring equipment while the device was programmed to on at 1. 0ma output current. Normal mode output current was then increased from 1. 0ma to 2. 0ma with no changes to the monitoring equipment. Due to patient discomfort, the vns therapy system was programmed back to 0ma after approximately 10 seconds. The pacemaker battery was then implanted and connected to the pacemaker leads. The vns therapy system was then programmed to on at 3. 5ma normal mode output current in order to test the vns generator with the pacemaker and the pacemaker's monitoring equipment. After approximately 10 seconds, the vns therapy system was programmed back to off. Upon completion of the pacemaker implant surgery, the vns therapy system was interrogated to confirm that the device was programmed to off (0ma output current). Investigation to date has been unable to determine whether a relationship exists between the episodes of asystole and the vns therapy system. The patient's neurologist indicated that he was not aware of the patient having cardiac problems prior to the vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=566648


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:32:43 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt was experiencing apneic events during stimulation. It was reported that the pt stops breathing during device stimulation cycles and that they did not experience such episodes prior to vns implant. Treating neurologist, was unsure when the pt began experiencing the apneic episodes. Normal mode output current has been decreased from 2. 5ma to 1. 75ma, after which the pt reports that the problem is a little better. 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=569048


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:34:49 PM
Model Number 102
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the pt's device has been programmed to off. The pt indicated that she has "suffered from all of the side effects listed in the pt manual since implant". Surgeon reported that he does not feel comfortable removing the device because he has never done it before. The pt has been referred for device explant.

Event Description
Reporter indicated that vns patient's seizures are "worse than that normally have been". The patient reported that they were wrestling with family member, at which time he stepped patient's neck. The patient reports that they experienced a "real bad" seizure that evening and has since felt a shocking sensation at their neck every time they touches something. Additionally. The patient reports feeling like they have a sore throat and difficulty swallowing along with shortness of breath, fatigue indigestion, vomitting and nausea. The patient attempted to contact their neurologist, but he were on vacation. Investigation to date has been unable to determine whether the patient has experienced an increased in seizure activity above pre-vns baseline frequency. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fed-ex 1, via telephone x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=596509


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:35:32 PM
Event Date 03/01/2005
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The most likely cause of the reported events is device stimulation.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Vns pt was experiencing shortness of breath and had subsequently purchased an over-the-conter inhaler. Treating neurologist indicated that he shortness of breath had improved following a decrease in programmed device settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=593026


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:36:13 PM
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: Respiratory
Post by: dennis100 on July 16, 2011, 10:36:59 PM
Event Date 09/01/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Depression study patient was hospitalized due to episodes of bradycardia and syncope. The feelings of bradycardia occurred "every second week", most often following the patient's psycotherapy sessions as the patient is always very excited after these sessions. The patient was recently seen in hospital emergency room (approximately six months after the onset of symptoms) with subsequent hospitalization due to syncope of uknown origin and suggestion of bradycardia. The patient with low oxygen saturation and respiratory insufficiency. Treating physician plans 24-hour holter monitoring and testing for sleep apnea. Investigation to date has been unable to determine the cause of the reported events.

Manufacturer Narrative
H. 6. Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. H. 6. Ncp system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=589362


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:37:38 PM
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: Respiratory
Post by: dennis100 on July 16, 2011, 10:38:24 PM
Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced a recent increase in seizure activity. It was reported that the pt experience 5 seizures in a 48-hour period and that this was not their normal seizure pattern. Device diagnostic testing was within normal limits, indicating proper device function. X-rays reviewed by treating ent surgeon did not reveal any obvious discontinuities in the vns therapy system;however, some tension in the lead wire was noted. Exploratory surgery is planned. Review of manufacturing records for both the pulse generator and the bipolar leas revealed no anomalies that would adversely effect device performance. Investigation to date has been unalbe to determine the cause of the reported increase in seizure activity.

Event Description
The explanted products have not been returned to manufacturer for analysis; therefore, the cause of the reported events cannot be determined.

Manufacturer Narrative
Six months after revision surgery the pt reported pain in their jaw and left ear with device stimulation and occassional incidents of feeling device stimulation travel down their arm and to their chest/stomach, causing them to gag. The pt reported that the pain was not as bad as it had previously been before the revision surgery and was tolerable. It was reported that the symptoms resolved after a reduction in programmed pulse width from to 250u to 130u but approx six months later, the pt reported feeling constant stimulation and an increased surge of stimulation every 5 minutes, at which time pt felt a shooting pain to their head and right shoulder. Occasionally, when pt turned their head to the left pt experienced a shooting pain to their chest and then down to their stomach. The pt reported that this pain resolved when pt turned her head back to a forward position and that "pt could live with it" as it was only an occasional occurence. Device diagnostic testing at that time was within normal limits, indicating proper device function. Normal mode output current was decreased from 1. 5 a to 1. 25 ma, after which the pt denied any discomfort. Follow-up one month later revealed that the pt continues to complain of feeling jolts and pain down her neck, arm and shoulder and sometimes her stomach. The pt was referred to a gi physician and an ent to rule out causes other than the vns therapy system due to the fact that the symptoms are sporadic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578485


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:39:08 PM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the pt began experiencing "constant choking". Neurologist reduced the device pulse width to try and help alleviate the pt's side effects. It is unknown at this time whether or not the reduction in device pulse width alleviated the pt's side effects.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist.

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: Respiratory
Post by: dennis100 on July 16, 2011, 10:39:45 PM
Event Date 04/15/2005
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Further follow-up revealed that the pt has experienced worsening of seizures which affect her breathing. The pt indicated that she feels like she needs tobe seen in the emergency room and that she has been hospitalized 3-4 times in the past month. The pt reported that there have been no changes in medication that could be contributing to the increase in seizures. The pt also indicated that her seizures are worse than her pre-vns baseline frequency.

Manufacturer Narrative
Report is incomplete because attempts to obtain name of patient's current neurologist have been unsuccessful to date.

Event Description
Reporter indicated that vns patient was hospitalized for treatment of seizures. It was reported that the patient's right arm has begun to move during their seizures and that this was new for the patient. The hospital reportedly did not administer any medications to the patient for three days. 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=603540


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:40:16 PM
Event Date 05/09/2005
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns patient had passed away due to respiratory insufficiency. No autopsy was performed. The patient experienced a >25% reduction in seizures with the vns therapy and was receiving therapy at the time of death. There is no evidence at this time that the vns therapy system caused or contributed to the reported event. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. In their response to manufacturer's request for additional information, treating neurologist did not indicate whether they believed there was a relationship between the vns therapy system and the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=610019


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:41:07 PM
Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: treating neurologist indicated that the event was not related to the vns therapy system.

Event Description
Reporter indicated that vns pt aspirated and subsequently developed aspiration pneumonia. It was reported that the pt recently coded, requiring use of a defebrillator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=610735


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:41:54 PM
Event


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:42:57 PM
Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter who identified herself as an "advocate" for the pt indicated that the pt wished to have the vns therapy system explanted due to severe shortness of breath with exercise. It was also reported that the pt has not experienced any clinical benefit with the vns therapy and that the pt had experienced an increase in seizure activity over the past year. It was reported that the pt's device was programmed to off. A nurse for the treating neurologist indicated that the pt wanted the device explanted because she is "not satisfied". The nurse indicated that the pt visited her surgeon and that the surgeon reportedly told the pt that he would not explant due to "risk of stroke". Further follow-up with neurologist's office revealed that the pt has reportedly been seizure-free for one month and has decided not to pursue explant. The pt's seizure type has not changed and her overall health condition is reportedly not worsening with the vns therapy. The pt as refused to tape the magnet over the device during excercise to determine if stimulation was a contributing factor to her shortness of breath during exercise. Device diagnostic testing performed approx two months prior to the onset of the pt's initial complaints was within normal limits, indicating proper device function at that time. The elective replacement indicator at that time was no, ruling out generator battery end of life as a possible cause of the pt's complaints. Stimulation has not been discontinued; however, normal mode output current setting was decreased from 1. 5ma to 1. 0ma approx two months after the onset of the pt's complaints.

Manufacturer Narrative
H. 6: treating neurologist indicated that the pt had not experienced an increase in seizure activity above pre-vns baseline frequency.

Event Description
Reporter indicated that the pt was experiencing an increase in seizures. It is unknown whether the increase is above the pt's pre-vns baseline frequency. The reporter also reported that the pt has been experiencing shortness of breath while exercising. They stated when they stop exercising their breathing goes back to normal. The cause of the increase in seizures is unknown at this time, event is currently under investigation.

Manufacturer Narrative
H. 6. : vns therapy labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. Report is incomplete because attempts (2 phone calls) to obtain additional information from the reporter has been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622433


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:43:54 PM
Event Date 06/19/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Pt hospitalized for medical complication of cancer treatment (gi bleed; infection, respiratory distress. ) has longstanding epilepsy and his vns had the current lowered before his radiation therapy. Had negative bronchoscopy in 06/2005. Two days later, pt had typical complex partial seizure and used the vns magnet for the 266th time. In the immediate postictal period pt went limp and pale and had apnea while seated. Duration may have been 20-30secs. Parents have never seen this before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=748697


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:45:14 PM
Model Number 102
Event Type Injury
Event Description
Further follow-up revealed that the patient experienced a slight improvement in seizures initally, but later experienced choking secondary to rapid cycling (increased settings); therefore, the device setting were returned to previous settings. Neurologist reported that the patient's mother has not called the office since programming the device back up previous settings. Neurologist indicated that the vns therapy is not related to the increase in seizures and that the cause is unknown. Initial reporter later indicated that the increase in seizures was not an increase above the patient's pre-vns baseline frequency.

Event Description
Vns patient was experiencing an increase in seizure activity above pre-vns baseline frequency. The patient is wheelchair-bound and had not suffered any recent injury or trauma that may have damaged the vns therapy system. 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. There had reportedly been some medication changes during the time of the increase in seizure activity as well as some adjustments to programmed device parameters.

Manufacturer Narrative
H6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolscents with partial onset seizures that are refractory to anepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolscents with partial onset seizures that are refractory to antiepileptic medications. It was reported that the incerease in seizure activity could be due to the progression of the patient's tuberous sclerosis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=619812


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 10:46:04 PM
Event Date 06/28/2005
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6: ncp system labeling lists voice alteration (hoarseness) and dyspnea (shortness of breath) as potential adverse events possibly associated with surgery or stimulation.

Event Description
Further follow-up revealed that the reported events resolved with device programming changes. Treating neurologist indicated that the pt has complained of chest wall pain since a motor vehicle accident approx 16 months prior to initial report. The pt has been referred to tertiary center or alternate neurologist and is no longer in the care of the aforementioned neurologist.

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: Respiratory
Post by: dennis100 on July 16, 2011, 11:03:22 PM
Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Vns patient began coughing approximately one month ago and that the coughing increased to the point that the patient developed bronchitis and subsequent pneumonia. The pneumonia was treated with antibiotics, but eh antibiotics did not help. This lead to chronic aspiration and now the patient is on continuous oxygen due to low oxygen saturation. The patient's device was programmed to off in attempt to allefiate their symptoms. The patient has been instructed to follow-up with neurologist at his office in a couple of weeks.

Manufacturer Narrative
Vns therapy system labelling lists increased coughing and aspiration as potential adverse events possibly associated with surgery or stimulation. H6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy stystem is approved for use in adults and adolscents with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=619815


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:05:07 PM
Model Number 102
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt was experiencing cyanotic events. Device normal mode output current was set higher than 2. 0ma (exact setting unknown). The events resolved after the pt's device was programmed to off. The pt's device was programmed back to on at a later date was programmed to a lower setting of 1. 75ma normal mode output current. The side effects were reportedly better at that time. It was later reported that the pt developed apneic episodes and underwent extensive workup for other causes that were negative. Normal mode output current setting was decreased from 1. 75ma to 1. 50ma, after which the apneic episodes abated; increased to 1. 75m approx three months after decreasing to 1. 50ma. Report is incomplete because 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=629376


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:05:53 PM
Event Date 07/08/2005
Event Type Death
Patient Outcome Death;
Event Description
Further follow-up revealed that the patient died while hospitalized. The death. The death certificate listed the cause of death as respiratory failure and cerebral palsy. The manner of death was listed as natural causes.

Event Description
Reporter indicated that vns patient had passed away. Cause of death is not known at this time. Autopsy was not performed and the ncp system was not explanted. The patient was receiving vns therapy at the time of death. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
H6: treating neurologist indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=625791


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:06:49 PM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Additionally, ncp system labeling cautions that pts with obstructive sleep apnea (osa) may have increase apneic events during stimulations. Cyberonics recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa. Treating neurologist indicated that the event was possibly related to the vns therapy.

Event Description
Reporter indicated that vns pt was experiencing apnea. It was reported that the pt did not experience episodes of apnea prior to vns implant. Programmed device settings were reduced, after which the pt was reportedly doing better. Treating physician plans to maintain low levels of stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=629369


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:07:47 PM
Event Date 04/05/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt began experiencing shortness of breath after exertion shortly after undergoing ncp system replacement surgery. It was reported that the pt has recently been diagnosed with asthma, which he reportedly never had before vns implant. The pt reported increased inhaler use during due to the shortness of breath. Prior to ncp system replacement surgery, normal mode output current was programmed to 1. 25ma. Replacement device was programmed to a lower setting of 0. 50ma normal mode output current at the time of the pt's complaints. Frequency setting has since been reduced from 20hz to 15hz, but no change was noted in the pt's condition after this adjustment as the pt was not showing any signs of shortness of breath at the time that the adjustment was made. Device diagnostic testing was within normal limits, indicating proper device function. Chest x-rays are planned to confirm proper placement of the vns therapy system, but have not yet been performed. In the meantime, treating physician simply plans to watch the pt and indicated that this could just be a coincidence and have nothing to do with the vns.

Manufacturer Narrative
Vns therapy system labeling lists worsening of asthma and bronchitis as a potential adverse event possibly associated with surgery or stimulation. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history of respiratory diseases or disorders, including dyspnea and asthma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643410


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:08:45 PM
Event Date 08/13/2005
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Further follow up revealed that the strider, headaches, dyspnes, and left vocal cord spasm have resolved with device parameter changes and there havebeen no signs of reoccurrences since these changes. In addition, the chest infection reported was described to be a common chest cold unrelated to vns therapy. Patient is reportedly currently tolerating vns therapy very well.

Manufacturer Narrative
Vns system labeling lists dysphea and spasms as potential adverse events possibly associated with surgery or stimulation. The reported events were likely related to the high device settings. The events resolved when the device settings were decreased.

Event Description
Pt was implanted for depression. The reporter indicated that the pt complained of headaches and throat discomforts which appeared to be temporary and related to stimulation. After changing the pulse width parameter, these symptoms resolved. However, the pt developed stridor 48 hours after vns stimulation settings were changed. The pt indicated that they had a fairly rapid onset of neck pain and developed breathing difficulties. The pt was admitted to the hospital and was discharged two days later. The vns device was turned off. The breathing difficulties resolved. An endoscopic nasopharyngoscopy revealed that the left vocal cord was spasming when the stimulation was on. Additionally, the pt experienced idiopathic paradoxical vocal cord movement which probably contributed to the reported breathing difficulties. Five days after the event, the vns was turned back on at lower settings. The pt reported no adverse effects at that time. She was seen by and ent and very mild vocal cord movement was observed. However, approx 5 days later, the pt again developed similar breathing difficulties, but she did not require hospital admission. The device was deactivated again. The pt was then started on antibiotics and steroids for a possible chest infection. The vns device was again activated approx 3 weeks after the initial event. The pt has been able to tolerate the current settings without further breathing difficulties or other adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643439


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:10:30 PM
Event Date 09/22/2005
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Due to an admin error, the suspect med device (pulse generator) product info was not reported.

Event Description
Reporter indicated that vns patient had passed away. It was reported that treating physicians were unable to extubate following generator replacement surgery and that the patient was found to have compression of the trachea by the cervical spine, presumably a long-standing condition. The vns therapy system was not explanted. The patient reportedly experienced a >50% reduction in seizures with the vns therapy and was receiving therapy at the time of death. No autopsy was performed.

Manufacturer Narrative
Treating neurologist indicated that the cause of death was not related to the vns therapy system.

Event Description
Death certificate listed immediate cause of death as respiratory failure caused by anatomic thoractic insufficiency, due to (or as likely consequence of) intractable epilepsy, due to (or as a likely consequence of) cerebral palsy with mental retardation, due to (or as a likely consequence of) history of pertussis resection. The manner of death was listed as natural.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642162


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:11:55 PM
Event Date 08/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Manufacturer does not believe that the reported events occur as a result of device failure; therefore, product analysis results will only be reported in the event that a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Manufacturer Narrative
Vns therapy system labeling lists dysphagia and dyspnea as potential adverse events possibly associated with surgery or stimulation. Physician sees pt as one that has identity revolving around her perceived medical needs and getting better creates some anxiety for her.

Event Description
Reporter indicated that pt underwent vns therapy system explant due to severe dysphagia and dyspnea. It was reported that programmed parameters were increased approx one month after stimulation was initiated. Approx five months later, the pt began to experience migraines, choking, shortness of breath, and abdominal pain. The pt was referred to both an ent and a gastroenterologist and was diagnosed with irritable bowel syndrome by the gastroenterologist following a normal abdominal ct scan for abdominal discomforts. Additionally, an mri showed degenerative lumbar regions of the spine. The pt's vns therapy system was programmed to off, but the pt continued to have the same complaints two months later. The pt was then referred to a psychiatrist and was subsequently explanted. Further follow up revealed that the pt continues to experience headaches without the device. Pathology of the sinus cyst removal was benign. There have been concerns with the pt's multiple emergency room visits and the pt is now on a list for no narcotics with headache and/or back complaints. It is reported that the pt's headaches diminished during vns use. The pt now reports that hoarseness was her largest complaint with the vns therapy and she simply did not like it despite the device showing some improvements in her seizures.

Event Description
The pulse generator was returned and analysis. There were no visual anomlies identified or observed. The pulse generator is operating within the manufacturer's final electrical test specifications. The pulse generator did not show any condition that would have contributed to the reported events. The lead was also returned and analyzed. The condition of the returned portion of the lead, in general, is consistent with conditions that typically exist following an explant procedure. The lead pin showed evidence of a proper mechanical and electrical connection as expected. The patient's voice alteration subsided after the explant. The dysphagia, dyspnea, headaches, choking sensation and abdominal pain were likely due to other diagnosed illnesses, not related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642192


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:12:54 PM
Event Date 09/11/2005
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Treating neurologist indicated that the pt's death was not related to the vns therapy system.

Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt experienced 2 bad seizures and was subsequently hospitalized approx 1 1/2 weeks post vns implant surgery. Stimulation had not yet been initiated. The pt aspirated while hospitalized and later passed away while hospitalized. The pt was diagnosed with ards (acute respiratory distress syndrome). Treating neurologist indicated that cause of death was aspiration pneumonia secondary to seizure and ards. The device was not explanted prior to burial. Certificate of death lists acute respiratory failure, secondary to acute respiratory distress syndrome, secondary to aspiration pneumonia-bilateral as the cause of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642198


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:13:47 PM
Event Date 08/01/2005
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that a lead break was identified during vns therapy system replacement surgery. Prior to the surgery, the pt reported no longer being able to feel device stimulation, feeling a shocking sensation in the area of the device, and experiencing severe shortness of breath. Stimulation was discontinued prior to the replacement surgery due to the shortness of breath. It was reported that the pt experienced a seizure approx six weeks prior to replacement surgery, after he experienced pain in his left shoulder and began feeling the shock sensations. Device diagnostic testing performed prior to vns therapy system replacement was within normal limits, indicating proper device function. Review of x-rays did not reveal any obvious discontinuities in the vns therapy system.

Event Description
Further follow-up revealed that the pt is no longer experiencing shortness of breath. Neurologist does not believe that the vns therapy was related to the patient's shortness of breath. The concomitant device was returned and analyzed. The pulse generator met electrical test specifications. The pulse generator did not show any condition that would have contributed to the reported events. The bipolar lead wasnot returned to manufacturer for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642025


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:15:21 PM
Event Date 09/12/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns therapy depression study pt was hospitalized due to shortness of breath. It was reported that 11 days prior to hospitalization, the pt experienced a recent asthma episode that was better, but not fully resolved at that time. The pt was discharged from the hosp five days later with a diagnosis of congestive heart failure. Approx two weeks later, the pt was again hospitalized for cardiac evaluation after being seen in emergency room for jaw pain. Chest x-ray revealed fluid in the lungs. The pt underwent a cardiac catheterization which showed two blocked arteries. The pt had a stent placed in one of the blocked arteries and was discharged.

Manufacturer Narrative
Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. Treating physician indicated that the event was possibly related to the vns therapy and that the event was most likely a progression of the pt's medical disease but that possible contributing elements from the vns could not be ruled out.

Manufacturer Narrative
Due to an administrative error, the suspect medical device (pulse generator) implant date was incorrect.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642026


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:16:25 PM
Event Date 09/10/2005
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Further information revealed that the patient is now doing well. It was also reported that the patient's friends and family believed the vns therapy is working for the patient as they can see the difference in the patient's behavior in regards to depression.

Event Description
Three days after stimulation was initiated, vns pt implanted for treatment of depression reported that she felt her heart racing but did not experience any chest pain. The pt also reported shortness of breath and left jaw pain. The pt reported that she felt that these symptoms were related to her anxiety. Treating physician indicated that the pt has experienced an increase in anxiety and a decrease in depressive symptoms with the vns therapy. Three days after reporting the event to her physician, the pt used the magnet to temporarily discontinue stimulation for one day; however her anxiety did not improve in the absence of the vns therapy. Treating physician then tapered the pt off of wellbutrin and increased her klonopin dosage from 1. 0mg to 2. 0mg tid. Treating physician continues to titrate vns settings for treatment of depression.

Manufacturer Narrative
Treating physician indicated that the reported events were possibly related either to the vns therapy or to spontaneous fluctuation or illness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642038


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:17:29 PM
Event Date 09/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Vns system labeling lists choking sensation, dysphagia, pain, and voice alteration as potential adverse events possibly associated with surgery or stimulation. The reported events are known adverse events and are therefore, likely caused by the vns system.

Event Description
The reporter indicated that vns patient's device was programmed to off approximately ten months post-op due to complaints of dysphagia following ncp system replacement surgery. The patient reported feeling burning in their neck, hoarseness, difficulty swallowing and choking sensation. The patient cannot feel stimulation. The patient has not a seizure in over a year; however, requested that the vns device be turned off, and it was. It is unknown at this time, if the patient's problems have resolved. The reported events (voice alteration, choking sensation, dysphagia and pain) are known adverse events associated with surgery or stmulation, therefore, are likely related to the vns system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=638707


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:18:18 PM
Event Date 08/12/2005
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
The vns therapy system is indicated for use as adjunctive therapy in reducing the frequency of seizures in adults and adolscents with partial onset siezures that are refractory to antiepiliptic medications. In the unites states, the vns therapy system is approved for use in adults and adolscents with partial onset seizures that are refractory to antiepiliptic medications. Additionally, vns therapy system labeling cautions that patients with obstructive sleep apnea (osa) may have an increase in apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency of prolonging off time may prevent exacerbation of osa.

Event Description
Reporter indicated that since vns implant surgery, the patient is experiencing periods where patient stops breathing in cycles that last about 6 seconds. The patient has reportedly been seen by treating pediatrician who could not identify any obvious causes of the apneic events. The patient's family member plans to tape the magnet over the device while the patient sleeps at night and follow-up with treating neurologist who was out of town at the time of the initial report. Report is incomplete because 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=634558


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:18:58 PM
Event Date 05/02/2005
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist.

Event Description
Reporter indicated that after increasing programmed parameters, the pt experienced a choking sensation. During the episode, the pt's eyes became dilated and pt passed out. Treating neurologist was unable to get a pulse for a short period of time, but reported that the pt regained consciousness after prgrammed settings were reduced to original parameters. The pt was sent home in good condition after resting in the doctor's office. It was reported that programmed parameters were increased due to an increase in seizures activity; however, investigation to date has been unable to determine whether the increase was above pre-vns baseline frequency. At follow-up office visit two days later, device diagnostic testing with within normal limits, indicating proper device function. Normal mode output current was reduced from 1. 25ma to 1. 0ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=613869


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:20:08 PM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Ap and lateral x-ray views of neck and chest evaluated by mfr. No anomalies were noted. Device failure is suspected but did not cause or contribute to permanent impairment or death.

Event Description
Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842295


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:21:40 PM
Event Date 12/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated that the patient's vns device was "not working". It was reported that the patient was having seizures and that when the magnet was swiped over the device, the vns did "not detect" the magnet swipe. Follow up with the physician revealed that the patient could no longer feel vns stimulation and that the patient's seizures had increased to pre-vns baseline or "maybe a little worse". It was reported that the patient has frequent falls from seizures. It was also reported that the physician felt the generator moves around inside the chest pocket. A system diagnostic test was then performed, and the test indicated high lead impedance. It was reported that the patient was recently hospitalized due to "cardiac and/or respiratory failure" and the patient" was released with code blue". The relationship to vns is unknown at this time. Revision surgery is likely.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=977680


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:24:16 PM
Event Date 08/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns patient was hospitalized for shortness of breath. Treating neurosurgeon has reportedly been adjusting device settings every two weeks since implant to the point that normal mode outoput current was set to 1. 0ma. Treating neurologist reduced normal mode output current setting to 0. 5ma because he believed that the patient's symptoms were related to the increased output current and that the surgeon was increasing the output current too rapidly. The patient reportedly did not experience any further shortness of breath after the reduction in device settings.

Event Description
Further follow-up revealed that device diagnostic testing at the time of initial implant was within normal limits, indicating proper device function at that time.

Manufacturer Narrative
H6: vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. Treating neurologist believed that the patient's symptoms are related to increasing normal mode output current too rapidly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=633690


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:25:47 PM
Event Date 11/17/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Vns therapy system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa. Treating physician indicated that the reported event was not related to the vns therapy system, but was possibly caused by the patient's airway physiology.

Event Description
Reporter indicated that pt developed respiratory difficulties after vns implant. The day after vns implant surgery, the patient was reintubated and sent to intensive care unit for two days. The patient was taken off the ventilator after one day in intensive care unit, and was discharged to home two days later. The pt has history of previous surgeries for tracheal stenosis and also has an enlarged tongue. Further follow-up revealed that the patient is doing well. The patient was not intubated during the implant procedure, although attempts were made to intubate unsuccessfully. During implant surgery, the patient's oxygen saturation decreased to 60% at one point and it was reported that dissection was lengthy due to previos tracheal stenosis surgery. The patient was intubated post implant due to snoring and nasal flaring. Pt was placed on a dipravan drip so she `could rest'. After the patient was extubated events had resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=654658


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:26:50 PM
Event Date 10/01/2005
Event Type Death
Patient Outcome Death; Life Threatening Hospitalization
Event Description
Death certificate was obtained and revealed that the immediate cause of death is listed as sudden unexplained death associated with epilepsy. No autopsy was performed and the manner of death was marked natural. Patient was reportedly hospitalized at time of death.

Event Description
Reporter indicated that pt was hospitalized approximately 15 weeks post vns implant due to respiratory arrest. While hospitalized, an ecg reportedly revealed a cardiac arrhythmia. Further follow-up revealed that the pt had passed away approximately one month from date of hospitalization. It was reported that the pt experienced prolonged cardiopulmonary arrest with significant cerebral hypoxic ischemic injury. Exact cause of death is not known at this time and it is not known whether the pt expired while hospitalized or whether she was discharged prior to death. There is no evidence at this time that the vns therapy system caused or contributed to the reported events. Report is incomplete because no response has been received to mfr's requests for additional info from staff at group home where pt resided. An incomplete response was received to mfr's request for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=649205


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:27:26 PM
Event Date 09/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The patient's family member was also implanted with the vns therapy system on the same day and also experienced stridor during device stimulation cycles (ref medwatch report 1644487-2005-00760). The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. Additionally, vns therapy system labeling states that initial treatment output current (starting new or after pulse generator replacement) should be set at the lowest setting (0. 25 ma) and cautions not to program the vns therapy system to an on or periodic stimulation treatment for at least 14 days after the initial or replacement implantation, indicating that failure to observe this precaution may result in patient discomfort or adverse events.

Event Description
Reporter indicated that vns patient experienced episodes of stridor during device stimulation cycles. It was reported that the patient's oxygen level dropped from 97% to 92% during device stimulation and that the patient's family member has noticed a snoring, wheezing, and whistling sound from the patient during stimulation cycles. Stimulation was initiated in the operating room on the day of initial implant surgery at 1. 0ma normal mode output current, 30hz frequency, 500 psec normal mode pulse width, 30 seconds on time, 1. 8min off time, 1. 0ma magnet mode output current, 60sec on time, 500 psec magnet mode pulse width. It was reported that programmed parameters were "too high" and that the events resolved after an adjustment in device parameters to 1. 25ma normal mode output current, 20hz frequency, 250psec normal mode pulse width , 7 seconds on time. 14min off time, 1. 5ma mode output current, 30sec on time, 250psec magnet mode pulse width.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=645487


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:28:08 PM
Event Date 10/18/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: vns therapy system labeling lists nausea and vomiting as potential adverse events possibly associated with surgery or stimulation. Treating neurologist indicated that the pt experienced post anesthesia nausea and was subsequently unable to take her medications, which resulted in low antiepileptic drug levels.

Event Description
Reporter indicated that pt was hospitalized in intensive care unit nd on a ventilator following vns implant surgery. It was reported that the patient "was not been able to keep anything down" after implant surgery and that she had been experiencing seizures ever since implant surgery. The pt was reportedly discharged to home on the day of surgery and returned to hospital emergency room the following day due to increased in seizure activity. Stimulation had not yet been initiated at the time of the event, but was initiated one week later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=645144


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:28:50 PM
Event Date 12/24/2005
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
Ncp system labeling lists increased coughing and dysphagia as potential adverse events possibly associated with surgery or stimulation.

Event Description
During device stimulation cycles and with use of the magnet to temporarily discontinue stimulation, vns pt was experiencing head drop towards his left shoulder with choking and coughing when he tried to pick his head back up. The pt was reportedly hospitalized for one day due to these 'shocking sensations,' but he no longer feels them and is concerned because he can feel very little stimulation now. Device diagnostic testing at follow-up office visit within normal limits, indicating proper device function. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the reported events. Further follow-up revealed that the pt was not using manufacturer's magnets to activate magnet mode stimulation cycles because he had lost them. The pt was reportedly using a magnet similar to a cow magnet to initiate magnet mode stimulation. Replacement vns therapy system magnets were shipped to the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=667526


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:29:52 PM
Event Date 12/07/2005
Event Type Injury
Patient Outcome Life Threatening;
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.

Manufacturer Narrative
H. 6: ncp system labeling list dyspnea as a potential adverse event possibly associated with surgery or stimulation.

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).

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


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:30:29 PM
Event Date 04/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's seizure type has changed from absence seizures to grand mal seizures since the patient experienced a fall. Device diagnostic testing was within normal limits, indicating proper device function and review of x-rays did not reveal any obvious discontinuties in the vns therapy system. It was also reported that the patient experiences wheezing at night when she lays down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=665007


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:31:10 PM
Event Date 12/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H6: vns therapy system labeling lists increased coughing, dysphargia, dyspnea and worsening of asthma and/or bronchitis as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 11:31:57 PM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
The patient's choking sensations have resolved since the vns system was explanted. The physician reported that the choking sensations were related to the vns stimulation. The pulse generator was analyzed. Product analysis summary: there were no visual anomalies identified or observed. The pulse generator is operating within designed limits, meeting the manufacturer's final electrical test specifications. The concomitant device (lead) was also analyzed. Product analysis summary: the condition of the returned portion of the lead is consistent with conditions that typically exist following an explant procedure. The lead pin showed evidence of a proper mechanical and electrical connection as expected. No anomalies that could have resulted in dysphagia were identified on the lead portion returned.

Manufacturer Narrative
Vns therapy system labeling lists dysphagia as a potential adverse event possibly associated with surgery or stimulation. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that pt was experiencing 'severe choking' during device stimulation cycles. It was reported that treating neurologist reduced programmed settings, but that the pt continued to experience the choking. The pt has experienced the choking sensation for several months with increased severity over the past 3-4 weeks. Further follow-up revealed that both the lead and generator were explanted, presumably due to the pt's choking issues. Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660592


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:32:46 PM
Event Date 12/05/2005
Event Type Injury
Patient Outcome Disability; Other Life Threatening
Event Description
The event occurred during vns system diagnostic testing. The patient's device is normally set to 0. 25ma output current. The output current during the diagnostic test was set to 1. 0ma. The patient was not able to tolerate the higher setting and experienced pain which led to the reported injury. The patient was set to 0. 25ma without any further problems.

Manufacturer Narrative
Ncp system labeling lists dysphagia, dyspnea, voice alteration (hoarseness) and left vocal cord paralysis as potential adverse possibly associated with surgery or stimulation.

Event Description
Reporter indicated that while performing device diagnostic testing during office visit, the patient started choking and fell off the table, hitting his head on the counter. After the fall, the patient's nose was bleeding and was broken in two places. The patient's eyeglasses were also broken as a result of the fall. The physician was able to re-program the patient's device back to prescribed settings with no additional harm to the patient and the patient was reportedly fine when he left the office. The patient's spouse indicated that the patient was seen in the hospital emergency room on the day of the event, at which time he was referred to an ent for evaluation of his broken nose and his vocal cords. The patient also has an appointment with his dentist because his two front teeth are loose as a result of the fall. During the course of the complaint investigation, it was noted that a previous report was received by manufacturer indicating that the patient's device had been programmed to off due to a lack of efficacy approximately 22 months post-implant with no plans at that time to reinitiate stimulation. The current report indicates that the patient's device was programmed to 0. 25ma normal mode output current at the time of the event; however, it is not known when stimulation was reinitiated. The device diagnostic testing that was performed at the time of the reported event requires a normal mode output current setting of 1. 0ma. The patient's spouse indicated that she was not at the office visit with the patient when the event occurred, but that the device malfunctioned and zapped him more than usual, after which the patient became short of breath and unconscious. The patient's spouse indicated that as a result of the fall, the patient's nose was broken in two places, his nose was bleeding, he has facial swelling, and a knot between his eyes and his two front teeth are loose. The day after the incident, the patient's voice was noted to be hoarse. Also during the course of the complaint investigation, manufacturer became aware of a previous diagnosis of temporary vocal cord paralysis that occurred approximately one week post-implant and lasted for approximately four weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=659792


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:33:40 PM
Event Date 01/25/2006
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Vns therapy system labeling lists heart rate/rhythm changes and dyspnea as potential adverse events possibly associated with surgery or stimulation.

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: Respiratory
Post by: dennis100 on July 16, 2011, 11:34:14 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


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:34:53 PM
Event Date 03/08/2006
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Sterilization of both the lead and the pulse generator prior to distribution was confirmed.

Event Description
Reporter indicated that the patient was experiencing laryngeal spasms, and had also deveoped an infection at the generator site. The vns therapy system was explanted due to both the infection and laryngeal spasm. Propr to explant, stimulation was temporarily discontinued, after which the laryngeal spasms did not resolve. The patient's condition has reportedly imporved after explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=730353


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:35:41 PM
Event Date 07/03/2006
Event Type Injury
Patient Outcome Disability; Other
Event Description
I have a vns therapy implant from cyberonics, inc. , for treatment of my epilepsy. On the date in question, i began to feel a strangling sensation. After a while, i called cyberonics thinking that the vns was causing the problem. Eventually, after much prodding, i received a call back about my immediate medical problem. The rep from the clinical and technical department suggested that i place the extra magnet over my implant site and leave it there, effectively turning off the system. This relieved my symptoms but, of course, with no activation, i was at risk of having a seizure, or more than one. As he instructed, i removed the magnet to see if the generator would fire normally. Within 20 seconds, the generator again fired continously and painfully. Eventually, i removed the magnet after 30 minutes and the symptoms resolved. The gentleman from cyberonics suggested that the generator was faulty. I called my doctor, and she said that i could come in the next day or so to have a computer diagnose any problems with the system. If the implant was indeed faulty, i would have to undergo surgery to remove the generator and replace it with a new one. Recovery the first time gave me an immediate focal seizure. For weeks and weeks afterwards, i experienced left vocal cord paralysis (diagnosed) and trouble breathing. I had the surgery. I did not go to my doctor because the symptoms had resolved but in any case, the doctor's office would have been too far to go in case of an emergency (either from the stimulation or the off mode), and very few doctors (less emergency departments) have the technology to interrogate and adjust the system in an emergency. Any help you can provided would be apprecitated. People need to know that the device can malfunction and produce adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=745178


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:36:20 PM
Model Number 302-20
Event Type Malfunction
Manufacturer Narrative
Vns therapy system labeling lists foreign body reaction to implants, including possible tumor formation, as a potential adverse event possible associated with surgery or stimulation. A majority of the explanted lead assembly was not returned for analysis. Only the electrodes, electrode bifurcation area, and a small portion of the lead body were returned. A discontinuity of the electrode, as was reported by the surgeon, was not observed; however, visual inspection vealed that a portion of the quadfilar coil between the detached negative electrode and the electrode bifurcation had dissolved within the inner silicone tubing. The end of the inner silicone tubing appears to be torn in the area of the dissolved coil wire, which may have resulted in the coil wire coming into contact with body fluids and subsequently dissolving in the presence of current flow. The cause of the apparent insulation tubing failure and subsequent coil wire failure has not been ascertained. The coil wire breakdown was the cause of the high lead impedance test results.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. The device was programmed to off pending revision surgery due to suspected lead discontinuity. The pt underwent revision surgery approximately one month after the high lead impedance condition was discovered. Both the lead and generator was explanted. At the time of explant surgery, the surgeon indicated that the pt's vagus nerve was dilated and expanded and that there was an encapsulated abscess around the vagus nerve with signs of infection. It was reported that the surgeon observed a discontinuity at the lead electrode upon explant of the lead. The pt reportedly experienced hoarseness and upper respiratory illness approximately one month before the high imepdance condition was discovered; however, device diagnostic testing at that time was within normal limits, indicating proper device function. Treating physician believes that the abscess may have been caused by an allergy to the device. Visual inspection and electrical testing of the concomitant device (pulse generator) did not reveal any anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=726444


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:37:01 PM
Event Date 04/01/2006
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Available info suggests that the reported events were directly related to device stimulation; however, it is unk whether the observed silicone abnormality was a causal or contributing factor to the reported events.

Event Description
Reporter indicated that a vns pt experienced difficulty breathing and left vocal cord paralysis, during device stimulation cycles. It was reported that adjustments to programmed device settings did not alleviate the pt's symptoms. Fluoroscopy revealed left hemidiaphragmatic tetany, during device stimulation cycles. Evaluation with a fiberoptic camera revealed left vocal cord tetany and paralysis, with partial involvement of the right vocal cord, during device stimulation cycles. It was reported that the pt was unable to breath during these episodes. Revision surgery was performed, during which the surgeon noted that "the silicone around the electrode was severed and the metal electrode was making direct contact with the nerve", the lead was explanted and replaced. Stimulation was initiated immediately after lead replacement surgery, after which all adverse events have reportedly resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=757095


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:37:40 PM
Event Date 02/02/2006
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
H6 code: vns therapy system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation. In addition, vns therapy system labeling states that patients with obstructive sleep apnea may have an increase in apenic events during stimulation. H6 code: treating physician reportedly believes that the left vocal cord paralysis may be related to the implant surgery. The patient's reported obstructive sleep apnea was most likely undiagnosed prior to the implant of the vns therapy system.

Event Description
Wife reported to manufacturer that spouse was experiencing increased apneic periods since vns implantation. Patient reported to the manufacturer on 10/18/2006 that he was seen by an ent on 10/2006 due to ". Worsened snoring" at which time he underwent a nasopharyngoscopy which resulted in the diagnosis of left vocal cord paralysis. Follow-up with the ent indicated that in addition to the nasopharyngoscopy, the patient underwent a polysomnogram which resulted in the diagnosis of severe obstructive sleep apnea with nocturnal desaturation. Patient was placed on nasal continuous positive airway pressure which according to treating physician, ". Seemed to correct the vast majority of his events. " in regards to the report of vocal cord paralysis received from the patient, the ent reported ". That there was complete compensation by the right true vocal cord. This takes a while, so i assume that the left paralysis is due to the operation itself. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=782086


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:38:38 PM
Event Date 12/14/2006
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
Vns therapy system labeling lists dyspnea as a potential adverse event possibly associated with therapy.

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: Respiratory
Post by: dennis100 on July 16, 2011, 11:39:10 PM
Event Date 01/09/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt developed shortness of breath 5 days post implant. Pt was hospitalized and intubated to treat reported shortness of breath. Treating physician reported issue was possibly related to implantation of the vns therapy system. Good faith attempts are being made to obtain add'l information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841707


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:40:06 PM
Event Date 01/01/2007
Event Type Injury
Manufacturer Narrative
A device malfunction is suspected but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that patient's vns device was turned off as it "caused more seizures and choking" in the patient. Pre-vns seizure rate is unknown to manufacturer. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841818


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:40:42 PM
Event Date 01/01/2006
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Rptr indicated that pt experienced dysphagia, dyspepsia, and swelling of the soft palate and uvula necessitating that the device be programmed off. Symptoms improved once the device was programmed off. Device was later explanted. Good faith attempts to obtain more info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841680


Title: Re: Respiratory
Post by: dennis100 on July 16, 2011, 11:41:19 PM
Model Number 103
Event Date 01/04/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2014 due to respiratory arrest from aspiration of food following a long seizure. 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=3738587


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:01:02 AM
Event Date 02/21/2005
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that the vns device has been turned off "for awhile" and the pt "is having problems with persistent coughing". Further investigation indicated that the pt also experiences constant dysphagia. The coughing and dysphagia events began after implantation and have persisted to date. The vns device was turned off over 9 mos ago; however, the coughing and dysphagia events have continued without vns stimulation. The treating physician believes the events are related to vns, although she is uncertain about how they are related. The physician indicated there is "possible laryngeal nerve irritation that is leading to these side effects. " there are no plans for intervention or treatment at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=838531


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:01:38 AM
Event Date 04/01/2007
Event Type Other
Patient Outcome Other;
Event Description
Reporter indicated that a patient passed away. From the information available to the treatiing physician, he believes the cause of death was from choking, however, the cause of death listed on the death certificate is sudep (sudden unexplained death in epilepsy).

Manufacturer Narrative
Death occurred but is not suspected to be related to vns therapy. Device failure is not suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=853046


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:02:19 AM
Event Date 01/01/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that "in the first 2-3 months post implant with side effects that his doctors felt were related to the vns. The patient indicated that during that initial time period, he was hospitalized because he was experiencing clamping of vocal cords obstructing his airway. " the patient also stated that the issue resolved and "emphasized that after nine months post implant, he is experiencing an improvement, is feeling better and is happy to have the implant. " good faith attempts were unsuccessful to obtain further information regarding the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861039


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:02:56 AM
Event Date 11/13/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt had his vns therapy system explanted due to infection, possibly due to the original implant surgery. The infection has since resolved. In addition, the pt has had a chronic cough and dysphagia since the original vns implant surgery, and these have not resolved to date, consult with an ent could not establish a cause for the coughing, and no vocal cord injury was noted. The dysphagia is caused by the coughing. X-rays were negative per reporter. The explanted products have been requested, but have not been returned. Attempts to get product info to review sterility records have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=859163


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:04:07 AM
Event Date 06/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt had developed laryngeal edema. It was reported that initial interrogation at an office visit indicated that the vns generator was set at a duty cycle of 30 seconds on and 0. 5 minutes off. It was also reported that the pt had been continuously swiping his magnet to initiate magnet mode stimulation. The physician changed the off time to 5 minutes in response to the event. No other treatments or actions were reported. It had been previously reported that the pt also experienced dyspnea, voice alteration, and painful stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=896345


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:05:07 AM
Event Date 05/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the patient had trouble breathing and was admitted to the emergency room. The patient's problems resolved after the vns device was turned off. The reporter indicated that the patient has requested that the device be programmed back on. The treating physician's office did not have any additional details of the reported event and did not have current diagnostic or programming history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=868449


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:05:41 AM
Event Date 02/01/2007
Event Type Other
Patient Outcome Other;
Manufacturer Narrative
No device malfunction suspected or reported in conjunction with the reported death.

Event Description
Reporter indicated that the pt expired from sleep apnea and that an autopsy would not be performed. It was also reported that the vns did not cause or contribute to the death. Patient's treating physician reported "pt found in the am, passed during sleep". Physician reported death "not related" to vns. No autopsy will be performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841898


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:06:17 AM
Event Date 07/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the patient could not tolerate programmed parameter settings. The patient went for a sleep study test that resulted in sleep apnea with vns therapy system stimulation only. As report of apnea was reported as the result of increased settings of the vns device, the patient's settings were decreased to see if the apnea resolves. Patient's treating physician believes the apnea is the result of vns stimulation. Good faith attempts are being made to obtain add'l info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900781


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:07:26 AM
Event Date 07/11/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the pulse generator confirmed sterilization of the device prior to distribution. Vns therapy labeling lists infection as a potential adverse event, related to surgery.

Event Description
Reporter indicated the pt "had a seizure and fell on his vns generator. As a result, there was swelling around the generator. " the pt had a possible seroma generator wound and was admitted to the hospital and an irrigation and debridement procedure was performed. The surgeon also noted that was some drainage at the neck site that also required an irrigation and debridement procedure. The pt developed an infection and subsequently had to have the vns therapy system explanted. The pt developed postoperative stridor. The pt was given antibiotics preoperatively, perioperative and postoperative. Cultures obtained, but the results are unknown. The last clinic note obtained indicated the infection has resolved. The site discarded the explanted vns therapy system; therefore, a product analysis will not be performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=926279


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:08:03 AM
Event Date 09/10/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient was experiencing painful stimulation in her throat, difficulty breathing, and a migration of her pulse generator. Follow-up with the patient's treating physician revealed that he believed that the migrating generator was pulling on the lead, causing the other adverse events. Patient subsequently had her pulse generator and lead removed due to these adverse events. No reimplant is planned at this time. Explanted generator and lead were subsequently returned to manufacturer for product analysis; however, that analysis is not yet complete. Follow-up with the explanting physician revealed that it was believed the migration was due to the original placement of the generator and the amount of fat at the generator suture location.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=924877


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:08:45 AM
Event Date 01/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected.

Event Description
Reporter indicated that recent diagnostic testing "suggested the possibility of lead fracture or disruption. " it was additionally noted that the patient is experiencing an exacerbation of his sleep apnea secondary to vns therapy, and that device disablement yielded an improvement with this apnea. Patient is currently scheduled for exploratory surgery with the possibility of replacing the lead. Good faith attempts for further information are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968185


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:10:01 AM
Model Number 102 GENERATOR; 302
Event Type Injury
Patient Outcome Disability;
Event Description
Cyberonics vagus nerve stimulator was implanted in our son just two years ago to help control his seizure disorder. We saw improvement early on, but due to problems created by the implantation his vocal cord retinoid on the right side was paralyzed limiting the ability to breathe at the higher settings of the device-the maximum settings could not be employed. Our physician continued to work with the settings and we did see improvements. The problems began in the spring of 2007. We saw a change in the severity of his seizures and the left side of his face was affected as well. We noticed that he had quit snoring , a side effect of the device and one night we could not get the device to turin on during a seizure. We now believe the device began to malfunction late spring of 2007. Our physician confirmed that the device was malfunctioning. After trying to get information from cyberonics -he had x-rays and our physician confirmed that the battery was still operational. They finally came to the conclusion that it was the leads to the device that were faulty. This is a costly device. I would assume a patient could expect a longer lifetime in a device that is so delicately connected to the vagal nerve. Next to the carotid artery. Our son now faces yet another surgery to remove the device -the battery compartment is now coming through his skin -and to leave the leads attached to the vagal nerve. Dates of use: 2005 - 2007. Diagnosis: seizure disorder.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962494


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:11:11 AM
Event Date 08/06/2007
Event Type Death
Patient Outcome Death; Hospitalization
Event Description
Reporter indicated that a vns patient experienced choking, gagging, and vomiting with stimulation, which led to the patient being admitted to a hospital due to dehydration. The reporter also indicated that the patient's seizures worsened with the stimulation. The patient then reportedly died a few weeks later due to respiratory failure. Previous correspondence with the treating neurologist revealed that the patient died of liver failure and death certificates states that the patient died due to respiratory failure, liver disease, and intractable seizures. The explanted generator and a portion of the lead were received from the funeral home. No anomalies were found with the generator as it performed according to specifications. The returned portion of the lead performed according to specifications. Good faith attempts for additional information have been successful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=957507


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:11:56 AM
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: Respiratory
Post by: dennis100 on July 17, 2011, 12:12:36 AM
Event Date 07/01/2006
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that a pt desired to have the vns generator and lead removed due to painful stimulation and dyspnea. The vns was disabled and the symptoms have improved. The pt has had a surgery consult but no surgery date has been set.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=937309


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:13:53 AM
Event Date 09/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt had experienced coughing, shortness of breath, and pain in the area of the electrodes on the left side of his neck. It was reported that the output current had been adjusted in an attempt to alleviate the events. It was reported that the pt wanted to have the vns device explanted. F/u with the treating physician revealed that the pt thought that the events were related to vns stimulation and that the "vns caused seizures", and the vns output current was then set to 0ma. The surgeon reported that the vns generator and leads were explanted due to pain and an increase in seizures, as the pt had experienced "more seizures than ever before". It was reported that the pt had at one time achieved good efficacy and seizure reduction after beginning vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=983383


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:14:27 AM
Event Date 04/01/2006
Event Type Injury
Patient Outcome Hospitalization;
Event Description
The rptr indicated that the pt mother left a message on their voicemail. "the problems referenced were increasing seizures, a feeling like the wires are pulling, choking every-time the magnet is used on the generator. The pt has been to the er, several times. The er sent her home, saying she has muscle spasms. The pt has been crying" it was reported that the pt was not able to find someone to perform ct scan or x-rays. The pt's mother wanted the vns sys removed from the pt. The pt underwent a full revision surgery. Good faith attempts for add'l info are in progress and awaiting response.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=997863


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:15:07 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
It was reported to manufacturer that the vns pt developed respiratory difficulties during sleep within months of implantation. Additionally, it was reported that the pt developed snoring and stridor-like sounds during sleep. Initially, the symptom was attributed to obstruction of upper airways due to obesity. However, no evidence of this was found when the pt was seen by an ent specialist. The physician has opted to turn the device output current (normal and magnet mode) to 0ma. There was a rapid disappearance of the symptoms following device disablement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=977562


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:15:44 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient has a past medical history of sleep apnea. It is unknown if the vns is related to the patient's sleep apnea. The notes indicate that the patient experiences problems with her breathing at high duty cycle so the settings were adjusted. The notes indicate that the patient felt better after the setting adjustment and device diagnostics were within normal limits. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Further follow-up revealed that the patient has not been seen for reassessment; therefore the relationship to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3396701


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:16:25 AM
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Navarrete, eduardo g. , et al. "vagus nerve stimulation (vns) for the treatment of pharmacoresistant epilepsy: the spanish experience. ".

Event Description
Reporter indicated that a pt's vns device was turned off due to severe dyspnea.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1007350


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:17:01 AM
Event Date 12/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Khurana, divya s. Et al (2005) vagus nerve stimulation in children with refractory epilepsy: unusual complications and relationship to sleep-disordered breathing. American epilepsy society meetings in washington dc, 2-6.

Event Description
It was reported a vns patient "developed a persistent cough after vns implantation before the device was turned on. The cough persisted after the device was turned on, and 1 month later, stimulation was turned off because of the severity and persistence of the cough. The cough, however, persisted despite cessation of stimulation and an extensive evaluation including testing for pertussis and bronchoscopy, which were negative. " the patient underwent vns therapy explantation. "immediately after removal of the vns, the cough stopped. " the cough "can only be explained as direct mechanical irritation of the recurrent laryngeal nerve as opposed to the more commonly seen stimulation-induced cough, which is usually mild, transient, and resolves spontaneously. " 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=1007397


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:17:54 AM
Event Date 12/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death.

Event Description
It was reported to mfr that the vns patient had revision surgery due to high lead impedance believed to be due to a possible lead discontinuity. Further follow up with the treating physician revealed that the pt had presented at an office visit complaining of pain, shortness of breath, and voice alteration which were all described as constant. A system diagnostic test was performed and revealed high lead impedance. As a result, the physician disabled the device and the adverse events resolved. The pt was referred for revision surgery. There was no trauma, manipulation, or other believed cause of events. X-rays were not taken prior to surgery to assess the continuity of the system. During surgery, a new system was implanted and only the generator was explanted, as the surgeon opted to leave the existing lead implanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=997057


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:18:53 AM
Event Date 02/01/2008
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt developed a hematoma in his neck which was continuing to swell and beginning to block his airway. Pt underwent emergency surgery to remove the hematoma, and the vns therapy lead was also removed during this process. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018988


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:19:33 AM
Event Date 02/13/2008
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to manufacturer that after the vns patient's device was interrogated at a routine office visit, the device output current was found to be a 2. 25ma, where the patient had previously been set to 0. 75ma. As a result of the high output current, the patient "grabbed her neck and was turning blue". The patient's device was interrogated using a different programming system and the settings were changed to the intentional settings. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1017637


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:20:18 AM
Event Date 02/08/2008
Event Type Death
Patient Outcome Death;
Event Description
It was reported to manufacturer that the vns patient passed away. The site reported that the patient had aspirated and was taken to the emergency room with decreased oxygen. The patient coded in the emergency room and was subsequently placed on a ventilator. The patient reportedly expired due to aspiration and respiratory distress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1012528


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:20:51 AM
Event Date 11/01/2006
Event Type  Injury   
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.
 
Event Description
An article titled "safety and efficacy of vagus nerve an article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that a participant developed an upper respiratory infection following implant. Attempts for add'l pt and event info have been unsuccessful to date.
 
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324465


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:21:35 AM
Event Date 01/08/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that a vns patient experienced respiratory issues and a seizure increase, relationship to pre-vns baseline unk. The reporter wrote that "his lung sounds are course and wet, and we're giving him nebulizer treatments every four hours. He's not sleeping much and is having more seizures. A chest x-ray showed possible pneumonia in his left lung, so we're treating it as pneumonia with antibiotics, steroids, and continued nebulizer treatments. " the reporter indicated that the patient recovered from his illness in 2007. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009078


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:22:16 AM
Event Date 12/01/2007
Event Type Injury
Patient Outcome Other;
Manufacturer Narrative
Pearl pl, conry ja, yaun a, taylor jl, heffron am, sigman m, tsuchida tn, elling nj, bruce da gaillard wd. Misidentification of vagus nerve stimulator for intravenous access and other major adverse events. Pediatr neurol 2008;38:248-251.

Event Description
It was reported that the patient experienced breathing difficulties and as a result, surgical intervention took place to explant the vns device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034250


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:22:56 AM
Event Date 06/01/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Since i was implanted with cyberonics, inc vagus nerve stimulator in 2007, i have suffered a series of adverse reactions. These included: weight loss over a 2 month period- requiring 2 hospitalizations for dehydration -due to anorexia and abdominal pain-; severe left ear pain requiring visits to my ent and subsequent lowering of the strength of stimulation; severe shortness of breath accompanied by airway constriction, and low blood oxygen levels requiring evaluation by a pulmonologist, pulmonary function studies, and a cat scan; sleep hypopnea demonstrated by polysomnogram and a choking sensation. I must use the magnet provided by cyberonics inc at least 75% of the time. The stimulator, which was implanted for trd, never seemed to relieve my depression. Dates of use: 2007 - 2008. Diagnosis or reason for use: trd. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1033973


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:23:47 AM
Event Date 03/19/2008
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated that a patient's vns was stimulating every two minutes and causing dyspnea and painful stimulation. The vns was disabled. The patient was also having increased seizures that were greater than pre-vns baseline. The patient has since undergone generator replacement surgery. The explanted generator has been requested for return. All attempts to the reporter for additional information regarding the reported events have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1035131


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:24:48 AM
Event Date 11/30/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated a vns patient experienced "post operative laryngospasm with respiratory arrest treated with oxygen and naloxone and diphenhydramine. Brief respiratory arrest from laryngospasm during her transfer to the recovery room treated with naloxone and oxygen. Diphenhydramine was also given as she had a (preexisting) thoracic rash. " the medical professional stated the event was definitively related to vns therapy implantation. 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=1132649


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:25:21 AM
Event Date 06/03/2008
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that a "pt is complaining about nightly breathing stridor. Pt is referred to a lung specialist. " good faith attempts are being made for add'l details surrounding the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068416


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:27:03 AM
Event Date 06/03/2008
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that they had been implanted with the vns for a couple of years, and when the vns goes off it "chokes him. " reporter indicated "he had a cold last week and it stopped him from breathing for 30 seconds and he turned device off. Patient reports he turned the device back on. " good faith attempts are being made to the pt's physician for additional details surrounding the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068174


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:27:40 AM
Event Date 04/22/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns was scheduled for revision surgery to have the lead and generator replaced due to a sudden onset of painful stimulation in the throat, tightening in the throat during stimulation, protrusion of two tie downs in the neck, and an increase in seizure activity. The events were preceded by a car accident in which the seat belt was across the left neck. A diagnostic test was performed pre-operatively and yielded normal results, indicating normal device function. No x-rays were taken to rule out a gross lead break. The generator was replaced prophylactically, and the lead and tie downs were replaced as well. The explanted portion of the lead and the generator has been returned to mfr and analysis is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051115


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:28:36 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
It was reported to manufacturer, that the vns patient was recently diagnosed with chronic obstructive pulmonary disorder (copd) shortly after having the vns device implanted. Additionally, the patient reported experiencing the onset of shortness of breath, which was not associated with stimulation on times. The patient reported that asthma was a pre-existing condition and that the condition has not declined since being implanted with vns. The patient has not informed his treating vns physician about the copd diagnosis, therefore the relationship of the event to the vns is unk. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=960031


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:29:26 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the pt entered the hosp after suffering with what was described as a "code blue," subsequently the pt "experienced three more cardiac arrests and/or respiratory arrests. " the reporter indicated that the pt was in the hosp for two weeks and discharged last week. The reporter did not explant the device and opt-ed to turn the device off. Since, the reporter wants to find the cause of the arrest. The pt was referred to a cardiologist for eval. Good faith attempts are in progress to obtain additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992765


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:32:02 AM
Event Date 04/10/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer that the vns patient recently began experiencing random muscle spasms in the chest at the generator site. Additionally, it was reported that the patient was experiencing shortness of breath during the random muscle spasms, constant hoarseness, an increase in seizure activity, below pre-vns baseline, and migraine headaches 4 or 5 times a week. The physician performed normal mode, system, and magnet mode diagnostic tests following the onset of the events, and the results revealed normal device function. The physician subsequently disabled the device and the events have reported resolved. As a result, the physician has referred the patient to a surgeon to have the lead and generator replaced. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047205


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:32:44 AM
Event Date 06/04/2008
Event Type Injury
Patient Outcome Required Intervention; Congenital Anomaly
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:33:20 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that pt went to see neurologist due to severe coughing. Her settings were lowered once, but the coughing persisted. The physician then decided to lower her settings a second time. This change made her cough and even choke to the point where she couldn't really breathe. The physician turned the device off for now. Pt is following up with her primary care physician and checking back with neurologist. Attempts for further info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1074563


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:34:08 AM
Event Date 05/23/2008
Event Type Injury
Patient Outcome Required Intervention; Other
Event Description
Reporter indicated that a vns patient had difficulty breathing and a "blood clot pressing on wind pipe". It was reported that the event was intermittent, moderate in severity, and related to implantation of the vns device. It was reported that the patient was seen in the emergency room in response to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069911


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:34:43 AM
Event Date 01/01/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Rossignol, e. , et al. , vagus nerve stimulation in pediatric epileptic syndromes, seizure: eur j epil (2008), doi 10. 1016/j. Seizure. 2008. 03. 010.

Event Description
During a review of an article regarding vns therapy for pediatric epilepsy pts, it was reported that a male pt died from upper airway obstruction when he was left unattended eating solid foods 2 months following initiation of vns. It was noted that the death could not be clearly attributed to vns as the child was left unsupervised with solid food. Attempts to obtain add'l info are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1139425


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:35:25 AM
Event Date 06/19/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in a scientific article that a vns patient, whose preexisting obstructive sleep apnea had been exacerbated by vns stimulation, required cpap treatment to preclude potential adverse events. Good faith attempt for additional information have been unsuccessful to date.

Manufacturer Narrative
Article reference: marzec, mary, jonathan edwards, oren sagher, gail fromes, and beth a. Malow. "effects of vagus nerve stimulation on sleep-related breathing in epilepsy patients. " epilepsia 44 (2003): 930-35.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1143660


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:36:20 AM
Event Date 03/07/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated that a patient underwent lead and generator revision surgery due to high lead impedance. The patient was also experiencing erratic stimulation and dyspnea prior to the revision surgery; the vns was disabled prior to the revision surgery. High lead impedance has been occurring since 2005. Vns diagnostics for the original implant surgery are unknown; all attempts to the implanting surgeon have been unsuccessful to date. The explanted lead and generator are currently in product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025382


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:36:56 AM
Event Date 05/01/2008
Event Type Injury
Patient Outcome Other;
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, vns placement appeared normal.

Event Description
It was reported that a vns pt was referred to an ent surgeon due to his dyspnea during stimulation. The pt indicated the surgeon scoped him and told him his larynx is scarred. The surgeon diagnosed him with "spasmotic dysphoria. " his larynx spasms and tightens during stimulation. This condition constricts his airway making it difficult to breathe. Taping the magnet over the device to stop stimulation resolves the dyspnea. The ent recommended the pt see a speech pathologist to assist in decreasing the muscle spasms. The neurologist sent x-rays to the manufacturer for review to assess the vns placement. Review of the x-rays showed placement of the vns device to be normal. No discontinuities were observed on the lead body. The neurologist also indicated the pt's vns device would be programmed off. The pt is currently being seen by a speech pathologist and is reported to be doing much better. 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=1120669


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:37:38 AM
Event Date 01/01/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in an article reviewed by manufacturer that the vns patient experienced periodic apnea in the outpatient clinic which subsided after deactivation of the device. Attempts to obtain additional information are underway.

Manufacturer Narrative
Aziz, e, radcliffe, j. J. "vagal nerve stimulators and anaesthesia: 1. " anaesthesia 2001; 56: 1209.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1102487


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:38:15 AM
Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported that the pt is experiencing pain sensations associated with stimulation and muscle spasms in the throat. Pt was having choking sensations as a result of this. X-rays were received and reviewed by the mfr. No gross fractures, discontinuities or acute angles in the lead were observed. System and normal mode diagnostics were performed and were within normal limits. Pt had complete revision surgery. Generator was replaced prophylactically. Surgeon removed the entire lead intact. He noted a section of lead wire which was exposed. This section is located on the negative lead body between the negative electrode and the anchor tether. The silicone was breached. On this section, there is only one layer of tubing. Product analysis is pending on the explanted lead.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180869


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:38:50 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the patient's device was removed, due to the patient experiencing pain and suffering from bronchitis. The device has been returned to the manufacturer for analysis however, the evaluation is not complete at the time of this report. Good faith attempts to obtain additional information regarding the patient's events have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1169948


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:39:43 AM
Event Date 08/11/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a vns therapy pt is experienced an "asthma attack - extreme shortness of breath. " it was stated it was a single episode that was probably related to vns therapy stimulation. The event resolved without intervention. 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=1155535


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:40:17 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was reported that pt has several issues with respiratory distress when he sleeps. In the last 2 months off and on, the skin around his collarbone would sink in and he would wheeze. Pt's caregiver attributed this to recent adjustments of the vns and dismissed it as it was infrequent; however, during his nap recently, he had his abdomen sinked under his ribs and had erratic breathing for about one min. It happened again fifteen mins later but much more violently. His heart was reportedly beating rapidly and his breathing was a high pitched wheeze. His entire abdomen was spastic. It took about a min for the pt to get back to normal. Attempts for further info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153329


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:41:05 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
A vns pt reported that she has post polio syndrome and indicated that with vns therapy she feels like she is being "strangled". The pt indicated her vns device is "nearly shut off" by her treating physician. Her treating physician has recommended that her vns device be removed. Good faith attempts to obtain additional info have been unsuccessful to date. Explant surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153331


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:41:56 AM
Event Date 08/14/2008
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported that a vns patient had experienced two episodes of respiratory stridor and shortness of breath. The initial episode was reported to be continuous in frequency and moderate in severity. The patient's treating physician ruled the event to be possibly related to stimulation, unlikely related to implantation and indicated that no interventions taken. The second episode was reported to be continuous in frequency and severe. The patient's treating physician ruled the event to be possibly related to stimulation, unlikely related to implantation and indicated that this episode was not a serious adverse event. The physician also indicated that the following interventions were taken: parameter changes were made, magnet used to disable generator, medication was added and that the patient was admitted to the emergency room and had an ent evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1215357


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:42:34 AM
Event Type  Injury   
Event Description
The abstract of the article, ¿sleep-related breathing abnormalities in children receiving vagus nerve stimulation¿, was received and reviewed by the manufacturer. The following is the abstract: ¿rationale: vagus nerve stimulation (vns) has been reported to affect breathing during sleep in children. Obstructive sleep apnea (osa) is the most significant sleep-related breathing abnormality reported with vns, but tachypnea and decreased oxygen saturation have also been reported. The purpose of this study was to determine the incidence and degree of sleep-related breathing abnormalities in children with refractory epilepsy who receive vagus nerve stimulation. Methods: this is a retrospective chart review of 12 children with epilepsy (ages 3. 3-16 yrs; 10 female) who underwent polysomnography after vns placement. Polysomnography was performed at the (b)(6) hospital sleep center utilizing nicolet vicvu equipment. The vns was turned on during the entire polysomnography. Data were analyzed using descriptive statistics. This study was approved by the (b)(6) college of medicine institutional review board. Results: all children had intractable epilepsy and were receiving vns therapy through the comprehensive epilepsy program at (b)(6) hospital. One patient was not taking any antiepileptic drugs (aed), 2 were taking 1 aed, 6 were taking 2 aeds, and 3 were taking three aeds. Seven children had a generalized epilepsy syndrome and five had localization-related epilepsy. The majority of the patients had neurodevelopmental disabilities with 5/12 being non-ambulatory and g-tube fed. The mean bmi was 16. 7 (sd 1. 86). The vns generator output current was 1. 5 ma in 9 children, 1. 75 ma in 2, and 0. 5 ma in 1 patient. Vns signal frequency was 30 hertz in 5/12 and 20 hertz in 7/12. The vns duty cycle had an on-time of 30 seconds for all patients and an off-time of 5 minutes in three patients, 3 minutes in 5 patients, 1. 8 minutes in 2 patients, and 1. 1 minutes in 2 patients. There was osa recorded in 5/12 (42%) patients and central sleep apnea recorded in 10/12 (83%) patients. However, the apnea was mild in 9/12 patients (75%), moderate in 1 patient (8%), and severe in 2 patients (17%). The patients who had severe apnea were multiply handicapped and nonambulatory. Conclusions: these findings demonstrate that sleep-related breathing abnormalities may occur in children with refractory epilepsy who receive vagus nerve stimulation. Children at highest risk appear to be those with more severe neurodevelopmental disabilities. Consideration may be given to prescreening these children with polysomnography before proceeding with vns therapy. ¿ attempts have been made for additional information; however, they have been unsuccessful. The relationship of the apneas to vns and details for each patient are unknown. The events have been reported under the following manufacturer report numbers: patient 1 1644487-2013-03771 sleep apnea, patient 2 1644487-2013-03772 general apnea, patient 3 1644487-2013-03773 general apnea, patient 4 1644487-2013-03774 sleep apnea, patient 5 1644487-2013-03775 sleep apnea, patient 6 1644487-2013-03776 sleep apnea, patient 7 1644487-2013-03777 sleep apnea, patient 9 1644487-2013-03778 sleep apnea, patient 10 1644487-2013-03779 sleep apnea, patient 11 1644487-2013-03780 sleep apnea, patient 12 1644487-2013-03781 sleep apnea. Patient 8 1644487-2013-03789 sleep apnea.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3520176


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:43:09 AM
Event Date 09/18/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt had her vns device turned off for three weeks, and when the device was turned back on, she began experiencing pain/burning sensations at the chest site. She also experienced extreme shortness of breath during system diagnostics test and magnet use. Diagnostic tests showed vns to be functioning properly. The pt's device was programmed off. X-rays were sent to the mfr for review. The negative electrode did not appear to be in the typical helical orientation. Additionally, the electrodes were not aligned vertically. The strain relief of the lead body at the neck did not appear to be adequate. No tie-downs were visualized. No obvious lead discontinuities were observed. The pt has currently been referred for a surgical consult. Good faith attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative
Method: mfr reviewed x-rays of implanted device. Electrodes not oriented according to what is typically viewed. Strain relief appeared to be inadequate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1212658


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:43:42 AM
Event Date 08/26/2008
Event Type Injury Event
Description
Initial reporter indicated that they had to place the magnet over their vns generator as she "gets a choking sensation and muscle spasm with stimulation. " the patient is going to be referred to a surgeon to have their vns removed. Good faith attempts are being made for further details surrounding the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1209558


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:44:18 AM
Event Date 09/18/2008
Event Type Injury
Patient Outcome Other;
Event Description
Rptr indicated a vns therapy pt is being referred to surgeon for explant of the device. The reason for the explant is exacerbation of asthma and painful stimulation. 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=1202921


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:44:52 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt was experiencing an increase in intractable seizures with apnea. The physician decided to replace the device even though it did not indicate end of service. Following surgery, it was reported that the pt's seizure level is back down to normal. Product was returned to manufacturer, but analysis is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1199828


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:45:35 AM
Event Date 07/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer by the vns patient that the device had been disabled due to shortness of breath. The shortness of breath event improved after the device was disabled. The patient now reports feeling pain at the "generator to the neck along the line of the lead. " attempts to obtain additional information from the treating physician are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1196283


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:46:04 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: Respiratory
Post by: dennis100 on July 17, 2011, 12:48:29 AM
Event Date 09/03/2008
Event Type Injury
Patient Outcome Hospitalization; Disability
Event Description
Pt is diagnosed with intractable complex partial seizure disorder. A vagal nerve stimulator was placed in 2001. She has taken different seizure medications and had numerous neuro consults. In 2003, an evaluation of the vns by the neurologist, dr was done due to change in seizure patterns. There were some battery problems and it was determined that she needed replacement of her vns leads. This procedure was done by another dr at hospital, in 2004. In 2008, inspiratory-whooping- sounds were noted. The vns settings were increased and she developed episodes of apparent stridor with a cyclic characteristic suggesting it may be related to the vns. Due to snoring, "whooping" sounds consistent with laryngeal spasm, the vns was adjusted downward with some improvement, but no resolution. Approx five months later, she wad admitted to the medical care unit at development center where she lives due to increased seizure activity. She had a ct scan of the head the next day, which revealed question of mild hydrocephalus although it was unclear whether it was old or new problem and prominent ventricles were noted. The vns was placed on inactive setting five days later. She was seen by dr(third), ent, the following day, and she had a flexible laryngoscopy while off the vns. The findings indicated bilateral cord paralysis and he stated she was a candidate for tracheostomy or arytenoidectomy. Pt was admitted to hospital the same day, and remained until eight days later, with a diagnosis of aspiration pneumonia, uti, uncontrolled seizures, partial airway obstruction-probably induced by vns. She was seen by the ent while in the hospital for her vocal cord paralysis. She had another flexible direct laryngoscopy and it was noted that her vocal cord paralysis was resolved. He recommended not using the vns at present. She had medication adjustments while in the hospital for her seizures. Since her return to development center, she hasn't had any of the "whooping" noises and her seizure activity has decreased tremendously. She is more alert. Dates of use: 2001 -- 2008. Diagnosis or reason for use: epilepsy. Event abated: yes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1270446


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:49:10 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Article reference: papacostas ss, myrianthopoulou p, dietis a, papathanasiou es. Induction of central-type sleep apnea by vagus nerve stimulation. Electromyogr clin neurophysiol 2007;47:61-3.

Event Description
It was reported in a scientific article that a vns patient had developed central-type apneas two years after being implanted with vns. The reporter stated that they believed the events were related to vns therapy as the patient had no preexisting symptoms, though the events appeared to be independent of "vns activation. " the reporter also stated that a decrease in therapy setting resulted in resolution of these central breathing events and added that the patient's high therapy settings could have potentially contributed to the events. It is unknown whether or not the decrease in therapy settings has affected the patients seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1246331


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:50:04 AM
Event Date 10/20/2008
Event Type Malfunction
Event Description
Initial reporter indicated that she recently had her vns turned up and now "had a cold and if feels like there is pressure in her throat. " she has also been "coughing a lot. " she reported that she had an increase in seizures, "4 last night and 2 this morning. " she did use the magnet and it did help all but one of her seizures. She felt like "she could not breathe, or catch her breath. " it is unk if the pt's seizures are above their pre vns seizure rate. The pt recently underwent root canal surgery. Good faith attempts are being made for add'l details surrounding the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1249827


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:51:00 AM
Event Date 02/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer by the patient's mother that the patient has been experiencing dysphagia and dyspnea since an increase in settings of the generator. It was indicated that these episodes were followed by seizures. It was also indicated that this frequency of seizures was above pre-vns baseline. The relationship between the increase in seizures and vns therapy is unknown at this time. The patient was suggested to use the magnet during meals to avoid aspirating. Good faith attempts to obtain additional information regarding the reported events have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1244594


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:51:42 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that the patient was having frequent, recurrent respiratory infections. The physician turned the device off to see if that would make any difference in his symptoms per the mother's request. Per the physician, the relationship of the event to vns in unk at this time and patient has not been seen since device was turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1242940


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:52:37 AM
Event Date 05/01/2008
Event Type Malfunction
Event Description
Reporter indicated that patient started feeling painful stimulation at the electrode site along with choking sensation and gasping during stimulations. X-rays were taken and sent to manufacturer for review. X-rays revealed a lead discontinuity near the electrode area below the anchor tether. Further follow up revealed that patient underwent complete revision and good faith attempts for additional information and product return are currently being made. Attempts for additional information are in progress.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248351


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:53:17 AM
Event Date 10/01/2008
Event Type Other
Patient Outcome Other;
Event Description
My son has microcephaly with spastic quadriplegia. He is nonverbal and requires total care. He had increased seizure activity while in the hospital for spinal rod placement, and his vagal nerve stimulator was "turned up" to try and help with this. He went home uneventful and in fact a day early and had 2 more visits to the neuro for adjustment of the vns. By approx two months later, pt developed severe breathing problems, erratic heart rates 45-152/min, loss of his voice when he cried and profuse sweating. He ended up requiring constant nasal oxygen with a nonrebreather at times. He now also requires cpap at night and daily breathing treatments. I taped the magnet onto the vns the following month to shut it off, because his doctor didn't believe it was the vns. If i hadn't of done this, my son would be dead today. I am a rn and am appalled at the lack of caring and knowledge r/t this device. I took him back to the surgeon that put it in and he turned the device down to the original settings. At the highest point, it was on for 30 sec and off for. 8 min with 2. 5 amp. It is now on for 30 sec and off for 5 min at 1. 75 amp. Dates of use: 2007 -- 2008. Diagnosis or reason for use: seizures. Event abated after use stopped: yes. Event reappeared after reintroduction: no.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1276206


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:54:09 AM
Event Date 10/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that a patient's vns device was explanted due to intolerable side effects. The patient felt like her throat was closing and it was hard to breathe. However, the physician indicated that the main concern for removing vns was the patient's future need for an mri. After vns was explanted, the physician indicated the patient's trouble swallowing has continued. The patient was diagnosed with left vocal cord paralysis. The physician also stated that the paralysis may be associated with some of her difficulty swallowing. The explanted product was returned to the manufacturer. Product analysis revealed no anomalies with the generator or lead. Both performed according to specifications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1230026


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:54:53 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient is experiencing shortness of breath especially in the later part of the day. Per reporter, patient is now undergoing surgery to remove the vns device due to this shortness of breath. Surgery date is unknown at this time. All attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1225766


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:55:25 AM
Event Date 10/15/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient was admitted to the emergency room due to severe shortness of breath and coughing. The physician, at the facility, related the event to asthma (a chest x-ray was taken and medication was prescribed). The patient reportedly did not feel the events were asthma related as the symptoms dissipated with magnet disablement and refused to take the prescribed medication. Follow up with the reporter revealed the cause of the sudden onset was unknown and added that a decrease in output current resolved the patient's discomfort. Diagnostics performed at this office visit were with in normal limits, confirming proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1222551


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:55:59 AM
Event Date 03/31/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient had her device turned off because she was having difficulty breathing during stimulation on times. She has requested that the device be removed. However no surgery has been scheduled at this time. Good faith attempts to obtain additional 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=1283158


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:56:38 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns patient was experiencing an increase in seizures and had her setting adjusted to give the pt better seizure control however, the pt began to experience other issues such as shortness of breath and nervousness which the pt felt was related to vns so, the physician programmed her device off. If the pt's seizure control does not change or worsens within the next 3 months, the device will be programmed back on. Otherwise, the device will be explanted. 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=1354378


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:57:11 AM
Event Date 12/30/2008
Event Type Malfunction
Event Description
Reporter indicated a vns therapy patient experienced a "recent onset of gagging and choking. " the physician reviewed x-rays, which "showed no evidence of a lead fracture or disruption. " however, the physician is planning have the patient's lead replaced due to "possible short in wire that is causing neck discomfort even when vns is no low power," and the generator because "it is 6 years old. " a battery life calculation revealed the patient's generator was found to be 0. 42 years until the elective replacement indicator read "yes. " 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=1363447


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:57:49 AM
Event Date 01/19/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to mfr that the vns pt was experiencing a coughing fit every day at about 2 pm during which the pt also experienced cyanosis. The pt's caregiver stated that the coughing started in january 09. The pt's device settings when the event was occurring were 2. 75 ma/30 hz/250 usec/30 sec on/3 min off. The pt was seen by the treating physician for a follow up appointment. At the appointment, the settings were decreased to 1. 25 ma/30 hz/250 usec/30 sec on/3 min off with magnet setting of 1. 5 ma/250 usec/60 sec on. These settings were changed about 10 minutes prior to the expected time that the event occurs. No adverse events were experienced at the lower settings. As a test, the magnet output current was increased to 2. 5 ma. The magnet was swiped across the generator site to initiate magnet mode stimulation, and the pt experienced the adverse events. At that time, the physician lowered the magnet current back to 1. 5 ma and the adverse event resolved. Diagnostic tests were performed revealing normal device function. The pt left the office with the previously stated device settings and the pt was tolerating stimulation well. The pt has not been seen for a follow up appointment since the settings were decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1347123


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:58:36 AM
Event Date 08/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer that the vns pt was experiencing a cough every day at 9 a. M. That lasts for about two minutes. The physician stated that the coughing started in 2007, shortly after having a new generator implanted, and recently disabled the device due to the adverse event. The coughing resolved with the device disabled. The previous settings were 2. 5 ma, 30 hz, 500 usec, 30 sec, 3 min. The physician then turned the device back on the week later with lower settings (2. 0 ma, 20 hz, 250 usec, 30 sec, 3 min) and monitored the pt's tolerability and seizure control. The pt's coughing did resolve with the lowered settings, however the pt began experiencing break-through seizures, below pre-vns baseline, as a result of the lowered settings. Both normal mode and system diagnostic tests were performed routinely by the physician, and revealed normal device function. X-rays were taken and reviewed by the physician and there were no anomalies observed. The physician opted to replace the generator, as there was concern that the pt did not experience this adverse event with the previously implanted generators. Additionally, the coughing event was affecting the pt's seizure control as the device setting had to be decreased for tolerability which subsequently lessened the seizure control. The pt subsequently had surgery where the generator was replaced. The explanted generator has been returned to manufacturer and is pending the completion of the analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341926


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 12:59:03 AM
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: Respiratory
Post by: dennis100 on July 17, 2011, 12:59:40 AM
Event Date 12/15/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Treating medical professional indicated that during attempts to interrogate the patient's device and run diagnostics, the patient would cough followed by vomiting. The patient reportedly had not experienced these events before and did not experience these events during normal stimulation. The medical professional was under the assumption that the generator might be nearing end of service, but programming history determined that the generator was not approaching end-of service. Due to the coughing and vomiting issues during interrogation and diagnostics, the treating physician decided to replace the generator. The patient underwent generator replacement surgery. Further follow up with treating medical professional revealed that the patient was seen for a post-operative visit and patient is reportedly doing well with no adverse events reported during interrogating and performing diagnostics. The cause of the adverse events and relationship to vns therapy is unknown at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1317799


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:00:15 AM
Event Date 01/12/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310986


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:01:00 AM
Event Date 02/01/2006
Event Type Malfunction
Event Description
Initial reported indicated that the patient was having pain and coughing about every 3 mins for about 10 sec every time the vns activated. System diagnostics in 2008, resulted in ok/ok/dc=2, eri=no. There was no change in settings, trauma or manipulation to cause the sudden onset of coughing with stimulation. X-rays were received for review on the patient's vns and no anomalies noted. Good faith attempts are being made to see if the patient had a surgery to replace their vns lead sometime in 2008. At this time, a lead issue is suspected, if the patient has the same lead implanted.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by manufacturer, no gross lead discontinuities visualized. Conclusions : device malfunction suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1344184


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:01:40 AM
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425022


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:02:12 AM
Event Date 12/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the patient is using magnet to stop vns stimulation at times because patient thinks that vns is triggering an asthma attack. Follow up with the physician's office revealed that the patient had reported about the asthmatic attack in 2009, but it took place in late 2008. Patient used the magnet to turn the device off and it helped her. The attack took place only once and has not repeated again since then. Physician did not want to allege vns at this moment since the attack happened in december and he never saw the patient when the event took place. Physician does not know if patient had pre-history of asthma prior to vns. Patient reported that asthma attack was because of vns and the cold weather made it worse. Physician does not know the severity of the event. As of right now, the device has been turned off. At the time of turning the device off, device diagnostics were within normal limits. No other intervention is taken right now.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368748


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:03:02 AM
Event Date 02/15/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that it appeared that the pt's lead was becoming more prominent in the pt's neck, and that the pt had begun to manipulate the device at that area. It was also noted that the pt would grab and pull at the site during stimulation, and as the pt is non-verbal, it is believed there was pain associated with the stimulation. It was also indicated that the pt had begun to cough more with stimulation since the protrusion began. The pt's treating neurologist believed that a tie-down had come loose, causing the protrusion, and that this was also the cause for the pain and coughing. As such he ordered a revision surgery, to resecure the lead in the underlying tissue. During the surgery only one tie-down was noted, and it was pushing against the outside of the neck. The surgeon decided to removed the tie down, and not secure the lead, as he believed the fibrosis that had built up was sufficient to secure the lead in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1362602


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:04:28 AM
Event Date 02/12/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that vns pt had trouble breathing. The pt was examined by an ear nose and throat specialist who stated that vns therapy was the cause of the breathing problem due to changes in the larynx and vocal cords. The current treating physician turned the device to 0 ma and stated that the vns device has worked well on the pt, but does not know if the breathing problem roots to the pt's pre-existing medical conditions. 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=1356628


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:05:33 AM
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure suspected.

Event Description
Reporter indicated that the patient was experiencing severe coughing and gagging during stimulation. The patient claimed that the coughing and gagging began following a seizure in which she fell. The physician believes that there may be a fracture in the lead, and has ordered x-rays to be taken. All attempt for further information and to have the x-rays forwarded to the manufacturer for review have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1456984


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:08:44 AM
Event Date 11/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the patient was experiencing nocturnal stridor with an increase in the intensity of snoring. Patient was also having episodes of nocturnal apnea. Per the reporter, both events are occurring with stimulation of the vns and are related to vns stimulation. The patient has a history of chronic roncopathy which intensified when stimulation output reached 0. 5 ma, but without a clinical diagnosis of sleep apnea. At this time, the patient also began presenting with episodes of irregular stridor during the night. There were no casual or contributory medication changes prior to the onset of the events. All device diagnostics are within normal limits. The device parameters were changed to address the issues, but patient continue to present with stridor at night.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403974


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:09:21 AM
Event Date 04/27/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt was reporting an increase in seizures that is above her pre-vns baseline levels. Diagnostics performed were within normal limits and there was no eri-flag. The physician believes that the device is approaching eos since the pt has been at 3. 0ma since 2005. It was also reported by the pt that the magnet was not activating vns properly and electrical "discharges" were not at regular intervals. Review of clinic notes from neurologist's office indicated that the pt was experiencing frequent auras, but some were associated with her knee surgery that she had over the summer. He also noted that her recent seizures have not included her typical prodromal symptoms, usually nausea and lip smacking and there was no warning. A recent seizure was described when she was at the store, where she grabbed hold of the shopping cart and had a blank stare. The seizures was followed by headaches and later nausea and vomiting. The pt reports of having 1-2 of these seizures per day and possible some during her sleep. The pt also reports some "difficulty with breathing during sleep. " the vns was interrogated and reprogrammed at the appointment. Pulse width was increased from 250 to 500 microseconds. At a later appointment , the pt reported that she noticed increased intensity of vns discharges for a couple of days then it improved. She was also started on lyrica at that time and complained of dizziness and fatigue for a couple of days. The pt indicated that she awoke that morning with the odd feeling that has preceded some of her more severe seizures. She did not go into a seizure, but felt like the magnet was not activating her vns properly, in addition, she felt that it was not discharging at regular intervals properly. The physician indicated that he believes her device is approaching eos and will need a battery replacement. Battery life calculation resulted in approximately 0. 36 yrs until eri=yes. The pt was referred to surgeon for battery replacement. Good faith attempts to obtain additional info have been unsuccessful to date. The cause for the change in seizure pattern and increase in seizures is unk at this time so no conclusion can be drawn. The relationship of the increase and change to that of the device or therapy is unclear. There is no suspected device failure at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1402165


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:10:59 AM
Event Date 05/01/2009
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was reported that the patient has recently had apneic spells lasting a few seconds each. One woke him up out of sleep and others occurred while he was awake. Patient has history of pulmonary embolisms, but lungs are currently clear. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1397395


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:11:40 AM
Event Date 04/17/2009
Event Type Injury
Patient Outcome Other;
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386564


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:12:52 AM
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported to mfr by the vns pt's caregiver, that the pt began experiencing increased coughing and choking sensation during stimulation of the device. According to the reporter, there had been no recent programmed setting changes, trauma, or manipulation of the device that could be contributing to the onset of the events. The pt was seen by the treating physician due to the coughing and dysphagia events, and the vns device output setting were decreased to help with the events. A system diagnostic test was performed at this office visit and revealed a dcdc code of "0". The setting change improved the coughing and dysphagia temporarily, until several weeks later, the events continued, again with no reports of trauma or manipulation. The device was temporarily disabled where the events resolved. The device settings were programmed back on shortly thereafter as the pt was receiving efficacy for their seizure disorder. Good faith attempts to obtain additional info from the treating physician have been made, but have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1477528


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:13:54 AM
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was initially reported that the pt began to "have a few breakthrough seizures which until now have been relatively well controlled for several years. " in addition, there was a concern of "early battery failure. " diagnostic testing found all systems intact and functioning normally with dcdc: 0 and eri = no. The pt's output current was increased to 2. 75ma which resulted in "an uncomfortable coughing and choking sensation in her ear and throat. " follow-up with the physician indicated that the pt's seizures were still below pre-vns levels which may have been related to the pt "getting sick due to infection. " the infection was not related to the vns but rather poor hygiene. The physician further explained that the pt's choking and coughing was related to intolerable settings as decreasing the pt's settings resolved the events. It was also noted that the pt was experiencing some weight loss. It was later reported on a follow-up that the pt is "continuing to tolerate the stimulator system well with no remarkable subjective complaints. There have been no changes in her general health status. " there is no allegation that the pt's weight loss is causing harm to the pt.

Manufacturer Narrative
Device malfunction is suspected, but did not contributed to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476500


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:14:39 AM
Event Date 01/01/2005
Event Type Malfunction
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 increase in cough. Patient had (b) (6), but vns system normally elicits the cough. Cough is worsened at night. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478394


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:15:40 AM
Event Date 03/15/2007
Event Type Malfunction
Event Description
It was reported that a vns patient experienced cough and subsequent muscle spasms in the neck with vns stimulation. X-rays were taken and reviewed at manufacturer no anomalies were observed. The patient's treating physician did witness the muscle spasms and correlated it with stimulation cycles. The patient's device was disabled and both cough and muscle spasms resolved. There are no plans to turn on the device. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

Manufacturer Narrative
Manufacturer review of x-rays. Results - x-rays reviewed by manufacturer, no gross lead discontinuities visualized. Conclusions - device malfunction suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478433


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:16:30 AM
Event Date 06/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported to manufacturer that they were experiencing throat pain, a stiffening of his neck, and breathing problems with stimulation following an increase in device output current. The events reportedly resolved following a subsequent decrease in device settings. It was later reported that the patient was again having trouble breathing and experienced painful stimulation and vomiting with magnet usage. Those events reportedly resolved following another programming change. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478447


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:17:50 AM
Event Date 07/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no anomalies were visualized.

Event Description
It was reported by the vns that vns would suspend the patient's breathing sometimes. Patient device has been functioning within normal limits. No patient manipulation or trauma was reported. No intervention was planned initially since the physician did not consider the event to be serious in nature. However, later it was indicated that the breathing problem had become serious, and the site tried changing the device settings, but it made the problem worse. Patient's x-rays were taken and reviewed by manufacturer. There were no anomalies identified in the x-rays that could be contributing to the reported events. Physician wanted to go ahead and plan a lead replacement surgery, or a lead exploratory surgery, to see if there is any problem with the lead. The breathing problem is taking place with every stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1488934


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:18:36 AM
Event Date 01/01/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the patient had to be taken to the hospital due to shortness of breath. While there, a ct scan confirmed that his airways were swelling. The patient's sister believed that this may be due to stimulation due to the parent being on rapid cycling of the stimulation. All attempts for further information from the patient treating neurologist have been unsuccessful to date, thus the relationship between the event and vns therapy cannot be determined.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464446


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:19:11 AM
Event Date 07/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer by a speech pathologist that the vns patient, implanted for seizures, and is diagnosed with tuberous sclerosis, has recently had a tracheotomy due to respiratory failure. The reporter indicated that the patient had aspiration pneumonia, which resulted in the respiratory failure. It was also reported that the vns patient has been vomiting more recently. The reporter was questioning the relationship of all these events to vns therapy. The reporter was referred to the patient's treating vns physician to obtain their opinion regarding the believed relationship of the reported events to vns. Good faith attempts to obtain additional information have been made with the patient's treating vns physician, however, no response has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464451


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:21:38 AM
Event Date 06/01/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported to manufacturer by the vns patient that the magnet had been taped over the generator for several months, because the stimulation causes gastric reflux, has made it difficult for him to breath, and causes voice alterations, which are uncomfortable. The patient additionally reported that he is experiencing sleep apnea, nightmares, coughing, and pain, even while the magnet was secured over the generator site to disable stimulation. Further follow up with the patient's treating physician revealed that they no longer follow the patient due to patient non-compliance and that the patient is 'difficult'. The physician stated that the patient did not mention any of the reported adverse events, while they were following the patient. The patient continues to contact the manufacturer, however, the patient has not provided the name of the physician that currently follows him. The patient stated that the vns device is now programmed off. The patient has indicated that he is seeking explantation of the device, however, it is unknown if the patient has contacted a surgeon.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1517127


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:22:19 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the patient was said to have right vocal cord paralysis, prior to the implantation of the device, but was not discovered until after the surgery. The patient had laryngoscopy performed, which resulted in a bilateral paralysis of the vocal cord. A sleep study was later performed in 2009, which indicated that the patient had "serious" apnea and stridor ("noisy breathing"). No further details were made available at that time. 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=1513593


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:22:55 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:23:24 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported by the pt's caregiver that, starting about a year ago, the pt had problems with breathing, and it has gotten gradually worse. Now sometimes, his breath is completely cut off. The event is not associated with stimulation, and seems to be more continuous, happening both when he's awake and asleep. Caregiver has spoken to the pt's physician about this, but she stated that he does not seem to think the event is related to vns. Physician thought it was due to a lung issue, but reporter stated that the pt has been a lung specialist, and they did not find anything wrong with his lungs. Pt thinks it may be related to the vns. Attempts to contact physician for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1495914


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:23:59 AM
Event Date 08/01/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in a scientific article that a vns pt experienced decrease in appetite and coughing/choking on food after 1 month of vns therapy. These symptoms did not resolve despite reductions in vns stimulation parameters and the pt subsequently underwent placement of a gastrostomy feeding tube. The author reported that the symptoms seen in the pt may have been related to vns therapy, but in the physician's experience, these symptoms were more likely a result of the natural clinical history of rett syndrome.

Manufacturer Narrative
Article citation: wilfong, angus, and rebecca schultz. "vagus nerve stimulation for treatment of epilepsy in rett syndrome. " developmental medicine & child neurology (2006): 683-86. Print.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552698


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:24:27 AM
Event Date 10/22/2009
Event Type Malfunction
Event Description
Initial rptr indicated that the pt was in clinic with severe pain in their neck area. The pt had been reporting shortness of breath and painful stimulation that had occurred sometime in the last week. The pt had not had any trauma or injury to the area. The pt reported that their stimulation feels much stronger now than it previously had, although no settings changes had been made. X-rays were reviewed at the mfr. In the ap view, an acute angle was observed in the lead body near one of the tie-downs. It cannot be determined if this acute angle is contributing to the dcdc = 0. A lead discontinuity cannot be ruled out. No other obvious anomalies were observed in the portions of the lead visualized that could be contributing to the reported dcdc = 0 results. At this time, no surgical plans have been made for the pt's vns. Their vns was programmed off on (b) (6) 2009.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead break seen. An area noted with a possible acute angle lead break cannot be ruled out.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1547258


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:24:55 AM
Event Date 10/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns therapy patient had trouble breathing post initial implant surgery, but prior to device stimulation was activated. The patient went to the e. R. , and was diagnosed with pulmonary embolism. The treating physician stated the event was not related to vns, as every surgery has a chance for a patient to have a pulmonary embolism. The patient is on coumadin now, and vns stimulation has not been activated to date. 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=1530569


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:25:30 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:26:05 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: Respiratory
Post by: dennis100 on July 17, 2011, 01:26:33 AM
Event Date 12/11/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient had her vns system removed due to breathing difficulties. The patient reported a pre-vns medical condition of asthma and stated that the week after vns surgery her breathing became bad. After the removal of the vns therapy system the patient reported the breathing problems have not recurred. Follow-up with the explanting surgeon revealed the reason for the explant was due to respiratory issues in which both the generator and lead were removed. Diagnostics were performed pre-op which indicated the device was working within normal limits. Information from the treating neurologist revealed the patient's asthma was being exacerbated by vns stimulation as the patient had difficulty breathing after vns was implanted. 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=1585896


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:27:07 AM
Event Date 11/12/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported to manufacture via clinic notes that the pt had three seizures in 2009. After four months, his throat closed up and he could not breathe after a seizure, laryngeal spasm. He went to the emergency room and had a barium swallow performed and they did not find anything mechanically wrong. The etiology is unclear. Since it potentially could be vns related the pt's treating physician will have the pt tape his magnet in place to discontinue therapy if it reoccurs. Diagnostic testing was performed and there was no malfunction noted and the battery was good. The pt had a prophylactic generator replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580285


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:27:38 AM
Event Date 12/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the physician, the patient was seen in the office due to severe neck pain which is located slightly lower than neck incision. Pain is associated with stimulation and started after she was wrestling with her children, and they were pretending to choke her around her neck. Physician wants to replace the whole system since he feels the battery needs to be changed anyway. Patient also had coughing and choking sensation with magnet stimulation. Device is currently been turned off due coughing and laryngospasm. Good faith attempts to obtain additional information has been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581537


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:28:07 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:32:05 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:33:04 AM
Event Date 10/07/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated a vns pt was experiencing bradycardia, central apnea, and obtundation with vns stimulation. The vns is beneficial for the pt's seizure control, but the pt has a significant history of bradycardia with vns since 2001. The previous bradycardia event is reported via mdr #1644487-2006-00432. The apnea and obtundation, and continuing bradycardia, are noted since the pt was reimplanted with new vns products in 2009. If the vns is disabled for several hours, the pt has frequent, uncontrolled seizures. If the vns output current is reduced to 1. 0ma, the seizures increase. The pt has progressive bradycardia and obtundation, mostly responsive to arousal, within days to weeks after the vns output current is increased to 1. 25ma. The pt has central apnea, awake and asleep, when the vns duty cycle is increased. The apnea is intermittent and timed to periodicity of the stimulator. On the one occasion that a higher duty cycle was tried at 1. 0ma, the respiratory depression was progressive and lead to respiratory failure. The respiratory failure was treated in the intensive care unit at the hospital and managed by changing the vns settings. The pt is currently stable with infrequent partial seizures only as of two months later at his last clinic visit. The current vns settings are 1. 2ma/25 hz/250 pulsewidth/21 sec on/5 min off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571192


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:34:07 AM
Event Date 12/13/2009
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Pt death believed to be a result of aspiration with vocal cord paralysis listed as a contributory factor. The left vocal cord paralysis is the result of the implant procedure and is captured in mdr 1644487-2010-00350.

Event Description
It was reported that a pt passed away. F/u with the surgeon revealed that the pt had developed left vocal cord paralysis eight months prior (captured in mdr 1644487-2010-00350) as a result of lead revision surgery. The pt had some ongoing right sided paralysis for unk reasons and this did not appear to be related to the device. The pt required a tracheostomy and was following an otolaryngologist for the right side paralysis and did show some improvement. The pt later died due to aspiration with the vocal cord paralysis listed on the death certificate as a contributory factor. The manner of death was listed as "natural" on the death certificate. No autopsy was performed and the pt was buried with the device still implanted. Good faith attempts to obtain additional info regarding the pt's death from the pt's neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614851


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:34:44 AM
Event Date 01/14/2010
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt passed away on (b) (6) 2010. Per reporter, the pt stopped breathing in the shower and could not be resuscitated. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1609358


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:35:27 AM
Event Date 01/23/2010
Event Type Injury
Patient Outcome Required Intervention;
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1650538


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:35:59 AM
Event Date 02/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that she was experiencing shortness of breath and chest pain, for which she went to the er. At the er it was found that she also had an elevated heart rate and decreased oxygen saturations. A number of tests were run which all confirmed that the issue was not likely heart or pulmonary related. Information was later received that the pt's neurologist decreased the pt's programmed output current which has resolved the issues, as per the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1641399


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:36:33 AM
Event Date 01/01/2010
Event Type Injury
Patient Outcome Other;
Event Description
Manufacturer review of the published article entitled "reversible sleep-related stridor during vagus nerve stimulation. Epileptic disord vol 12, no 1. 2010, st louis, e and faber, k" identified that a vns patient developed stridor during sleep when the vns output current was increased from 0. 5ma to 0. 75ma. The stridor was determined to occur regularly with the vns duty cycle. "snoring and stridor halted completely during vns deactivation, recurred immediately following resumed vns, and sequential reductions of vns output current to 0. 5ma completely obviated stridor. " the vns duty cycle was changed to 21 seconds on, 0. 8 minutes off to control seizure frequency with change in dose. Two years later, "snoring, stridor, and daytime sleepiness have not recurred, and there has been a 50% reduction in seizure frequency. " due to privacy laws per the author, the author was not able to provide any additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1638557


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:37:46 AM
Event Date 02/18/2010
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that during the intraoperative system diagnostic test performed during the pt's implant procedure, the pt stopped breathing for about 10 seconds. Once the test was completed, the issue resolved. The surgeon stated that the issue was not considered severe and no interventions were taken.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637150


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:38:32 AM
Event Date 01/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the pt was having a tracheotomy due to vocal cord paralysis. The relationship to the vns and paralysis is unk at this time. 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=1630514


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:39:27 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:40:22 AM
Event Date 12/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the nurse that the pt is being implanted with a vital stimulator to stimulate pt's vocal cord. She stated that the pt has left vocal cord paralysis after his second vns implant. Pt had a gall bladder surgery and after that he developed a respiratory failure and vocal cord paralysis. She felt that some of this might have been due to his vns. Good faith attempts made with the physician have been unsuccessful till date. The cause of events is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1623693


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:42:01 AM
Event Date 03/01/2010
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was initially reported to the mfr that the pt was admitted to the er because, the pt was experiencing neck swelling, painful stimulation and dyspnea. The pt was referred to a surgeon and was scheduled for a lead revision surgery due to a suspected lead break. The pt's treating neurologist believes the swelling and dyspnea are related to vns, dyspnea occurs with stimulation and the pt does not have any history of dyspnea pre-vns. The pt's lead body was replaced due to a lead break. It was indicated that there were no casual or contributing factors, or any pt manipulation or trauma that occurred to have contributed to the lead break. Good faith attempts to obtain more info regarding the suspected lead discontinuity have been unsuccessful to date. The explanted lead body has been returned to the mfr and analysis is in process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675414


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:42:47 AM
Event Date 04/22/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient experienced inflammatory adenopathy (nodules) along the lead pathway. The nodes were noted upon palpation of the lead body. The patient is additionally experiencing dysphonia and a pulling sensation in the neck area. The patient has been scheduled to have a cervical ecograph performed. It was indicated that the reported event could be possibly related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702791


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:43:18 AM
Event Date 04/14/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Our country representative in (b) (4) reported that a physician noted that he had a vns patient with inflammatory adenopathy (nodules) along the lead pathway. The nodes were noted upon palpitation of the lead body. The patient is additionally experiencing dysphonia and pain near the area of the nodules. The patient's lead impedance is reported to be not changing. Cervical ecograph identified that the patient had these nodules bilaterally in their neck region. Their treating physician at this time reports the event could be possibly related to their vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698797


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:44:12 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:45:01 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:45:32 AM
Event Date 05/01/2010
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was reported to the mfr that the vns pt has experienced apnea recently. The pt indicated that the event was preceded by programming changes at his recent office visit. The physician indicated that the pt's reported event is related to the pt getting accustomed to new settings. Diagnostic tests performed on the pt's device revealed proper device function. No interventions have been planned or taken for this event. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1735671


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:46:05 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:47:12 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:47:37 AM
Event Date 03/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to mfr that the vns pt experienced hyperventilation alternating with sleep apnea. It is unk if the event occurred with stimulation. Additionally the physician indicated that the sleep apnea was related to an increase in pt's settings and that the event resolved with a decease in output current. The pt did not have a medical history of this event pre-vns, however, the event did not occur since. Diagnostic testing was reportedly performed at each of the pt's follow up visits and no abnormalities were identified, however, specific results were not given. 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=1712629


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:48:02 AM
Event Date 08/01/2010
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was initially reported by the pt's mom that the pt was admitted to the hospital as pt was having some difficulty breathing. She wanted her vns turned down by a physician. Pt was referred to her treating physician. F/u with the treating physician's nurse revealed that the pt has sleep apnea and is been scheduled for a sleep study to find out the cause of the event. The site does not know the cause of the event at the moment. Device was checked and it showed everything working within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1825611


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:48:27 AM
Event Date 01/01/2010
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was initially reported by the physician that the patient has been having some issues recently with vocal cord paralysis and shortness of breathing. Patient has been fine all along until the last few months. Physician stated that the patient is a chronic smoker and he thought maybe this had something to do with her issues as patient started smoking recently and not when she was originally implanted. 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=1817100


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:48:56 AM
Event Date 06/23/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The pt recently had surgery for routine generator replacement, and during surgery, the surgeon cut the lead in error and therefore had to implant a new lead as well. The surgeon uses a single incision implant technique. The pt was seen by the neurologist for the first follow up appointment since surgery, and when the device was programmed on to "the lowest setting", the pt experienced intolerable coughing and painful stimulation in the neck and was not able to tolerate any stimulation. The surgeon was notified of the events, and it was noted by the surgeon that it is possible that based on these side effects, that the lead may be implanted on the wrong structure, possibly the phrenic nerve, rather than the vagus nerve. The pt is scheduled for surgery to have the lead replaced by a new surgeon, which is scheduled to occur on (b)(6)2010. Per the neurologist, diagnostic testing was performed which revealed normal device function; however, the specific results were not provided. In addition,the neurologist noted the device has been programmed off at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801204


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:49:22 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/24/2007
Event Type  Death   
Event Description
It was found through an obituary search that the patient had passed away. A battery life calculation was reviewed and showed the device was working as intended as the dcdc value was within normal limits. No anomalies were observed. Additionally, the battery life calculation estimation showed approximately 9. 4 years were remaining at the time of the patient's death; therefore, the device was likely still functioning. It was later reported by the patient's last known physician that he saw the patient the spring prior to her death. He stated he believed the death was not related to vns; however, since he did not see her at the time of her death, he could not be certain. Additionally he noted the patient also had lung issues (unrelated to vns) and rhett's syndrome.
 
Event Description
A death certificate was later received showing the patient died of leukopenia, anemia, and thrombocytopenia. The death was noted to be natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6438083


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:49:55 AM
Event Date 08/07/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt developed respiratory distress the day after vns generator replacement surgery. The pt's lead had been implanted in 2008. An ent was consulted who diagnosed the pt with vocal cord paralysis. The pt is under observation and the device has not been turned on yet. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846176


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:50:23 AM
Event Date 08/26/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a vns patient that she experienced vocal cord paralysis since initial vns implant in 1998. Additionally, the patient reported she experiences voice alteration with stimulation and occasional dyspnea with stimulation. Follow-up was made with the patient's treating neurologist who indicated the patient was followed by him since 2005 and had no additional information regarding the previous treating physician. Moreover, during the office visits, the neurologist indicated the patient did not mention vocal cord paralysis during implant. 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=1843803


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:51:04 AM
Event Date 08/01/2010
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported by the treating neurologist that the vns epilepsy pt was being evaluated for investigation of her respiratory status while she was also being evaluated for surgery that was scheduled to prophylactically replace the vns pulse generator. The surgery was cancelled as the surgical team determined that the pt's respiratory status was compromised, and the pt required hospitalization for treatment at that time. The patient was seen by a pulmonologist, who reported to the neurologist that the pt's respiratory issues, which were initially thought to be asthma, but after eval, it appears that the issue is episodes of tachypnea with respiratory rates of 50/minute. Additionally, the patient has been experiencing dyspnea, which is unrelated to asthma, and is not relieved by albuterol. Add'l info from the pt revealed that the pulmonologist, who, per the pt, told her that the left airway was still at a sub-optimal level, and the specialist was wondering if the electrodes placement could be moved so that it is "not in the way of breathing. " there was some discussion, per the pt, of exploring the left neck region surgically; however, this has not been confirmed by the patients treating neurologist. The patient has been re-scheduled for surgery to replace the pulse generator and possibly explore the neck region, which is to occur in october. Add'l info was received from the pt's treating neurologist that prior to the pt's surgical eval, the pt was asymptomatic for any side effects from vns stimulation. The patient did complain of intermittent hoarseness with stimulation. In addition, the physician noted that the patient has pre-existing respiratory issues, prior to having been implanted with the vns device in 2002. The respiratory side effects were exacerbated by stimulation when the physician attempted to increase the output current to control the patient's seizures better. The physician stated that the device settings have always been kept at 'lower settings' so as to minimize any contribution that stimulation may have on the existing respiratory issues. The vns device setting has recently been decreased to an output current of 0. 75ma, a magnet output current of 1. 25 ma, on time of 30 seconds and off time of 3 minutes. The physician noted that the patient was at the above noted settings for approx 2 years with no complaints. Recent diagnostic testing done on the patient's device has revealed normal device function. In addition, the neurologist reported that the patient also has been evaluated by an ent, where left vocal cord paralysis was diagnosed by a ct scan of the neck. The physician noted that "since the cord appears to be paralyzed, it looks like this may be a nerve compromise from the lead" and it is not associated with stimulation of the vns device. The neurologist continues to monitor this patient's events along with the other physicians involved in the patient's care. Add'l info is expected to be communicated by the neurologist regarding the findings of the surgical procedure and whether the respiratory issues are related to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845930


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:51:31 AM
Event Date 07/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a nurse that a vns pt experienced hypoxia after a programming session with her treating neurologist. The nurse indicated the pt's oxygen level dramatically dropped and was placed on oxygen after the vns programming. At the moment the nurse is not able to tell if the condition is exacerbated by vns; however, the pt's seizures are very well controlled since vns implant. Additional info was received from the treating neurologist indicating the pt a current conditions of tracheostomy, recurrent pneumonia and edema. However, the neurologist still increased the pt's settings. Moreover, at the moment it is likely that vns stimulation is exacerbating the current medical conditions of the pt. However, clear evidence has not been provided to confirm vns is a direct contributory factor for the reported hypoxia. Lastly, current diagnostics indicate the device is working within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833655


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:51:59 AM
Event Date 07/22/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns patient who had recently been implanted was suffering from dyspnea and dysphagia. The events are not associated with stimulation, as the vns had yet to be programmed on. An ent specialist was consulted who diagnosed the vns patient with left vocal cord paralysis. This was attributed to the electrodes being placed close to the recurrent laryngeal nerve during the vns implant surgery, and the adverse events are believed to be temporary. Add'l attempts for updates on the vns patient's status are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828531


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:52:32 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:53:11 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:53:46 AM
Event Date 01/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the pt was scheduled to have the generator replaced due to unk reasons. Later it was indicated that the pt had been "experiencing dyspnea and stimulation was affecting her distally. " the pt's lead and generator were said to have been replaced. The explanted lead and pulse generator have been returned to the mfr for analysis, but has yet to be completed. A search performed in the mfr's programming history database indicates that the last known diagnostics performed on (b)(6) 2006 were within normal limits. 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=1908000


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:54:19 AM
Event Date 10/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the physician that the pt was admitted to an icu due to choking and aspiration and pt was "clawing at his vns. " diagnostics test was performed and confirmed that the device was functioning fine. Device was turned off due to the events. Good faith attempts to obtain additional info has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894924


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:55:09 AM
Event Date 10/08/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported through clinic notes dated (b)(6) 2010, that a vns pt experienced choking along with and increase in seizures. The pt's increase in seizures occurred about six months ago and since the event has been having medications changed. At the moment the relationship of the events to vns therapy is unk as well as pre-vns baseline for the pt's seizures. 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=1894928


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:55:42 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:56:19 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:57:05 AM
Event Date 09/20/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns was taken to the er due to erratic stimulation and also "freezing" diaphragm with stimulation. The information was provided by a physician in the er, who indicated the patient had not had his device checked in a long time. Patient recently switched insurance and needed a list of doctors who treat vns patient's for epilepsy and take county insurance. Follow-up was made with the patient's last treating neurologist who indicated the last time the patient was seen was in (b)(6) 2009 and had not heard anything from patient. Review of the patient's diagnostic history was indicative that the last known diagnostics were from 2003. At the moment, it is unknown if the patient is being followed up by another physician 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=1879521


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:57:39 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:58:46 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 01:59:30 AM
Event Date 12/07/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported through clinic notes dated (b)(6) 2010 that a vns pt has developed severe obesity along with wheezing and shortness of breath, possibly due to the pt's aforementioned obesity and sleep apnea. The pt does have a medical history of heart disease. On exam, the pt's blood pressure was 130/80 and his pulse was 95. The pt's respiratory rate is labored and he is wheezing possibly related to upper respiratory infection or airway obstruction due to obesity. The pt was currently referred for vns replacement surgery as his device was found to be set at eri=yes. Additional information was rec'd from an implant card indicating the pt underwent generator replacement successfully due to end of service. At the moment, the relationship of the pt's obesity and sleep apnea to vns therapy is unk. Good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1963293


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:00:17 AM
Event Date 12/17/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a surgeon that a vns pt's mother indicated the pt experienced cough and could not talk. The surgeon indicated that the pt had been implanted approximately 1-2 weeks prior to the report. The surgeon further stated that the pt was programmed on to received therapy the following day after surgery. The manufacturer told the surgeon that per the manufacturer's labeling, it's recommended not programming the device on for 2 weeks after surgery to allow pt to recover from surgery. The surgeon agreed to contact the treating neurologist on the manufacturer's labeling as he programmed the pt on. Additional information was received from a company representative indicating the pt was experiencing extreme coughing and her voice was gone/having a hard time talking (voice alteration) since her implant on (b)(6) 2010. Additionally, the company representative reported that the treating neurologist had programmed the pt's device off due to the voice issues. In addition, the nurse at the neurologist's office indicated the pt had some numbness under chin above incision. Further information was received from the implanting surgeon indicating the pt was diagnosed with left vocal cord paralysis by an ent who was not familiar with vns therapy. 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=1963278


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:00:56 AM
Event Date 11/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a vns pt that she felt fast heartbeat in her chest, tightening in throat, difficulty breathing, and nausea when coming within 5-10 feet of a family member who had a pacemaker. Per manufacturer's labeling, pacemakers are not expected to affect the operation of vns system; however, it is recommended to keep a distance of 4 inches or 10 cm to avoid any interruption. The pt also stated that by holding her magnet over the vns device, the generator was disabled and her symptoms were alleviated. She was also concerned that the device may be malfunctioning due to trauma she experiences during her grand mal seizures; i. E. She falls down during her grand mal seizures. Lastly, pt complained about lack of efficacy of device that vns device has never stopped a seizure for her. Further follow up with the pt treating neurologist revealed that pt hasn't been seen since these adverse events were reported to the manufacturer. 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=1961088


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:01:37 AM
Event Date 10/15/2010
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that following the surgical procedure where the pt's vns device had been replaced prophylactically, the pt suffered from a ruptured bleb on both lungs, which led to pneumothorax. This in turn caused the pt to experience heart rhythm problems. The pt had to be intubated to restore his respiration. F/u with the pts treating neurologist revealed that the blebs is a genetic disorder and was not caused by vns stimulation or the surgery. F/u with the neurosurgeon who was present when the events occurred, revealed that the anesthesia and ventilation from the vns surgery triggered the rupture of the blebs which lead to pneumothorax. The surgeon stated that the cardiac arrhythmia (heart rhythm problems) was unrelated to vns and was related to pneumothorax. The neurosurgeon had programmed the device on the pt's previous setting at the time of surgery. Subsequent f/u with the neurologist indicates that the pt is doing well, and diagnostic tests performed following the surgical procedure reveal normal device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953518


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:02:27 AM
Event Date 07/05/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in (b)(6) 2009 that the vns pt began experiencing coughing and pain in the jaw during stimulation on times. At the time of the onset of the events, there had been no preceding setting changes that took place prior to the onset of the coughing and painful stimulation, and no reports of pt trauma. Diagnostic testing following the onset of the events revealed normal device function. The device settings had been unchanged since (b)(6) 2009. The pt was seen by the treating physician for follow up following the onset of the events, where the output current was decreased from 1. 75ma to 0. 5ma and the events had significantly improved; however, the pt did begin experiencing an increase in seizure vigor, and per the physician this was a result of having lowered the vns device setting intentionally. The pt was seen by a surgeon in (b)(6) 2009, where diagnostic testing revealed normal device function, and the setting was kept at a low output current. The surgeon advised that they could wait on any surgical interventions at that time, and see how the pt responds with respect to seizure control at the lower settings. The physician had noted that the interventions taken up to this point were for pt comfort, and not to preclude a serious injury. Additional info was received in 12/2010, via receipt of a document from the hospital containing vns implant info, which revealed that the pt had surgery in (b)(6) 2010 where only the lead was replaced. On the documentation received, it was noted that the reason for replacement of the lead was due to "neuropathic pain from stimulation of left nerve. " the documentation provided was hand written and due to poor handwriting, the additional writing on the form was not clear. Good faith attempts with both the surgeon and the treating physician to obtain additional info on the current status of the pt, as well as what was observed during surgery have been made, however, no further info has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947542


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:03:11 AM
Event Date 11/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the nurse that the pt was hospitalized for aspiration problems and she was not sure if this was related to vns. She state that the pt has many issues not related to vns and pt is a very difficult case to handle. The nurse was informed to turn off the device and see if the problem resolves. 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=1938615


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:03:55 AM
Event Date 07/28/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt experienced coughing with stimulation every 5 minutes. The patient's current settings were 0. 25/20/250/30/50 magnet 0. 5/60/250. The pt was recently re-implanted on (b)(6) 2010 and diagnostics from (b)(6) were within normal limits (no specifies). Info from the treating neurologist indicated the cough was related to vns and he was going to decrease either the pulse width or hz to reduce the coughing. Moreover, a company representative assisted the office of the treating neurologist and she indicated the coughing did not resolve after settings were changed. However, it was noted that the pt was programmed on right after revision surgery on (b)(6) 2010. The company representative stated the manufacture's recommendation for re-implanted patients but the physician decided to leave the pt programmed on and scheduled a follow-up for the following month. Additional info was received from a company representative indicating the patient's cough got worse and now, the pt is vomiting due to the cough. Moreover, the pt was recently admitted to the hospital due to the coughing and treating physician at this time is not sure if vomiting is related to vns. Vns was disabled due to the event of vomit and pt was still vomiting but not as much.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936149


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:04:38 AM
Event Date 09/21/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt was unable to have the vns settings increased to therapeutic levels due to coughing, painful stimulation, and muscle twitching. The patient's seizures have increased slightly but are still below pre-vns baseline levels due to the vns settings not being therapeutic. Different vns settings were tried but the events have continued. No changes to the vns settings were made prior to when the events began. Prior to the pt being unable to tolerate the stimulation, she had a neck adjustment by a chiropractor, which may be contributing to the issues. X-rays were reviewed which did not note any anomalies. Surgery to replace the vns appears likely.

Manufacturer Narrative
Mfr reviews x-rays of implanted device. X-rays reviewed by the mfr, no anomalies visualized.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026137


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:05:17 AM
Event Date 02/03/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in clinic notes dated (b)(6) 2010 that a vns pt was having a change in seizure pattern as the pt was experiencing more intense seizures and they were worse with stress. The pt further indicated that she had never had a convulsion. Additionally, the pt reported changes in speech, trouble with sleep and shortness of breath. Good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date. The pt currently underwent generator replacement surgery due to end of service as the generator was read at the following diagnostics in (b)(6) 2010 (system diagnostics ok, 2, yes). Good faith attempts to obtain the explanted generator have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009639


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:05:47 AM
Event Date 11/05/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On 02/23/2011, a cyberonics consultant reported that a vns pt was experiencing left laryngeal nerve paralysis as a result of the implant surgery. The pt was noted to be improving as the vns device was not programmed on. It was determined by an ear nose and throat physician that the paralysis was present. As a result of the paralysis, the pt is having laryngeal spasms, which is causing anxiety and panic attacks with stridor. Due to these problems, the physician determined that the pt needed a tracheostomy, which occurred in the last two weeks. The pt was experiencing breathing issues as a result of the panic attacks. Currently, the pt has not been programmed on and is being referred to a hosp for eval. After evaluation, it will be decided if the device will be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2010599


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:06:15 AM
Event Date 06/04/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Clinical notes were received to the manufacturer indicating a vns patient was experiencing sleep apnea. The patient does not tolerate c-pap treatment for the sleep apnea, and remains untreated. The patient also has chronic obstructive pulmonary disease (copd). The patient is currently seeing a new neurologist. The clinic notes received to the manufacturer were from the previous neurologist, who has left the practice. Attempts to the new neurologist for information regarding the sleep apnea revealed no interventions are currently planned other than running some lab tests. The relationship of the vns to the sleep apnea was unknown. All attempts for vns product implant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1983038


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:06:49 AM
Event


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:07:40 AM
Event Date 03/21/2011
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated a patient was hospitalized postoperatively for seven days due to respiratory and anesthesia issues after having the vns therapy system implanted. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2070195


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:08:08 AM
Event Date 01/24/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns patient has been experiencing shortness of breath since being implanted and it had been progressively been getting worse. It was also noted that vns therapy is not believed to have helped with the patient's depression. The patient's vns has not been checked in the past year as per the patient. The patient's psychiatrist has referred her for surgery to explant the device. Attempts for additional information including if interventions will be taken to preclude a serious injury have been unsuccessful to date. No device failure is suspected at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069275


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:08:35 AM
Event Date 01/24/2011
Event Type Injury
Patient Outcome Other;
Event Description
It was reported by the pt's parent that the pt was experiencing breathing problems and numbness of her lips. The pt was seen by her family physician, who said her lungs sounded clear. A x-ray was performed and nothing abnormal was seen at this time. Even use of a rescue inhaler was not beneficial. Diagnostic testing on (b)(6) 2010 revealed normal device function, and the device had just been recently implanted. F/u with the pt's physician indicated that neither the dyspnea nor the numbness was related to vns. The numbness was stated to have first occurred on (b)(6) 2011. Last known settings from (b)(6) 2011 were 0. 75ma, 20 hz, 250microsec, 60 sec, 1. 8 min, 1. 00 ma, 60 sec, 500 micro sec. Later info showed that the pt had undergone more testing by an ent doctor, who saw that the pt's tonsils and adenoids were abnormally large and her left vocal cord was partially paralyzed. He also suggested removal of the adenoids and tonsils. The pt's vns physician, though, did not feel that the adenoid and tonsil issues were related to vns whatsoever, though it was causing the breathing and other issues previously reported. It was not known how the vns affected the paralysis event, though. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133424


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:09:07 AM
Event Date 06/29/2010
Event Type  Death   
Manufacturer Narrative
Although this particular report houses a death due to a specific type, no information is available on the cause of death of the corresponding patient, but this report will trace this specific death report to a known patient. (b)(4).
 
Manufacturer Narrative

Event Description
On (b)(6) 2013, the abstract for the article ¿major health issues in a cohort of epilepsy patients treated with vagus nerve stimulation therapy¿ was received and reviewed by the manufacturer. The following is the abstract for the article: rationale: vagus nerve stimulation (vns) is an adjunctive treatment for refractory epilepsy. Patients with vns typically have severe epilepsy and may have greater medical comorbidity than similarly aged cohorts. The vns device can complicate the management of comorbid conditions as some procedures are contraindicated by the device, or will require additional safeguards. To date, there have been few studies describing epilepsy sequelae and comorbidity in the vns treated patient population. This study aimed to identify major health issues in patients with refractory epilepsy treated with long-term vns. Methods: a retrospective analysis of major health issues, including significant medical issues and side effects, was performed in a cohort of 52 epilepsy patients treated with vns. Significant medical issues were defined as myocardial infarction, cerebrovascular accident, cancer, chronic pulmonary conditions, chronic gastrointestinal conditions, acute pulmonary events, acute gastrointestinal events, seizure-related injury, suicide attempt, and death. Results: the mean age at vns initiation and time of study was 39. 5 and 48. 3 years, respectively. Mean duration of therapy was 8. 9 years. Side effects limiting therapy were observed in 15. 4% of patients. At least one significant medical issue was seen in 38. 5% of patients. Death (19. 2%), seizure-related injury (15. 4%), chronic pulmonary conditions (11. 5%), and acute pulmonary events (9. 6%) were most commonly observed. Death occurred after a mean 8. 3 years of vns therapy at 54. 9 years of age, attributable to cancer in three (5. 7%) cases and likely to sudden unexpected death in epilepsy (sudep) in two (3. 8%) cases. Lack of follow-up limited vns management in 25. 0% of patients, representing an additional challenge in this population. The vns device mitigated medical management in five cases, including three cancers, one pulmonary, and one emergency surgery. Conclusions: while some illness may be anticipated due to aging and epilepsy refractory to treatment, comorbidity and mortality in this cohort were greater than expected. Consequently, knowledge of how vns impacts medical management in both acute care and outpatient settings is essential. Furthermore, medical comorbidity may have been under based on the number of patients in the study and the percentages provided, there were 10 deaths reported (two due to sudep, three due to cancer, and five from unknown cause), one patient who experienced an adverse event requiring emergency surgery, and one pulmonary event in which surgery could not occur. These events were reported on the following manufacturer reports: 1644487-2013-03741¿reports the 1st patient's death due to sudep, 1644487-2013-03742 ¿ reports the 2nd patient's death due to sudep, 1644487-2013-03743 ¿ reports the 3rd patient's death due to cancer, 1644487-2013-03744 ¿ reports the 4th patient's death due to cancer, 1644487-2013-03745 ¿ reports the 5th patient's death due to cancer, 1644487-2013-03746 ¿ reports the 6th patient's death (due to unknown reason), 1644487-2013-03747¿ reports the 7th patient's death (due to unknown reason), 1644487-2013-03748¿ reports the 8th patient's death (due to unknown reason), 1644487-2013-03749¿ reports the 9th patient's death (due to unknown reason), 1644487-2013-03750¿ reports the 10th patient's death patient (due to unknown reason) 1644487-2013-03751 - reports the patient with adverse event requiring emergency surgery 1644487-2013-03752¿ reports the patient with serious injury dyspnea [one pulmonary event in which surgery could not occur].
 
Event Description
Patient information has been received; however, no information has been received in which manner the patients passed away. The deaths were reported to not be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3517630


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:09:38 AM
Event Date 03/31/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A vns programming nurse in the (b)(6) reported to our consultant that they had a pt in a pulse2 study and he complained of his epilepsy worsening (no longer receives warning that the seizure is about to occur), hoarseness with the regular stimulation and breathlessness on exertion. He requested that his vns be programmed off. Their voice alteration and breathlessness on exertion were related to the regular stimulation. The cause of their seizures was unk. Pulse width and signal frequency were lowered at one point but device was disabled on (b)(6) 2011.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115162


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:10:12 AM
Event Date 01/24/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns patient has been experiencing shortness of breath since being implanted and it had been progressively been getting worse. It was also noted that vns therapy is not believed to have helped with the patient's depression. The patient's vns has not been checked in the past year as per the patient. The patient's psychiatrist has referred her for surgery to explant the device. Attempts for additional information including if interventions will be taken to preclude a serious injury have been unsuccessful to date. No device failure is suspected at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069275


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:10:50 AM
Event Date 01/09/2001
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that during a generator implant the pt developed a pneumothorax. The generator was placed subpectoral as opposed to subcutaneously.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=330198


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:11:18 AM
Event Date 05/09/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:11:48 AM
Event Date 03/31/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A vns programming nurse in the (b)(6) reported to our consultant that they had a pt in a pulse2 study and he complained of his epilepsy worsening (no longer receives warning that the seizure is about to occur), hoarseness with the regular stimulation and breathlessness on exertion. He requested that his vns be programmed off. Their voice alteration and breathlessness on exertion were related to the regular stimulation. The cause of their seizures was unk. Pulse width and signal frequency were lowered at one point but device was disabled on (b)(6) 2011.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115162


Title: Re: Respiratory
Post by: dennis100 on July 17, 2011, 02:13:57 AM
Event Date 05/04/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6), 2011, a vns surgeon's nurse reported that the vns patient is scheduled for a vns revision surgery in (b)(6) 2011. The patient's physician reported that the patient had an altercation with her boyfriend soon after implant surgery, dislodging the generator. The patient had previously been complaining of breathing difficulty and voice alteration with stimulation. The physician said that he was going to do some programming adjustments to alleviate the patient's breathing difficulties and voice alteration. If additional information is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2148838


Title: Re: Respiratory
Post by: dennis100 on September 08, 2011, 05:13:27 AM
Event Date 07/06/2011
Event Type Malfunction
Event Description
Patient who had vagal nerve stimulator implanted ~3 years ago (pt had history of intractable epilepsy). He subsequently moved to out of state and reports establishing care at a neurology practice, and a physician there changed settings as the device was affecting his voice. After that time, he began to have difficulties which retrospectively he feels were related to his device. He was an avid runner, and would experience shortness of breath when he would run after about 5 minutes, and would then improve after he would stop for a few minutes. At the time he attributed it to the change of climate. He eventually developed severe shortness of breath and it was found that his stimulator was misfiring causing constriction of the vocal cords. After that time, the device was turned off and it subsequently has been off ever since. The patient returned for removal of the stimulator. The lead remains in the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2192706


Title: Re: Respiratory
Post by: dennis100 on September 08, 2011, 05:13:57 AM
Event


Title: Re: Respiratory
Post by: dennis100 on October 06, 2011, 05:55:05 AM
Event Date 08/29/2011
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated a vns patient was hospitalized due to difficulty breathing with stridor, asthma, and vocal cord paralysis. The vns was disabled and the patient improved. The patient is being treated with medication. The patient had recently had the vns generator replaced on (b)(6) 2011. The patient was originally implanted with vns on (b)(6) 2007. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2265822


Title: Re: Respiratory
Post by: dennis100 on November 04, 2011, 06:24:22 AM
Model Number 102R
Event Date 05/03/2006
Event Type Injury
Patient Outcome Death; Hospitalization Required Intervention
Event Description
It was reported via clinic notes received that the patient was hospitalized due to status epilepticus on (b)(6) 2006, hospitalized due to pyelonephritis aspiration pneumonia on (b)(6) 2007, and hospitalized due to a urinary tract infection complicated by pneumonia with respiratory failure in (b)(6) 2010. These events have an unknown relationship to vns. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2312348


Title: Re: Respiratory
Post by: dennis100 on November 04, 2011, 06:24:57 AM
Model Number 102
Event Date 09/25/2011
Event Type Death
Patient Outcome Death;
Event Description
The patient's physician indicated that she had passed away. The patient had suffered from a stroke and respiratory failure. The patient had previously been known to have a high impedance as reported on manufacturer report # 1644487-2011-02149. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2308986


Title: Re: Respiratory
Post by: dennis100 on December 05, 2011, 10:47:28 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt underwent placement of a feeding tube because of excessive weight loss. It was reported that the pt "couldn't keep anything down". The surgery to place the feeding tube reportedly went well; however, the pt suffered a status seizures shortly afterward and subsequently aspirated. The pt then developed pneumonia in both lungs. Breathing treatments and antibiotic therapy were prescribed. The pt was not comatose, but was reportedly in an "altered level of consciousness" for unk reasons during this time. At this time, it is unk if the reported events are a result of the pt's disease progression or whether they are vns-related. Due to the length of time that the pt has been implanted with the vns therpay system, it is not likely that the events are vns-related. Report is incomplete because attempts to identify the pt's current treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=646478


Title: Re: Respiratory
Post by: dennis100 on December 09, 2011, 12:27:32 PM
Model Number 302-20
Event Date 01/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The patient reported that the lead would migrate and "block her throat" during her asthma attacks. Per the patient, this was preventing her from breathing. The patient did not know when the event started. At the time of this report, the patient also indicated that she did not experience efficacy from the device. The patient's vns system has since been explanted and the lead and generator have been returned to the manufacturer for product analysis. Analysis is not yet complete. It is unclear at this time, if the explant was performed for the reported migration or lack or efficacy. Attempts for additional information are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2351148


Title: Re: Respiratory
Post by: dennis100 on December 09, 2011, 12:28:10 PM
Model Number 103
Event Date 02/23/2011
Event Type Injury
Patient Outcome Required Intervention;
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2351767


Title: Re: Respiratory
Post by: dennis100 on January 05, 2012, 08:11:46 AM
Model Number 102
Event Date 11/01/2011
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Date received by manufacturer (mm/dd/yyyy), corrected data: initial report selected (b)(6) 2011 as the aware date; however the aware date is (b)(6) 2011.

Manufacturer Narrative

Event Description
It was reported that a patient was hospitalized due to issues with asthma on (b)(6) 2011 and previously, in (b)(6) 2011. Per the patient, the device had previously been programmed off but when it was programmed back on, the patient began to have issues with asthma. Follow up with the patient's treating physician revealed that the device stimulation is probably a contributing the asthma as it appears to come and go with the device on and off; however, when on, the asthma is not limited to stimulation on times only. The patient does have a medical history of asthma prior to being implanted with vns. There were no causal or contributory medication or programming changes prior to the onset of the asthma. The device was programmed off on (b)(6) 2011 per the physician when the patient was in the emergency room due to asthma. No additional information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2379152


Title: Re: Respiratory
Post by: dennis100 on February 09, 2012, 07:57:56 AM
Model Number 102
Event Date 12/10/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported by a funeral home that the patient passed away on (b)(6) 2011. Additional information was received indicating that the patient's death was related to pnumonia caused by respiratory failure. Attempts for additional information and product return are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2405299


Title: Re: Respiratory
Post by: dennis100 on February 09, 2012, 07:58:46 AM
Model Number 103
Event Date 12/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the patient reported cyanosis, tachycardia and shallow breathing after having vns increased from 1. 25 ma to 1. 75 ma. The clinic notes state patient was increased over a short period of time (a couple of weeks). Patient came in to have the settings turned back down to 1. 25 ma. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2400668


Title: Re: Respiratory
Post by: dennis100 on March 08, 2012, 05:44:28 AM
Model Number 300-20
Event Date 05/01/2010
Event Type Injury
Patient Outcome Hospitalization; Required Intervention

Manufacturer Narrative

Event Description
It was reported to the manufacturer that a vns patient had developed severe laryngeal narrowing due to laryngeal muscular hypertrophy requiring tracheotomy. It was reported that the patient's symptoms were gradually worse while he was using the vns device with hoarseness and obstructive sleep apnea. Cat scan of their larynx showed irregular and thickened true and false left vocal cords. It appeared like an infiltrative mass. Their vns device was disabled: (b)(6) 2010. He developed progressive laryngeal obstruction due to hypertrophy of his left vocal cords requiring tracheotomy that was performed on (b)(6) 2010. The patient did not have a history of this prior to vns implantation. His symptoms and laryngeal hypertrophy gradually resolved after stopping the vns. His voice and breathing returned to normal in a few months. Tracheotomy was removed on (b)(6) 2011.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2434152


Title: Re: Respiratory
Post by: dennis100 on March 08, 2012, 05:45:11 AM
Model Number 102
Event Date 02/01/2012
Event Type Injury
Event Description
It was reported by a nurse that a vns patient experiences vns related asthma. The patient claimed to not have seen her vns physician since 2009 and was warned prior to implant that this could possibly be a side effect from therapy. At the moment, the patient is looking for another physician. Additional information was received from the previous treating nurse indicating the patient suffers from psychological problems. The respiratory problems referred to by the patient have been looked at by a lung specialist and many settings were tried out in order to accommodate the patient, but patient remained unhappy, claiming depression when generator was turned off and asthma when turned on.

Event Description
Moreover, additional information from the treating physician indicated the patient was psychologically unstable prior to vns. After vns was implanted, the patient would have periods of depression which nonetheless were higher than pre-vns baseline.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2467534


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 01:31:20 PM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was scheduled for explant for unknown reason after less than one year of service. Further follow-up revealed that the patient had experienced an increase in seizures "by 20 times" after vns implant and has subsequently required 22 emergency room visits for seizure activity. The patient also reported constant worsening of asthma, shortness of breath, and burning in the throat. The patient's device was programmed to off five days prior to explant. Device diagnostic testing on day of explant was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. X-rays on day of explant surgery revealed that the location of the lead was inconsistent with normal vns lead placement. There were no tie-downs used, the lead was in disarray, not aligned in the normal parallel orientation, and was located lower than normal. It was reported that the lead electrodes were not wrapped around the vagus nerve. Poor implant technique at time of initial implant is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461860


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 01:33:38 PM
Event Date 04/05/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt began experiencing shortness of breath after exertion shortly after undergoing ncp system replacement surgery. It was reported that the pt has recently been diagnosed with asthma, which he reportedly never had before vns implant. The pt reported increased inhaler use during due to the shortness of breath. Prior to ncp system replacement surgery, normal mode output current was programmed to 1. 25ma. Replacement device was programmed to a lower setting of 0. 50ma normal mode output current at the time of the pt's complaints. Frequency setting has since been reduced from 20hz to 15hz, but no change was noted in the pt's condition after this adjustment as the pt was not showing any signs of shortness of breath at the time that the adjustment was made. Device diagnostic testing was within normal limits, indicating proper device function. Chest x-rays are planned to confirm proper placement of the vns therapy system, but have not yet been performed. In the meantime, treating physician simply plans to watch the pt and indicated that this could just be a coincidence and have nothing to do with the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643410


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:14:47 PM
Event Date 09/26/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that patient had passed away. The patient reportedly went into status epilepticus at which time they aspirated and suffered a pneumothorax. The patient was taken to the operating room for placement of a chest tube at which time the pt expired in the operating room.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426114


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:18:49 PM
Event Date 03/25/2003
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. Exact cause of death is unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as pulmonary edema and hypernatraemia, due to (or as a consequence of) hypoalbumenemia and fever from hypothalamic dysfunction, due to (or as a consequence of) malnutrition and encephalopathy, due to (or as a consequence of) congenital mental retardation and severe epilepsy. The manner of death was listed as natural.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468591


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:19:55 PM
Event Date 05/15/2002
Event Type Death
Patient Outcome Death;
Event Description
Manufacturer became aware of patient death and evaluated available information against current procedures. The event did not meet mdr reporting criteria per manufacturer's current. In an effort to obtain additional information regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by manufacturer. Cause of death is listed as respiratory insufficiency and acute pulmonary edema secondary to probable seizure. No autopsy was performed. There is no evidence that the ncp 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 patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=497000


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:21:31 PM
Event Date 10/09/2002
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evalauted available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate lists immediate cause of death as respiratory insufficiency secondary to pulmonary congestion and edema with aspiration and probable seizure. Autopsy results were considered in determining the cause of death. There is no evidence that the ncp 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 patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=507048


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:22:31 PM
Event Date 12/16/2001
Event Type Death
Patient Outcome Death; .
Event Description
Reporter indicated that vns pt had passed away. The pt was seen by their neurologist six days prior to their death. The pt was started on depakote during this visit. In order to treat the pt's seizure flurries or periods of poor responsiveness, diastat was also prescribed. The physician indicated that the diastat would help to determine if the pt is dealing with hepatic encephalopathy or seizures. The vns generator settings were not changed during this visit. It was reported that the pt died while hospitalized under the care of their gastrointestinal physician. Treating neurologist indicated that the pt had a metabolic and liver disorder and it is unk whether the vns caused or contributed to the pt's death. Certificate of death lists respiratory failure as immediate cause of death, secondary to pulmonary edema. The pt was receiving vns therapy at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522787


Title: Re: Respiratory
Post by: dennis100 on March 09, 2012, 02:23:24 PM
Event Date 03/16/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the death certificate listed the immediate cause of death as acute pulmonary edema. The manner of death was listed as natural. Other significant conditions were listed as mental retardation, peripheral vascular disease.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=518615


Title: Re: Respiratory
Post by: dennis100 on April 05, 2012, 05:20:23 AM
Event Date 02/01/2011
Event Type  Injury  
Patient Outcome  Required Intervention;
Manufacturer Narrative

Event Description
It was reported by the patient's father that the vns patient had initially experienced a decrease in simple seizures with vns therapy however her complex seizures had increased. The patient then tried deep brain stimulation so the vns was turned off. After some time on deep brain stimulation, the patient had some large seizure episodes which prompted the physician to stop deep brain stimulation and resume vns in (b)(6) 2011. The patient was also noted as having difficulty breathing during magnet stimulation and therefore is reluctant to perform magnet activations to abort seizures. The patient's deep brain stimulator has recently been reactivated as per the patient's father. The patient's settings have been turned down to help with the difficulty breathing. The patient's neurologist office has declined to provide any further information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2487671


Title: Re: Respiratory
Post by: dennis100 on April 05, 2012, 05:21:57 AM
Model Number 103
Event Date 12/01/2010
Event Type  Injury  
Patient Outcome  Required Intervention; Other
Event Description
Additional information was received indicating that given the patient's genetic condition, (b)(6), the patient could experience pulmonary events. If the patient were to cough a couple of times in succession, she could experience a pulmonary embolism. It is believed that the coughing the patient experienced with device stimulation did contribute to the patient having pneumothorax. The physician did not have any additional information to provide.
 
Event Description
It was reported on (b)(6) 2012 that an implanted patient was experiencing coughing associated with stimulation once the device was turned on, which resulted in the patient having a pneumothorax 4-5 times; however, the reporter also stated that the patient "had some additional pneumothorax events after the device was turned off, so they appear to not be related to stimulation. " the patient has a history of lymphangioleiomyomatosis (lam) and tuberous sclerosis. The patient expressed wanting the device explanted; therefore, surgery is likely but has not been scheduled to date. Good faith attempts to obtain additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2488590



Title: Re: Respiratory
Post by: dennis100 on April 05, 2012, 05:28:10 AM
Model Number 300-20
Event Date 12/22/2011
Event Type  Injury  
Patient Outcome  Required Intervention;
Manufacturer Narrative

Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated a vns patient was experiencing lead protrusion in the neck, and that this was very painful. Additionally, performing vns systems diagnostics caused the patient to have painful stimulation, dyspnea, and coughing. The vns was disabled, and the patient was sent for a surgical referral and x-rays. Although surgery is likely, it has not occurred to date. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2493185


Title: Re: Respiratory
Post by: dennis100 on May 18, 2012, 06:07:11 AM
Model Number 102
Event Date 03/07/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
Reporter indicated the patient's pulmonary symptoms are exacerbated by the vns stimulation, but it was not known what to attribute the pulmonary obstruction to. Follow up with the patient's treating pulmonologist revealed the vns stimulation is causing and exacerbating the pulmonary obstruction, but this is in conjunction with one of the patient's vocal cords (unsure which one) being paralyzed. The paralysis is a result of a traumatic intubation many years ago and is pre-vns implant. The combination of the paralyzed vocal cord and the vns stimulation is causing the pulmonary obstruction event, also known as variable extra thoracic obstruction. This was diagnosed with pulmonary function tests. Normally, a methylene challenge test is used to determine if asthma is present during pulmonary function tests. For this patient, the vns stimulation was used as the "challenge". It was confirmed the pulmonary obstruction is occurring with stimulation on times. There are no interventions currently planned, but the pulmonologist will assist with care if needed.
 
Event Description
Reporter indicated that she has been diagnosed with pulmonary obstruction and that the pulmonary obstruction is caused and exacerbated by her vns device. All attempts to the reporter's treating psychiatrist for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2514458


Title: Re: Respiratory
Post by: dennis100 on July 05, 2012, 02:22:21 AM
Model Number 102R
Event Date 06/17/2011
Event Type  Injury  
Event Description
The patient had sinus surgery on (b)(6) 2011, and one week afterwards, her symptoms were first noticed.
 
Event Description
Additional information was received from the neurologist's office. It was reported that the neurologist saw the patient and "took care of it. " however, no additional information or clarification was provided.
 
Manufacturer Narrative

Event Description
It was reported that the patient had sinus surgery on (b)(6) 2010 and one week after the surgery, she had a post-surgical check-up and the ent physician used a scope to look at her throat after tilting her head back which reportedly strained it. Since that time, she has been having an altered perception of the stimulation as if it were stimulating stronger, "terrible" tremors, increased seizures, dyspnea, and gasping for breath during stimulation times. The patient reported that she has seen her neurologist about this after she fell and hit her head. The neurologist disabled her device for a couple of days which resolved the tremors. The neurologist then programmed her device to low settings. Additional information was later received on (b)(6) 2012 from the patient reporting that she believes the vns leads were cut or something from the sinus surgery in (b)(6) 2010 because since then, she has been experiencing tremors. The patient explained that she is so frustrated about this that she was thinking about committing suicide. Case management later spoke with the patient and the patient was reportedly calm and grateful for any help offered to her. She showed no signs of harming herself. The patient reported that she had discussed with the neurologist that she thinks her device is "emitting too much electricity," but the physician told her that these adverse events are psychological. The patient wants a permanent solution to her adverse events, even if it means explant of the device. Follow up with the neurologist on 05/22/2012 revealed that additional information will not be provided. The patient has a psycho-muscular disorder, so there is not anything to resolve the issue. He checked the patient's device, and it was "fine. " the neurologist does not want the company representative to run diagnostic tests on the patient's device. It is unknown when the last normal diagnostics were obtained. The company representative did see that the patient had tremor episodes with stimulation on this day. Attempts for additional information form the neurologist's office have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2602916


Title: Re: Respiratory
Post by: dennis100 on August 10, 2012, 02:55:46 AM
Model Number 102R
Event Date 09/01/2011
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was initially reported by a physician that a vns patient experienced heavy breathing issues with coughing to the point that patient was taken in an ambulance. The patient was later seen by an ent who declared left vocal cord paresis on the patient. The reported cough was found to be exacerbated by vns stimulation as found with increase in parameters. Diagnostics on the patient were within normal limits. At the moment plans are to program the patient's device off. X-rays were taken of the patient and evaluated by the manufacturer. The generator was visualized in the left upper chest. The filter feed-through wires appear to be intact. The lead connector pin seems to be fully inserted into the generator connector block. Part of lead is placed behind the generator and could not be assessed. Electrodes seemed correctly aligned on the vagus nerve. Moreover, the treating physician mentioned there was a relationship between the vocal cord paralysis and vns stimulation. Fiberoscopy shows that when stimulation is on, the vocal cord twitches. When off, it has a much reduced motility. Ent physician did not believe there was a necessary connection between mobility and the cough attacks. There are other factors such as polyposis, that could contribute to the cough. At the moment patient does not want the vns programed off, stimulation was reduced instead.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2638765


Title: Re: Respiratory
Post by: dennis100 on August 10, 2012, 02:56:24 AM
Model Number 103
Event Date 04/01/2012
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was initially reported by the patient's mother that the patient had been experiencing stridorous breathing that appeared to be related to his vns stimulation. The patient also underwent a sleep study in (b)(6) 2012. Follow up was performed with the patient's treating neurologist who did not believe that these issues were related to vns. However, additional follow up with the epileptologist who performed the sleep study indicated that the patient's breathing issues were in fact related to vns and the patient's rapid cycle. She stated that the sleep study showed a correlation between the patient's issues and vns stimulation. Per the physician, the sleep study showed desaturation at night with stimulation as well, resulting in sleep apnea. During the day, the desaturation was not occurring, however, the patient was having voice alterations with stimulation as well as stridorous breathing. The patient's settings were changed from 30secs on and 1. 8min off to 30secs on and 5min off, and the issues resolved completely. It was indicated that the patient was not experiencing desaturation any more and the voice alterations and breathing issues with stimulation went away before the patient left the office on the date of the setting adjustment. No additional information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2666922


Title: Re: Respiratory
Post by: dennis100 on August 10, 2012, 02:56:58 AM
Event


Title: Re: Respiratory
Post by: dennis100 on September 07, 2012, 08:12:29 AM
Model Number 102R
Event Date 04/03/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Clinic notes were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient had a stroke. It was also stated that after the infection the seizures were better. Daily interventions were reported for the utis. No changes were made to the patient's device, and the battery was fine. The following clinic notes were also received: notes dated (b)(6) 2012 indicated that the patient had had complications with a suprapubic tube. Interventions were unsuccessful at stopping the utis. The patient had two seizures in the past week induced by the infection or trauma. The patient's generator was checked, and it was determined that the patient would need a new battery in late september or october. Notes dated (b)(6) 2012 indicated that the patient had had 13 seizures since (b)(6). The patient visited the er after a seizure on (b)(6) 2012. The patient was not breathing for three minutes. The seizures were reportedly less severe and less frequent. Notes dated (b)(6) 2011 stated that the patient had three seizures over the past weekend. The patient also had a uti and urine retention, confirmed by urethra, penis, and urine cultures that test positive for (b)(6). Eeg notes from (b)(6) 2011 stated that the patient has a history of cva (cerebrovascular accident). Notes dated (b)(6) 2011 from the patient's brain ct showed that the patient had seizures with head trauma 12 days prior; however, there was no evidence of new intracranial abnormalities. Attempts for additional information have been unsuccessful. Surgery is likely but has not occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2687220


Title: Re: Respiratory
Post by: dennis100 on November 12, 2012, 02:26:34 PM
Model Number 103
Event Date 07/06/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that this vns patient had a past medical history of (b)(6). The notes also indicated that the patient continued to have breakthrough seizures but that the seizure frequency was significantly improved since vns therapy. The patient had generalized tonic-clonic seizures, complex-partial seizures and frontal lobe seizures. On occasion, the patient needed diastat to treat severe seizure activity. Notes dated (b)(6) 2012 indicated that the patient had a seizure on (b)(6) 2012 for which he was taken to the emergency room. During transport the patient aspirated and stopped breathing. There was no provoking factor for the episode but may have been triggered by fluctuating serum levels of his antiepileptic drugs. During follow-up, the physician stated that he did not know if the (b)(6) was related to vns as the event occurred prior to the patient being in his care, and the patient medical history was filled out by the patient's sister. No additional information was available. 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=2806978


Title: Re: Respiratory
Post by: dennis100 on February 03, 2013, 08:09:18 AM
Model Number 102
Event Date 12/18/2007
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was initially reported that the patient had left vocal cord paralysis and apnea. Follow-up indicated that the patient had their generator disabled for a mri in 2007 and did not have it turned back on due to having aggravating existing respiratory and pulmonary issues in the past. There was no specific as to what the respiratory and pulmonary issues were. There was no indication of the reported vocal cord paralysis or apnea noted in the clinic notes. The patient has several co-morbidities (not specified) that likely contributed to any issues. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854764


Title: Re: Respiratory
Post by: dennis100 on February 03, 2013, 08:09:41 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was initially reported that the patient had a history of cardiac or respiratory problems. It is unclear if the problems were cardiac or respiratory and if they were related to vns. There was no further information provided. Good faith attempt for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2855520


Title: Re: Respiratory
Post by: dennis100 on February 03, 2013, 08:10:09 AM
Model Number 102
Event Date 11/09/2012
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
Neurology reported on (b)(6) 2012, that the patient has had their vns implanted for approximately 6 or 7 years, never had any problems with it until today. For the last four hours she said it feels like a pager is going off every 2 minutes, a very strong vibration. She taped the magnet over it for the last hr, no changes. No other problems other than this feeling of vibration. She has had a feeling of vibration on and off, consistent with stimulation but not with every one, since (b)(6). She had the settings increased twice over the last year. She had noticed in the last year a feeling of shortness of breath when ambulating up the stairs, also worsened with exercising in the gym. Her neuro has encouraged her to use the magnet to turn off the device when working in the gym. The patient is being referred for generator replacement surgery. Good faith attempts are underway for further details about the reported events. No surgery is planned at this time.
 
Event Description
Additional information was received in regards to the patient's muscle spasms. They were first experienced on (b)(6) 2012 and that though they feel it is related to vns, it was not due to stimulation. The patient would feel the sensation in the chest and neck area. There were no diagnostics available and there is no intervention planned or taken for this issue. Regarding dyspnea that this was also first experienced on (b)(6) 2012 and that this was not due to the vns as the patient has had this issue for a long time. This was not felt during stimulation. There were no diagnostics available and there is no intervention planned or taken for this issue. It was additionally reported to their office on (b)(6) 2012 by the patient that she felt her vns is stimulating every 2 minutes, however, the stimulation is programmed for every 5 minutes. In the past, she never felt the stimulation until now. She claims it feels like a strong vibration, like a pager. She tried taping the magnet over the device to turn it off, but to no avail. No other problems were noted. Patient states she feels fine; other than concerned about the constant strong vibration. The patient was told her battery is going dead and needs to be replaced asap. At this time no surgery date has been scheduled that the manufacturer is aware of. On office visit (b)(6) 2012 the patient reported she has had flurries of seizures that occurred in april and in june. When she exercises and her vagus nerve stimulator turns on and she feels very short of breath. At that visit her vagal nerve stimulator was interrogated and increased to output to 1. 5 as well as the extra magnet output to 1. 75. She was also given a prescription for valium to take for the flurry of seizures. It is unknown if these were above or below baseline and the relationship to their vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2863171


Title: Re: Respiratory
Post by: dennis100 on February 03, 2013, 08:10:37 AM
Model Number 304-20
Event Date 11/07/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
A vns patient called to report that since their implant (b)(6) 2012, they were having issues. It was reported that since he had his vns placed, he has had shortness of breath and voice alteration that won't go away. The patient also reported that he had one of the worst seizures last night that he has ever had. The patient's vns was not programmed on. The patient reported that their neurology office would not program his vns on till his shortness of breath and voice alteration resolve. The estimated time of surgery was 45 minutes. There were no complications reported during the procedure. Final interrogation showed device was at 0. 0 output current, and 0. 0 magnet current. The patient was seen by an ent physician and it was noted that his left vocal cord was "weak" due to vocal cord paralysis. The patient reported that the ent and implanting surgeon said his device could be turned. The patient also no longer reports shortness of breath, but still has hoarseness. The patient is scheduled to have a procedure with the ent to adjust his vocal cords closer together using a scope. Further followup will be performed to attain more details about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870353


Title: Re: Respiratory
Post by: dennis100 on February 03, 2013, 08:10:59 AM
Event Date 04/25/2003
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received on (b)(6) 2012, when the author of the article stated that she no longer has access to any of the information about the patients in the article as she is no longer at that facility.
 
Manufacturer Narrative
Age at time of event, sex; corrected data: inadvertently did not include this information on the initial report.
 
Event Description
It was reported through a scientific article that a vns patient was treated in with oral appliance of cpap for obstructive sleep apnea while being in a sleep study. The patient was reported to have continued to having seizures at a similar frequency before and after the treatment using oral cpap. The author did indicate the patient's vns may have been associated with apneas and hypopneas during sleep as the vns was not programmed off during the study. Vns related respiratory events did not resolve with used of the oral appliance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2637646


Title: Re: Respiratory
Post by: dennis100 on February 06, 2013, 10:30:38 AM
Model Number 302-20
Event Date 04/16/2012
Event Type  Injury  
Event Description
On (b)(6) 2012, it was reported that the hospital could not find the explanted generator; it was reported that it might have been disposed of. It was later reported that the hospital did indeed have the generator and would be returning it to the manufacturer for product analysis. The explanted generator was returned to the manufacturer on (b)(6) 2012. 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 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; there were no anomalies found with the pulse generator.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2012, revealed that the patient was in the emergency room twice the night before with seizures. The emt taped the magnet to her vns and the device was turned off. The patient was referred for battery replacement due to a low battery. It was reported that the patient has not been feeling stimulation over the last 5-6 months. The patient was noted to have an increase in seizures over the last months. The patient has multiple seizure types; psychomotor, gtc, and dualistic with aura. The patient was noted to have a past medical history of acute myocarditis, respiratory failure, gerd, cardiomyopathy, lymphadenitis, and a family history of lung cancer and diabetes. It was later reported that although a dcdc of 4 was observed during a system diagnostics test on (b)(6) 2012, high impedance was not observed. The increase in seizures was first observed 2-3 months ago. The physician believes the increase in seizures is due to loss of therapy and stress. The patient has been scheduled for prophylactic battery change. The increase in seizures is below pre-vns baseline levels. All the patient's seizure types have increased. It was unknown if any causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. No causal or contributory programming or medication changes precede the onset of the stimulation not perceived. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient underwent prophylactic battery replacement on (b)(6) 2012. Pre-operative system diagnostics showed output=ok/lead impedance=ok/dcdc=2/eri=no. The patient's settings were output=2. 25ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=3min/magnet output=2. 5ma/magnet pulse width=250usec/magnet on time=60sec. The generator was replaced and system diagnostics showed the system to be functioning properly with output=ok/lead impedance=ok/dcdc=2/eri=no. Attempts for the return of the explanted generator have been made but have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2818913


Title: Re: Respiratory
Post by: dennis100 on February 06, 2013, 10:31:05 AM
Model Number 103
Event Date 08/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
It was reported that the vns patient was making new "breathy or wheezy" noises that were different than normal. The patient was noted as having to go to the hospital in august due to increased seizures. The patient was noted as no longer experiencing seizures in the daytime. The patient used to experience 1-2 seizures per week in the daytime that are approximately 30 seconds in duration however now the patient experiences 5 seizures per night that are approximately 10 seconds in duration. Vns magnet activations are usually effective at stopping the patient's seizures. The patient was also noted as experiencing a change in vocalizations. The patient's vns was noted as now being near end of service. The patient has been referred for vns generator replacement. Attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2832892


Title: Re: Respiratory
Post by: dennis100 on February 06, 2013, 10:31:32 AM
Model Number 103
Event Date 09/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The patient presented for low battery. The patient had excellent prior response to stimulation with reduction of seizures and earlier abortion of her seizure episodes with use of the magnet. May weeks ago, the patient began having sporadic discharges from her vns which results in throat discomfort, coughing, breathing difficulties, and speech hoarseness. The patient was also concerned that the increase in seizures could make it difficult to work. The notes stated that the patient needed urgent replacement of her device due to the severe symptoms attributable to low battery resulting in sporadic discharges. An implant card dated (b)(6) 2012 indicated that the patient underwent generator revision on (b)(6) 2012 due to battery depletion.
 
Event Description
On (b)(6) 2012, it was reported that the device had been discarded. Attempts for additional information have been unsuccessful.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2847361


Title: Re: Respiratory
Post by: dennis100 on February 06, 2013, 10:32:01 AM
Model Number 103
Device Problems Device operates differently than expected; No Known Device Problem
Event Date 12/08/2010
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the patient stated that she feels tingling in her heels, legs, and groin when she is around cell phones or technology. She said that the magnet is not turning off her device. She said she sleeps with the magnet taped on and she said that it is still stimulating. She said the device is stimulating erratically. The patient stated that her physician does not entirely believe that she is feeling these things. Per the patient, diagnostics come back fine, and the doctor says the device is working properly. She stated that the device turns on and off at "suspicious intervals". She said that the vns has worked really well for her, and these events began in (b)(6) 2013. The patient¿s new following physician will not provide information.
 
Event Description
Additional information was received from the neurologist stating that vns patient¿s psychosis was related to the event. The patient was having fixed delusions. The patient¿s device was disabled on (b)(6) 2014. The patient was referred for surgery but no know interventions have occurred to date. The patient believed that the police were accessing her device and harassing her.
 
Manufacturer Narrative

Event Description
The patient again reported concerns that the vns device has been ¿hacked¿ to the physician. The physician was asked to interrogate the device to confirm that the device is still off and that the output currents are set to 0ma. It was later found out that the patient¿s vns was re-initiated in 2015 and patient has done well with vns stimulation for several months. Patient quit taking her antipsychotic medications again and now is stating that someone again is trying to "hack" her vns and the fbi is reading her thoughts through the vns device. Per the patient, the vns also causes vaginal pain and stimulations and the fbi is sexually assaulting her through the vns device. Additional information was received from a different nurse practitioner that the patient's device had been turned on and off three times over the course of a few months in 2015 and 2016. The neurologist disabled the patient's device on (b)(6) 2016. Diagnostics were not performed patient was referred to a psychiatrist.
 
Event Description
Additional information was received that the patient is able to feel the stimulation on demand when the magnet is swiped across the generator in spite of this device being disabled by the neurologist. It is unknown if the magnet mode stimulation was also disabled. Attempts for additional relevant information were unsuccessful.
 
Event Description
Additional information was received stating that the vns patient believed someone had hacked into her device and was experiencing difficulty with stimulation. The patient did not have any seizures since vns. The patient wanted to have her device removed. The patient¿s device was programmed off on 04/02/2014. The neurologist stated that there were no issues with the patient¿s device and that the patient was suffering from some type of psychotic disorder. The patient continued to have issues after her device was programmed off. The neurologist stated that the patient¿s issues were not related to vns attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Patient reported having episodes of dizziness, increased heart rate, difficulty breathing, etc. These episodes began one night when she was trying to sleep and her heart rate increased and she began having tingling in her body. She then heard a voice telling her ¿allegations¿ that someone was tampering with her body. She reported getting a jolt and repeated her previous concerns of device being hacked to spy on her. She is concerned about getting the device replaced and is not confident in the device security as it was disabled and turned itself back on at one point in time. Based on available information from physicians, the device has been disabled since (b)(4) 2016. Patient was seen by multiple neurologists and psychiatrists and has been found to have schizophrenia and multiple other psychiatric conditions. She has been found to have pseudo seizures and some real seizures controlled when she takes her meds. The neurologists and psychiatrists have been unable to verify the reports that patient had reported and turned vns off as it make the patient more paranoid.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3483718


Title: Re: Respiratory
Post by: dennis100 on February 08, 2013, 07:18:37 AM
Model Number 103
Event Date 08/03/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2012. The clinic notes mention that the patient's most recent seizure was typical and associated with a longer postictal period. It was noted that the initial diagnosis of the patient's seizure disorder was year(s) ago and since diagnosis the disease has been worsening. The patient's settings were output=1ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=1. 5ma/magnet on time=60sec/magnet pulse width=500usec. The patient mentions that he wants his vns explanted and is having shortness of breath with stimulation. The patient's output current was then programmed to 0ma. Clinic notes dated (b)(6) 2012 mention that the patient is having difficulty breathing and difficulty breathing on exertion. The patient's most recent seizure was typical and associated with a longer postictal period. It was previously reported that the patient is experiencing shortness of breath in (b)(6) 2012 and was being seen by their physician for a dosing appointment. After the appointment the patient was reported to be doing great. The appointment went well and all symptoms had alleviated. The patient was set at a pulse width of 500usec and frequency of 30hz and had never been changed. The patient's settings were adjusted and the patient was doing great with no problems. The patient's voice alteration was better and he was much more comfortable. All symptoms alleviated with dosing changes. There have been no falls, etc. , that were related or could have contributed to the events. The patient's mother later reported that her son's device was programmed off on the week of (b)(6) due to severe voice alteration and shortness of breath. The patient's mother stated that the magnet mode was left on when they programmed the device off in (b)(6) 2012. The mother was unsure of the exact date of the disablement. She explained that both the dyspnea and the voice alteration occurred during stimulation of the device. The mother stated that adjusting the patient's settings was already attempted in august. She explained that after this adjustment, the patient did not get much better and that she feels the symptoms got worse. She did explain however, that this may have been due to him starting school shortly after. She denied any trauma or medications changes and stated that the patient's seizures have been about the same. Although surgery is likely, it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2938421


Title: Re: Respiratory
Post by: dennis100 on February 08, 2013, 07:19:07 AM
Event Date 12/14/2012
Event Type  Injury  
Patient Outcome  Hospitalization,Other
Manufacturer Narrative

Event Description
It was initially reported that the patient was being hospitalized for apnea episodes. It was unknown when the apnea began or if it was occurring with stimulation. The physician was curious the percentage of patient with vns that had apnea but there was no information as to if the physician believed that the apnea was caused or made worse by vns. Good faith attempts for more information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2912140


Title: Re: Respiratory
Post by: dennis100 on March 08, 2013, 12:36:45 PM
Model Number 102R
Event Date 06/20/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated a patient experienced wheezing with vns stimulation. Disabling the vns with the magnet did help with the wheezing, but the patient's seizures increased so the patient was not comfortable leaving the vns disabled with the magnet. The wheezing is described as audible upon inspiration. The wheezing occurs with vns stimulation and an increase in exercise. No vns programming changes or medication changes precipitated the wheezing, and the patient did not have a pre-vns history of wheezing. The vns settings were lowered, which helped the wheezing. The vns was later disabled as recommended by a pulmonologist, to preclude a serious injury to the patient's pulmonary system. The patient was initially placed on inhalers and steroids which did not resolve the wheezing, so the vns was disabled. The wheezing has resolved since the vns was disabled, however; the vns may be turned back on at a later date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2960148


Title: Re: Respiratory
Post by: dennis100 on March 08, 2013, 12:37:34 PM
Model Number 304-20
Event Type  Injury  
Patient Outcome  Other
Event Description
A vns treating physician reported that they had a patient who was implanted (b)(6) 2012 who was experiencing vocal cord paralysis and shortness of breath. Good faith attempts thus far have been made and no further information has been attained. Date of event onset is not known at this time.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2969151


Title: Re: Respiratory
Post by: dennis100 on March 26, 2013, 11:36:27 PM
Model Number 101
Event Type  Injury  
Patient Outcome  Life Threatening;  
Event Description  
Further follow-up revelaed that the device remains programmed off. It was reported that the reported events have not recurred. It is unknown if the reported events are related to vns therapy due to lack of information from treating physician.  
 
Event Description  
Further follow-up revealed that the vns system is still turned off and the pt has not experienced further assystole. The physician reported the vns therapy is possibly related to the event. The physician also reported that the pt does not have any cardiac history that might have contributed to the event. The plan is to keep the vns system turned off. The device was reportedly not on the time of the reported event (dysphagia, dyspnea and asysteole), therefore, it is not likely that the vns contributed to the event.  
 
Event Description  
While undergoing an ekg, the pt developed dyshagia and dyspnea and their heart stopped. Cardiopulmonary resuscitation was not required. It was reported that the pt's device was programmed to off at the time of the event. Report is incomplete because no response has been received to mfr's request for additional info from treating physician (via fax x1).  
 
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=616495


Title: Re: Respiratory
Post by: dennis100 on April 05, 2013, 03:57:26 AM
Model Number 102
Event Date 07/29/2012
Event Type  Injury  
Patient Outcome  Other
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.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2995749



Title: Re: Respiratory
Post by: dennis100 on April 05, 2013, 03:58:23 AM
Model Number 300-20
Event Date 08/11/2005
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
Reporter indicated that a patient had vns lead and generator replacement surgery performed on (b)(6) 2006, due to voice alteration with vns stimulation and dyspnea. Vns setting changes did not resolve the issues. The patient was also having shock-like sensations in the neck that did not correlate to vns stimulation. Vns diagnostics were reported to be within normal limits. The patient had no trauma and was not spastic. The patient was reported to be doing well following the vns replacement surgery. The reporter felt there could be some current leakage along the length of the lead causing the adverse events. The explanted devices were returned for analysis. No anomalies were noted with the returned lead portion that would affect device function. An opening was noted in the outer tubing. No anomalies were noted during the generator analysis, and the generator performed per specifications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2985786


Title: Re: Respiratory
Post by: dennis100 on April 05, 2013, 05:08:50 AM
Type


Title: Re: Respiratory
Post by: dennis100 on April 06, 2013, 05:46:46 AM
Model Number 102
Event Date 05/15/2011
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported that the vns patient had voice alterations and it becomes hard to breathe while exercising when the device is stimulating. It was also reported that a small firm 2mm elevated lump was noted, and that an increase in seizure frequency was also noticed and the patient cannot be certain how effective the vns is. Attempts to contact the physician have been unsuccessful to date. A battery life calculation was calculated and the vns generator was found at 6. 55 years remaining until end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2994918


Title: Re: Respiratory
Post by: dennis100 on April 06, 2013, 05:48:14 AM
Model Number 101
Event Date 01/27/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Clinic notes dated (b)(6) 2013 reported that the patient presented for follow-up of seizures. These were the first seizures that the patient had for a "very long time. " on (b)(6) 2013, the patient experienced a series of wetting which were thought to be seizures with altered consciousness's that lasted several seconds. After about 45 minutes, she was seen in the emergency room, where a ct scan was performed and was read as having no significant change. The patient was then discharged. A day and a half later, the patient had another episode in which she felt like she could not breathe. The patient was provided oxygen. Of note, the patient was noted to have been ill with an upper respiratory infection and bronchitis treated with antibiotics for about a week before the first seizure. However, by (b)(6) 2013, she was off of the antibiotics. The patient has not felt the vns stimulation for more than a year and feels that it has stopped working for her since her headaches have gotten a little worse. The physician's impression presented in the notes were that the breakthrough seizures may have been related to the illness. However, it was stated that the patient "does not have any sort of function for her vns, something that would not be too surprising given the fact that it was implanted in 2001. " it was planned to have the patient admitted for 48 hours continuous eeg with video and neuro-telemetry to see if it would be appropriate to replace the vns generator. If the eeg looks normal for that eeg period, the physician noted that it may not be necessary to replace the generator. "it has probably not been functioning for some time because she has such an old unit. " notes dated (b)(6) 2013 indicated the patient continues to have spells but they were not as severe as the spells the patient was experiencing about three weeks prior. The patient has intractable epilepsy and was now having spells that are poorly defined, per the clinicals. Given the patient's history of anxiety and depression, the physician noted that psychiatric etiology must be ruled out. Follow up with the neurologist's office revealed that the patient did experience breakthrough seizures recently around (b)(6) 2013 which the physician's office attribute to the battery being at end of life even though eri=no. They believe the device is no longer functioning. The patient had one big seizure which was a change for her so that is why they evaluated her vns. They believe it's at end of life due to the patient's headaches again and stimulation no longer perceived. There were no recent medication, programming changes or external factors that could have contributed to these events. They have referred the patient for generator replacement due to breakthrough seizures and length of implant (implanted in 2001). No additional information was provided. Although surgery is likely, it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3021300




Title: Re: Respiratory
Post by: dennis100 on May 10, 2013, 04:13:51 AM
Model


Title: Re: Respiratory
Post by: dennis100 on May 10, 2013, 04:14:17 AM
Model Number 302-20
Event Date 01/01/2011
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was reported that the patient was referred for explant due to shortness of breath with device stimulation. It was reported that the patient is unable to exercise. The surgeon's office indicated that the device was disabled approximately 6 months ago, but that the patient now wants the device completely explanted. Clinic notes dated (b)(6) 2013 noted that the patient reports that the implant "cuts off respirations. " the notes indicated that the plan of care was discussed with the patient and that is was discussed that removal of the device will not improve the patient's exercise tolerance at all. The notes indicate that a fiber exam shows a very mild left cord weakness only with good airway caliber. The notes indicated that the patient's symptoms were worse when the device was programmed on. The patient's speaking voice is normal. The patient desires removal despite the physician's warnings that exercise tolerance will not change. Surgery is planned; however, has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3081202


Title: Re: Respiratory
Post by: dennis100 on June 07, 2013, 11:37:28 AM
Model Number 302-20
Event Date 04/04/2013
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the vns patient saw a pulmonologist recently and after reviewing her x-rays said that the "wire is doing something to her throat and needs to be removed because it could cause an infection. " it was stated that the device was disabled sometime the previous year but the patient is choking, vomiting, and wetting herself. The patient stated that when she had previously had her leads replaced, the surgeon told her that he had to get closer to her vocal cords when putting the new wires in. Good faith attempts for further information from the physician were unsuccessful. Although surgery is likely, it has not occurred to date. It was previously reported that when the patient's device stimulates, it causes her to cough. The diagnostic history of the generator was searched and all results show normal diagnostic results and no evidence of a device malfunction. The patient's doctor reduced the output current in an attempt to alleviate the reported coughing. There was no indication that this intervention was taken to preclude a serious injury. Follow-up with the physician's office revealed the patient was recently seen and the output current was reduced from 1. 75 to 1. 5ma, and diagnostics were normal per the chart. The patient has not contacted the office since that time and as such it is assumed by the office the patient is tolerating the vns settings. In (b)(6) 2012, the patient reported that she has been having an issue with coughing for a few years, but has progressively gotten worse and is now causing difficulty in breathing. She said that when she disabled her device with the magnet for four days, it did get a little better, but returned when the magnet was removed. She also reported that she stopped seeing her physician because she didn't feel he was taking her complaint seriously, and currently doesn't have a physician. The patient stated that she saw her family practitioner and was given medications for coughing and allergies, but that didn't resolve the issue, which is why she thinks it is due to the vns. The patient later reported that she found a physician who would be able to turn her device off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3087279


Title: Re: Respiratory
Post by: dennis100 on June 07, 2013, 11:37:54 AM
Model Number 302-20
Event Date 09/01/2012
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative

Event Description
It was initially reported that this vns patient experiencing light-headedness and shortness of breath after a dog fell on her neck. Settings and diagnostics were all normal. X-rays were taken, but the physician did not see any abnormalities in the lead. Additional information was received that diagnostics were run on (b)(6) 2013, with the patient's neck in several different positions, and each time, the diagnostics were all ok. The patient also reported pain in the neck area during stimulation where her head was up. The device was temporarily disabled, and the pain and breathing problem improved. There was no recent settings change. The patient fell in the shower in december and the shortness of breath began after that; however, a dog also jumped on the patient's neck at in (b)(6) 2012; however, the time of this event cannot be confirmed. There was no report of dizziness on this date. The patient had not experienced this shortness of breath prior to the incidents of the dog jumping on the neck/falling in the shower. The patient was visibly uncomfortable with stimulation. The patient's settings were provided. The settings were titrated down, and the dyspnea recurred. The settings were further reduced to bearable settings. Ct images were provided for review; however, due to image quality, they could not be assessed. Surgery is likely but has not taken place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3102490


Title: Re: Respiratory
Post by: dennis100 on June 07, 2013, 11:38:18 AM
Event Date 07/12/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was initially reported on (b)(6) 2013 via a (b)(4) message that the patient was having breathing problems during deep sleep since vns implantation. A video was posted of the patient's sleeping issue. The patient's caregiver reports that she is certain that these problems started with vns implant and have continued to get worse as settings increase. Later on (b)(6) 2013, the caregiver reported that she has brought up the sleeping issue concern with the patient's vns neurologist and primary care physician (pcp), but the physician did not seem concerned and said it was "normal," but she feels that this is not. The caregiver said that she understands that there are warnings for patients with pre-existing issues and being evaluated prior to vns for things like this, but she felt that the patient does not have any physical issues that would cause her to have a pre-existing condition that would be exacerbated by the vns therapy. She did confirm that the patient has not had a sleep study done since so far her pcp did not think it was needed and also has not referred her to an ent. The caregiver then went on to explain that during the episodes, the patient's oxygen levels are dropping into the 80s, especially more recently and was not an issue in the past. The issue only occurs during deep sleep, is not position dependent or due to an illness like a cold, is present when breathing through mouth or nose, or if the patient is lying flat or elevated. The patient had generator replacement on (b)(6) 2012, and the caregiver reported that this issue was present with the patient's previous generator implanted on (b)(6) 2009. (the sleeping issues with the previous generator are captured in mfg report number: 1644487-2013-01308. ) however, the issue has worsened since generator replacement in 2012. She said that as far as she knew there had not been any attempts to alleviate the issue with settings adjustments, however when the patient's output current was lowered (settings unknown) for a few days the patient had increase in her seizure frequency, so the patient's settings were increased again. That patient is stilling having about 20+ seizures every 24-hours and has several seizure-types due to a traumatic brain injury several years ago, which appears to have several focal points in her brain, so her treatment options are limited. The patient was started on a new medication about a year ago. The caregiver does not feel that cpap is an option due to the patient's seizures which have been violent and would likely cause the cpap to be damaged within a few days. The caregiver was suggested to discuss these issues with the physician for further discussions and suggestions. Follow-up with the treating vns neurologist was performed which revealed that the patient was evaluated on (b)(6) 2013. She reported that she was not aware of the patient's breathing troubles and lower oxygen levels (below 80) until the vns manufacturer contacted her office. The patient/caregiver had not reported this to her until her appointment on (b)(6) 2013. The caregiver brought in the video of the patient sleeping to show the physician. The physician reported that the breathing troubles appear to be related to stimulation, so she lowered the output current and pulse width. She further indicated that it is "clear that the patient gets gassy during stimulation. " she reported that if this does not resolve the issue, she plans on lowering the stimulation further. She stated that when the patient/caregiver disabled the device with the vns magnet, the issues resolved so it is "obviously" related to vns. The physician lowered the output current to 2. 5ma and pulse width to 250usec. However, the patient did not want the settings lowered, but the physician elected to turn down the settings to see if this helps the breathing troubles. No additional information was provided by the physician as she was not previously aware of the breathing issues during sleep. Attempts for the product information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3102380


Title: Re: Respiratory
Post by: dennis100 on June 07, 2013, 11:38:39 AM
Model Number 102
Event Date 11/08/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3118167



Title: Re: Respiratory
Post by: dennis100 on August 10, 2013, 08:07:52 AM
Model Number 103
Event Date 06/25/2013
Event Type  Injury  
Patient Outcome  Other
Event Description
The patient had prophylactic generator replacement surgery on (b)(6) 2013. The patient was implanted with a replacement model 103 device. The first system diagnostic test inside pocket with the skin open was within normal limits at 2380 ohms impedance value. The second system diagnostic test inside pocket skin closed was within normal limits at 2420. Anesthesia reported to the company specialist to the surgeon in surgery that during two stimulation events during device testing, the patient ¿stopped breathing¿ for one to two seconds during stimulation on-times. He said it was spontaneous recovery so he did not intervene with any drugs or other intervention. The crna rechecked the patient post-operatively and reported that the patient was doing ¿fantastic,¿ so no further apnea episodes were noted by him or in post-op follow-up. The patient¿s device was reset to pre-operative settings per the treating physician¿s requested and re-interrogated. Settings were verified. Implant card was received which confirmed lead impedance following generator replacement was ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3237105



Title: Re: Respiratory
Post by: dennis100 on September 06, 2013, 09:02:06 AM
Model Number 102
Event Date 05/02/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
Initially, it was reported that the patient was experiencing ten seizures per week with the output current at 0. 75ma and that the device was then programmed off and the patient did not experience a seizure for three weeks after having the device off. Further follow-up revealed that the ten seizures per week was an increase above the patient's pre-vns baseline frequency which was two to four seizures in one month. It was reported that the patient's device was programmed on initially on (b)(6) 2013. The output current was increased to 0. 5ma on (b)(6) 2013 and then up to 0. 75ma on (b)(6) 2013. The patient was then seen on (b)(6) 2013 at which time it was noted that the patient had experienced 10 seizures in one month. It was also reported by the patient's wife that the patient seemed to take longer to recover to his normal breathing in the postictal period of night seizures. It was reported that the device was programmed off at this visit. The patient was later seen on (b)(6) 2013 at which time it was noted that the patient had not experienced any seizures. It was reported that the patient's seizures have now returned to pre-vns baseline and that the vns was not programmed back on. The patient's medications were adjusted. The physician believes that the increase in seizures is related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3319359


Title: Re: Respiratory
Post by: dennis100 on September 06, 2013, 09:03:05 AM
Model Number 102
Event Date 07/30/2013
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported that the patient had the vns device explanted because it was implanted for seven years and never worked, and now the patient is having breathing problems, or dysphagia, with vns. The explanted device was returned on (b)(4) 2013 and is pending product analysis. Attempts will be performed for additional information. No additional information has been received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3313844


Title: Re: Respiratory
Post by: dennis100 on October 03, 2013, 11:17:55 PM
Model Number 102
Event Date 01/01/2013
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the patient was complaining of erratic stimulation and pain in the left arm that were making it difficult to breathe. The physician advised the patient to disable the device temporarily and to either have the generator replaced or explanted. The physician informed the patient that the device battery could be wearing down and causing the erratic stimulation. The patient chose generator replacement and was referred for surgery. It was later reported that the patient was hospitalized for pneumonia and that the generator replacement surgery had been cancelled and not yet rescheduled. Surgery is still planned; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3330760


Title: Re: Respiratory
Post by: dennis100 on October 03, 2013, 11:18:17 PM
Model Number 102
Event Date 08/06/2013
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing spasms of the sternocleidomastoid muscle with device stimulation which was causing the patient to experience head deviations which resulted in airway obstruction. It was reported that the patient used the magnet to disable the device and that the spasms resolved for about 10 minutes, but then started back up. It was reported that it is unclear if the magnet moved off the device because the physician was not present at this time. The patient was seen by the physician at the hospital and the device was programmed off. The physician indicated that it was unclear whether or not the patient's accessory nerve was being stimulated to cause this or whether there is current leakage to the muscle. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3329805



Title: Re: Respiratory
Post by: dennis100 on October 03, 2013, 11:18:42 PM
Model Number 102
Event Date 01/01/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
The patient has been diagnosed with left vocal cord paralysis, confirmed on direct laryngoscopy. Symptoms developed about six months after surgery. The physician presumes that it is due to compression, ischaemia, or fibrosis and requested literature on the subject as it was not related to direct surgical injury at the time of surgery. Clinic notes were received which indicate the patient's voice became noticeably weak about six months ago when the settings were changed due to shortness of breath. This weakness deteriorates presumably in relation to periods of stimulation. The patient does not have any significant stridor, respiratory distress, or difficulty swallowing at present and there is no history suggestive of significant aspiration. On the date of this visit (date unknown), the notes state that the patient's voice was fairly normal and general examination was otherwise unremarkable. The patient was particularly co-operative during flexible laryngoscopy. The left vocal cord was immobile and sitting in a paramedian position with a reasonable degree of glottic closure due to compensation from the right side. During periods of stimulation, the left vocal cord seemed to be bowed and flaccid resulting in a larger phonatory gap. During this time, there was inadequate compensation from the right vocal cord with closure being predominantly supraglottic. The patient appears to have left vocal cord paralysis with good compensation. The phonatory gap increases during periods of stimulation, associated with glottic closure. The physician states in the notes that he does not have the experience to predict whether or not left vocal fold function will deteriorate with longer term vns use, but if this was to occur, the adverse effect on phonation could be managed by vocal fold augmentation. However, the physician very much doubts that this will be necessary. Programming history was provided which indicates the patient coughs with stimulation. The patient also experienced respiratory difficulties when sleeping and is seeing an ear nose throat doctor for his altered voice. Follow up with the physician indicates the respiratory difficulties were noisy breathing during sleep. There was also a complaint of breathlessness during exercise around the same time. This seemed to be due to stimulation, as reducing the on time but maintaining the approximate duty cycle improved the symptoms. It is difficult to be certain of this relation to stimulation as there was no specific monitoring performed to confirm this; however, it was assumed to be the case. The symptoms resolved with reduction of the on time. The physician stated that the respiratory difficulties became apparent over time, potentially as the current was increased. The patient has severe neurological problems and these issues were relatively minor in the broad scheme of things, per the physician. The patient did not have a medical history of this prior to vns. In regards to the vocal cord paralysis, the physician stated that the relationship to vns is uncertain. The onset of the dysphonia was six months after implantation. There was no trauma at that time. Nerve injury possibly occurred at the time of surgery and the manifestations were delayed. The discomfort and prominent cough at very low stimulation following implantation might suggest an acute problem following implantation. There was no periodicity to the dysphonia and it was not related to vns stimulation. The ent exam indicated permanent left vocal cord paralysis. As intervention, the vns may be turned off as it does not seem to have been effective in reducing seizures over the last two years. No other causal or contributory programming or medication changes, besides the usual gradual increase in stimulation current each month following implantation, preceded the onset of the event. The patient does not have a medical history of vocal cord paralysis prior to vns. No additional information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3338126


Title: Re: Respiratory
Post by: dennis100 on October 03, 2013, 11:19:09 PM
Model Number 103
Event Date 08/16/2013
Event Type  Injury  
Patient Outcome  Hospitalization,Other
Event Description
It was reported that the patient remained hospitalized for approximately four days following vns implant due to respiratory problems. The surgeon's office did not have record of this. It is unknown if the respiratory problems are related to the vns surgery. It was reported that the patient was discharged and then later seen by the neurologist to have the vns programmed on. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3357470


Title: Re: Respiratory
Post by: dennis100 on October 03, 2013, 11:19:39 PM
Model Number 302-20
Event Date 06/13/2008
Event Type  Injury  
Patient Outcome  Other
Event Description
On (b)(6) 2013, this patient reported that the lead has been close to the vocal cord since implant. There was no pain. The patient experienced voice alteration with magnet activation. The patient was referred for revision. The patient indicated that the device settings could not be increased because it causes her to have difficulties breathing. When the magnet is used, she has problems catching her breath for awhile. She also cannot make but a "raspy squeak" for a short while after magnet use. At the current device settings, the patient did not experience difficulty breathing. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3372834


Title: Re: Respiratory
Post by: dennis100 on November 08, 2013, 03:14:32 AM
Model Number 103
Event Date 07/15/2013
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported the patient stated that one morning when he was sleeping, he was unable to breathe and catch his breath. "it almost felt like a dream, but i know it wasn't a dream, it was very scary. " the patient mentioned that he was unsure if lowering his dose of topamax had anything to do with the event. His doctor lowered his dose of topamax, after he turned up the vns device. The patient also reported feeling a rapid heart beat when the device is activated. He then stated "i don't think i experience that now. " he received the vns therapy in (b)(6) 2013. He started using topamax approx. 1- 1 1/2 year ago. The patient is still receiving topamax and still has the vns device implanted. Attempts are underway for additional information. No other relevant information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3408210


Title: Re: Respiratory
Post by: dennis100 on December 06, 2013, 02:02:10 AM
Event Date 10/04/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient was scheduled for vns explant due to pseudomonas infection. It was reported that the patient recently underwent generator replacement. It was reported that the patient has a permanent tracheostomy in place. Further follow-up revealed that the implanting surgeon's notes indicated that the patient has not been seen since reimplant and that the patient was a no show for the post operative appointment. It is unknown if the patient underwent vns explant as previously reported. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3467794


Title: Re: Respiratory
Post by: dennis100 on December 06, 2013, 02:02:32 AM
Model Number 102
Event Date 10/04/2013
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Initially, it was reported that the patient has been experiencing difficulty swallowing and shortness of breath. The patient reported that this is more often than not. The patient also reported that it feels like the device is shocking her from the generator to up under her tongue. The patient reported that taping the magnet over the generator was attempting, but was too painful. The patient also reported that the generator feels like it is slipping down into her armpit. The patient reported that the device has not been checked in three to four years. The patient was later seen by a surgeon and surgery was scheduled. It is unknown whether or not surgery occurred as planned. Attempt to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3472747


Title: Re: Respiratory
Post by: dennis100 on December 06, 2013, 02:02:57 AM
Model Number 103
Event Date 07/03/2013
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
 
Event Description
It was reported that the patient was seen by the nurse in clinic on (b)(6) 2013. The patient wants the device explanted because of continuing shortness of breath. The patient's device was switched off (to 0ma). The impression was that the shortness of breath was not related to stimulation; however, the patient did not experience shortness of breath prior to vns implant. The patient is a heavy smoker and was sent for x-rays. Follow up with the physician found that the shortness of breath persisted when the vns device was turned off. No causal or contributory medication changes preceded the onset of the event. The patient did not have a medical history of dyspnea prior to vns. The patient complained of shortness of breath prior to vns programming. The patient was programmed three months post op up to 0. 25ma for seven days only (starting (b)(6) 2013). The patient requested the vns device switched off on (b)(6) 2013. The patient will be seen by a neurosurgeon. No other information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3452734


Title: Re: Respiratory
Post by: dennis100 on December 06, 2013, 02:03:19 AM
Model Number 102
Event Date 09/04/2013
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Clinic notes dated (b)(6) 2013 indicated recurrent aspiration bronchitis/pneumonia and dysphagia (aspiration with a history of pneumonia) in the patient¿s past medical history. Attempts for additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444161


Title: Re: Respiratory
Post by: dennis100 on January 12, 2014, 10:11:24 AM
Model Number 102
Event Date 09/25/2013
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was hospitalized due to respiratory decompensation after vns therapy was initiated. It was reported that the relationship to the implant procedure and device stimulation was possible. It was reported medication was added and the patient had a consultation with a pneumologist. It was reported that the patient was recovering.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497504


Title: Re: Respiratory
Post by: dennis100 on March 14, 2014, 03:40:43 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: Respiratory
Post by: dennis100 on April 04, 2014, 07:30:11 AM
Event Date 02/05/2014
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
 
Event Description
It was reported that a vns patient has apnea. The relationship to vns is unknown. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3665129


Title: Re: Respiratory
Post by: dennis100 on April 04, 2014, 07:30:35 AM
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported by the neurologist that the vns patient was experiencing apnea. Attempts for additional information have been made, but no further details have been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3665149


Title: Re: Respiratory
Post by: dennis100 on April 04, 2014, 07:31:07 AM
Model Number 102
Event Date 10/20/2009
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
 
Event Description
It was reported that a vns patient has apnea. The relationship to vns is unknown. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667090


Title: Re: Respiratory
Post by: dennis100 on April 04, 2014, 07:32:29 AM
Model Number 102R
Event Date 01/01/2013
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Clinic notes dated (b)(6) 2013 note that the patient was recently hospitalized for sepsis. It was noted that the patient presented dehydrated and in septic shock and has probably had a respiratory source. It was noted that the patient had quite a bit of cough and "chest rattling" with progressive shortness of breath prior to the hospitalization. The notes indicate that there is concern regarding dysphagia and possible aspiration pneumonia contributing to her respiratory tract infection and possible sepsis. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667641


Title: Re: Respiratory
Post by: dennis100 on May 09, 2014, 04:30:25 AM
Model Number 102
Event Date 01/21/2014
Event Type Injury
Patient Outcome Other
Event Description
It was reported that the vns patient¿s oxygen level would drop with stimulation. The patient¿s device settings were adjusted and the patient¿s breathing had improved. No known interventions have occurred to date. The patient complained of throat tightening during an office visit with his epileptologist on (b)(6) 2014. The patient's device was tested during the office visit and diagnostic results showed normal device function at the time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3746076




Title: Re: Respiratory
Post by: dennis100 on June 06, 2014, 12:39:48 PM
Model Number 102
Event Date 08/13/2009
Event Type Injury
Patient Outcome Hospitalization
Event Description
Clinic notes were received indicating that the vns patient was hospitalized for 7 days due to problems with airway management following her initial vns implant surgery. Attempts for additional relevant information were made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3790744


Title: Re: Respiratory
Post by: dennis100 on June 06, 2014, 06:04:41 PM
Model Number 102R
Event Date 02/01/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain. The patient¿s asthma had exacerbated at the time. The patient was given steroids and an inhaler and the symptoms resolved. The patient later reported experiencing pain at the lead site and pain from laughing and coughing. The patient also reported discomfort at night and began snoring. The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night. The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort. Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing. The patient is expected to receive antibiotics and a follow-up x-ray. Attempts for additional relevant information were made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800594


Title: Re: Respiratory
Post by: dennis100 on June 06, 2014, 06:05:46 PM
Model Number 103
Event Date 03/25/2014
Event Type Injury
Patient Outcome Required Intervention
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.

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


Title: Re: Respiratory
Post by: dennis100 on July 03, 2014, 11:13:40 PM
Model Number 102R
Event Date 01/16/2012
Event Type Death
Patient Outcome Death
Event Description
It was reported that the vns patient passed away. Further follow-up revealed that the patient passed away in the hospital. The cause of death was listed as respiratory insufficiency, pneumonia, and cerebral palsy. It was reported that the device was buried with the patient; therefore will not be returned for analysis. The relationship of vns therapy to the patient's death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3872661


Title: Re: Respiratory
Post by: dennis100 on July 04, 2014, 01:44:26 AM
Model Number 103
Event Date 06/23/2013
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
Hospital discharge notes dated (b)(4) 2014 were received. The notes indicated that the patient was seen in the emergency department after a near drowning incident. Device diagnostics were within normal limits. The device was not at end of service. A head ct was performed that showed no trauma or abnormality. The patient was then transferred to another hospital. It was noted that while enroute to the hospital the patient had a generalized tonic clonic seizure for one minute. She dropped her oxygen saturations into the 70's and placed on a non-rebreather mask and loaded with fosphenytoin. She had a second, gtc seizure lasting around 30 seconds and was given a dose of ativan. During this time, her oxygen saturations dropped to the 40s, but responded to bag-mask ventilation and was subsequently intubated and admitted to the pediatric icu. The notes indicate that the patient suffered respirator failure secondary to near-drowning episode and aspiration pneumonia. She was maintained on mechanical ventilation until (b)(6) 2014. The problem list noted status epilepticus. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3886200


Title: Re: Respiratory
Post by: dennis100 on August 07, 2014, 11:55:05 PM
Model Number 103
Event Date 03/03/2014
Event Type Death Patient Outcome Death
Manufacturer Narrative
Event Description
It was reported that the patient passed away. It was reported that the patient passed away while under hospice care. The physician reported that the patient passed away from chronic obstructive pulmonary disease and not seizures. The relationship of the death to vns is unknown. The physician reported that the device was not explanted and the patient was buried. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910657


Title: Re: Respiratory
Post by: dennis100 on August 08, 2014, 12:34:43 AM
Model Number 303-20
Event Date 06/04/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance on (b)(6) 2014. The patient¿s device was programmed off and the patient was referred for surgery. X-rays were taken and were reported by the physician to be unremarkable. The patient was reported to be hospitalized. Clinic notes were received indicating that the patient was discharged from the hospital on (b)(6) 2014. The patient¿s respiratory panel came back positive for parainfluenza. An eeg ruled out subclinical status epilepticus which was at his baseline. The patient was receiving ippb aggressively, cough assist, albuterol and suctioning. The patient was transferred to the picu for cpap initiation due to retaining co2 likely due to hypotonia and his respiratory illness. The patient experienced a few seizures which were at baseline levels. The seizures lasted less than one minutes and resolved when magnet mode stimulation was activated. The clinic notes indicate that the patient¿s device was disabled on (b)(6) 2014. Further follow-up revealed that the patient underwent surgery on (b)(6) 2014 to explant his generator and lead due to high impedance. The patient was unable to be re-implanted due to fibrosis and limited amount of space on the nerve. The surgeon also noted that the patient¿s respiratory issues were not related to vns. The explanted generator was returned to the manufacturer for analysis. The explanted lead has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913043


Title: Re: Respiratory
Post by: dennis100 on August 08, 2014, 01:07:50 AM
Model Number 103
Event Date 01/25/2013
Event Type Death Patient Outcome Death
Event Description
It was reported that the vns patient passed away. The physician reported that the cause of death is unknown as the office was notified after the patient's death. The relationship of the event to vns therapy is unknown per the physician. The physician reported that the patient was noted as having respiratory issues. It was noted that the vns system was not explanted after the patient's death. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913833


Title: Re: Respiratory
Post by: dennis100 on August 08, 2014, 03:21:37 AM
Model Number 102
Event Date 06/13/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the vns patient¿s device was programmed back on during an office visit on (b)(6) 2014 and began affecting the patient¿s heart rate. The patient also had asthma and choking sensations. The patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3927782


Title: Re: Respiratory
Post by: dennis100 on August 08, 2014, 11:48:26 AM
Model Number 103
Event Date 03/26/2014
Event Type Death Patient Outcome Death
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the vns patient passed away on (b)(6) 2014, from respiratory failure due to seizure disorder. The patient¿s device was not explanted prior to burial. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3947172


Title: Re: Respiratory
Post by: dennis100 on August 08, 2014, 11:48:52 AM
Model Number 103
Event Date 05/01/2014
Event Type Injury Patient Outcome Other,Required Intervention
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient's seizures have continued with six relatively mild type seizures within the past month. It was reported that the device is functional and is noted to be near end of service. The notes indicate that the patient has had some breakthrough events, and is having more choking and respiratory complications. It was noted that there is a possibility that the generator is causing complications as it is going out of service and should be reversible when generator is replaced. The notes indicate that the patient currently has recurrent respiratory complications including aspiration. The patient was referred for surgery. The physician reported that he does not believe anything is wrong with the device, but that the events were related to the battery nearing end of service. No known surgical intervention has been performed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3956176


Title: Re: Respiratory
Post by: dennis100 on September 05, 2014, 01:01:40 AM
Model Number 106
Event Date 06/30/2014
Event Type Injury Patient Outcome Required Intervention,Hospitalization
Manufacturer Narrative
Event Description
A serious adverse event form for a study patient was received. It was noted that the patient suffered an intermittent breathing disorder that was moderately severe. The patient was hospitalized and the device was programmed off. It was noted that the event was possibly related to implantation and stimulation. Clinic notes noted that the patient reported that the magnet was used to disable the device the night prior to hospitalization due to breathing problems. It was noted that the breathing problems improved following device deactivation. The physician advised the patient to leave the device disabled until further examination takes place. It was later reported that the vns was successfully programmed back on. Device diagnostics were within normal limits and the patient was discharged from the hospital on (b)(6) 2014. The event was resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3988716


Title: Re: Respiratory
Post by: dennis100 on September 05, 2014, 02:29:50 AM
Model Number 103
Event Date 06/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was unable to turn off the vns with any of the magnets she has. The vns was later disabled. The patient reported that she tried to disable her generator because of severe pain at the time of stimulation. She has had the magnets since 2006, when she was first implanted. The physician turned the 2. 5ma down to output of 2. 25ma, then 2. 0ma, 1. 75ma, and then 0ma and back to 0. 25ma. The planned intervention is for the patient to undergo a generator replacement surgery. The physician stated that the magnet did cause/trigger violent coughing episodes upon application. System diagnostics were performed and no abnormalities were noted and the device was not near eos. No causal or contributory programming changes preceded the onset of the painful stimulation. The surgery was planned to preclude a serious injury, per the physician. The physician further stated that the patient¿s magnet mode stimulation is always off unless it is ¿spontaneously switching¿. The patient later clarified that she had begun to experience painful stimulation when she received her original implant in (b)(6) 2006. The anatomical location of the painful stimulation comes from the vagus nerve, up and down her neck, during stimulation. There has been no trauma to the left side or the vagus nerve. The patient has been using new magnets that she received a few weeks ago. The physician stated that he could not provide clarification on his statement that the device may be ¿spontaneously switching¿; he stated that he has never activated magnet current and no other physician programs the device. He stated that the ¿device is faulty no matter what¿. The physician indicated that the patient was slowly titrated up after implant in order to allow for accommodation to the stimulation. The physician later stated that the patient underwent a cervical rhizotomy soon after the issue began with the generator. The patient stated that she always has had pain with stimulation. She said it is at a low level and has never bothered her. She stated that her current generator has caused her different side effects than with her previous ones. The physician interrogated it at every visit to make sure the generator is functioning at the levels, he has set. She stated that at the end of (b)(6) 204, she suddenly had intense pain. She immediately put the magnet in place and instantly began to cough violently and her throat constricted so much she couldn¿t breathe. The physician set up an emergency visit for her to see him and at that visit she demonstrated what happened when she put the magnet in place over the generator. She again when into a violent coughing attack and her throat constricted as it had when she tried to use it in june. The physician quickly lowered the current down and got the same response. After doing so, a couple of times, he turned the generator off completely. After a bit, he turned the generator back on to 0. 25ma. The physician instructed her to put the magnet in place as he increased the output to 0. 25ma and interrogated it at the same time. The magnet worked normally and the diagnostics of the generator showed it functioning normally as well. The patient clarified that she is fully aware how to use the magnet. The patient stated that before the event in june she had just seen her physician two weeks prior, when her device was interrogated, and the physician did not change anything at that visit. The patient underwent generator replacement on (b)(6) 2014. The explanted generator has not been returned for product analysis to date.

Event Description
On (b)(4) 2014 the explanted generator was returned for product analysis. Product analysis was completed on the generator on (b)(4) 2014. 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. No magnet parameters (as received or programming history) available for this generator, magnet current was set to 0. 50ma. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. 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 reported allegations against the generator were not duplicated in the product analysis lab. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
The patient's magnet was tested with the new generator, and the physician reported that it was working well. It is also noted that the as-received explanted generator frequency parameter was set to 1hz. Per manufacturer labeling, frequencies programmed to <10hz do not ramp and cause excessive battery drain regardless of output current.

Event Description
On (b)(6) 2014 the physician reported that the patient has not yet tried the magnet with her new generator but that they will test it at the next visit.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4036475



Title: Re: Respiratory
Post by: dennis100 on September 05, 2014, 06:36:49 AM
Model Number 105
Event Date 07/16/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
Event Description
It was reported that the recently implanted vns patient was hospitalized for four days following generator replacement surgery due to a low heart rate and difficulty swallowing. The physician did not attribute either event to vns and plans to have the patient evaluated by a cardiologist. During the replacement surgery, the patient¿s device was programmed back to the original settings. That same afternoon, the patient experienced several episodes of stridor after waking up from the anesthesia. The stridor occurred when the vns device was on and off when the magnet was used to temporarily disable the device. When a magnet swipe was applied, the patient did not experience any stridor. The magnet did activate the generator as confirmed by interrogating the device afterwards and seeing the magnet swipe count increase by 1. The physician did not believe the event was caused by vns and the patient was admitted overnight to ensure she was not having any difficulty breathing prior to being discharged. Additional information received revealed that the bradycardia was occurring with and without stimulation. Follow-up revealed that the physician attributed the cardiac event to either surgery or some underlying cardiac issue. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012288


Title: Re: Respiratory
Post by: dennis100 on September 05, 2014, 06:37:15 AM
Event Type Injury Patient Outcome Other
Event Description
An article titled ¿vns in the treatment of pharmacoresistant epilepsy¿ studied the efficacy of vns in hospitalized patients with pharmacoresistant epilepsy. The article included adverse event that occurred during the study. One patient passed away three year following implant surgery. It was noted that the cause of death was likely suffocation following a grand mal seizure. This event was captured in manufacturer report # 1644487-2014-02123. One patient experienced transient asystole during implant surgery that was successfully treated with atropine. This event was captured in manufacturer report # 1644487-2014-02125. One patient experienced serial elementary partial seizures and worsening asthma. This event was captured in this manufacturer report. The patient previously mentioned also experienced muscular pain at the generator site which required surgery to reposition the patient¿s device due to dislocation in the left pectoral region. It was noted that the patient was a woman with asthenic constitution. This event was captured in manufacturer report # 1644487-2014-02124. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4045854


Title: Re: Respiratory
Post by: dennis100 on September 05, 2014, 06:41:29 AM
Model Number 105
Event Date 07/13/2014
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013497


Title: Re: Respiratory
Post by: dennis100 on October 10, 2014, 12:51:35 AM
Model Number 103
Event Date 04/10/2012
Event Type Injury
Event Description
On (b)(6) 2012, a physician's office reported that this vns patient was admitted to the hospital, had been in status epilepticus, and needed vns battery replacement. Clinic notes were received on (b)(6) 2012 for (b)(6) 2012 through (b)(6) 2012. These notes indicated increased seizure duration, increased seizure intensity, and increased seizure frequency. The notes also contained ''"date noted"''; for aspiration pneumonia ((b)(6) 2011), respiratory distress ((b)(6) 2011), respiratory syncytial virus pneumonia (rsv) ((b)(6) 2011), and chronic pulmonary aspiration ((b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's mother reported that the patient occasionally has a few ''smaller'' seizures, but no big seizures. However, for the past three days (beginning (b)(6) 2012), the patient began crying with both arms flexed and stiff with bilateral fisting. These episodes last up to 30 minutes. The patient ceased crying when the mother was present, but began crying again when the mother left. The physician's impressions of the patient indicated that over the past one to two months there has been an increase in seizures again with eyes rolling, stiffening, and respiratory irregularities. The notes also reported that another physician reported that the patient has had several episodes of longer seizures for the past several weeks (approximately (b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's device was interrogated for the first time since (b)(6) 2011. The patient's vns settings indicated that the device was disabled due to end of service. No stimulation was being provided as the normal mode and magnet mode output currents were found to be 0 ma. The device was programmed to a normal mode output current of 0. 25 ma (magnet mode 0. 50 ma), and it was stated that the patient is having increased seizures due to the vns battery dying. Consult for replacement surgery was recommended. Notes dated (b)(6) 2012 indicated that the patient had recurrent respiratory infections; however, at this time, there were no features of an active infection or aspiration. Notes dated (b)(6) 2012 stated that the patient's device was disabled due to it being problematic. Follow up with the physician's office on (b)(6) 2012 revealed that the statement regarding the generator being ""problematic""; was a reference to the generator at end of service. The physician's office stated that the patient's reported increase in seizure duration was an increase in the actual seizure time. They were unable to state the relationship of the increased seizure duration and increased seizure intensity to vns because medication changes and the loss of therapy due to end of service were simultaneous. No details were available regarding the increased seizure intensity: it was only stated that the patient's eeg was worse. No interventions have been planned. When asked about the respiratory difficulties, pneumonia, and aspiration, it was stated that this was the patient's baseline and that these issues remained unchanged with relation to vns. Vns replacement surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2594672


Title: Re: Respiratory
Post by: dennis100 on October 10, 2014, 10:53:48 AM
Model Number 102
Event Date 08/01/2008
Event Type Injury
Event Description
It was reported that the vns patient¿s device was disabled and later explanted on (b)(6) 2013 due to respiratory issues. The patient previously experienced trauma to the airway and was respiratory issues during stimulation on-times even at low settings. The patient¿s explanted device has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2009. The patient¿s device was disabled on (b)(6) 2010.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4059317


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 12:19:54 AM
Model Number 304-20
Event Date 09/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the patient has been experiencing breathing problems, so his pulmonologist referred him to an ent. The patient's airway was scoped and it was determined that the patient has left vocal cord paralysis. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4203417


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 12:20:46 AM
Model Number 103
Event Date 10/09/2014
Event Type Injury
Event Description
It was reported on (b)(6) 2014 that the patient has been having difficulty breathing with lowering of o2 levels associated with stimulation on times and that this event started exactly a week ago. Diagnostics were taken in the past week and came back within range. The nurse practitioner stated that she lowered the pulse width and frequency and that this helped reduce the breathing problems but that they did not resolve completely. There had not been any recent traumatic events for the patient. It was stated that the patient¿s o2 levels dropped somewhat significantly during his sleep, also associated with stimulation and that this drop in o2 saturation levels was the most severe during sleep for the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4202053


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 12:21:25 AM
Model Number 304-20
Event Date 02/21/2014
Event Type Injury
Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2014 due to end of service and lead discontinuity, the vns patient was breathing heavily and began having difficulty breathing. The cause of the patient¿s breathing issues was believed to be due to vocal cord paralysis resulting from replacement surgery. The patient was treated with steroids and the patient¿s condition improved. Follow-up revealed that the patient was diagnosed with vocal cord paralysis on (b)(6) 2014. Following steroid treatment, the patient¿s breathing had almost returned back to normal. The lead discontinuity was reported in manufacturer report #1644487-2014-00753.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4196981


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 12:22:15 AM
Model Number 105
Event Date 09/09/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was hospitalized on (b)(6) 2014. The patient was experiencing coughing, breathing issues, nausea, vomiting, and chest pain at the generator site. Patient also stopped eating and had lost weight. The patient¿s caregiver wanted the patient¿s device explanted as the events began when the device was programmed on a week after vns surgery. The patient¿s seizures had increased and patient was on more seizure medications than prior to vns therapy. However, the surgeon and neurologist stated that the patient is fine. The patient is diabetic and was admitted with a very high blood sugar level. The patient¿s physician believed the events were due to the patient¿s high blood sugar levels as well as vns stimulation. Following revealed that the patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4194303


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 01:48:12 AM
Model Number 102
Event Date 07/15/2007
Event Type Death
Manufacturer Narrative
Event Description
It was reported that vns patient passed away on (b)(6) 2007 due to respiratory arrest. The relationship of the death to vns is unknown. No further information relevant to the death has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4185969


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 02:45:18 AM
Model Number 102
Event Date 04/01/2012
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the vns patient¿ began experiencing worsening symptoms associated with his apnea hypopnea syndrome in (b)(6) 2012. The patient had a history of the condition since 2000 prior to vns. The patient¿s device output current was decreased from 1. 5ma to 0. 5ma to determine if the worsening condition of the patient was associated with stimulation in (b)(6) 2014. After a month, the patient had a noticeable improvement in condition with a decrease in apnea-hypopnea index from 33 per hour to 22 per hour. A polysomnography was expected to be performed, but attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4178553


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 02:45:50 AM
Model


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 04:04:15 AM
Model Number 103
Event Date 08/15/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that since vns placement, the patient has experienced two pediatric intensive care unit stays for status epilepticus and subsequent breathing problems. It was reported that the patient is now requiring bipap to assist with her breathing throughout the night and sometimes during the day. It was reported that the patient has trouble managing her secretions. It was reported that the physician does not believe that the patient's settings are high enough to be a causative factor, but the patient's mother is unsure. It was reported that the patient experienced issues with increased secretions pre-vns. Device frequency was decreased from 30hz to 20hz. It was reported that the patient was diagnosed with severe apnea prior to vns implant and the drooling is associated with the patient's rhett syndrome. The patient was hospitalized on (b)(6) 2014 and again on (b)(6) 2014. It was reported that the patient's seizures were not necessarily status epilepticus, but were longer. It was reported that the seizures were similar to pre-vns baseline frequency. Clinic notes dated (b)(6) 2014 indicate that the patient experienced status epilepticus and prolonged seizures. The physician mentions that the status epilepticus and prolonged seizures may be secondary to zyrtec as in rare occasion, zyrtec is felt to decrease the threshold for seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4174806


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 04:30:16 AM
Model Number 103
Event Date 01/08/2013
Event Type Death
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
An explanted generator and lead were received for analysis from another medical device manufacturer. The devices had been inadvertently returned to the wrong manufacturer. It was noted that the vns patient had passed away. It was noted that in the last several weeks the patient had been feeling weak and his breathing had stopped. The patient was unresponsive on arrival. No cause of death or relationship of the death to vns was indicated. It was noted that an autopsy was performed. No additional relevant information has been received to date. Analysis of the devices are underway, but have not been completed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4167523


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 06:58:23 AM
Model Number 102
Event Date 09/12/2014
Event Type Injury
Event Description
It was reported that the patient demanded the vns to be explanted. It was reported that the vns did not meet the patient's expectations and that the patient experienced shortness of breath during sports. It was reported that during sports the patient was disturbed when his colleagues saw the implanted device. Since the patient did not experience efficacy he wanted to be explanted. The patient underwent generator and partial lead explant (leaving electrodes). The explanted generator and lead portion were received for analysis. Analysis is underway, but has not been completed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164063


Title: Re: Respiratory
Post by: dennis100 on November 07, 2014, 06:59:06 AM
Model Number 102
Event Date 03/27/2012
Event Type Death
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) 2012. Follow-up revealed that the cause of death was chronic respiratory illness and cerebral palsy. The patient was buried with his device still implanted; therefore, no analysis can be performed. No further information relevant to the patient¿s death have been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164029


Title: Re: Respiratory
Post by: dennis100 on December 04, 2014, 09:57:09 PM
Model Number 105
Event Date 04/01/2014
Event Type Injury
Event Description
It was reported that since vns implant the patient has had more snoring. A night polygraph was performed and found that normal breathing was detected for 3 minutes and then when device stimulation is initiated the patient has a long hybrid respiratory distress. It was reported that the respiratory movements clearly decrease and there is a mild-degree decrease in oxygen saturation. Further follow-up revealed that the hospital will give the patient a ball shirt to prevent the patient from sleeping on his back which causes sleep apnea. The device frequency will be lowered and the off time will be increased. The patient does not have a history of sleep apnea prior to vns implant. There were no medication changes that could have caused or contributed to the sleep apnea. The patient is scheduled to undergo a night polysomnography. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4280624


Title: Re: Respiratory
Post by: dennis100 on December 04, 2014, 10:30:47 PM
Model Number 104
Event Date 09/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
Clinic notes dated (b)(6) 2014 were received indicating that the patient experienced severe neck discomfort on the left side, swallowing problems, and a sense of not being able to breathe. The vns was interrogated and then programmed to off. The patient felt better for a few seconds and then immediately grabbed his throat again claiming that vns was still causing him problems despite being off. The device was again interrogated and reprogrammed. The physician also taped the magnet over the patient's chest. The patient claimed to continue to feel the sensation in his throat. The physician palpated the left neck right over the location he was complaining about but there was no reproducible pain on palpation. It was noted that the patient was on extremely low settings and there were no recent changes made to device settings for years. The physician noted that perhaps the events are completely unrelated to vns therapy with maybe some focal vocal cord changes. The notes indicate that the patient was asked to follow-up with his usual neurologist. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274516


Title: Re: Respiratory
Post by: dennis100 on December 05, 2014, 05:07:27 AM
Model Number 102
Event Date 10/13/2014
Event Type Injury
Event Description
It was reported that the patient was going to the emergency room for asthma and difficulty breathing which worsened during vns stimulation on-times. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4228385


Title: Re: Respiratory
Post by: dennis100 on January 09, 2015, 04:02:21 AM
Model Number 103
Event Date 11/20/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the patient was admitted to the intensive care unit following vns implant because the patient's lungs collapsed. It was later reported that the patient was discharged from the hospital and was recovered. The physician reported that the patient developed right and left sided pneumothorax due to barotrauma after vns implant. Chest tubes were placed while the patient's lungs healed. The physician reported that the event was related to positive pressure ventilation and not related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330484


Title: Re: Respiratory
Post by: dennis100 on January 09, 2015, 07:51:38 AM
Model Number 101
Event Date 03/18/2012
Event Type Death
Manufacturer Narrative
Event Description
It was reported that a patient passed away and the death was unrelated to vns. Follow-up with the coroner¿s office revealed that the manner of death was respiratory arrest due to chronic seizure disorder due to rasmussen's encephalitis. The coroner felt the death was sudep as the patient was found unresponsive at a group home with no apparent contributing factors. No autopsy was performed as the death was determined to be natural. A toxicology report performed did not reveal any abnormalities. The patient¿s vns device was not explanted. The patient¿s vns physician indicated that the last diagnostics performed on the patient¿s vns device were within normal limits and did not have any additional information to provide.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4305989


Title: Re: Respiratory
Post by: dennis100 on January 09, 2015, 07:52:25 AM
Model Number 103
Event Date 10/20/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

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=4300491


Title: Re: Respiratory
Post by: dennis100 on February 06, 2015, 02:27:17 AM
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
An article titled ¿an electrical cause of stridor: pediatric vagal nerve stimulators¿ was received which reported that the (b)(6) year old child patient initial presented with difficulty sleeping, apneic episodes, frequent awakenings, and noisy breathing during the day. These symptoms began after implantation of a vns device. Polysomnography (psg) demonstrated mild osa with an apnea-hypopnea index (ahi) of 3 and the patient subsequently underwent tonsillectomy, adenoidectomy and inferior turbinoplasty. At his (b)(6) month post-operative appointment, the patient¿s symptoms had improved, but apneic episodes continued during the day and at night. Postoperative psg demonstrated persistent osa with an ahi of 1. 5. On physical examination, the patient demonstrated episodic stridor and increased work of breathing. The patient¿s nasopharyngoscopic examination was notable for intermittent decreased motion of his left tvc. Airway evaluation in the operating room, in conjunction with a pediatric neurologist, revealed adduction of the left tvc and contraction of the left supraglottis during stimulation on-times. The patient¿s device output current was decreased to 1. 75 ma and device on-time was changed to 3 min. The patient¿s tvc and supraglottic contractions ceased, his stridor and osa resolved, and he continued to have excellent seizure control 3 years after these adjustments. The other patient involved in this article was reported in manufacturer report # 1644487-2015-03618. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4425832


Title: Re: Respiratory
Post by: dennis100 on February 06, 2015, 05:07:16 AM
Model Number 104
Event Date 09/28/2014
Event Type Death
Manufacturer Narrative
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death was respiratory distress/ fever. The relationship of the death to vns is unknown. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4403133


Title: Re: Respiratory
Post by: dennis100 on February 06, 2015, 08:37:59 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.

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


Title: Re: Respiratory
Post by: dennis100 on March 06, 2015, 04:35:59 AM
Model Number 103
Event Date 01/09/2015
Event Type Injury
Event Description
It was reported that during generator replacement the patient stopped breathing. The patient's mother reported that she was not informed by the surgeon and that her daughter overhead the medical professionals saying the patient turned blue during the procedure. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4525040


Title: Re: Respiratory
Post by: dennis100 on March 06, 2015, 04:36:34 AM
Model Number 103
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient's mother indicated that the patient was taken to the hospital because he could not catch his breath and was coughing and wheezing. The hospital indicated that the patient was experiencing an asthma attack and would need to be placed on medication. The patient's mother reported that magnet mode stimulation was initiated during a seizure and the patient's asthma worsened and the patient could not catch his breath. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4517482


Title: Re: Respiratory
Post by: dennis100 on March 06, 2015, 04:37:12 AM
Model Number 102
Event Date 01/07/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient underwent surgery to explant her device due to lack of efficacy. Follow-up indicated that the reason for surgery was throat pain and dyspnea. No further information relevant to the event has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515632


Title: Re: Respiratory
Post by: dennis100 on March 06, 2015, 04:37:49 AM
Model Number 104
Event Date 07/11/2014
Event Type Injury
Event Description
It was reported that following vns generator replacement surgery the patient suffered a seizure and was given medication to abort the seizure. The patient's breathing was "too shallow" and the patient was put on a respirator for two days following the surgery. The patient reported that the experienced an out of body experience during the seizure. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4475965


Title: Re: Respiratory
Post by: dennis100 on April 18, 2015, 12:20:28 AM
Model Number 103
Event Date 05/01/2014
Event Type Injury
Event Description
Clinic notes from (b)(6) 2014 mention that the patient had a prolonged seizure and the vns magnet was swiped twice, but the patient stopped breathing for about 3 seconds after each application. The patient was given diastat which was effective but the nurse was hesitant to use the magnet. It was noted that when the patient had another intense seizure later a different magnet was used and was effective. Attempts for further information have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4627438


Title: Re: Respiratory
Post by: dennis100 on April 18, 2015, 12:21:15 AM
Model Number 103
Event Date 12/23/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(4) 2014 shortly after being admitted to the hospital. The physician suspects the cause of death was sudep as the patient had medically intractable secondarily generalized seizures, apnea, morbid obesity, and ictal bradycardia. Attempts for additional relevant information have been unsuccessful to date. The patient¿s hospital admission was reported in manufacturer report # 1644487-2015-03613.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4617015


Title: Re: Respiratory
Post by: dennis100 on April 18, 2015, 12:22:02 AM
Model Number 104
Event Date 02/25/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing the following events which the physician believed were related to vns: congestive heart failure, stomach ulcers, tachycardia not associated with stimulation, dyspnea not associated with stimulation, and voice alteration. The physician elected not to disable the patient¿s device due to its effectiveness in reducing the patient¿s suicide attempts and depressive episodes. The physician noted that vns is not the source of these issues but believed that may be contributing to the patient¿s events. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623006


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:36:47 AM
Model Number 102
Event Date 03/25/2015
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the patient passed away due to respiratory issues. The patient's online obituary indicated that the patient passed away after a short illness. The relationship of the death to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4740330


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:37:29 AM
Model Number 102
Event Date 11/10/2005
Event Type Injury
Event Description
It was reported on (b)(6) 2015 that the patient¿s vns device has been turned off for many years due to health issues and lack of efficacy. The physician reports that the patient is a non-responder to vns therapy and has always had breathing problems and eventually chose to discontinue vns since the issues were not improving. The vns therapy was reported as worsening her breathing issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728074


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:38:13 AM
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient had experienced hypoxia, coma, voice alteration, and other unspecified adverse events. It was noted that the patient did not receive efficacy from the device and that the patient¿s caregiver wanted to have the device explanted. No known surgical interventions have occurred to date. No further information relevant to the events has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4724926


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:38:59 AM
Model Number 303-20
Event Date 03/03/2015
Event Type 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).

Event Description
It was reported that the vns patient had presented voice alteration and dyspnea which debuted one day after the implant. The stimulation had not been enabled yet when the side effects occurred. The patient underwent speech therapy. The patient was referred to an otolaryngologist. Further information was received indicating that the patient had presented also dysphagia and left vocal cord paralysis. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts to obtain further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4705329


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:39:35 AM
Model Number 105
Event Date 02/27/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that at the patient's two week vns post implant check the patient experienced coughing and gasping with magnet mode stimulation. It was reported that the patient would aspirate after gasping. The device pulse width was adjusted from 500 usec to 250 usec which resolved the coughing. The patient was seen again at which time it was reported that the patient was tolerating the settings well. The patient's mother clarified that when the magnet would be used the patient would gasp and then aspirate and cough. Since the patient was reported to be doing well the physician's assistant increased the settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702373


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:40:32 AM
Model Number 105
Event Date 11/11/2014
Event Type Injury
Event Description
It was reported that the patient was having difficulties breathing and reports that it is worse when she exerts herself. The treating vns physician lowered the vns settings from 0. 75ma to 0. 5ma at the last visit, but the issue persisted. As a result, the plan was to have the patient see pulmonology if the difficulty breathing did not improve because the patient does have asthma. Clinic notes dated (b)(6) 2015 reported that there was concern for diaphragmatic dysfunction per asthma consultation, review of prior records, and examination on that day. A chest fluoroscopy ("sniff test") was ordered to assess for diaphragmatic dysfunction to be done with vns on and then with vns off. The vns output was decreased to 0. 5ma (the setting at which the patient historically did not report symptoms) and continued at reduced tolerability settings. The magnet on time was also reduced from 30 to 21 seconds. It was reported that the patient feels as though she is ¿suffocating¿ with orthopnea (shortness of breath) and snoring also noted. Wheezing typically occurs with exercise. The patient used to smoke, but reportedly quick smoking several weeks ago but restarted about a week prior. The patient was seen by the allergy/asthma specialist on (b)(6) 2015 at which time there was no mention of the status of her asthma then but she has not been seen for any asthma problems up until she had the breathing problems after vns was implanted. The patient had not filled any albuterol (inhaler) until then. It was noted that albuterol has not really helped her current dyspnea. The patient was prescribed asmanex in (b)(6) 2014, but the patient reports that she has not been taking it. She was prescribed this back in (b)(6) 2013 as well, but it was not clear why. It was not clear she has persistent asthma. The specialist felt that the patient was likely getting diaphragmatic spasm or flutter due to vns and assessed that the patient may have some mild asthma. Previous history revealed that the device was turned on in (b)(6) 2014 and patient tolerated it well. On (b)(6) 2015, the patient reported dyspnea associated with magnet swipe at 0. 75ma current. On (b)(6) 2015, the patient had dyspnea with exertion with output increased to 0. 75ma. The pulse width and frequency were decreased to attempt to improve tolerability. On (b)(6) 2015, there was stated improvement with change in tolerability setting with output increased to 1ma. The results of the chest fluoroscopy were that there was no change in diaphragmatic dysfunction with or without vns stimulation on. 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=4668087


Title: Re: Respiratory
Post by: dennis100 on May 08, 2015, 04:41:16 AM
Model Number 105
Event Date 03/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient has been referred for an explant surgery as the patient has been calling the physician for 2 weeks with choking sensations and problems breathing. It was noted that the patient¿s settings were last increased in the initial titration visit in (b)(6) 2015. Good faith attempts for further information from the physician 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=4647694


Title: Re: Respiratory
Post by: dennis100 on June 05, 2015, 02:11:14 AM
Model Number 302-20
Event Date 03/26/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation. The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not. The settings were programmed at 1. 5ma, 25hz, 130usec, 30secs on and 5mins off. The patient has dystonia and moves her neck quite a lot. X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled. Additional information was received indicating that the patient was implanted for depression. The pulse generator vns was disabled as the patient was experiencing severe discomfort. The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns. It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously. It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters. It was believed that these symptoms were related to the patient¿s depression. Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804054


Title: Re: Respiratory
Post by: dennis100 on July 12, 2015, 07:12:59 AM
Model Number 103
Event Date 05/10/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing respiratory issues associated with the vns. The physician reported that the patient was admitted to the hospital on (b)(6) 2015 for respiratory issues and it was felt that these issues could be related to vocal cord spasms caused by the vns. It was reported that the patient experienced previous respiratory issues, but that this is more severe and was sustained for longer than before. The physician programmed the generator off and it was reported that the plan is to leave the device off due to other medical issues not related to vns. It was reported that the patient will be admitted for several more days. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4840647


Title: Re: Respiratory
Post by: dennis100 on July 12, 2015, 07:13:53 AM
Model Number 103
Event Date 12/01/2013
Event Type Injury
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:13:06 AM
Model Number 103
Event Date 04/17/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received indicating that following recent implant surgery, the newly vns patient began experiencing shortness of breath and stridor when straining to perform tasks. The patient was seen two weeks post-op and a neurologist and cardiologist cleared the patient for these issues. Additional information was received stating that the patient was in the hospital in (b)(6) 2015 due to a relapse in seizures and underwent a sleep study on (b)(6) 2015. It was noted that the patient had been diagnosed with sleep apnea prior to vns. The patient was evaluated by an ent on (b)(6) 2015 and diagnosed with left vocal cord paralysis. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4954785


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:13:47 AM
Model Number 103
Event Date 08/23/2011
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes received for patient indicate that the patient had several instances of aspiration. The aspiration is believed to be due to vns stimulation and vns settings were decreased as a result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907255


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:14:34 AM
Model Number 103
Event Date 05/18/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient presented on (b)(6) 2015 as an emergency to adjust his vns output current. For three weeks, he had experienced constrictive larynx and was unable to breathe in the morning, per the physician. The output current was decreased from 0. 75ma to 0. 25ma. Additional information was received that the patient was experiencing pain in the throat and jaw with stimulation. The plan was to obtain x-rays of the leads and to discuss the symptoms with the surgeon. Lead impedance was okay with impedance around 3700 ohms. 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=4886749


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:15:23 AM
Model Number 102
Event Date 08/22/2014
Event Type Injury
Manufacturer Narrative

Event Description
The patient began experiencing painful stimulation in the throat on (b)(6) 2015. Diagnostic results were checked and within normal limits. The patient did not experience any trauma or manipulation that may have contributed. On 06/16/2015 the patient reported that he is planned to have his vns removed and he had a consultation that day in which the physician agreed to the removal. The patient noted that he was planning to have the device removed due to being unable to breathe associated with stimulation. He also has coughing and throat pain associated with vns stimulation. He noted that his diagnostic results, both systems and normal were fine and within range. Follow-up with the physician was unclear on whether the explant is for patient comfort or to preclude a serious injury. Further attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4919084


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:16:03 AM
Model Number 103
Event Type Injury
Event Description
It was reported that the vns patient's device was explanted in 2010 due to issues that caused her to stop breathing at one point. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010. The patient¿s device settings were gradually ramped down from (b)(6) 2010 and eventually disabled on (b)(6) 2010. No further information relevant to the event has been received 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=4939683


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:16:42 AM
Event Date 06/30/2015
Event Type Injury
Event Description
It was reported that the vns patient had presented acute vocal cord paralysis and shortness of breath. The patient was examined by an otolaryngologist and was referred for computerized tomography. It was reported that the events were suspected to be secondary to vns. The patient had had myocardial infarction previously. It was reported that the patient¿s generator was programmed at reduced pulse width and signal frequency, with an output current of 1. 25ma and a 44% duty cycle since 2011. It was reported that the patient was a good responder to vns therapy. Further information was received indicating that the vocal cord paralysis had debuted on (b)(6) 2015. There had been no changes in medication and the patient¿s settings had remained unchanged for a number of years. The patient does not have a previous history of vocal cord paralysis. It was reported that the medical professionals suspected that the myocardial infarction might have led to pulmonary embolism which, in turn, might have contributed to the event, and that a role of vns on the paralysis was believed to be unlikely. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4934372


Title: Re: Respiratory
Post by: dennis100 on August 07, 2015, 04:17:28 AM
Model Number 106
Event Date 06/17/2015
Event Type Injury
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that the patient was admitted to the icu following vns implant due to having difficulties being extubated. It was reported that when the patient was extubated, the patient began to experience obstructive apnea and was subsequently placed on cpap. It was reported that the patient had previous airway problems due to a traumatic brain injury, but that the respiratory difficulty was increased following vns implant. Further follow-up revealed that a sleep study was planned. The patient was later transitioned to bipap and was discharged home in stable condition on (b)(6) 2015 with plan to follow-up with sleep medicine to have the sleep study performed. The patient was reported to be a medically complex patient and it is unknown whether or not vns is related to the patient's breathing issues. The device has been programmed on; however, no further programming changes will occur until the respiratory issues resolve. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4923797


Title: Re: Respiratory
Post by: dennis100 on October 08, 2015, 06:16:55 AM
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: Respiratory
Post by: dennis100 on October 09, 2015, 04:09:19 AM
Model Number 102
Event Date 08/20/2015
Event Type Injury
Event Description
It was reported that the vns patient recently began exercising and was experiencing shortness of breath, difficulty breathing, and syncope after exercise. The patient did not have a medical history of these events. The patient also reported experiencing erratic stimulation from her device. Prior to the events, the patient's device pulse width was increased to 500usec at the patient's previous office visit in (b)(6) 2015. The patient returned to the clinic following the events and the device pulse width was reduced to 250usec. The patient's device was tested and showed normal device function. The patient's issues resolved and the patient has been doing well following the setting adjustment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5074735


Title: Re: Respiratory
Post by: dennis100 on October 09, 2015, 06:30:36 AM
Model Number 304-20
Device Problem No Information
Event Date 07/02/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received which indicated that a patient was having difficulty breathing. The patient had been evaluated by a pulmonologist and an ear, nose, and throat (ent) physician who were unable to determine the cause of the breathing difficulties. The ent observed paradoxical vocal cord movement. Vns function was noted to be normal with normal diagnostics. Device settings were adjusted to try to alleviate the breathing problems but were unsuccessful. The patient's breathing problems were alleviated by disabling vns therapy. It is noted that the patient's generator and lead are both implanted on the right side following a high impedance observation on a prior lead implanted on the left side (reported in mfg. Report #: 1644487-2014-00786). The providers are considering moving the system back to the left side but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The provider reported that the patient's breathing difficulties started in (b)(6) 2014, at approximately the 3rd clinic visit after implant. The provider stated he did not know the cause of the paradoxical vocal cord movement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5071956


Title: Re: Respiratory
Post by: dennis100 on October 09, 2015, 06:31:14 AM
Model Number 106
Event Date 08/11/2015
Event Type Injury
Event Description
It was reported that during generator and lead replacement surgery (mfr. Report # 1644487-2015-05096), the patient stopped breathing during diagnostics with the new generator and lead. Device diagnostics were run again and the patient stopped breathing again for the duration of the diagnostic test. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5061390


Title: Re: Respiratory
Post by: dennis100 on October 09, 2015, 08:28:04 AM
Model Number 103
Device Problem Use of Incorrect Control Settings
Event Date 08/07/2015
Event Type Injury
Event Description
Additional information was received from the patient's neurologist that he does not believe that any of the patient's symptoms are related to vns. The symptoms do not only occur with stimulation and do not resolve when the device is disabled. Settings and diagnostics for the patient were reported to be as intended and within normal limits.

Manufacturer Narrative

Event Description
It was reported that the patient has experienced autonomic dysfunction, low blood pressure, headaches, swallowing issues, decreased perception of stimulation, and loss of breath during exercise prior to a recent vns settings adjustment. It was also reported that the patient stayed at a clinic for three weeks and had her vns turned off for five days with no resolution of the symptoms. It was reported that the vns had not been medically ruled out. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5046658


Title: Re: Respiratory
Post by: dennis100 on November 06, 2015, 01:06:08 AM
Model Number 102
Event Date 09/23/2015
Event Type Injury
Event Description
It was reported that a vns patient experienced painful stimulation at low settings. System diagnostic results were reported to be ok. Follow up with the patient's physician for additional information resulted in unclear information. Physician reported that the patient has a girdle, "viral incerfrolitis" (probably viral encephalitis), and has sustained a lot of injuries. The patient had problems with vocal cord paralysis, spells of breathlessness, and choking.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5191161


Title: Re: Respiratory
Post by: dennis100 on November 06, 2015, 07:17:26 AM
Model Number 105
Event Date 07/20/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient is experiencing severe pain and dyspnea. The pain was noted to be located at the neck and the generator site. The patient's caregiver is interested in having the device explanted. Settings were lowered, but symptoms did not resolve. The device was programmed off to assess for efficacy. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5143696


Title: Re: Respiratory
Post by: dennis100 on November 06, 2015, 08:54:31 AM
Model Number 105
Event Date 09/09/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
A physician reported to an international distributor that a patient experienced dyspnea and syncope. The physician was advised to reprogram vns settings but it is unknown if he did so or if he took any other form of intervention. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5125415


Title: Re: Respiratory
Post by: dennis100 on December 04, 2015, 04:12:36 AM
Model Number 102
Event Date 10/01/2015
Event Type Injury
Event Description
It was reported that the vns patient was having problems breathing that worsened during sleep. Endoscopy showed that the left vocal cord was not mobilizing compared to that of the right vocal cord. The medical professional was unable to determine if there was a partial loss of movement or complete paralysis of the left vocal cord. The device was subsequently disabled to determine if the issues were occurring with device stimulation on-times. The physician's office was unable to determine whether the patient had a history of sleep apnea or dyspnea and was not aware of any medication changes that could contribute to either the reported events. No further relevant information has ben received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5253872


Title: Re: Respiratory
Post by: dennis100 on December 04, 2015, 08:26:52 AM
Model Number 103
Device Problem Material Protrusion
Event Date 03/01/2015
Event Type Injury
Event Description
It was reported that the patient's lead is protruding from the neck during stimulation. The patient is having painful stimulation around where the generator is located, which "stings and burns. " there were no issues following the implant per the mother and the issues were believed to have started in (b)(6). Additional information was received that the patient continues to have seizures 10 to 30 minutes long despite vns and other medications. Patient's caregiver was educated about magnet use but the patient could use the magnet himself. During 1 previous er visit, patient's shoulder/collar bone muscle was reported to have been torn at the location where vns was placed. Patient did not have any injuries or falls that could have caused this. It is unknown if this is related to the presence of device or surgery. Patient was however reported to be manipulating the device. As patient is autistic, patient often flips the generator repeatedly and this causes the lead to be pulled at the nerve. Patient's vns was adjusted a few times for reaching patient's therapy level but is still at a low dose. Follow-up with the patient's mother showed that the vns also made it difficult for the patient to breathe sometimes, but the patient's pulse ox was normal. Attempts for additional relevant information were unsuccessful.

Event Description
Additional information was received that the patient did not show three times to the neurologist's office. During patient's next visit, the parent insisted on changing physician. Other than the device settings from (b)(6) 2015, no other relevant information was obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224983


Title: Re: Respiratory
Post by: dennis100 on December 04, 2015, 12:21:46 PM
Model Number 103
Device Problem No Information
Event Date 10/14/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient went to the er on (b)(6) 2015 due to shortness of breath and a choking sensation which began (b)(6) 2015 but progressively got worse, so the patient went to the er. It reportedly became so severe that the patient felt she was going to pass out. Furthermore, it was reported that the patient was trying to use the magnet to disable the device by moving the magnet back and forth over the generator rapidly. No additional relevant information has been obtained to date.

Event Description
Additional information was received that the patient was feeling much better after being discharged from the emergency room. The patient's settings were as intended. The patient's dyspnea and dysphagia were only occurring with stimulation cycles and appeared to diminish with magnet inhibition. Settings were not adjusted but patient left the emergency room feeling better. There were no known interventions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5206928


Title: Re: Respiratory
Post by: dennis100 on December 04, 2015, 12:22:33 PM
Model Number 104
Event Date 10/08/2015
Event Type Injury
Event Description
It was reported that the patient underwent a vns generator replacement surgery on (b)(6) 2015 due to eri=yes. Pre-op diagnostics confirmed eri=yes. After the surgery, the patient was programmed to 1/2 of the pre-op output current. However, the patient was having difficulty breathing in the recovery room. The normal and magnet output currents were then turned off. Final interrogation confirmed the output and magnet currents were both set to 0. 0 ma. The difficulty breathing reportedly did not resolve immediately following device disablement. The patient was also given a breathing treatment by the anesthesiologist at approximately the same time. The difficulty breathing resolved within approximately 5 minutes after these two events. The difficulty breathing was continuous but the patient was in the process of waking up from the anesthesia so it was difficult to communicate and get any answers to any questions the patient was asked. The anesthesiologist stated he thought the difficulty breathing may have also been caused by the type of airway he used for intubating the patient for the surgery but ordered the generator to be programmed off as a secondary precaution. No additional relevant information has been obtained to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194052


Title: Re: Respiratory
Post by: dennis100 on December 04, 2015, 12:23:05 PM
Model Number 302-20
Device Problem Insufficient Information
Event Date 06/18/2015
Event Type  Malfunction   
Event Description
The patient reached out to a company representative explaining that she requested help with implant removal for the vns. It appears the patient is looking for a physician to "take out the damaged coils and leads". The patient later explained that she would like to find somebody who can help her deal with her damaged vagus nerve. The patient also stated she now has tachycardia and that she had a mild transient ischemic attack/stroke. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the patient that she has nerve damage due to the surgeon who explanted her vns on (b)(6) 2015. The patient also noted that she has experienced vocal cord paralysis, a hematoma in her neck, and gastroparysis ever since. The patient also explained that she can't walk any more because she gets out of breath. The patient later spoke to a company representative and explained that she has no complaints about vns. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5061282



Title: Re: Respiratory
Post by: dennis100 on January 07, 2016, 10:08:44 PM
Model Number 105
Event Date 11/23/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient was hospitalized for a respiratory condition. During the patient's stay in the hospital, the pulmonologist told her that if the vns was removed, she would breathe better. However, the neurosurgeon and the epileptologist stated they disagreed with the pulmonologist and do not believe the patient's respiratory issue was related to vns. It is unknown why the neurosurgeon and the epileptologist believe the respiratory issue is not related to vns. The patient's vns was programmed off on (b)(6) 2015 and the patient will have a follow up appointment for an additional assessment. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5331935


Title: Re: Respiratory
Post by: dennis100 on January 07, 2016, 11:30:22 PM
Model Number 103
Event Date 04/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient had an event that was not typical that involve the same jerking motion but it did not cluster. The patient's seizures typically occur in clusters. During the events, the patient will quickly jerk her arms and legs, typically pulling them in. Sometimes only one arm will pull upward and this can be at slow rhythm or quick, rapid jerks. A cluster of these events will last 7-10 minutes resolving in return to baseline. The second type of event has only occurred twice and involved the same extremity jerking but the patient holding her breath during the jerk. This event occurred three weeks prior to for the first time and lasted 7-10 minutes, like the jerking events. The third type of event involved staring straight forward, possibly slightly upward, while she is non-responsive. This occurred two weeks ago while the patient was hospitalized. The event last 40 seconds and involved arrested behavior including sucking on her pacifier. The device was reportedly at end of service no longer providing a charge. These events had increased over the last few months, likely correlating with battery failure on the vns. The patient was referred for generator revision. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to end of service. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis on the generator was completed on (b)(6) 2013. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118624



Title: Re: Respiratory
Post by: dennis100 on January 08, 2016, 12:10:58 AM
Event Date 07/13/2015
Event Type Injury
Event Description
On (b)(6) 2015 it was reported that the patient's vns is scheduled for removal on (b)(6) 2015. The patient was bothered by stimulation and had device turned off in (b)(6) 2015. It was noted that the patient's depression has not worsened and he is having good results with ect. The nurse reported that the patient's vns had been disabled on (b)(6) 2015 and is scheduled to be explanted due to dysphonia and dyspnea. She also reported that the patient's vns had been implanted on (b)(6) 2013 and that the patient's (b)(6). The patient underwent explant of the vns on (b)(6) 2015 but the product cannot be returned for product analysis as the site discards explants. Good faith attempts for further information from the physician were unsuccessful. Attempts were also made for the patient's product information but no further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297223


Title: Re: Respiratory
Post by: dennis100 on January 08, 2016, 12:49:22 AM
Model Number 102
Event Date 11/01/2010
Event Type Death
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2010 and the patient's cause of death was unspecified threat to breathing, including unspecified threat to breathing, other and unspecified convulsions, and asphyxiation. A sudep (sudden unexpected death in epilepsy) evaluation was performed by a panel of expert medical professionals and it was determined on (b)(6) 2015 that the death met criteria for classification of probable sudep. There is no allegation or other information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5292868


Title: Re: Respiratory
Post by: dennis100 on January 11, 2016, 03:59:45 AM
Model Number 102
Event Date 08/27/2012
Event Type Injury
Event Description
No further information has been received after good faith attempts have been made.

Event Description
Clinic notes were received for review dated (b)(6) 2012: the patient reported that since last seen, he was baseline during most of (b)(6). He reports a seizure on (b)(6), that was longer than his previous seizures. His wife states that he had a seizures, was laying still, and had stopped breathing for about 2 minutes, she swiped the magnet multiple times, and nothing happened. She states that she attempted cpr, and was giving him breaths, and he woke up with another magnet swipe. Afterwards, he slept the whole day, and had a headache. He states that during the month of (b)(6) , he did not have any seizures. His last seizure was on (b)(6). He states that he is not in favor of take any more aeds currently, but would prefer increasing his vns settings. Vns interrogation: - current output - 2. 75 increased to 3. 00, signal frequency - 20, pulse width - 500, signal on time - 21, signal off time - 0. 8, magnet output current - 3. 00 increased to 3. 25, magnet on time - 60, magnet pulse width - 1000. Assessment/diagnosis: 780. 39 sz d/o - at baseline - plan notes: "adjusted vns settings - increased output". Good faith attempts are underway for further details about the patient's apnea following their seizure and their longer seizure not aborted by magnet usage. An estimated battery life calculation was performed and showed and estimated remaining life until near end of service is yes (years): 0. 17.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993315


Title: Re: Respiratory
Post by: dennis100 on January 25, 2016, 01:23:15 PM
Model Number 102
Event Date 02/07/2012
Event Type Malfunction
Event Description
It was reported via clinic notes received for review that a vns patient was having seizures on clinic visit date (b)(6) 2012. Reported patient doing ok. Currently off vimpat. Doing about the same, still having some drops and the seizures which last about a minute. The patient gets a little cyanotic with these spells. On visit date (b)(6) 2012 the patient reported that he's been having more seizures. Over the prior 3-4 weeks he had been having more episodes of not breathing for over a minute and can be cyanotic. The patient was going to be referred to their surgeon for follow up. It is unknown the relationship of their seizures to the vns baseline and if this is a new seizure type for the patient. Thus far no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2775951


Title: Re: Misc. Respiratory
Post by: dennis100 on March 04, 2016, 12:17:47 AM
Model Number 102
Event Date 08/02/2010
Event Type Injury
Manufacturer Narrative

Event Description
Programming data was received for patient from the physician for a battery life estimation. In this data , it was noted that the patient experienced apnea at night in 2010 and was mainly seizure free. It is unknown if the apnea is related to vns stimulation. Patient also experienced apnea in 2014 (reported in manufacturer report # 1644487-2016-00441) after the generator was replaced due to battery depletion. The explanted generator was received on 04/20/2012. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for additional relevant information were made but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5466456


Title: Re: Misc. Respiratory
Post by: dennis100 on March 04, 2016, 09:17:50 AM
Model Number 103
Event Date 12/03/2015
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2015 note that the patient was experiencing difficulty breathing. The patient was seen by an allergist and given an inhaler. There was no audible wheezing and no clinical evidence of asthma. The physician was unsure if the difficulty breathing was related to vns. Attempts to obtain additional relevant information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5420367


Title: Re: Misc. Respiratory
Post by: dennis100 on April 08, 2016, 01:32:16 AM
Event Date 12/16/2015
Event Type Injury
Event Description
It was reported that vns patient with intractable epilepsy, significant sleep disorder and apnea both obstructive and central is having negative impact of the vns on the sleep patent. It was reported that patient is under the sleep service cares but wouldn't tolerate any mechanical device for the apnea. It was reported that has a really high seizure frequency but there is clear evidence that the vns therapy did reduce this. It was reported that the patient was implanted with vns (b)(6) 2015 is now having negative impact of the vns on his sleep patent. It was reported that the patient is currently going through clusters of seizures during which he 'gags' repeatedly and has apnea. It was reported that nevertheless, the patient is having good seizures reduction with vns therapy. Patient settings were reduced to 9% duty cycle which did not improved patient's sleep. Patient is currently programmed to 1. 75ma output current, 30hz signal frequency and 250 sec pulse width. It was reported that although patient has always had problems with sleep and the apnea was diagnosed a few years ago, the negative impact started in (b)(6) 2015. The concerns are insomnia, snoring, gagging and apnea events bot obstructive and central. It was reported that vns system was checked on (b)(6) 2016 and was performing as intended. It was reported that patient's parent are keen to maximize the use of the vns. Following manufacturer advices, the signal frequency was reduced to 20hz and patient will be followed up form improvements.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5525646


Title: Re: Misc. Respiratory
Post by: dennis100 on April 08, 2016, 01:32:48 AM
Model Number 103
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that vns patient with learning disability implanted on (b)(6) 2010 suffers from upper respiratory problem. Patient's parents have asked the medical professional if reducing the vns settings may improve the issue. It was also specified that parents are not meaning the cough when using the magnet but they mean generally and all the time. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5525644


Title: Re: Misc. Respiratory
Post by: dennis100 on April 08, 2016, 03:13:16 AM
Model Number 304-20
Event Date 09/24/2014
Event Type Injury
Event Description
On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns. He said that the memory issues are not applicable. All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016. The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced. The patient does not have a medical history of these events prior to vns. The only event preceding the onset of the chocking/painful stimulation is replacement of the vns. It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram. The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient. It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation. Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement. On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision. The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time. The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects. She also is experiencing memory issues. The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016. She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on. The patient noted that the magnet is still programmed on. She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder. The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off. The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this. She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on. The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this. The patient said that the old system was completely removed according to the x-rays. On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures. He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498371


Title: Re: Misc. Respiratory
Post by: dennis100 on April 08, 2016, 03:13:56 AM
Event Date 01/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by the vns patient that they are having issues with the vns system. It was reported that the magnet cannot stop the stimulation when taped on the vns generator. It was reported that patient loss much weight and fat tissue between the generator and the skin, and was wondering if this could be the reason why the magnet now works intermittently. It was reported that patient has difficulties breathing during exercises. Patient reported that the problem started about a year ago, and that this was discussed with the nurse. Additional information was received by the nurse patient could switch the device off on many occasions, but not all the time. Nurse reported that she was not made aware that it was a major issue until been contacted by the manufacturer. It was reported by nurse that there were some inconsistencies in the patient's report which will be clarify with patient during the next clinic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5500658


Title: Re: Misc. Respiratory
Post by: dennis100 on May 05, 2016, 04:28:16 AM
Model Number 106
Event Date 12/04/2015
Event Type Injury
Event Description
On (b)(6) 2016 it was reported that the patient has been experiencing dyspnea associated with stimulation and stridor/apnea with stimulation while asleep since (b)(6) 2015. The physician reported that the patient has no history of sleep apnea. Good faith attempts for further information from the physician have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5563731


Title: Re: Misc. Respiratory
Post by: dennis100 on May 05, 2016, 04:28:57 AM
Model Number 102
Event Date 04/21/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient who is subject to a vns study had "breathlessness" event. The event was moderately severe, probably related to implant and probably related to vns stimulation. It was reported that the treatment was interrupted. It was reported that the event was not a serious adverse event and it did not cause the subject to discontinue from the study. System diagnostics were reported to return normal impedance results with dcdc code 3. Additional information was received indicating that the breathlessness ended after the generator was switched off. Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution. No further relevant information were provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5586534


Title: Re: Misc. Respiratory
Post by: dennis100 on June 16, 2016, 03:11:23 AM
Event Date 05/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by medical professional that vns patient had upper airways obstruction likely related to vns stimulation. Additional information received that the vns amplitude was reduced and then patient was treated for obstructive sleep apnea (osa) with mask bipap ventilation, which worked well till (b)(6) 2015. Patient has been implanted for many years now. It was reported that the problem started few years ago. Additional information was received that patient, now 10 years old, developed severe, intermittent upper airway obstruction, worse during sleep, after the implantation of a vns device at the age of 7. 5 years. It was reported that patient had no past history of respiratory problems. Within six months of implantation of the vns, a change in her nocturnal breathing was noted. A sleep study showed ¿regular episodes of desaturation with absent airflow every 6-7 minutes that interestingly were unrelated to sleep state. ¿ patient needed night-time face mask home ventilation for over one year due to worsening upper airway obstruction. Concern was raised by the patient¿s mother about the effect of the vns on her breathing. Reduction of output, pulse width and frequency resulted in an immediate and noticeable improvement in her breathing. It was reported that patient underwent a repeat sleep study with the vns device switched off for half the study, showing the impact of vns on patient breathing and saturation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5666152


Title: Re: Misc. Respiratory
Post by: dennis100 on June 17, 2016, 01:57:23 AM
Event Date 08/23/2002
Event Type Injury
Manufacturer Narrative
Zaaimi, b. , grebe, r. , berquin, p. , wallios, f. Vagus nerve stimulation induces changes in respiratory sinus arrhythmia of epileptic children during sleep. Epilepsia: 1-8, 2009. Doi: 10. 1111/j, 1528-1167. 2009. 02190. X.

Event Description
It was reported in a scientific article reviewed by the manufacturer that the vns epilepsy patient was subject to overnight polysomnographic recording of cardiorespiratory activity. During the recording, signals were collected from an ecg, thoracic and abdominal piezoelectric sensors, a nasal thermistor, eight eeg leads, an oxygen saturation monitor, and a chin emg. The physician observed that this pt experienced a decrease in the respiratory sinus arrhythmia (rsa) magnitude. This patient's rsa magnitude varied from the baseline by a factor of -7. 729+/-4. 554. The decrease started and ended abruptly with the onset and end of vns. The decrease in rsa magnitude was concomitant with no obvious effect on the patient's heart rate. The physician notes that the observed effects of vns on rsa may result from the following four possible factors: activation of brainstem loop via stimulation fibers; alteration of vagal afferent tone which modulates specific tonic and phasic parasympathetic efferent fibers; activation of efferent vagal fibers in the case of partial vns anodal block resulting in disturbance or abolition of physiologic efferent phasic and tonic firing or additive excitatory input to the heart, or; a combination of both efferent and afferent vagal fiber stimulation. In addition, changes in respiratory due to vns could also modify rsa. The physician indicates that "rsa can be altered during each vns period and gas exchange performance can, therefore, be repeatedly altered. This must be taken into account together with repeated hypoxic- and hypercapnic-induced transient effects in subjects with already disturbed brain function when evaluating vns side effects. " in addition, the physician indicates that altered rsa and cardiorespiratory synchronization may also affect the epilepsy-related alteration of sympathetic-parasympathetic balance due to either epilepsy, or chronic usage of antiepileptic medication. The physician indicates that the interaction between the effects of vns and potential autonomic nervous system (ans) dysfunction in epileptic patients may be considered to be a potentially life threatening condition, although no serious injuries specific to this event were noted with this particular patient. The physician also states that the understanding of these processes in epilepsy is limited, and suggests further evaluation of respiratory changes during vns. This patient was also included in an article by the same author titled "vagus nerve stimulation induces concomitant respiratory alterations and a decrease in sao2 in children" which was reported in manufacturer report # 1644487-2006-00105.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471012


Title: Re: Misc. Respiratory
Post by: dennis100 on June 17, 2016, 01:58:01 AM
Model Number 102
Event Date 01/01/2014
Event Type Injury
Event Description
Clinic notes were received regarding a patient's history of stridor and aspiration pneumonia from 2014. The patient had a lengthy history of aspiration pneumonia, which was not initially attributed to vns stimulation. The patient then started experiencing stridor around (b)(6) 2014, for which the physician decreased the patient's pulse width. The adjustment improved the patient's breathing. However, the patient was hospitalized soon after due to aspiration pneumonia. The physician stated on (b)(6) 2014 that the decrease in patient's settings from (b)(6) 2014 decreased the stridorous respirations, but it resumed a couple days later. The physician noticed that the stridourous breathing was directly related to stimulation, and it was also stated that the recurrent aspiration pneumonia may have been due to the stridor and excessive secretions. The patient's settings were adjusted again, and the stridorous respirations were barely audible after the change. The physician believed that the vns was functioning properly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5636215


Title: Re: Misc. Respiratory
Post by: dennis100 on July 08, 2016, 03:11:24 AM
Model Number 103
Event Date 05/25/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a vns patient, who is implanted since (b)(6) 2016, was not comfortable with vns. It was reported that when the physician tried to increase the output current from 0. 25ma to 0. 5ma, the patient had pain, suffocation, not really comfortable and crying. It was reported that the modification of the device parameters did not solve the issue. The event was described by the physician as serious ; the physician was looking to switch the device off and definitely explant it, but she finally decided to let it turned on at 0. 25ma and see if there will be any improvement. It was reported that the device was tested on 05/25/2016 and system diagnostics returned impedance results within normal limits. It was reported that in beginning (b)(6) 2016, the device was turned off due to big seizures (high intensity than before vns implantation) but this was not related to vns at all. The device was then switched back on 1 month later, at the output current of 0. 25ma. Review of manufacturing records confirmed all tests passed for the generator and lead prior to distribution. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5722569


Title: Re: Misc. Respiratory
Post by: dennis100 on July 09, 2016, 01:42:30 AM
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that vns patient in mid-teens, in transition to adult services suffers upper airways obstruction. Patient had multi-drug resistance epilepsy and was implanted with vns in 2008. The obstructive episodes occur like clockwork every 95 seconds through all sleep states. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5702767


Title: Re: Misc. Respiratory
Post by: dennis100 on August 05, 2016, 09:09:08 AM
Event Type Injury
Event Description
An article titled "the therapeutic dilemma of vagus nerve stimulator-induced sleep disordered breathing" was received for review on (b)(6) 2016. The author stated that a patient with obstructive sleep apnea experienced airflow limitation and mild tachypnea correlating with vns stimulation and sao2 desaturation during only some vns stimulation events. The patient's vns settings at that time were output current = 2. 25ma /frequency = 30hz / pulse width = 250microsec / on time = 30sec / off time = 3min, and the majority of the patient's respiratory events were not associated with vns stimulation. The patient then had a tonsillectomy/adenoidectomy and lost weight, which improved the patient's obstructive sleep apnea to the mild range. However, now the vast majority of the patient's obstructive respiratory events were associated with vns stimulation. Most of the events were associated with a 3% sao2 desaturation and occurred during rem sleep, non-rem sleep, and wakefulness. During non-rem sleep, the patient also had arousals and body movement at the termination of stimulation. However, there was a much lower degree of airflow reduction and no sao2 desaturation during vns stimulation while awake. The patient's vns output current was then serially decreased from 2. 25ma to 1. 75ma to 1. 25ma, and the degree of flow limitation improved with each reduction in output current. The sao2 desaturation and arousals stopped after the output current was below 2. 25ma. The patient's output current was then programmed to 0ma, and all respiratory events resolved. However, it was decided to program the patient's device back on to 1. 75ma to prevent breakthrough seizures. The output current had to be programmed back on to 2. 25ma because the patient started having breakthrough seizures. Since the patient's output current could not be reduced due to breakthrough seizures, the patient was started on cpap titration. The patient exhibited the same sao2 desaturations and arousals during supine sleep, but they could not be eliminated by cpap pressures. However, the patient was not compliant with cpap at home because of the inability to tolerate cpap pressure. No further relevant information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5788599


Title: Re: Misc. Respiratory
Post by: dennis100 on August 05, 2016, 09:10:03 AM
Model Number 106
Event Date 07/05/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient's daughter reported that her mother began seizing and then stopped breathing. The patient was coded and came back. It was reported that the patient was ok but everyone was shaken by the situation. The patient will be evaluated by the physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817109


Title: Re: Misc. Respiratory
Post by: dennis100 on August 05, 2016, 09:11:01 AM
Model Number 304-20
Event Date 07/23/2014
Event Type Malfunction
Event Description
It was reported that the patient was seen in the physician¿s office due to the previous night¿s experience of a choking that woke her up. This reportedly started occurring on (b)(6) 2016. The patient taped the magnet over the device which reportedly helped the issue. When the magnet was removed, the patient began having problems again. However, the experiences of breathing difficulties, choking sensations, and pain were not consistent and occurred erratically. The physician¿s office decided to disable the device. Device diagnostics were reported to be within normal limits at that time. There was no recollection of contributing trauma. A review of the available programming history showed that the device diagnostics that occurred in office were all within normal limits. The current outputs of all the device diagnostics matched the programmed levels. The downloaded internal device data was reviewed. The last >25% change in impedance was estimated to occur on (b)(6) 2015. The pre-change value was 4925 ohms and the post-change was 2820 ohms, representing change within normal limits. The historic >25% changes history showed evidence of intermittent high impedance as far back as (b)(6) 2016, where 14188 ohms was registered in that day's automatic 24-hour check. The generator and lead dhrs were reviewed and found that all specifications were met prior to distribution. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5796039


Title: Re: Misc. Respiratory
Post by: dennis100 on September 09, 2016, 05:11:54 AM
Model Number 103
Event Type Injury
Event Description
It was further explained that the patient had right sided vocal cord paralysis, which was not associated with vns. However, when the vns would stimulate, the left side would be paralyzed causing the 2 sides to touch. When the two sides touched, it caused the dyspnea and syncope to occur. The vns was programmed off and the patient's parents were told that if the seizures increase, they could come back and be evaluated for a right-sided implant of vns since the right vocal cord is already paralyzed. No surgical interventions have occurred to date.

Event Description
It was reported the patient was experiencing syncope and trouble breathing with vns stimulation. The physician did not believe the syncope was related to vns. The patient had also been seeing a surgeon who reported he was unsure if the syncope was related to vns. The patient's device was disabled on (b)(6) 2016 to determine if the issues reported were related to vns or not. It was later reported the patient saw an ent on (b)(6) 2016 and it was observed that the patient had right-sided vocal cord paralysis. It was noted to be relevant because when the vns stimulates, the left vocal cord meets the right side in the middle and blocks the patient's airway. This was the cause for the reported dyspnea. It was also noted the patient's seizures began due to a car crash and it is uncertain if this is also the reason for the paralysis. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5871168


Title: Re: Misc. Respiratory
Post by: dennis100 on September 09, 2016, 05:12:35 AM
Model Number 304
Event Date 07/14/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
On (b)(6) 2016 an email was received regarding a patient who had their pleura punctured during a replacement surgery. While attempting to implant the new lead, the patient's pleura was punctured by the surgeon, which resulted in the patient's lung collapsing. The patient's oxygen saturation rapidly dropped. The patient was then incubated with chest tubes and the new generator was quickly implanted. The patient was then admitted to the hospital where they spent a few days before being released. As of (b)(6) 2016, the patient has reportedly recovered.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5853375


Title: Re: Misc. Respiratory
Post by: dennis100 on September 09, 2016, 05:13:18 AM
Model Number 106
Event Date 07/04/2016
Event Type Death
Manufacturer Narrative
(b)(4).

Event Description
It was also reported that the patient died "gasping for air" on (b)(6) 2016. The cause of death was listed as "seizure causing cardiac arrest. " the device was not explanted. The patient's physician did not agree with the cause of death listed on the death certificate since the patient was a healthy individual other than having epilepsy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835928


Title: Re: Misc. Respiratory
Post by: dennis100 on November 29, 2016, 02:48:31 AM
Model Number 103
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities. The physician tested the vns and found high impedance. The vns was programmed off and the patient was referred for surgery. The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016. It was noted that the lead pin was not fully inserted into the generator. The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket. Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019996


Title: Re: Misc. Respiratory
Post by: dennis100 on November 29, 2016, 02:49:53 AM
Event Type Malfunction
Event Description
It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6031775


Title: Re: Misc. Respiratory
Post by: dennis100 on December 09, 2016, 10:49:36 AM
Model Number 106
Event Type Injury
Event Description
It was reported that the patient's central apnea was exacerbated by vns stimulation. The physician reduced the pulse width and frequency to help with the apnea. It was unknown when the stimulation started exacerbating the apnea or if the patient had central apnea prior to receiving vns stimulation. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6129136


Title: Re: Misc. Respiratory
Post by: dennis100 on January 06, 2017, 08:48:57 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 11/28/2016
Event Type Injury
Event Description
It was reported by a medical professional that a vns patient¿s mother brought him into clinic and complained of increased stridor she believed it to be due to stimulation. A settings change was last performed on (b)(6) 2016 which increased the duty cycle by lowering the off time from 3 minutes to 1. 8 minutes. The patient's mother also reported the patient has an increase in their basal heart rate and that the patient has been choking while eating when the device is stimulating. She also stated the patient has an increased heart rate from his normal baseline which is at 50s and 60s. The mother said the patient is "getting worse" over the last six months but the doctor reports that at the last clinic visit, she did not observe any trouble or difficulty. The mother described the symptoms as stridor, but the physician stated she did not believe the patient's symptoms observed to be wheezing, to be related to vns. The physician is concerned that this could be an airway structure problem and is not actually related to the vns. The patient was referred to an ent for evaluation. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6199949


Title: Re: Misc. Respiratory
Post by: dennis100 on January 06, 2017, 08:49:41 AM
Model Number 103
Event Date 09/20/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported by a representative from the physician's office that the patient passed away on (b)(6) 2014. From the death certificate and physician's office, it was gathered that the patient was having breathing problems the morning of (b)(6) 2014. An ambulance was called and the patient died naturally of cardiac arrest in the ambulance. The funeral home stated the device was explanted and discarded. The physician was not able to make any assessments concerning the relationship between vns and the death. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6139626


Title: Re: Misc. Respiratory
Post by: dennis100 on January 06, 2017, 08:50:31 AM
Model Number 304-20
Event Date 07/23/2016
Event Type Injury
Event Description
It was reported that a patient was having dyspnea and voice alteration. The symptoms occurred even between stimulations. Diagnostics were within normal limits. The physician decided to disable the device to see if the symptoms get better. The patient was still experiencing vocal cord problems even with the generator programmed off. The vocal cord issue did not start until later into the titration phase and did not resolve with the disablement, so the physician believed that the nerve was inflamed and wanted to wait and titrate the device up again. The patient later reported that her implant surgery took two times as long as it should have because the surgeon had difficulty implanting the lead. While in recovery, she choked on water and could not swallow. The patient lost a large amount of weight because she could not swallow food. She also reported that she was diagnosed by an ent with left vocal cord paralysis, spasms in the trachea and esophagus, and damage to the swallow and sensory nerves. Due to these issues, she could not talk, breathe, or sleep. The left side of her face was also reportedly paralyzed. The patient was having speech and swallow therapy, but she was told that this would not help. The physician considered disabling the patient's device to allow inflammation at the nerve to go down, but the patient was receiving efficacy from vns therapy. The physician decided program the patient's device to low settings for all modes of stimulation. No further intervention was taken. No additional information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150194


Title: Re: Misc. Respiratory
Post by: dennis100 on January 30, 2017, 12:43:20 PM
Model Number MODEL 250
Event Date 08/19/2008
Event Type Malfunction
Event Description
Initial reporter indicated that they had a problem with a programming session with their patient. Reported "patient was in for office visit and she interrogated patient and when she pressed the interrogate button the patient immediately started screaming that she couldn't breath. " reporter indicated that prior to this the patient was programmed at 1. 25 output current with 250 pulse width. The settings were checked on the handheld and it was set to 1. 5 output current and 500 pulse width. The settings were immediately changed back to what patient was previously on and then in the course of the office visit she changed patient's settings to 1. 50 output current, 250 pulse width before patient left office without difficulty or further incident. Manufacturer is pending receipt of the programming system for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172126


Title: Re: Misc. Respiratory
Post by: dennis100 on February 06, 2017, 04:36:54 AM
Model Number 304-30
Event Date 01/04/2013
Event Type Injury
Manufacturer Narrative

Event Description

Event Description
It was initially reported that the patient was experiencing a sore throat and was having problems with her voice which made it so she could barely talk following vns implant surgery. The patient was diagnosed with left vocal cord paralysis by an ent after being scoped. The patient also reported having trouble breathing and swallowing and felt like there was something stuck in her throat. The family was told that she had an adverse reaction to the vns surgery. The patient had her generator disabled and was given a steroid which did not help. The patient has been weak, tired and nauseous at times since the surgery. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2981130


Title: Re: Misc. Respiratory
Post by: dennis100 on February 09, 2017, 02:24:43 AM
Model Number 102
Event Date 01/09/2013
Event Type Death
Manufacturer Narrative
Event Description
It was initially reported that the patient passed away and no other information was provided at that time. The patient passed away his home surrounded by loved ones, so the death seemed that it may have been expected. Good faith attempts for more information have been unsuccessful to date.

Event Description
Additional information was received that the generator and lead will not be returned to the manufacturer for evaluation. The crematory typically gives explanted medication device to a company that deals with the deposition of them. What happened to the explanted product is unknown. The reported history of cardiac and respiratory issue was not related to vns.

Event Description
Additional information was received from the death certificate that the cause of death was multiple organ failure and lennox-gastaut syndrome. The manner of death is natural. The physician provided the cause of death as pneumonia and not related to vns. The patient had a history of cardiac and respiratory issues. The death was witness by the patient's mother.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986302


Title: Re: Misc. Respiratory
Post by: dennis100 on February 10, 2017, 05:15:10 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/02/2014
Event Type Injury
Manufacturer Narrative

Event Description
The patient's device was disabled due to the worsening of the patient's sleep apnea and breathing issues. A programming history review was performed and identified that the patient's device had been disabled on (b)(6) 2014. The most recent diagnostics from (b)(6) 2016 were normal. No further information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6240508&pc=LYJ


Title: Re: Misc. Respiratory
Post by: dennis100 on February 12, 2017, 09:35:31 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
It was reported that the explanted generator was discarded by the hospital. Therefore, analysis cannot be performed.

Event Description
On (b)(6) 2013 it was reported that the patient was referred for generator replacement due to "discomfort and movement". It was previously reported that the patient's vns was at end of service; but diagnostics later confirmed that the device was not at end of service. It was later clarified that the "movement" was migration of the vns generator. Clinic notes were received dated (b)(6) 2013 that state the patient is awaiting prophylactic surgery for her generator to be replaced due to discomfort and movement. The patient has a medical history of copd and went to the e. R. With difficulty breathing during a seizure on (b)(6) 2012 and to the e. R. On (b)(6) 2013. The clinic notes dated (b)(6) 2013 indicate that the patient states her magnet mode stays on after a magnet swipe and she has to hold the magnet over the generator for a few minutes so that it will go back. It was later reported that the patient first noticed the device started moving around a couple of months ago after being admitted to the hospital for west nile virus. A cat scan had been performed at that time. The patient also started experiencing a burning pain at the generator which goes up to the neck that occurred with stimulation. The patient also mentioned that the magnet stimulation is particularly painful, and mentioned that when the device is swiped, it will stay on at the magnet settings until she holds the magnet over it to disable the stimulation. The patient said, after doing so and removing the magnet, it will go back to the normal generator settings. The patient says they have tried to make changes to the parameter settings to lessen the painful stimulation but there has been no improvement. The patient said she discussed this with the implanting physician who told her the device "is probably messed up". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not yet occurred.

Event Description
The surgeon's office reported that it was unknown if a non-absorbable suture was used to secure the generator to the fascia during implant surgery as it was not in records.
Manufacturer Narrative

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

Event Description
On (b)(6) 2013 it was reported that the patient saw another neurologist and it was determined that she does not have epilepsy so she wants the vns removed.

Event Description
It was reported that the patient's vns device was removed on (b)(6) 2013. Attempts were made for additional information and product return; however, they were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025829


Title: Re: Misc. Respiratory
Post by: dennis100 on February 12, 2017, 09:36:20 AM
Model Number 102
Event Date 12/19/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. The online obituary confirmed the date of death and that the patient passed away at the hospital. The cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The funeral home indicated that the patient was buried with the device. The cause of death was unknown. The patient suffered from hypertension and copd. The patient experienced seizure reduction with vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5592417


Title: Re: Misc. Respiratory
Post by: dennis100 on February 13, 2017, 04:52:32 AM
Model


Title: Re: Misc. Respiratory
Post by: dennis100 on February 15, 2017, 02:48:44 AM
Model Number 102
Event Date 01/26/2012
Event Type Injury
Event Description
Additional information was received indicating that the apnea and aspiration were not believed to be related to vns as the patient had these prior to being implanted. These events did not occur with stimulation and there were no causal/contributory programming or medication changes that preceded the onset of the apnea or aspiration. The patient has since received a g-tube and will undergo a 2nd sleep study for the apnea. No additional information was received.

Event Description
It was reported through clinic notes received on (b)(6) 2012, that the patient has a medical history significant for obstructive sleep apnea and aspiration. While it is known that the patient has a history of apnea pre-vns, it is currently unknown if the apnea is exacerbated by vns therapy. The relationship between the patient's aspiration and vns is also unknown. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480386


Title: Re: Misc. Respiratory
Post by: dennis100 on February 16, 2017, 01:36:32 AM
Model Number 102
Event Date 11/01/2011
Event Type Injury
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently referenced the wrong mfr report number for the sleep apnea event. The correct mfr report number is 1644487-2012-00596 for the sleep apnea event.

Manufacturer Narrative

Event Description
On (b)(6), 2012 clinic notes from a vns treating psychiatrist were received by the manufacturer. Review of the clinic notes dated (b)(6), 2011 revealed that he patient's suicidal thoughts were at baseline. The patient stated that the closest he has ever come to killing himself is holding a gun to himself years ago but did not pull the trigger. There is no history of suicide attempts according to the clinic notes. Clinic notes dated (b)(6), 2011 reveal that the patient has increased suicidal ideation and he wanted to kill himself bad. The following clinic notes dated (b)(6), 2011 stated that the suicidal thoughts are pretty up there but about at baseline. On (b)(6), 2011 his suicidal thoughts are maybe a little worse than baseline. He denies plan/intent to harm self; he is thinking that he wants to die. The patient's longtime friend and neighbor had passed away from cancer that week. The clinic notes further state that this is a bad time of the year for him as it was this time last year that he was in the hospital and got out the day before (b)(6). Clinic notes dated (b)(6), 2011 state that his suicidal thoughts are stable; he has thoughts of shooting himself intermittently but denies plan or intent to do so. He does not want to be admitted. On (b)(6), 2011 clinic notes stated that the patient says he is tired of living and expresses that it is just a matter of time before he kills himself the patient refuses to go to inpatient because he said its stupid up there. His thoughts of harming himself were at baseline. In clinic notes dated (b)(6), 2011 the patient stated my thoughts were bad a couple of days ago, he did not take any steps to harm himself at that time; he just stated his thoughts were bad. The patient reported his thoughts are back to baseline that day and he does not have any plan or intent to harm or kill himself. Clinic notes dated (b)(6), 2011 again state that the patient's thoughts of harming himself were bad a few days ago and are at baseline. The patient states he is just having thoughts and has not taken steps to harm himself. The patient was reported to be talking with a surgeon about vns removal and the patient stated he has not been feeling vns stimulation as well as in the past. On (b)(6), 2011 the patient stated he is not doing well and was worse than last week. The patient expressed repeatedly that he is just tired of living. On (b)(6) 2012's clinic notes the patient had a wall fall on him and he stated that he wished it would have killed him. Clinic notes dated (b)(6), 2012 stated that the patient has thoughts of shooting himself and wanting to die daily that is at baseline levels but he denies any plan or intent to harm himself. (b)(6), 2012 the patient continues to be very depressed and stated that he has not been sleeping well in general at nights. He is not sure if his suicidal thoughts are at baseline but there are still there. Clinic notes dated (b)(6), 2012 reveal that the generator is not working and is broken; the patient is making a decision about whether he will get vns again. On (b)(6), 2012 the patient was sent to the emergency department to be evaluated for voicing suicidal thoughts. The patient reported thinking about suicide daily but denied a plan and says he is not close to harming himself. He reported to the psychiatrist that he does not feel that he needs to be admitted to the hospital and does not want to be admitted. The patient's wife reported that she has not noticed any acute change in him and she did not expect him to be sent to the emergency department based on how he was this morning. She stated that he has not made any statements about harming himself lately. The psychiatrist stated that the patient appears to be at baseline. However, according to the psychiatrist the patient has generally been doing worse in terms of depression and suicidal thoughts for the last 6 months. The patient states that even this new baseline is only a smidge worse than his previous state. The psychiatrist stated that the fact that he saw a resident in the clinic who does not know him, may be part of why he was sent to the emergency department that day. The patient admits to baseline thoughts of harming himself with intermittent thoughts of shooting himself, but denies plan or intent to harm himself at this point. He does not want to be hospitalized nor does he feel he needs to be hospitalized. The clinic notes state the patient has a history of chronic obstructive pulmonary disease, obstructive sleep apnea (reported on mfr. Report # 1644487-2012-00597), diabetes, dyslipidemia, and hypertension. The psychiatrist later reported that the increased depression and suicidal ideations were first noticed recently, (b)(6) 2011, and occurred after the vns stopped working. The physiatrist further states that the patient's sleep apnea probably contributed to the increased depression and suicidal ideations (reported on mfr. Report # 1644487-2012-00597). No patient manipulation or trauma occurred that is believed to have caused or contributed to the altered perception of stimulation. The patient's most recent programmed settings are: output=2ma/frequency=30hz/pulse width=300usec/on time=30sec/off time=1. 1min/magnet output=0ma. The last system and normal mode diagnostics tests showed output=ok/lead impedance=ok/dcdc=2/eri=no and output=ok/lead impedance=ok/dcdc=2/eri=no respectively. The psychiatrist stated that the increased depression level is back to pre-vns baseline levels and the suicidal ideations levels is also back to pre-vns baseline levels. The psychiatrist also clarified that what was meant by the vns is broken is that the generator battery is depleted. On (b)(6), 2012 they were unable to interrogate the patient's generator due to the device being at end of service. A battery life calculation had been performed which revealed negative years until eri=yes.

Event Description
The clinic notes state the patient has a history of chronic obstructive pulmonary disease, obstructive sleep apnea (reported on mfr. Report # 1644487-2012-00596), diabetes, dyslipidemia, and hypertension. The physiatrist further states that the patient's sleep apnea probably contributed to the increased depression and suicidal ideations (reported on mfr. Report # 1644487-2012-00596).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2478470


Title: Re: Misc. Respiratory
Post by: dennis100 on February 16, 2017, 01:37:50 AM
Model Number 102
Device Problem No Information
Event Date 12/14/2010
Event Type Death
Event Description
The patient's death certificate was obtained and reviewed. The cause of death was aspiration with respiratory arrest ((b)(6)) and seizure disorder ((b)(6)). Other significant conditions contributing to death but not resulting in the underlying cause of death were mental retardation and spastic quadriplegia. An autopsy was not performed, and the manner of death was natural. The patient was cremated. As the cause of death was aspiration, sudep is no longer suspected as a cause of death. Manufacturer follow-up with the funeral home revealed the vns was explanted prior to the cremation and given to a disposal company.

Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2010 due to causes of respiratory arrest; other and unspecified convulsions; foreign body in respiratory tract, part unspecified; inhalation and ingestion of other objects causing obstruction of respiratory tract. Other contributing factors were provided as unspecified mental retardation; spastic tetraplegia; osteoporosis, unspecified. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep. There is no allegation or other information indicating that the death is related to vns.

Event Description
Reporter indicated a vns patient had died. The circumstances of the death were described as: "during night time bed checks the direct support staff person went in and checked on him and found him. She called the nurse who started cpr and it was called when the ems arrived and took over. Pronounced by the coroner"; the patient lived in an assisted-care facility, indicating he was in a reasonable state of health. The patient was compliant with his medications, and had no history of cardiac or respiratory problems, or substance abuse. The patient was found unresponsive during a night check at the facility. It is not specified the patient was in his bed, but this is likely as it was nighttime. The death was also not witnessed. The patient had a history of nocturnal seizures but no febrile seizures. Vns provided a 25% reduction in seizures. The patient was receiving vns therapy at the time of death, but vns settings were not provided. The available information suggests the death is probable sudep. Per the reporter, the death was unrelated to the vns. Attempts for the death certificate and disposition of the vns device are in progress.

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.

Manufacturer Narrative
Date received by manufacturer, corrected data: inadvertently not provided in follow-up report #02. The received date for follow-up report #02 was 03/03/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480496


Title: Re: Misc. Respiratory
Post by: dennis100 on February 16, 2017, 01:39:01 AM
Model Number 101
Event Date 01/25/2012
Event Type Injury
Manufacturer Narrative

Event Description
The clinic notes also noted on (b)(4) 2012 that the patient had "rapid heart beat and lost respiration for a second then came back to breathing normally. ".

Manufacturer Narrative
Corrected data: initial report inadvertently did not indicate that patient had prophylactic generator replacement due to the age of the generator and not related to the patient's "rapid heartbeat and lost respiration.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect age. Describe event or problem, corrected data: the initial report inadvertently did not include that the events only lasted for a second, and then the patient was breathing normally again.

Event Description
Additional information was received indicating the patient had prophylactic generator replacement due to the generator's length of implant and not the rapid heartbeat and lost respiration. The explanted generator was returned and underwent analysis. The generator performed to specifications and no anomalies were found. An implant card was received indicating that lead impedance was normal at the time of replacement.

Event Description
It was reported via clinic notes received that the patient recently experienced 2 strong seizures and was concerned of a rapid heartbeat and lost respiration. It is unknown if these events are related to vns or the patient's seizure pattern. Diagnostics taken on (b)(6) 2012 were within normal limits. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2477725


Title: Re: Misc. Respiratory
Post by: dennis100 on February 22, 2017, 02:44:13 AM
Model Number 102
Event Date 01/27/2009
Event Type Malfunction
Event Description
Clinical notes were received by the manufacturer from the vns patient's physician during the investigation of the patient's death. The treating physician determined that the death was not related to vns therapy, rather the patient's respiratory condition and the patient ultimately dies due to respiratory distress and cardiac arrest. Within the clinic noted received was detail of a follow up appointment that occurred two weeks prior to the death. At this appointment, it was noted that the mother noticed, after the patients' recent hospitalization, that the patient was "having more staring seizures, which typically occur in clusters, lasting for a few seconds. The seizures occur sporadically and have decreased over the past week. " there was no note of interventions taken for the adverse event. The vns device was interrogated and a normal mode diagnostic test was performed revealing normal device function. There were no setting changes performed. The physician noted that the plan was to check the patients' medication levels and schedule an eeg to assess the ictal and interictal abnormalities. The patients current antiepileptic drug medications were noted as lamictal, depakote, and clobazam. Good faith attempts were made with the physician to obtain additional information regarding this event, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1358277


Title: Re: Misc. Respiratory
Post by: dennis100 on February 26, 2017, 01:44:55 AM
Event Date 02/01/2003
Event Type Injury
Manufacturer Narrative
Laryngopharyngeal dysfunction from the implant vagal nerve stimulator. Zalvan, c, et. Al. Laryngoscope 113. Pp 221 - 225. February 2003.

Event Description
It was reported in a scientific article following pts how were implanted with the vns device that a pt developed left vocal cord paresis following implant as well as difficulty breathing while drinking. Follow up one month later showed no improvement in vocal cord mobility and antibiotics administered to the pt resolved the pt's breathing difficulties. Good faith attempts to obtain additional info including pt implant info have been unsuccessful as the author no longer has access to the pt's chart.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1288587


Title: Re: Misc. Respiratory
Post by: dennis100 on February 26, 2017, 01:45:45 AM
Event Date 11/28/2007
Event Type Injury
Manufacturer Narrative
Gschliesser, v. , hogl, b. , frauscher, b. , brandauer, e. , poewe,w. , luef, g. "mode of vagus nerve stimulation differentially affects sleep related breathing in patients with epilepsy", seizure (2009) article in press. (see scanned pages).

Event Description
It was reported in an article reviewed by manufacturer which investigated the influence on vagus nerve stimulation with standard mode (30 sec on and 5 min off) and rapid cycling mode (7 sec on 12 sec off) on sleep related breathing. The findings for patient 2 (male) was an increase in the flow limitation index with the rapid cycling mode compared to the standard mode.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1291967


Title: Re: Misc. Respiratory
Post by: dennis100 on March 02, 2017, 09:27:42 AM
Model Number 102
Event Date 07/25/2011
Event Type Injury
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.

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.

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
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.

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


Title: Re: Misc. Respiratory
Post by: dennis100 on March 03, 2017, 09:01:48 AM
Model Number 304-20
Event Date 03/16/2011
Event Type No Answer Provided
Event Description
Reporter indicated the patient may be seen by a neurosurgeon for evaluation of the patient¿s neck at the patient¿s request, but no surgery date has been set. The reporter declined to provide additional information.

Manufacturer Narrative
The event of the patient's worsening asthma was inadvertently omitted from the initial mdr report.

Event Description
Clinic notes from the new treating physician were received indicating surgery to replace the vns generator and possibly the lead may be done in order to relieve the patient's symptoms of voice alteration, dyspnea and painful stimulation. It is suspected the lead placement may be the cause of the patient's adverse events. A surgery date has not been set. Attempts for additional information are in progress.

Event Description
Rptr indicated that since she was implanted with the vns in (b)(6) 2011, she was experiencing vocal cord paralysis when the vns would stimulate. The rptr stated she had a bronchoscopy performed and it was confirmed the left vocal cord had "some sort of paralysis" during vns stimulation. The patient did not wish to have the vns disabled by her treating neurologist. Mfr follow up with the treating neurologist's office revealed the neurologist was aware of the pt's reported vocal cord paralysis, but that the pt had been released from their practice as of (b)(4) 2011 and they had no info. The office did state that the pt was seen on (b)(6) 2011 and the vns was working properly at that time. In addition, the pt refused to have the vns disabled. It is unk which physician the pt may be seeing at present.

Event Description
Reporter indicated that in addition to the vocal cord paralysis, she has also experienced worsening asthma since the vns was implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405348


Title: Re: Misc. Respiratory
Post by: dennis100 on March 04, 2017, 02:18:04 AM
Model Number 102R
Event Date 10/25/2013
Event Type Death
Event Description
It was reported that the patient passed away on (b)(6) 2013. The cause of death was unknown. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.

Event Description
Additional information was received stating that the vns patient was in the icu at the time of her death. The patient¿s discharge summary and expiration note were received. The patient was admitted to the hospital for persistent right hip pain following a fall six days prior. It was noted that the patient was a ¿medically complex patient¿. The patient had obvious bruises to her right hip and was unable to bear significant weight on her right leg. She had complained of a dry cough for the past week and was placed on antibiotics, and she was recently diagnosed with acute urinary tract infection (uti). A ct of the head revealed left middle ear cavity and mastoid disease suggesting otomatoiditis, status post right mastoidectomy, but no acute intracranial abnormality. Her chest x-ray revealed increased pulmonary lung markings and her inr in the emergency department was 11. 5 (very high). The patient was subsequently admitted for further treatment. The death summary lists additional final diagnoses as follows: mechanical fall with pelvic rami fractures; severe community-acquired multilobar pneumonia; septic shock; and acute hypoxemic respiratory failure. Following her admission, the patient became increasingly dyspneic and tachypneic with a very pernicious cough and she required increasing levels of supplemental oxygen in the icu. The patient developed hypotension and acute hypoxemic ventilatory failure requiring mechanical ventilation, but failed to respond to positive end expiratory pressure and was placed on bi-level ventilation. On the fifth day of her hospitalization, the patient developed profound refractory hypotension and pulseless electrical activity, followed by ventricular tachycardia and subsequent asystole. The physician who drafted the death summary suspected that the cause of the patient¿s death was ¿myocardial ischemia¿. There was no mention of the patient¿s implanted vns system in any of these hospital records. Based on the available information about the patient¿s death, an internal classification has determined that the death may be unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551654


Title: Re: Misc. Respiratory
Post by: dennis100 on March 04, 2017, 02:18:38 AM
Model Number 103
Event Date 10/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient presented in (b)(6) 2013 with complaints of bad sleep and excessive daytime fatigue. The patient underwent two consecutive nights of polysomnography and pulmonary evaluation. The patient experienced 13 obstructive apneas and 2 mixed ones; 48 hypopneas and respiratory-effort related arousals. The vns was programmed off and the patient experienced 4 obstructive apneas; 11 hypopneas and respirator-effort related arousals.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3561597


Title: Re: Misc. Respiratory
Post by: dennis100 on March 04, 2017, 02:19:21 AM
Model Number 102
Event Date 10/16/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. It was reported that it is believed that the death was from seizures, but that the patient reported on (b)(6) 2013 that she had been seizure free since vns implant. The physician's office reported that the cause of death was unknown and the relationship to vns therapy is unknown. It was reported that the patient did not have a history of cardiac or respiratory problems. The state vital records will not release a death certificate to device manufacturer. No additional information can be obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3579238


Title: Re: Misc. Respiratory
Post by: dennis100 on March 10, 2017, 06:18:50 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 10/13/2014
Event Type Injury
Event Description
It was reported that the patient had been breathing poorly since her vns was replaced. The patient described the assessment of her treating ent physician in her own words. Of the portions of the throat that open and close with breathing, only one side opens correctly. The other side only opens about halfway due to being disturbed by the stimulation from the vns, leading to less efficient breathing cycles. Follow up with the patient¿s treating neurologist showed that the patient has vocal cord paralysis and a long history of dyspnea. It was initial stated it was unclear when these events began. However, a subsequent comment indicated that the patient dates the shortness of breath issues to her 2014 generator replacement. Review of programming history showed that device settings and diagnostics were within normal limits before and after the generator replacement. Attempts for additional pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300095


Title: Re: Misc. Respiratory
Post by: dennis100 on March 10, 2017, 06:19:31 AM
Model Number 102R
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that a pt was admitted to the hospital for unrelated respiratory issues. While in the hospital, the pt underwent several medication changes and the pt began to experience an increase in seizures above pre-implant baseline levels. The pt's mother believes, the increase in seizures is due to medication changes and wanted to have the vns adjusted to see if this would help. 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=1670986


Title: Re: Misc. Respiratory
Post by: dennis100 on March 10, 2017, 06:20:08 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 01/16/2017
Event Type Injury
Event Description
The patient reported that she was having difficulty breathing and went to her ent physician to be evaluated. There the ent physician diagnosed her with vocal cord paralysis and considered placing a trach to help these issues. It was unclear if these issues were being associated with vns therapy. Attempts for information from the neurologist who manages the patient's vns found that the patient suffers from numerous other health issues. However the neurologist was going to let the ent physician care for the vocal cord paralysis and difficulty breathing. A review of the internal programming history found that the impedance value of the system was within acceptable limits for most of the implant life however the last recorded test occurred approximately 2 years prior to this report. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6324827


Title: Re: Misc. Respiratory
Post by: dennis100 on March 10, 2017, 06:20:51 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2016
Event Type Injury
Event Description
It was reported by a patient that approximately 2 months prior, he woke up with shoulder pain and was having difficulty breathing. The patient went to the hospital and remained there for 5 days, and the physicians told him that his heart rate had decreased to 30 beats per minute. He said that the physicians determined that the shoulder pain and difficulty breathing were caused by the bradycardia and lower oxygen levels, but the physicians were unsure if the patient's bradycardia was caused by the vns. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300371


Title: Re: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:02:21 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 08/10/2013
Event Type Death
Manufacturer Narrative

Event Description
It was found through obituary that the patient passed away at a hospital, where he lived and was treated by his following neurologist. The patient's death discharge report indicated that the final cause of death was cardiopulmonary arrest secondary to possible aspiration pneumonia with not direct cause as: seizure disorder and paranoid schizophrenia. During the eight months prior to the patient's death, he became increasingly wheelchair bound and kyphoscoliotic, and was working with speech therapy for dysphagia. Two weeks prior to death, he had an episode of respiratory distress that led to intubation and icu stay; the patient chose comfort feeds as a method of treatment and developed increasing respiratory distress likely secondary to pneumonitis and aspiration that eventually led to his death. A battery life calculation found that the patient's generator was expected to have reached end of service approximately 10 months prior to the patient's death. 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=6404628


Title: Re: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:02:59 AM
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: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:03:36 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 01/08/2017
Event Type Injury
Event Description
It was reported that a patient's generator had migrated in the left chest wall. The patient started having discoloration above the generator site about one month after implant surgery. The device had been working itself out of the pocket because the patient was wearing a vibrating vest at night (used to prevent respiratory issues/asthma not related to vns). The patient started wearing the vest about one month after surgery, and that is when the skin at the generator site started to break down. The generator was confirmed to have been sutured in place. The patient had generator pocket revision surgery due to the migration. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6437356


Title: Re: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:04:09 AM
Model Number 106
Device Problem No Known Device Problem
Event Type Injury
Event Description
It was reported that a patient was making a gurgling sound during stimulation when the physician increased the patient's settings. The physician ordered a sleep study and saw that the patient had a drop in oxygen levels associated with stimulation. The physician decreased the pulse width in response. The physician planned to continue to adjust settings to get the patient to a therapeutic level while decreasing the symptoms of stimulation. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6451768


Title: Re: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:04:47 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
A presentation discussing vns therapy case studies was provided from a nurse and reviewed for complaints. One patient was reportedly experiencing very noisy breathing overnight, and an increase in seizures began in (b)(6) 2015. After making programming adjustments, the patient's seizure rate improved by (b)(6) 2016. The patient then experienced another increase in seizures a few months later, over christmas, and the patient's antiepileptic drug regimen was increased. The patient's overall quality of life was reportedly improved. The patient's mother wanted to try an alternative duty cycle, so the patient's on time was reduced after (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6444014


Title: Re: Misc. Respiratory
Post by: dennis100 on April 19, 2017, 12:05:22 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 02/08/2017
Event Type Injury
Event Description
It was reported by the patient that following generator replacement, the patient experienced an onset of bronchitis along with a metallic taste and an increase in coughing which occurred with vns stimulation. Review of the implant card confirmed that the generator was functioning as intended at the implant procedure. A review of manufacturing records confirmed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6445975


Title: Re: Misc. Respiratory
Post by: dennis100 on April 26, 2017, 12:27:33 AM
Model Number 102
Event Date 11/01/2009
Event Type Malfunction
Event Description
Initial reporter the pt's neurologist office reported that their pt is reporting that she noticed an increase in seizures on nov 1st along with a shocking sensation at the tip of her tongue with stimulation that is intermittent and does not correlate to the pt's vns on time. The pt continued to have seizures (b) (6), (b) (6) and (b) (6). Reported to be over their prevns rate. The pt has cycles of seizures but not usually as bad as what they have been having. It was additionally reported that the last time the pt was in the office in (b) (6) 2009 her diagnostics wer all ok. The pt was set at 1. 5/30/250/7/0. 2 but was changed to 1/30/500/7/0. 2 because she was complaining of some throat pain with stimulation and dyspnea that was a one time event in (b) (6). It was unknown the relationship of their seizures to their vns at this time. It was addition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575417


Title: Re: Misc. Respiratory
Post by: dennis100 on May 01, 2017, 12:50:11 AM
Model Number 102R
Event Date 07/16/2014
Event Type Death
Event Description
It was reported that the vns patient passed away. It was reported that the cause of death was not known, but that the patient went into pulmonary distress and then ultimately was pronounced brain dead later that day. It was reported that the patient's family wanted the explanted devices returned for analysis. The explanted devices have not been received to date. The relationship of the cause of death to vns is unknown. No additional relevant information has been received to date.

Manufacturer Narrative

Event Description
The explanted devices are not expected to be returned; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4009938


Title: Re: Misc. Respiratory
Post by: dennis100 on May 02, 2017, 02:01:51 AM
Model Number 103
Event Date 03/11/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. The online obituary noted that the patient passed away peacefully at home. The funeral home reported that the device was not explanted because the patient was buried. The cause of death was reported to be respiratory infection. The relationship of the vns to the cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3995362


Title: Re: Misc. Respiratory
Post by: dennis100 on May 02, 2017, 11:25:54 PM
Model Number 106
Event Date 09/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing an increase in seizure frequency and duration. The patient had two 4-minute seizures in one month and it was noted that the length of the seizure was unusual for the patient. The patient had also been experiencing hyperventilation and reported that his head was not feeling well. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient¿s issues were not related to vns but to an endocrine problem that resulted in a loss of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309662


Title: Re: Misc. Respiratory
Post by: dennis100 on May 02, 2017, 11:27:51 PM
Model Number 103
Event Date 11/17/2014
Event Type Death
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the results of lead analysis.

Manufacturer Narrative
Describe event or problem, corrected data: the initial repot inadvertently did not report this information.

Manufacturer Narrative

Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner tubing. No obvious point of entrance was noted other than the end of the returned lead portion. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator performed according to functional specifications.

Event Description
The autopsy report was received from the medical examiner on (b)(6) 2015 and indicated the following: the deceased died of combined nortriptyline and verapamil intoxication. Hypertensive cardiovascular disease contributed to death. Per the report, ¿enlarged hearts are pathologic, prone to electrical instability and sudden cardiac arrest, and less tolerant of the combined toxicity of nortriptyline and verapamil. ¿ the manner of death was suicide. The deceased was pronounced dead at the scene after being found unresponsive by friends, sitting in the living room. No attempt at resuscitation was made. Based on the available information about the patient¿s death, an internal classification has determined that the death is unlikely sudep.

Event Description
It was reported that the vns patient passed away. It was reported that the autopsy was pending. The cause of death is unknown. The relationship of the death to vns is unknown. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The physician provided the patient death follow-up form. The patient¿s concurrent illnesses were copd, depression, headaches, hypertension, overweight. The patient achieved seizure reduction with vns therapy. The physician reported that the believed cause of death was unknown, but the cause of death was not believed to be related to vns therapy. It was also indicated that the patient tested positive for cocaine by pain clinic.

Event Description
The available death information has been reviewed by the device manufacturer and with the available information has been determined to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330172


Title: Re: Misc. Respiratory
Post by: dennis100 on May 03, 2017, 01:31:57 AM
Model Number 105
Event Date 12/01/2014
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data; corrected data: inadvertently did not include the udi on the initial report.

Event Description
It was reported on (b)(6) 2014 that the patient is continuing to have dyspnea and dysphagia and that there has been no apparent change in his symptoms.

Event Description
On (b)(6) 2014 it was reported that the patient had a seizures on (b)(6) 2014 she had a seizure while driving which resulted in a loss of consciousness and crashing her car. The patient was seen on (b)(6) 2014 by the physician who interrogated her device and during system diagnostics saw the following low output message, output current=low/current delivered=2. 25ma. However, the patient was programmed to 2. 5ma. The patient has not had a grand mal event in well over 3 years. The nurse practitioner was concerned that something may be misfiring or the vns was damaged in the car accident as a result of the seatbelt. The nurse practitioner reported that diagnostics taken on (b)(6) 2014 showed an impedance of 3169ohms and a low output status with 2. 5ma being the current intended to be delivered and 2. 25ma being the actual current delivered to the patient. They decided to lower the output current to 2. 25ma and raised the pulse width to 750usec. System diagnostics test then came back in range with an ¿ok¿ output delivered and impedance of 3139ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340411


Title: Re: Misc. Respiratory
Post by: dennis100 on May 05, 2017, 03:28:39 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 02/11/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported the patient was seen by the nurse and noted she wanted the device removed and that she has not been able to breath for a year. The vns diagnostic results were within normal limits at 2009 ohms. The patient presented to the office again a few days later and the device was programmed off. There were no known plans made at that time to have the device explanted. It was reported the clinic notes showed that the patient had been complaining of shortness of breath for a while; however, an exact date was not obtained. It was noticed that the patient's pulse width was set to 500 usec. It was later reported the patient had passed away due to sudep. The relationship between the patient's shortness of breath and death with vns is currently unknown. The device history record for bot the lead and the generator were reviewed. It was found that both devices had passed all required testing prior to distribution. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6533120


Title: Re: Misc. Respiratory
Post by: dennis100 on May 05, 2017, 03:30:07 AM
Model Number 103
Event Date 01/06/2013
Event Type Death
Event Description
Additional information was received from the hospital where the patient passed away. The patient was brought to the er by ems with respiratory arrest. He was then admitted to the picu where he was noted to have evidence of respiratory syncytial virus (rsv). He remained on ventilator support throughout his hospital stay. Following confirmation of brain death, his family agreed to withdraw support and the patient was extubated and died on (b)(6) 2013. An internal sudep evaluation was performed where it was determined that the death is unlikely sudep as the cause of death is a viral respiratory infection.

Event Description
It was reported that the vns patient passed away. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3884859


Title: Re: Misc. Respiratory
Post by: dennis100 on May 06, 2017, 10:27:29 AM
Model Number 304-20
Event Date 05/11/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted lead. During product analysis a break was identified in the positive and the negative coil. 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 the fracture mechanism cannot be determined. Scanning electron microscopy images of the negative coil show that a stress-induced fracture (due to rotational forces) has occurred on the coil. Also, the negative coil shows what appears to be mechanical distortion (smoothed surfaces) in the vicinity of the broken end. The outer silicone tubing has a superficial opening at approximately 6. 3 cm from boot. The outer silicone tubing is abraded open at approximately 24. 6 cm from boot. Another abraded opening was identified at approximately 0. 4 cm past the electrode bifurcation. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. Also, lead assembly has what appears to be moisture inside the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. 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 mentioned discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead and the observed abraded opening of inner tubing near electrode bifurcation area and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
On (b)(6) 2012 clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2012 revealed that the patient has high impedance. The patient was experiencing an increase in seizures, anywhere from 2-4 seizures a day. The patient was scheduled for emu admission in february but didn't show. The patient did not think that her vns was working and upon interrogation it showed high impedance. The patient was previously programmed to output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2011 but was disabled on (b)(6) 2012 due to the high impedance. The system diagnostics test performed on (b)(6) 2012 showed results of output=low/current delivered=0. 25ma/lead impedance=high/impedance value=9473ohms/ifi=no. The clinic notes also state that the patient has chronic obstructive pulmonary disease. The patient was referred to a surgeon due to the high impedance and her keppra medication was increased. The physician further stated that due to the patient's recurrent daily seizures, they will get monitoring, however it may have been worsened by her vns not working. The physician later reported that there was no recollection of trauma to the area that could have caused or contributed to the high impedance. Seizures have increased above pre-vns levels which the physician attributes to the high impedance. X-rays were taken but the physician stated they will not be sent to the manufacturer for review. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date reported on initial report.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(6) 2012, when the explanted generator and lead were returned for product analysis. Product analysis on the generator was completed on (b)(6) 2012. 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. Review of the programming history from the generator (decoder spreadsheet) revealed that the impedance value went from 7534ohms to 9474 ohms on (b)(6) 2012; both of which are high impedance values. Product analysis on the lead is still underway and has not yet been completed.

Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the patient underwent full revision surgery that day. The lead was replaced due to high impedance and the generator was replaced for prophylactic reasons. Attempts have been made for the return of the explanted products but they have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2635868


Title: Re: Misc. Respiratory
Post by: dennis100 on May 07, 2017, 01:49:47 AM
Model Number 102
Event Date 09/16/2013
Event Type Malfunction
Event Description
It was reported that the patient experienced low oxygen saturations following generator replacement last year. The device was programmed on; however, was immediately programmed off due to dysphagia. The patient's sister does not want the vns programmed on because the patient is not experiencing any increase in seizures without vns therapy. The neurologist's nurse indicated that there was no record of the low oxygen saturations following vns implant.

Manufacturer Narrative

Event Description
The patient's implant information has been received and has been included in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3878550


Title: Re: Misc. Respiratory
Post by: dennis100 on May 07, 2017, 01:50:37 AM
Model Number 102
Event Date 06/02/2009
Event Type Death
Event Description
A death certificate was received which reported the cause of death as the following: 1) respiratory arrest, 2) epilepsy. The patient passed away at his residence.

Event Description
It was reported that the vns patient passed away on (b)(6) 2009. The hospital does not release patient information; therefore, no additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3877195


Title: Re: Misc. Respiratory
Post by: dennis100 on May 07, 2017, 08:07:37 AM
Model Number 102
Event Date 08/17/2014
Event Type Death
Event Description
It was reported that the vns patient passed away. The exact date of death is unknown but it was reported that the patient had passed away a few weeks ago. The cause of death and relationship of the death to vns is unknown. It was reported that the device had been discarded and would be returned to manufacturer for analysis. The explanted devices have not been received to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The generator and lead were received for analysis. Analysis of the generator was completed on (b)(4) 2014. 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. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis, with the exception of the spot-weld / slugs still attached to the end of each quadfilar coil; therefore, a complete evaluation could not be performed on the entire lead product. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. The abraded opening and slice marks 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 inside the outer silicone tubing. The slice marks found on the inner silicone tubes 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 inner silicone tubes. 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.

Event Description
It was reported that the patient was seizure free with vns therapy. The death was witness. The circumstance of death was noted to be that in the post ictal state the patient developed respiratory and then cardiac arrest likely caused by pulmonary hypertension. The generator and lead were explanted. It was reported that the cause of death was not related to vns therapy. It was reported that the explanted devices have been returned for analysis, but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4090041


Title: Re: Misc. Respiratory
Post by: dennis100 on May 07, 2017, 08:09:07 AM
Model Number 102
Event Date 08/04/2012
Event Type Death
Event Description
It was reported that the vns patient passed away. A search online found the obituary which stated the patient passed on (b)(6) 2012 after a life long illness. No further information has been received to date.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this information.

Event Description
The physician reported that the believed cause of death was chronic respiratory failure. The cause of death was not believed to have relationship to vns. The device was not explanted after death. An autopsy was not performed. The death was witnessed, but the details are unknown. The patient had a history of chronic respiratory insufficiency.

Event Description
The national death index database was reviewed, and the cause of death was identified to be unspecified encephalopathy and unspecified respiratory failure.

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=4111684


Title: Re: Misc. Respiratory
Post by: dennis100 on May 08, 2017, 11:28:41 AM
Model Number 102
Event Date 06/16/2014
Event Type Injury
Event Description
It was reported that the patient was hospitalized for five days on (b)(6) 2014 for rapid ventricular rate, atrial fibrillation and flutter. On (b)(6) 2014 the patient was admitted to the hospital for chest pain. The patient underwent transesophageal echocardiogram on (b)(6) 2014 and no clots were observed. The patient received cardioversion on (b)(6) 2014 and the heart rate returned to normal. The patient indicated that his inr was high and he had undergone pulmonary and gi testing. The patient's inr dropped below 2 and the patient underwent cardiac catheterization. The patient was released from the hospital on (b)(6) 2014. The relationship of the cardiac events to vns are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
The patient's cardiologist reported that the patient has a history of mitral valve regurgitation with replacement and cardiomyopathy. There were no medication changes or other factors that could have caused or contributed to the arrhythmia. The patient also has a history of first degree av block and sinus bradycardia. The patient the patient experienced atrial flutter with a heart rate of 122 bpm. The patient experienced dyspnea and palpitations during the atrial flutter. The patient underwent tfe with cardioversion. The atrial flutter did not recur. The patient's neurologist indicated that there is no relationship between the atrial flutter and vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166277


Title: Re: Misc. Respiratory
Post by: dennis100 on May 08, 2017, 11:29:39 AM
Model Number 103
Event Date 09/16/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient is showing possible adverse affects as a result of vns. It was reported that the patient has been noted to be holding her breath which appears to coincide with device stimulation. As the patient is disabled it is difficult to identify why they are holding their breath through any technique. It was also noted that the patient has experienced bradycardia. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166418


Title: Re: Misc. Respiratory
Post by: dennis100 on May 09, 2017, 01:23:40 AM
Model Number 101
Event Date 11/11/2008
Event Type Death
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. The physician did not have any additional relevant information. The cause and date of death are unknown. The relationship of the cause of death to vns is unknown. No additional relevant information has been received to date.

Manufacturer Narrative
Corrected data: this information was inadvertently left off of follow-up mfr. Report #01.

Event Description
Hospital records were received indicating that the patient's primary diagnosis was status epilepticus. The secondary diagnoses were listed as disseminated intravascular coagulation, cardiopulmonary arrest, seizure disorder, hydrocephalus, respiratory failure, mental retardation, and cerebral palsy. The patient's past medical history was listed as seizure disorder, hydrocephalus with vp shunt, (b)(6) status post decompression and mrcp. It was noted that the patient was found during sleep to have seizure activity and diastat was given with no improvement. The patient was brought to the emergency room with fever, increased heart rate to 200 and low blood pressure (74/42). Labs were taken and the patient had an increased pt, ptt and inr. Blood gases showed the patient was acidotic and having worsening respiratory distress including metabolic and respiratory acidosis so the patient was intubated. The patient became hypotensive and bleeding from the mouth. The patient developed large hematomas at multiple sites where blood was drawn. The patient received fresh frozen plasma and was placed on ventilator support. Metabolic acidosis continued and the patient was given sodium bicarb. The patient's heart rate dropped and the patient became pulseless. Cpr was initiated along with defibrillation. The patient's family requested withdrawal of support.

Event Description
The patient's online obituary indicated that the patient passed away at the hospital. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164211


Title: Re: Misc. Respiratory
Post by: dennis100 on May 10, 2017, 01:33:51 AM
Model Number 102
Event Date 04/20/2014
Event Type Death
Event Description
The death certificate noted that the patient died while hospitalized. The manner of death was listed as natural. The cause of death was listed to be acute on chronic respiratory failure/bilateral pneumonia, likely aspiration/seizures, acute exacerbation of copd. No autopsy was performed.

Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death is believed to be respiratory failure. The relationship between the death and vns is unknown. The patient¿s device is believed to have been buried with the patient. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
The patient's physician indicated that the patient's death was not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262086


Title: Re: Misc. Respiratory
Post by: dennis100 on May 10, 2017, 01:34:43 AM
Model


Title: Re: Misc. Respiratory
Post by: dennis100 on May 10, 2017, 01:35:50 AM
Model Number 102
Event Date 06/26/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns is unknown. No further information relevant to the patient¿s death has been received to date.

Manufacturer Narrative
Supplemental report #1 indicated a sudep evaluation was performed however this is a depression patient and sudep is for epilepsy patients. The information has been corrected on this report.

Event Description
Additional information received from the coroner revealed that the patient was under hospice care for copd condition that ultimately resulted in the patient¿s death. There was no autopsy performed and the manner of death was natural. An internal sudep evaluation performed revealed that the death was unlikely sudep.

Event Description
No sudep evaluation should have been performed as this death involves a depression patient and sudep is for epilepsy patients.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4213376


Title: Re: Misc. Respiratory
Post by: dennis100 on May 10, 2017, 01:36:38 AM
Model Number 102
Event Date 09/01/2014
Event Type Malfunction
Event Description
It was reported that the patient's vns device has not been checked to date.

Manufacturer Narrative

Event Description
It was reported that the patient did well with vns therapy, but it ¿may not be working as well. ¿ good faith attempts for additional, relevant information have been unsuccessful to date. The patient previously reported in (b)(6) 2014 that he was no longer sure if his device was still working. Upon follow-up, the patient reported that he was no longer experiencing asthma-like symptoms during physical activity. The patient reported that he was not certain whether the device was ¿active¿ or reached end of service because he could never feel stimulation during normal activity which was considered normal for the patient. The patient had not followed-up with a physician for some time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4192843


Title: Re: Misc. Respiratory
Post by: dennis100 on May 10, 2017, 01:37:23 AM
Model Number 103
Event Date 08/04/2014
Event Type Death
Event Description
Additional information was received when the physician reported that the patient¿s cause of death was chronic obstructive pulmonary disease (copd). The patient¿s concurrent illnesses at the time of death were noted to be emphysema, copd, asthma, depression, and anxiety. The physician does not believe that the patient¿s death was related to the vns. The patient was noted to be at end stage lung disease and was on oxygen.

Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. An online obituary identified that the patient passed away at home. The cause of death and relationship of the death to vns are unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245861


Title: Re: Misc. Respiratory
Post by: dennis100 on May 11, 2017, 01:03:31 AM
Model Number 101
Event Date 08/05/2007
Event Type Injury
Event Description
Initial reporter indicated that their daughter had been admitted to hosp for treatment of pneumonia and respiratory problems. They reported that they felt their pt's vns generator "had a dead battery. " they felt that was what caused the decline in their pt's condition and need to be hospitalized. The pt had their vns generator replaced. The generator was returned to the mfr and met product specifications during analysis. Analysis indicated that the device had reached normal end of battery life. Good faith attempts are being made for add'l info about the reported events and their relationship to the pt's vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=997216


Title: Re: Misc. Respiratory
Post by: dennis100 on May 13, 2017, 03:33:45 AM
Event Date 01/01/2008
Event Type Injury
Event Description
Review an article written in reference to the vns therapy system revealed the following excerpt "a review of available literature suggests that the cardiac or respiratory problems that theoretically may be a concern with vagus nerve stimulation are rarely of clinical significance. " the excerpt was taken from an article titled "cardiorespiratory variables and sensation during stimulation of the left vagus nerve in patients with epilepsy". Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1176174


Title: Re: Misc. Respiratory
Post by: dennis100 on May 14, 2017, 01:03:46 AM
Model Number 104
Event Date 06/06/2008
Event Type Death
Event Description
During an investigation for increase in seizure activity (reported in medwatch # 1644487-2008-01545), the physician reported to manufacturer that the vns pt had passed away. The physician did not attribute the increase in seizure activity to vns; rather the seizures were related to the patients' pulmonary disease progression. The physician does not believe that an autopsy was performed and the vns device was not removed following the event. The pt had progressive pulmonary disease. No specific cause of death was reported. No diagnostic tests were available to confirm proper device function. The physician's assessment on the relationship of the pt death to vns is not known. Attempts to obtain additional info are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1146144


Title: Re: Misc. Respiratory
Post by: dennis100 on May 14, 2017, 01:04:17 AM
Model Number 302-20
Event Date 03/12/2008
Event Type Injury
Event Description
Reporter indicated a pt had developed left vocal cord paresis that was diagnosed by an ent physician. The pt's vns system was previously explanted for pt lack of efficacy. Reporter indicated the cause of the left vocal cord paresis was unk, but that the pt was experiencing dysphagia, dyspnea, and voice alteration prior to vns explant surgery. The reporter stated the pt has had vocal cord injection and speech therapy interventions for the left vocal cord paresis. The pt continues to have difficulty with hyperfunction of larynx and poor voice. The explanted devices were returned for product analysis. The lead and generator performed per specifications and no anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155248


Title: Re: Misc. Respiratory
Post by: dennis100 on May 14, 2017, 10:46:46 PM
Event Date 07/23/2008
Event Type Injury
Event Description
Vagus nerve stimulator implanted: 2006, turned on: the following month, explanted the following month: coil/electrodes not removed. Er visit: infection at incision site on my neck: a month after the original month. I told the nurse practitioner that something felt wrong with the lead in my neck. It felt like something had moved, it just didn't fell right. The first time i told her was in five months later, i believe. Er visit: nerve stimulator malfunction: the following month, no one there knew what to do, taped my magnet on and went home. Had x-ray, that was sent to cyberonics i had it turned off for at least a month. I was so afraid of turning it back on. Once i had it turned back on, i started having migraines almost everyday. I put up with it for several more months, then i asked for it to be turned off, and i asked about getting it removed. I believe it was turned off in 2007. After it was turned off, i started getting severe cramps in my neck. I had an appointment with dr at medical center in 2008 to discuss removal of my vagus nerve stimulator. He said the surgery was too dangerous, there could be scar tissue entangled around the carotid artery and or jugular vein. Surgery could result in a stroke or even death. He also said surgeons do not like to remove items implanted by other surgeons, because he doesn't know how it was put in. He suggested i do some stretching exercises. He said a muscle relaxer might help, but would not be good for my bi-polar. He said if it were him, he would leave it in until i couldn't bear the pain any longer. He also said, he thought there may be something else going on, the leads may not be causing the spasms. I told him that if i were not able to stretch my neck and get the cramping to stop, i would have to go to the er. I am afraid of that happening more, so now after what he has said about the surgery. I had to go to the er after an adjustment caused severe electrical shocks. The doctor in the er didn't have a clue what to do, and had never heard of the vns. They told me to go to the doctor that implanted it. That doctor is in missouri! the cramps/spasms are becoming more frequent. What happens if i do have to go to the er, are they going to have a doctor-neurosurgeon- there to do emergency surgery! my asthma is worse. I have to use inhaler every night. As soon as i lay down, i start to wheeze and cough. I wake up coughing and have to use the inhaler again. I don't need the inhaler during the day? - my abdomen has sharp pains when i turn over during the night. -the abdomen pain comes and goes - happened during the day only a couple of times - i am having terrible sneezing attacks that last 12-15 hours per day. But, if i sit completely still, i will not sneeze. These attacks are about every other week, or more. They completely wear me out! i have not felt well for a couple of months, fatigue, nausea and lots of bouts of diarrhea. I have pain - comes and goes - in both my breasts, like electrical shocks from the top all the way to my nipples. They are sore to touch, comes and goes. May be: the vagus nerve stimulator has aggravated my vagus nerve - and who knows what else - and is causing some of the problems i listed above. I called the surgeon in missouri - i live in nc now - and the nurse told me the doctor said the leads should not be removed. She said the doctor said surgery would cause more scar tissue. I was never told that the complete device couldn't be removed. Had to remove device approx four months later. Dates of use: 2006 -- 2007. Diagnosis or reason for use: depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1100549


Title: Re: Misc. Respiratory
Post by: dennis100 on May 15, 2017, 12:49:03 AM
Model Number 106
Event Date 09/28/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient underwent prophylactic generator replacement surgery. Diagnostic testing at the surgery showed that the generator was functioning properly. It was then programmed on following the surgery. A week later, the patient was experiencing an increase in seizures after missing doses of antiepileptic drugs for several days. She presented to the hospital in a status epilepticus state with symptoms that suggested the patient was suffering from meningitis and/or sepsis. Lab results showed the patient had elevated levels of white blood cells which led to concerns of a possible infection. The generator incision site was evaluated and it was noted that there were no sign of an active infection as the wound was dry and healing well. There was no erythema or purulence observed around the generator. The neurosurgery department did not suspect that the symptoms of sepsis were related to the recent generator replacement surgery. However due to the timing of events, the surgery was not ruled out as a possible contributing factor at the time. Manufacturing records showed that the generator was sterilized prior to distribution. The patient was then admitted to the intensive care unit where she was intubated, an eg tube was placed and a picc line was placed to deliver a course of antibiotics. While admitted the antibiotics were continued for 7 days and the antiepileptic drugs were titrated. During her admittance, she reportedly suffered from intermittent tachycardia. She also suffered from acute hypoxemic respiratory failure which was believed to be associated with her seizures and the sedation from the antiepileptic drugs. The patient also experienced hematuria which was caused by the placement of a foley catheter. After a few days in the icu, the patient was extubated. A couple of days later, an ultrasound found a small amount of fluid around the generator which appeared to be a seroma. After a week of being admitted the hospital, it was decided that the patient's clinical presentation was more consistent with status epilepticus than an infection. Therefore, the picc line was removed and antibiotics were discontinued. The patient was discharged the following day where she was noted to be medically stable and her white blood cell had returned to normal. She was instructed to continue her antiepileptic drugs and to monitor her heart rate and the fluid collection at the generator site. No additional relevant information has been received to date.

Event Description
It was reported that two days prior to presenting to the hospital in a status epilepticus state the patient had 2 grand mal seizures. Then 24 hours later she had another 2 grand male seizures. The following day she went into a status epilepticus state. Her caregiver attempted to give her a dose of midazolam however it did not stop the seizures. The patient then missed doses antiepileptic medication due to the frequency of the seizures. At a follow-up appointment since being released from the hospital it was noted that the patient was mentally and physically stable. The physician did not know the cause of the status epilepticus event however it was noted that the patient had missed a dose of antiepileptic medication. During the visit it was noted that the vns was functioning.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6064124


Title: Re: Misc. Respiratory
Post by: dennis100 on May 17, 2017, 11:24:14 PM
Event Date 10/01/2003
Event Type  Injury   
Manufacturer Narrative 
Article reference: holmes md, chang m, kapur v. Sleep apnea and excessive daytime somnolence induced by vagal nerve stimulation. Neurology 2003:61:1126-9.
 
Event Description 
The reporter indicated in a scientific article that a vns patient developed excessive daytime sleepiness after vns placement. The reporter attributed this event to the apneas, hypopneas, tachypneas and arousals associated with vns stimulation during sleep. The reporter stated that the episodes occurred exclusively during the 30-second stimulation and that the patient refused to have her device disabled during sleep. At the patient's request, vns therapy was discontinued after polysomnography, resulting in a complete resolution of daytime sleepiness.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1246325


Title: Re: Misc. Respiratory
Post by: dennis100 on May 18, 2017, 12:57:47 AM
Event Date 01/01/2003
Event Type  Injury   
Event Description 
The reporter indicated in a scientific article that a vns patient demonstrated very marked increases in respiratory frequency during vns stimulation with a simultaneous, consistent decrease in carbon dioxide in the blood or hypocapnia. The reporter also indicated that vns had no detectable effects on heart rate during the study.
 
Manufacturer Narrative 
Article reference: holmes md, miller jw, voipio j, kaila k, vanhatalo s. Vagal nerve stimulation induces intermitted hypocapnia. Epilepsia 2003;44:1588-91.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1246330


Title: Re: Misc. Respiratory
Post by: dennis100 on May 20, 2017, 08:13:03 AM
Model Number 102
Event Date 11/12/2008
Event Type  Malfunction   
Event Description 
It was reported that a vns patient experienced some breakthrough seizures while he was hospitalized with rsv. Diagnostics show vns to be functioning properly. Good faith attempts to obtain additional information about the seizures have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1350684


Title: Re: Misc. Respiratory
Post by: dennis100 on May 20, 2017, 08:14:00 AM
Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description 
It was reported that a vns pt's device had been disabled due to lack of efficacy and that the event was believed to be due to the pt's progressive dementia. The pt's clinic notes were received, which described events of worsening depression, increased anxiety, suicidal ideations and events of dyspnea, two of which led to emergency room admission, while receiving vns therapy. The clinic notes indicate that the pt's pre-vns medical history was significant for each of these events, though their relationship to the pre-vns baseline is unk. Diagnostics performed on the pt's device prior to device disablement indicated proper device function. The clinic notes also state that many of these events were proceeded by and related to medication changes and adjustments. The pt's treating vns therapy physician does indicate in these notes that "my impression is pt is slightly better than at start of study, moderately ill. " good faith attempts for additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1321655


Title: Re: Misc. Respiratory
Post by: dennis100 on May 20, 2017, 08:15:50 AM
Event Date 10/01/2000
Event Type  Death   
Event Description 
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric patient was received at mfr for review. The article was astudy on a pt found deceased in bed in 2000. Their vagus nerve stimulator was programmed on at the time of death. Autopsy showed the patient died from asphyxiation. Patient identifying information is unknown. Good faith attempts are being made for additional details surrounding the reported event. Reference mdr number: 1644487-2008-02704 for the reported nerve issue.
 
Manufacturer Narrative 
Article: histological appearance of a chronically stimulated vagus nerve in a pediatric patient. Pediatr neurosurg 2001, 35:99-102, may 29th, 2001, r shane tubbs. Et al.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1225135


Title: Re: Misc. Respiratory
Post by: dennis100 on May 23, 2017, 01:35:07 AM
Model Number 102
Event Date 12/01/2007
Event Type  Injury   
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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030178


Title: Re: Misc. Respiratory
Post by: dennis100 on May 23, 2017, 01:37:06 AM
Event Date 12/01/2008
Event Type  Injury   
Event Description 
It was reported that explant surgeries were performed on patients due to the following reasons - persistent breathing, coughing, throat discomfort associated with lack of efficacy and parental request.
 
Manufacturer Narrative 
Pearl pl, conry ja, yaun a, taylor jl, heffron am, sigman m, tsuchida tn, elling nj, bruce da gaillard wd. Misidentification of vagus nerve stimulator for intravenous access and other major adverse events. Pediatr neurol 2008;38:248-251.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034246


Title: Re: Misc. Respiratory
Post by: dennis100 on May 25, 2017, 01:17:37 AM
Event Date 06/13/2006
Event Type  Injury   
Manufacturer Narrative 
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizures 2006 pp 1-13. (see scanned pages).
 
Event Description 
It was reported in an article following pediatric pts that were implanted with vns that a pt with focal left-parieto-occipital epilepsy experienced prolonged episodes of seizures and peri-ictal apneas following the vns implantation. The pt's seizures frequency also increased. The pt's device was turned off because of lack of clinical benefit 1 year after implantation. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1303649


Title: Re: Misc. Respiratory
Post by: dennis100 on June 03, 2017, 05:42:35 AM
Model Number 103
Event Date 08/01/2009
Event Type  Injury   
Event Description 
It was reported that a patient's generator was programmed off, due to a rapid heartbeat and difficulty breathing. No programming or device diagnostic history is available in the i-house database. Good faith attempts to obtain this information as well as additional information on the patient's reported events have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1484730


Title: Re: Misc. Respiratory
Post by: dennis100 on June 05, 2017, 08:20:19 AM
Event Date 06/08/2009
Event Type  Injury   
Manufacturer Narrative 
Article citation: bhatt, y. M. , and hans belloso. "airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists. " the journal of laryngology & otology 3rd ser. 1 (2009): 1-3. Print.
 
Event Description 
It was reported in a scientific article that a vns pt presented via the emergency department following a series of six to eight seizures over 24 hours. The pt remained in an uncharacteristically protracted post-ictal state, and developed intermittent stridor associated with respiration embarrassment and hypoxia. Intercurrent vomiting episodes, coupled with widespread pulmonary crepitations, led to a provisional diagnosis of aspiration with laryngospasms. Treatment with continuous positive airway pressure ventilation, intravenous steroids and nebulised bronchodilators improved oxygen saturation, and normal consciousness returned. The stridor continues and was noted to be intermittent and not associated with desaturations. The pt was also noted to be aspirating on feeding. Furthermore, flexible laryngoscopy at rest revealed both vocal cords to be lying in a paramedian position during quiet respiration. During stridulous episodes, the glottis was noted to narrow further, with adduction of the left vocal and vestibular fold. It was suspected that vagus nerve stimulation was contributing to laryngeal dysfunction so the device was programmed off. Subsequent flexible laryngoscopy revealed a fully mobile left vocal fold but persistent right vocal fold palsy. At the moment, it is known that the vagus nerve stimulator remains programmed off and alternative medical therapy was initiated for seizure control. However, 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=1520362


Title: Re: Misc. Respiratory
Post by: dennis100 on June 09, 2017, 01:08:51 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 05/05/2017
Event Type Injury
Manufacturer Narrative

Event Description
A patient reported that vns gave her vocal cord dysfunction. She stated it mimics asthma or choking. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600076


Title: Re: Misc. Respiratory
Post by: dennis100 on June 09, 2017, 02:42:32 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 04/10/2017
Event Type Injury
Event Description
The patient underwent a prophylactic full revision surgery. It was later reported that the patient's lung collapsed during surgery, requiring the patient to be hospitalized for 5 days following the completion of the surgery. The lung collapsed while the surgeon was removing the patient's old lead. The surgeon later reported that the patient's event was caused by barotrauma from the ventilator that was used during the surgery. There was no sign of a pleura or lung problem aside from the bilateral pneumothoraces identified during surgery. The patient reportedly had not had a prior lung surgery and was not known to have a preexisting lung condition. The surgeon noted that when he spoke with other medical professionals, they determined that the cause was not due to the vns placement itself, but damage from the laryngeal mask airway ventilation, as it appears the patient's ventilation pressures were adjusted several times during surgery. The surgeon had seen the patient and his mom informally since the surgery and subsequent hospitalization, and the patient was reportedly doing well. The mother had not reported any additional issues to the surgeon since. Both the explanted lead and generator were returned to the manufacturer for analysis. Analysis for the generator was approved. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead has not been approved to date. No additional relevant information has been provided to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6578818


Title: Re: Misc. Respiratory
Post by: dennis100 on June 09, 2017, 01:46:12 PM
Model Number 10X
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
An article was reviewed and found to contain information regarding one patient who was implanted with vns for treatment of medically refractory focal dyscognitive seizures, with generalized convulsions. The patient had reported witnessed snoring with rare witnessed apneas. The patient underwent testing for the assessment of possible vns-associated sleep-disordered breathing. During the vns activation, snoring was dramatically reduced during non-rapid eye movement (nrem) sleep, but not during rem sleep. During nrem, snoring artifact was observed on the snore microphone and nasal pressure transducer airflow channel. With vns activation, airflow was reduced and snoring was almost abolished. With non-activation of the vns, the snoring returned and airflow improved. Attempts for additional relevant information have been unsuccessful to date. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6562946


Title: Re: Misc. Respiratory
Post by: dennis100 on June 10, 2017, 01:52:28 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.
 
Event Description
Clinic notes were received on 04/01/2016 from the surgeon's office. The physician stated that the patient has a broken lead, which needs to be replaced during surgery. The patient had vns initially implanted in the 1990's, and vns stopped his seizures. However, he had it deactivated because it took his breath away and made him feel like he could not breathe. The patient is wanting to use vns again. The notes also mention that the device was recently tested, and it was not working. The patient uses an inhaler for breathing issues, which supports that the patient has breathing issues without vns stimulation as well and were not related to the high impedance. Attempts for further information were unsuccessful to date. No surgical intervention has occurred to date.
 
Event Description
It was reported that patient underwent lead and generator replacement surgery. The explanted lead and generator were discarded following the surgery. Therefore, product analysis cannot be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5512641


Title: Re: Misc. Respiratory
Post by: dennis100 on June 10, 2017, 01:53:40 AM
Model Number 106
Device Problem Energy output to patient tissue incorrect
Event Date 04/11/2017
Event Type Malfunction
Event Description
It was originally reported by the physician's office that they had performed a vns adjustment and received the message "programmed current not being delivered". The nurse stated diagnostics were not performed, but she did note that no high impedance message was observed. It was later reported the patient began to experience tachypnea and labored breathing after the office visit. It was first occurring every 5 minutes and then it was occurring every 20 minutes, so they were unable to tell if is was occurring with vns stimulation. The device history record for the lead and the generator were reviewed and it was found both devices had passed all testing prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6553128


Title: Re: Misc. Respiratory
Post by: dennis100 on June 10, 2017, 01:54:40 AM
Model Number 302-20
Device Problem Fracture
Event Date 02/01/2017
Event Type Malfunction
Event Description
It was reported that the patient had been feeling shocks that caused the patient to be unable to talk and barely breathe. The patient experienced such painful shocks that he had to be restrained at the emergency department. The written notes from the physician stated that he thought the "ground pulled off the nerve" without any clarification. The patient had full revision surgery due to the painful stimulation, and the physician later reported that there was an observed lead break during the surgery. However, diagnostics were within normal limits immediately prior to the surgery. The explanted product has not been received to date.

Manufacturer Narrative

Event Description
The generator was received into analysis. The lead was not received from the explanting hospital. The device performed according to functional specifications. Analysis 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=6551020


Title: Re: Misc. Respiratory
Post by: dennis100 on June 24, 2017, 02:12:42 AM
Model Number 302-20
Event Date 10/01/2009
Event Type Malfunction
Event Description
It was reported that the patient's device showed high impedance results on system diagnostics. The patient was not experiencing any adverse events, is currently seizure-free, and is not on any medication. No known trauma or manipulation occurred, but per reporter, the patient is very active. It was also noted that the patient had a severe respiratory illness at one point and required a tracheotomy which the physician feels may have damaged the lead. Site took x-rays (b)(6)2009 and reported visualizing a lead break on the x-rays. Patient's device was turned off (b)(6)2010 and revision surgery is likely, but has not occurred to date.

Manufacturer Narrative
Conclusions: 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=1724224


Title: Re: Misc. Respiratory
Post by: dennis100 on June 30, 2017, 07:57:58 AM
Model Number 102
Event Date 02/05/2010
Event Type Injury
Event Description
New info was received from the treating neurologist's office regarding the pt's vocal cord paralysis and stridor. The vocal cord paralysis is further discussed in mfr report number 1644487-2010-00594. The pt was initially evaluated for dental extractions under anesthesia at the end of 2009. She had severe wheezing and shortness of breath and was referred to a pulmonologist to clear her for anesthesia. She was then referred to an otolaryngologist for inspiratory stridor. The pt was evaluated in the ent office on (b)(6)2010 and underwent a fiberoptic direct nasal pharyngolaryngoscopy, which showed true left vocal cord paralysis. A tentative tracheostomy was scheduled after that appointment. The neurologist's office was made aware of the pt's issues and was seen on (b)(6)2010. The pt was unable to walk for 10-feet without severe dyspnea on exertion. She had to stop to catch her breath, she had audible inspiratory stridor, and her color was dusky. She was unable to complete a full sentence without stopping to catch her breath. Immediately after the vns was turned off, her breathing improved. The stridor was done, she was able to ambulate long distances without stopping and she had no further shortness of breath. Her color improved and her oxygen saturation was 97% (did not have one done with vns on). A follow up with her ent on (b)(6)2010 showed continued improvement. There was no stridor, her voice was clear, she was speaking in full sentences without getting winded, and her breathing was comfortable. A stroboscopic exam was [completed] which "was consistent with bilateral vocal cord motion with some restriction abduction of the left vocal cord. " there was no known history of vocal cord paralysis pre-vns insertion. The neurologist's office indicated that they feel that it is most likely that the cause of this problem. System diagnostics last noted by the physician's office were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833668


Title: Re: Misc. Respiratory
Post by: dennis100 on July 02, 2017, 08:53:28 AM
Model Number 102
Event Date 08/01/2010
Event Type Injury
Event Description
It was initially reported by the treating nurse practitioner that the pt was recently diagnosed with sleep apnea. The nurse believed that they were going to attempt to disable the device in the evenings during sleep to see if that would help resolve the issue as he was not having seizures at night, so the therapy was not needed at that time. The pt later reported that he believed the device was going to be disabled. He said that he was having difficulties breathing, had sinus issues, couldn't breathe through the nose, tightness in his chest and was not getting any sleep. He was said to have had a sleep study which did not provide any further info on the issues. He reported that when the magnet was taped to his chest, the issues resolved. The pt also reported the physician did not believe there was anything wrong with his heart. The pt claimed that since his lead and generator repositioning in 2008 (at the pt's request), he has lost seizure control since the seizures have returned to pre-vns baseline levels and the magnet activations have no longer become affective. The pt is requesting removal of the device. Programming history reviewed in manufacturer's programming history database indicating that the last known diagnostics performed were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889162


Title: Re: Misc. Respiratory
Post by: dennis100 on July 07, 2017, 11:26:45 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The physician reported that the patient had experienced respiratory arrest and had undergone cardiac massage. During this procedure, it is suspected that the generator had migrated and was no longer in the pocket. The patient has reported about not feeling the stimulation and increasing depression since the chest procedure. However, the physician clarified that the patient reports feeling stimulation every once in a while, but not as much as before. Based on good diagnostic test results, it was explained to the physician that the device is functioning as intended and that the patient could have become acclimatized to the sensation at the current settings. It was recommended that the output current could be increased to the next level. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6649701


Title: Re: Misc. Respiratory
Post by: dennis100 on July 08, 2017, 04:43:40 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 04/21/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing difficulty breathing which the patient attributed to her vns device. The patient felt that the vns stimulation was suffocating her. Chest x-rays were reviewed by the physician who did not observe any anomalies. The physician decided to refer the patient for a vns generator replacement due to the breathing difficulties and the length of the implant. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6607524



Title: Re: Misc. Respiratory
Post by: dennis100 on July 12, 2017, 03:36:44 AM
Model Number 300-20
Event Date 11/10/2010
Event Type  Injury   
Event Description
It was reported by a neurosurgeon that a vns pt whom she will be performing lead revision surgery, had left laryngeal palsy and swallowing difficulties. At the moment, good faith attempts to obtain add'l info have been unsuccessful to date. Furthermore, per the treating surgeon intervention will be taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1923717


Title: Re: Misc. Respiratory
Post by: dennis100 on July 13, 2017, 03:43:36 AM
Model Number 302-20
Event Date 10/29/2010
Event Type  Injury   
Event Description
It was reported by an epileptologist that a vns patient was still in the hospital with laryngeal paralysis. The patient had been implanted with vns on (b)(6) 2010 and at the moment was unknown if the patient had been programmed on with vns therapy. Good faith attempts to obtain additional information from the surgeon's office have been unsuccessful to date. Review of the manufacturer's in house programming history was done and concluded that the patient's parameters and diagnostics were not available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917762


Title: Re: Misc. Respiratory
Post by: dennis100 on July 13, 2017, 03:44:14 AM
Model Number 102
Event Date 09/23/2008
Event Type  Injury   
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.

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


Title: Re: Misc. Respiratory
Post by: dennis100 on July 14, 2017, 10:54:42 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that after a recent generator replacement surgery the patient now has a depressed cough reflex and an increased heart rate of about 30 bpm higher. The patient's device was checked according to the nurse and appears to be working properly. The patient's neurologist increased her settings in response to the issues. Also, after the replacement surgery the patient was hospitalized with pneumonia. No additional or relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The neurologist indicated the relationship of the depressed cough reflex to vns is unknown, and that she was unable to assess the patient's arrhythmia and pneumonia. It was noted that the patient's heart rate increased preoperatively and returned to a normal value postoperatively. Also, information was received from the patient's neurologist that the patient was hospitalized with fever, constipation, urinary retention, hypoxia, gastric paresis, and dyspnea. Follow up was performed with the neurologist regarding these events. The neurologist stated the cause of these events was unknown as the patient was hospitalized at a separate facility, and she was unable to assess the patient directly. The neurologist was informed the patient had recovered completely and was discharged from the hospital. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Describe event; corrected data; supplemental mdr #1 inadvertently omitted information that was known prior to submission.
 
Event Description
The pneumonia reported on supplemental report #1 occurred before the replacement surgery and it was also noted in this report that the patient's heart rate increased pre-operatively. Since these events occurred before the replacement surgery, they will be reported on report number 1644487-2018-00290.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7171999


Title: Re: Misc. Respiratory
Post by: dennis100 on July 16, 2017, 08:16:56 AM
Model Number 302-20
Event Date 01/21/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that she experienced problems swallowing and was out of breath due to the event. The pt described the event as if her throat was closed and would not open. The pt consulted with her treating surgeon and neurologist and they informed the pt there was no issue with the vns although it could be related to a throat spasm. The pt further indicated that the events occurred more than once and each time seemed to be worse as the last one lasted at least 30 seconds before the pt's throat opened, in accordance to the pt. At the moment, good faith attempts to obtain additional information from the pt's treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000330


Title: Re: Misc. Respiratory
Post by: dennis100 on July 25, 2017, 04:37:08 AM
Model Number 100
Event Date 12/27/1997
Event Type  Injury   
Event Description
During the investigation of a vns patient's reported event, it was noted that the patient had her leads removed in 1997. There was no reported reason for this removal at this time of the discovery. Follow-up revealed that the patient had been a part of an epilepsy study, which she exited in 1996. However, information from the patient's last known following physician indicated that the patient had in fact undergone a full explant in 1997 due to "chest pain and difficulty breathing. " no more information on the issues could be given by the site. A search of the manufacturer's programming history database showed last known diagnostics were performed on (b)(6) 1997. Results were within normal limits at this time. Furthermore, last known settings on this date show the device's being disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069297


Title: Re: Misc. Respiratory
Post by: dennis100 on July 25, 2017, 04:38:08 AM
Model Number 103
Event Date 03/08/2011
Event Type  Injury   
Event Description
It was reported via clinic notes received that although the vns patient's daytime seizures had improved, the patient was experiencing an increase in nocturnal seizures that is believed to be related to "problems with breathing. " the noted breathing issue is believed to be related to vns stimulation. Attempts for additional information from the neurologist's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2077820


Title: Re: Misc. Respiratory
Post by: dennis100 on July 30, 2017, 09:44:41 AM
Model Number 300-20
Event Date 04/01/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after her prophylactic generator replacement on (b)(6) 2011, she started experiencing dysphagia, dyspnea, voice alteration and decrease perception of stimulation. Pt was instructed by surgeon to disable the device by placing a magnet over the generator. The dysphagia and voice alteration became less intense but they were still present. Pt reported that she was having difficulty breathing immediately after surgery as well. The pt saw a neurologist and he reported that adverse events of dyspnea, dysphagia and voice alteration were present even after the device was disabled. However, the treating neurologist did not know why the pt had a decreased perception of stimulation even though she was at her previous settings. Pt's last known settings were 1. 0ma/250usec/30 seconds and magnet mode of 1. 25ma/500usec/60 seconds. The system diagnostics were within normal limit (ok/ok/ok/dcdc=1/eri=no). The pt decided to leave her device 'on' and was advised to see an ent specialist. The treating neurologist believed that voice alteration may be related to intubation at the time of surgery. Later, pt notified the manufacture that she was admitted to emergency room and the attending physician and neurosurgeon examined pt's airways and believed that she has partial paralysis of the vocal cord. The device was turned off at that time. Good faith attempts to obtain more info regarding pt's vocal cord paralysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082993


Title: Re: Misc. Respiratory
Post by: dennis100 on July 31, 2017, 07:58:01 AM
Model Number 102
Event Date 05/23/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing new, frequent or severe headaches. Per clinic notes, the pt's seizures are under control, but the vns device is at end of service. The pt is also having observed apneas and is somewhat sleepy during the day. The pt had generator replaced due to end of service on (b)(6) 2011. Attempts for further info and product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2153181


Title: Re: Misc. Respiratory
Post by: dennis100 on August 02, 2017, 12:42:47 AM
Event Date 06/01/2011
Event Type  Malfunction   
Event Description
It was reported by a nurse through a company rep that a recently implanted vns pt experienced hoarseness and became breathless. The event occurred after the pt was programmed on after surgery in the recovery area. Diagnostics were performed on the device and they were indicative of high lead impedance (10,000 ohms). The device was programmed off and the pt was referred for x-rays. X-rays were reviewed by the treating surgeon who indicated all was well with the lead and generator. Further info was received from the pt's caretaker who indicated that the pt remained hoarse and breathless. At the moment, good faith attempts to obtain add'l info have been unsuccessful to date.
 
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=2191857


Title: Re: Misc. Respiratory
Post by: dennis100 on August 02, 2017, 12:43:23 AM
Model Number 102
Event Date 03/24/2014
Event Type  Death   
Event Description
Follow-up revealed that the patient died at the hospital due to acute respiratory failure suspected to be secondary to aspiration. The patient was admitted to the hospital with respiratory difficulties thought to be secondary to aspiration with pneumonia. The patient had a do not resuscitate and therefore was given morphine and made comfortable. The patient passed away shortly after being removed from bipap.
 
Manufacturer Narrative

Event Description
It was reported that the patient passed away. It was reported that the cause of death was not related to vns therapy. It was reported that the patient's device has been at end of service for approximately two years. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3765234


Title: Re: Misc. Respiratory
Post by: dennis100 on August 02, 2017, 12:44:28 AM
Model Number 101
Event Date 08/10/2008
Event Type  Death   
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns pt passed away on (b)(6) 2008. No further info regarding the pt's death was provided at that time. The pt's physician passed away the week of (b)(6) 2011 and the physician's nurse quit; therefore, the manufacturer's consultant was only able to obtain the pt's clinic notes from their medical records and had no medical professional to f/u with. The pt's clinic notes were rec'd which revealed that the pt's last visit was on (b)(6) 2008. The pt's settings that date were output= 2. 75ma/frequency=20hz/ pulse width = 130usec/on time=60sec/ off time=1. 1min/magnet output=3ma/magnet on time=60sec/magnet pulse width=250usec. A system's diagnostic test performed that day showed output=ok/lead impedance=ok/dcdc=2/eri=no. The clinic notes reveal that the pt had a myocardial infarction as well as chronic obstructive pulmonary disease in the past and has a strong family history of heart disease. It is unk if these events are related to the pt's death or not. The pt's death certificate will be requested from the state the pt passed away in. When add'l info is rec'd, it will be reported.
 
Event Description
On (b)(6), 2011 the patient's death certificate was received. The death certificate stated that the cause of death was cardiorespiratory arrest and chronic obstructive pulmonary disease. Other significant conditions contributing to the death were listed as seizures/epilepsy. If further information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2194537


Title: Re: Misc. Respiratory
Post by: dennis100 on August 04, 2017, 03:43:21 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 11/22/2016
Event Type  Injury   
Event Description
It was reported that following the vns generator replacement, the patient appeared fine after the surgery. However, shortly after the surgery, the patient had labored and heaving breathing with excessive coughing spells. It was reported that the patient was experiencing a raspier voice than normal. The symptoms were reported as happening all of the time and not just with stimulation. The patient had stated that he did not have these symptoms with the previous generator. There were no concerns from the physician during or after the surgery and the patient has not reported any seizures. A surgeon who was not involved with the implantation stated that the patient vocal cord paralysis, but the implanting surgeon had disagreed. It appears that the prior to surgery the patient's vns normal mode stimulation was programmed off for an undetermined amount of time. The patient was programmed back to therapeutic levels post-op without titration. Follow up with the implanting surgeon revealed that the surgeon who stated that there was vocal cord paralysis performed his test in the month of implantation. The implanting surgeon stated that the other surgeon had no prior experience with vns placement and that no change of leads had been performed during the replacement surgery. The implanting surgeon performed the same test half a year later and the results showed that the patient had mild paresis of the left vocal fold.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727766


Title: Re: Misc. Respiratory
Post by: dennis100 on August 04, 2017, 03:43:58 AM
Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/25/2008
Event Type  Injury   
Event Description
Information was received that the patient did have re-implant surgery for vns therapy.
 
Event Description
It was reported that the patient had too much scar tissue in the past from vns. No additional or relevant information has been received to date.
 
Event Description
It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data. Supplemental mdr 31 inadvertently listed incorrect aware date, correct aware date is 03/23/2018.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189


Title: Re: Misc. Respiratory
Post by: dennis100 on August 04, 2017, 03:44:53 AM
Model Number 303-20
Device Problem No Known Device Problem
Event Date 06/28/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had vns implant surgery, and the patient had a hard time coming out of anesthesia and was unable to breathe on his own. The patient had prior respiratory issues as well. The patient's device was not programmed on during the surgery. It was reported that the patient saw his neurologist about a week later, and the physician stated that the patient had vocal cord paralysis from the implant surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6734531


Title: Re: Misc. Respiratory
Post by: dennis100 on August 04, 2017, 08:38:23 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 06/22/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that she had her vns disabled several years ago however following a recent altercation she developed a knot and swelling in her neck at the vns electrode site. She also began having severe headaches and dizziness along with episodes of passing out and trouble breathing. Because of the symptoms the patient was concerned that her vns lead was damaged during the altercation and causing these symptoms. A review of the internal programming history database found that the normal mode output current was disabled however the magnet mode was left programmed on. Its unclear if the magnet mode was later programmed off. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6728030


Title: Re: Misc. Respiratory
Post by: dennis100 on August 06, 2017, 01:41:14 AM
Model Number 102
Event Date 08/02/2004
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently listed the incorrect patient age.
 
Event Description
It was reported that during the patient's previous implant procedure she stopped breathing. At the time, no interventions were performed and no serious injury had occurred. The patient went home the same day. It was just mentioned to the mother that the patient had stopped breathing and then started again. The patient's current physician has ordered a full cardiac work-up prior to her generator replacement. Attempts for additional information have been unsuccessful to date.
 
Event Description
The explanted generator was returned on (b)(6) 2011 and product analysis has been completed. During product analysis, 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. Attempts for additional information have remained unsuccessful.
 
Event Description
The patient's generator was replaced on (b)(6) 2011. The product has not yet been returned to the manufacturer. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229161


Title: Re: Misc. Respiratory
Post by: dennis100 on August 07, 2017, 03:26:30 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: Misc. Respiratory
Post by: dennis100 on August 08, 2017, 02:19:09 AM
Model Number 102
Event Date 09/01/2009
Event Type  Injury   
Event Description
On (b)(6) 2011, an implanting hospital reported that the vns pt's device was disabled since (b)(6) 2009 due to dyspnea and the pt had their device explanted on (b)(6) 2011. The explanted product was returned to the mfr for product analysis which completed on (b)(6) 2011. In