VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on June 13, 2018, 05:22:39 AM



Title: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 05:22:39 AM
Model Number 103
Event Date 12/06/2010
Event Type Injury
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported to a cyberonics country manager in the (b)(4) that during titration of the vns device the patient experienced an arrhythmia. The patient's pulse rate decreased as well as the time between pulses. This occurred three times while the vns output current was set on 0. 50ma. The patient was therefore left at a lower output current of 0. 25ma. The patient did not present with any symptoms, traumatic events, or have any triggers suggesting an arrhythmia post operative. No medication changes were noted. The arrhythmia correlated with the on time of the programmed device settings and occurred following a setting change of 0. 25 ma to 0. 50 ma output current. Electrocardiography was used to diagnose the arrhythmia and the physician believes that the arrhythmia is related to vns therapy stimulation. The vns was set to a lower output current as an intervention to prevent the patient from continued arrhythmia. Attempts have been made for information; however, no more information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2008487


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:25:17 AM
Model Number 102
Event Type Malfunction
Manufacturer Narrative

Event Description
The physician reported that the patient had some arrhythmia at different moments in her past with vns. The physician could not say if this was related to bradycardia, or asystole, but did say the patient's heart rate would become erratic at times. The physician was unsure of the relationship of this event to vns therapy. Attempts have been made for additional information; however, no further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3524128


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:26:08 AM
Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after her prophylactic generator replacement surgery, she developed an allergic reaction to antibiotics prescribed by neurosurgeon as a precaution. The pt was hospitalized for 3 days ((b)(6) 2011). Also, while she was hospitalized, she was told that her ekg was abnormal which necessitated referral to cardiology, capture in mdr #1666487-2011-00976. Pt also reports hand tremor, cognitive issue and memory problems since the generator replacement. Good faith attempts to obtain more information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082998


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:27:18 AM
Model Number 103
Event Date 10/28/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the patient reported that she is having bradycardia episodes when her vns goes off. The patient stated that she has an appointment with her cardiologist that day. She states she has a pacemaker, but in the conversation she says that her heart rate goes down to 20 beats per minute and she starts to feel worse. According to the patient she experience dizziness, nausea and ringing in her ears when her heart rate gets so low.

Event Description
On (b)(6) 2011, a vns patient reported that she had a seizure on (b)(6) 2011 and fell on her face and broke her nose. She stated that her vns settings had been increased on (b)(6) 2011. While in the hospital having surgery on her nose, the patient was hooked up to the heart monitor. It was discovered that every five minutes when the vns device stimulated, the heart monitor would alarm and her heart would skip two beats. The patient reported that she is also experiencing some shortness of breath. The patient was scheduled to see her neurologist on (b)(6) 2011. The neurologist later reported that the patient's arrhythmia (heart skipping 2 beats) was first noticed on (b)(6) 2011 and was related to the vns stimulation. The neurologist decreased the patient's settings as the arrhythmia event appeared to have occurred after the programmed settings were increased and a holter monitor was used. The patient does not have a medical history of arrhythmia prior to this event. The neurologist reported that it is unknown if the arrhythmia event has recurred, they are in the process of evaluating this. Good faith attempts were made to the patient's implanting hospital for the lead product information but no further information has been received to date. On (b)(6) 2011, the vns patient reported that she is experiencing a slow heart rate as well as the heart rate skipping with stimulation. The patient reported that after the neurologist increased her settings on (b)(6) 2011, she also experienced coughing and painful stimulation. After 10-14 days the events stopped and the patient said she could tolerate settings. The patient stated that after her seizure on (b)(6) 2011, she had another one on (b)(6) 2011. She stated that she saw a physician on (b)(6) 2011 and was referred to an ear nose and throat surgeon on (b)(6) 2011 to operate and repair her nose. On (b)(6) 2011, she had the surgery and during pre-op, she was hooked up to the heart monitor which revealed a slow heart rate and that every five minutes , her heart skipped two beats. The ear nose and throat surgeon informed her to go back to the neurologist to have the settings decreased. The patient's settings were decreased but the patient's heart was still skipping and at half rate according to the holter monitor. The patient was referred to a cardiologist and stated she is going to have a pacemaker implanted. The patient also reported that prior to vns, she did not have any pre-existing heart conditions. The patient further divulged that she has been now diagnosed with a/v stage 2 heart disease and claimed that her heart is only beating 24 beats/minute. On (b)(6) 2011, the patient had a pacemaker implanted. Prior to surgery the patient's output was decreased to 1. 75ma and the patient's heart rate was in the 50's bpm, at 1. 5ma the patient's heart rate was in the 60 bpm (so within normal limits), then at 2. 25ma, the patient's heart rate was in the 40's bpm, and lastly at 2. 5ma, the patient's heart rate showed 40 bpm. The patient's device was then turned off and the patient did not experience bradycardia. The surgeon implanted the pacemaker with the vns disabled through the entire procedure and the patient did not experience bradycardia. After the pacemaker was implanted, the vns was programmed back on. The patient was set to varying settings and the pacemaker was observed to be pacing indicating a decrease in the patient's heart rate. The pacemaker was able to keep the patient's heart rate within normal limits when the vns stimulated. With the patient turned to an output of 2. 0ma, the patient's heart rate was in the mid 60's-68bpm. System diagnostics were performed which showed output=ok/lead impedance=ok/impedance=2834ohms/ifi=no. The patient was programmed to output=2ma/frequency=20hz/pulse width=130usec/on time=21sec/off time=5min/magnet output=2. 25ma/frequency=60hz/pulse width=130usec. The patient wants her device at a higher output current because this is where she reaches efficacy.

Event Description
On (b)(6) 2014 it was discovered that this event was reported in a duplicate report; on mfr. Report # 1644487-2014-01642.

Event Description
Additional information was received on november 29, 2011 when the patient provided further information that her heart missed two beats every 5 minutes. The patient said that since she has had the pacemaker implanted everything is fine. The patient said that vns has been great for her and she still wants it implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2347665


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:28:05 AM
Model Number 102
Event Date 01/01/2008
Event Type Injury
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.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:28:51 AM
Model Number 102R
Event Date 09/01/2013
Event Type Injury
Event Description
The vns patient inquired whether or not vns therapy could cause an irregular heartbeat after receiving therapy for a while. The patient was informed that verification would be needed by a cardiologist. The patient reported that he was given a stress test and that the cardiologist informed him that he has an irregular heartbeat and that he needed to follow-up with his neurologist regarding this issue. The relationship of the irregular heartbeat to vns is unknown. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3576871


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:29:42 AM
Device Problem No Known Device Problem
Event Date 07/16/2017
Event Type Injury
Event Description
A research article comprised of data from a national registry of all vns patients implanted between july 2010 and december 2012 reported several deaths, adverse events, and device malfunctions. Mfr report #1644487-2017-04547 captures the deaths reported in the article. The infections and intraoperative and postoperative cardiac complications observed during the study are captured in this report, the high impedance observed during the study is captured in mfr report #1644487-2017-04549, and the seizure increases observed during the study are captured in mfr. Report #1644487-2017-04550. Seven patients experienced intraoperative arrhythmias at implant, and 2 of these patients required their implant surgeries to be ended without device implant due to arrhythmias caused by the stimulation provided during a system diagnostic test. One patient experienced postoperative arrhythmia 12 months after implant surgery. Six patients experienced local infections at the start of stimulation, 3 months after implant, 12 months after implant, or 36 months after implant. Six patients' devices were explanted due to infection. No additional relevant information has been received to date.

Manufacturer Narrative
Kawai, k. & tanaka, t. (2017). Outcome of vagus nerve stimulation for drug-resistance epilepsy: the first three years of a prospective japanese registry. Epileptic discord, 19(3), 1-12. Doi:10. 1684/epd. 2017. 0929.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6916441


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:30:47 AM
Model Number 103
Device Problems Break; Migration of device or device component
Event Date 09/01/2015
Event Type Injury
Event Description
Additional information was received that the patient underwent prophylactic generator replacement on (b)(6) 2015 due to the migration and discomfort. The explanted generator has not been received by the manufacturer for analysis to date.

Manufacturer Narrative

Event Description
It was reported that the patient's generator was migrating and causing her great difficulty. The neurologist disabled the device. The difficulty was later clarified to mean discomfort. Additional information was received that the vns generator migration was due to the patient having received cpr about a week and a half prior (for a reason not related to vns) which caused the suture securing the generator to break, allowing it to move around more freely in the patient's chest. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5138545


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:32:37 AM
Model Number 103
Event Date 06/22/2011
Event Type Injury
Event Description
It was reported by a neurologist that a vns pt reported a "tickle" in her ear with stimulation. Pt underwent cardiac pacemaker implantation and post operatively her neck pain became severe. Consequently, pt's generator settings were lowered from 1. 25ma to 0. 75ma and pt's neck pain was resolved. The physician believed that he may have titrated the pt generator settings too fast.

Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the patient's cardiac events were not related to vns. On (b)(6) 2011, the physician reported that the patient has not complained of any neck pain or ear tickle and that they are improved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2190432


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:33:44 AM
Event Date 11/10/2011
Event Type Injury
Event Description
An op note from the date of initial implant was received. Product information was not provided, however the note did indicate that the patient had a heart condition prior to vns, including a previous mitral valve replacement.

Event Description
It was initially reported that following a mitral valve replacement procedure, the patient was unable to feel his vns stimulation. It was then reported that the patient was experiencing an increase in seizures. The patient was then referred for a generator replacement, which was to be performed during an implant procedure for a pacemaker. The revision surgery took place on (b)(6) 2011, and the generator was replaced due to "battery depletion" with "ok" lead impedance. Information regarding the reason for the pacemaker implant, as well as information on the patient's increase in seizures is currently unknown. Attempts for additional information and product return are underway.

Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2365121


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:34:43 AM
Model Number 102
Event Date 11/06/2011
Event Type Injury
Event Description
It was initially reported that the patient was being implanted with a pacemaker by another company representative. The other's company representative did not know if the reason the patient was being implanted with a pacemaker was related to vns, but did provided the treating cardiologist name. Follow-up with the cardiologist that the other's company representative provided had no record of the patient seeing or planning on seeing anyone in their practice. It is still unknown if the reason for the patient was being implanted with a pacemaker is related to vns. (b)(4) attempts for more information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2356182


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:36:02 AM
Model Number 102
Event Date 01/25/2013
Event Type Injury
Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:36:52 AM
Event Date 01/20/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the vns patient was in the icu due to being shot that day. The physician indicated that they have been unable to get the patient's blood pressure down from (b)(6) despite various medications and was questioning whether it could be due to the vns. She confirmed that the patient was not shot in the left chest, so the device was likely intact. The physician was asked for the patient's information, but she didn't have it since the details were in the er at the time. Good faith attempts for further information from the physician, including the identity of the patient, were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2956709


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:37:46 AM
Model Number 105
Device Problem No Known Device Problem
Event Type Injury
Event Description
Additional information was received from the patient. She stated that she was having the fainting spells due to cardiac issues. She followed up with a neurologist who is stated to believe that the fainting spells are related to the vns device. Follow up attempts to the neurologist have been unsuccessful to date.
Manufacturer Narrative

Event Description
It was reported by the patient that she has passed out several times and was found to have an arrhythmia. The patient is getting a holter monitor and having a cardiac workup due to these issues. Information was received that the patient had reported fainting prior to getting the vns device however the relation of the vns device to these issues is unknown at this time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6860725


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:38:42 AM
Model Number 303-20
Device Problem No Known Device Problem
Event Date 08/09/2017
Event Type Injury
Event Description
Report was received that a patient started experiencing arrhythmia while under anesthesia. The patient was receiving a full revision surgery. After the new generator and lead were implanted, system diagnostics were run and showed high impedance (reported in mfr. Report #1644487-2017-04401). A second lead was tried but the surgeon had difficulty wrapping the electrodes around the nerve. The surgeon reported this was related to the vagus nerve being too big for the 2 mm lead used. This led to extended time under anesthesia. Due to this duration of surgery and the manipulation of the vagus nerve, the patient experienced arrhythmia. The anesthesiologist reportedly recommended that the surgery be terminated as a result. The generator was reportedly left implanted without any lead attached. Further information was received that the arrhythmia was not occurring with stimulation as it appeared about an hour after the last system diagnostic had been performed. It was also reported that the arrhythmia was benign. The lead passed all quality inspections prior to release for distribution. Device evaluation is not necessary due to the arrhythmia not being related to delivery of therapy. No further information has been received to date.

Manufacturer Narrative
Device evaluation not necessary due to the event not being related to delivery of therapy at all.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6844458


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:39:42 AM
Model Number 106
Event Date 09/12/2016
Event Type Injury
Event Description
Follow-up to the physician 10/12/2016 revealed that the patient had seen a cardiologist, but he did not know all of the details surrounding the event. He was uncertain if the arrhythmia occurred in the or, but was present after the surgery. He stated they were not sure of the cause of the arrhythmia. The device was briefly turned on, and then turned off. He provided that the patient has a rare genetic syndrome characterized as similar to rhett¿s syndrome. He said that as a result, it can develop into cardiac arrhythmias, in addition to worsening seizure states. After speaking with the cardiologist they are planning to admit the patient for telemetry to try and diagnose the patient. Follow-up to the company representative who was at the case provided that the arrhythmia occurred during the surgery after the device had been turned on, including the autostim. It was decided by the surgeon to turn off all the settings at the time and then check the patient post-operatively to evaluate the arrhythmia if it was related to vns or not. The plan would be to turn on the normal mode and magnet mode, but leave the autostim mode off. The patient had never had an arrhythmia with the previous vns device. The patient and family had left before diagnostics could be performed.

Manufacturer Narrative
(b)(4).

Event Description
It was reported to a company representative by a patient's caregiver that a vns patient experienced arrhythmia due to a replacement device. It was stated the patient would go see a cardiologist. It was stated the device had not been turned on. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6012922


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:40:23 AM
Model Number 103
Event Date 12/31/2010
Event Type Injury
Event Description
It was initially reported that the pt has been experiencing chest pain and a feeling that the generator was moving since implant especially when taking in a breath. Pt had cardiac arrest twice in may and was in the icu at the time of the initial report. The generator was disabled and the pain was reported to have stopped. Add'l info was received from the physician's office that indicated that the pt was taken to the er after going into cardiac arrest where she was resituated and placed on a ventilator. When the pt was removed from the ventilator she would go back into cardiac arrest. It was indicated that the pt has been complaining of pain in the chest, which was described as both an irritation and supposed heart palpitations with vomiting. When the pt had a work up by the cardiologist there were no apparent issues. It is not clear to the physician if the events are in fact related to the device or psychosomatic. The pt is anorexic so it is unclear what effect that has had on the cardiac issues that pt has been experiencing. It is unk what the plan is or if interventions will be taken. The pt's mother wants vns removed. Good faith attempts for more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141191


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:41:15 AM
Model Number 102R
Device Problem No Information
Event Date 06/25/2011
Event Type Death
Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2011 due to unknown reasons. Diagnostic history did not suggest any device malfunction. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report #s of the five deaths of known deceased patients are: 1644487-2015-06606 1644487-2015-06607 1644487-2015-06608 1644487-2015-06609 1644487-2015-06610.

Event Description
The patient's obituary stated that the patient died in his home. According to the funeral home, the cause of death was: 1. Chronic arterial sclerotic heart disease, 2. Chronic diffused arterial sclerosis, and 3. Left ventricle hypertrophy and cardiomegaly. The patient's device was explanted, but it was not available for return from the funeral home. The patient's physician did not believe that the death was related to vns. The patient was a very sickly person and had heart issues before he had vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256304


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:41:56 AM
Model Number 105
Event Date 10/27/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient developed a virus and had fluid around his heart. The patient was placed on steroids and suffered a seizure. The patient then "went downhill" continuing with seizures approximately once a week. It is unknown whether or not the seizures are an increase above the patient's pre-vns baseline and whether or not the seizures are related to vns therapy. Device diagnostics were within normal limits and the patient underwent generator replacement surgery. The explanted generator has not been received for analysis to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5241945


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:42:35 AM
Device Problem No Known Device Problem
Event Date 10/23/2017
Event Type Injury
Event Description
It was reported that the patient presented with hydrocephalus and high pressure, not related to the vns device, that needed emergency surgery. It was noted while the patient was in the hospital that there were fluctuations in the patient's heart rate. The patient's baseline was usually over 100 but with vns stimulation would drop to around 70-80. The device was disabled due to this issue and the patient's heart rate was stated to stabilize. The physician stated the patient's device would be left disabled until the acute neurological issues resolved. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7072611


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:43:17 AM
Model Number 102
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the patient is looking to explant the vns device. The patient states that she needs the device removed because for the last several years she has complained of fatigue, diarrhea, decreased libido, headaches, blood pressure fluctuations and slurred speech. Follow-up with the physician showed that these issues are thought to be related to vns therapy, resulting in vagus nerve dysfunction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4634916


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:44:06 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 10/01/2017
Event Type Injury
Event Description
The physician reported that the heart fluttering would occur independent of vns stimulation. The physician did not believe that the heart fluttering was related to the vns. The patient was evaluated by a cardiologist and the physician did not believe the heart fluttering was cardiac related.

Manufacturer Narrative

Event Description
The patient reported that he felt his heart fluttering and appeared concerned that it may be related to his vns device. The patient intended to address his concerns with the physician. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7031952


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:45:00 AM
Model Number 105
Event Date 02/24/2016
Event Type Injury
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.

Manufacturer Narrative

Event Description
Additional information was received that a physician at the hospital believed that the vns could have been contributing in someway to patient's cardiac problems. However, the patient has had a cardiac pacemaker for a long time and the neurologist does not feel that the vns has contributed in anyway to patient's heart problems. Per the neurologist, the vns has helped his seizures dramatically and is concerned with the idea of patient's generator being turned off. It is unknown if the vns was disabled prior to the mri. The diagnostic tests have always been within normal range in the past. The patient has a long history of cardiac problems. The patient is currently seen another neurologist. No other relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:45:41 AM
Model Number 102
Event Date 05/24/2011
Event Type Injury
Event Description
It was reported that the pt was scheduled for a vns explant. The surgery took place on (b)(6) 2011. The explanted products will not be returned to the mfr as they have been discarded. Add'l info was received from the surgeon indicating that the pt was explanted due to pain and a heart arrhythmia. Info received from the pt's cardiologist indicated that the pt's arrhythmia was not related to the vns, as the pt had a medical history of arrhythmia prior to implant. Attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2263013


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:46:23 AM
Model Number 103
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported that the pt is having possible cardiac events, described as "triples" and "pcas" on the ekgs by the treating neurologist. The pt was referred to a cardiologist for eval. The neurologist indicated that the patient is currently on high doses of benzo medications and also depakote, so he believes the pt may possibly having reactions to the high doses of medication and causing the problems with her heart. Diagnostics were said to have been within normal limits, but no specifics were available at that time. Further f/u indicated that the pt is still having afib issues with occasional episodes of passing out (not associated with stimulation on-times or seizures). The pt is wearing a holter monitor for 22 days to evaluate her issues. The patient is bipolar/depression and is on several medications. The patient has very low weight and body fat, so the neurologist believes that the issues she is experiencing are due to her medications in relation to her physician condition. Last known diagnostics available in the mfr's programming history database were at the time of implant, which were within normal limits. Good faith attempts to obtain add'l info are still in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774910


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:47:06 AM
Model Number 103
Event Date 07/31/2010
Event Type Injury
Event Description
It was reported by a vns patient's mother that the patient who was implanted with vns in (b)(6)2009, was sedated for a procedure about one month ago and while sedated, the anesthesiologist informed the mother that the patient had arrhythmia. The patient went to a cardiologist a week later, and an echo cardiogram was performed which indicated good heart function however, the measurements were off a little. The patient was going to follow up with the cardiologist in about 18 months. Follow up with the neurologist revealed that it was unk whether or not the arrhythmia was related to vns. The arrhythmia did not occur with stimulation. There were no causal or contributory medication or programming changes prior to the onset of the arrhythmia. 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=1852350


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:48:25 AM
Model Number 103
Device Problem Insufficient Information
Event Date 08/23/2012
Event Type  Death   
Event Description
Attempts were made to the funeral home and the patient's devices were not explanted at the time of death. Additionally attempts for a death certificate were unsuccessful as the state indicated that the manufacturer could not obtain a copy of the death certificate without signed consent and a photo id from a family member. Attempts for additional information from the treating physician have remained unsuccessful to date.
 
Event Description
A sudep evaluation was performed with the available information and it was indicated that the patient's death was possible sudep.
 
Event Description
Product information was received on (b)(4) 2012. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported that the patient passed away. The date of death was (b)(6) 2012. The relationship between the patient's death and vns is currently unknown. Attempts for additional information are in progress.
 
Manufacturer Narrative
Describe event or problem: corrected data. The sudep evaluation was inadvertently omitted from follow-up report #2.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was major cardiovascular disease, atherosclerotic heart disease, unspecified mental and behavioral disorder due to use of tobacco, essential (primary) hypertension, chronic obstructive pulmonary disease (unspecified), and other and unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that there was no sudep indicator. There is no allegation or other information indicating that the death is related to vns. Due to the cause of death being atherosclerotic heart disease, there is no suspected relationship between vns and the cause of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2785554


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:49:29 AM
Model Number 304-20
Event Date 10/01/2014
Event Type Malfunction
Event Description
It was reported that high impedance was observed on the patient's device. It was reported that the physician did not program the device off after observing the high impedance. It was reported that the patient recently underwent open heart surgery and that the surgery may have damaged the lead. The patient was referred for surgery for lead replacement. No known surgical intervention have been performed to date. No additional relevant information has been received to date.

Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description
It was reported that the cardiologist wants the patient to stay on anticoagulation medications for one to two more months. It was noted that the patient began experiencing an increase in seizures and the patient was referred for surgery. No known surgical interventions have been performed to date.

Manufacturer Narrative

Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not check this data. However, increased seizures were reported in desc of event. Outcomes attributed to adverse event, corrected data: the supplemental report #1 inadvertently did not check this data. However, increased seizures and planned outcome were reported in desc of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4207881


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:50:10 AM
Model Number 102
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's atrial fibrillation and heart failure were previously determined to be not related to vns. Attempts for additional information have been unsuccessful.
 
Event Description
Clinic notes dated (b)(6) 2012, were received on (b)(6) 2012. Notes from both dates indicated that this vns patient had a medical history of stroke, sleep apnea, atrial fibrillation, and heart failure. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2799378


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:50:57 AM
Model Number 103
Event Date 01/04/2011
Event Type Injury
Event Description
It was reported by a vns patient that while following up with his primary care physician, he was informed that he had an irregular heartbeat. Follow up with the patient's neurologist revealed that he told the patient to follow up with a cardiologist. However, the neurologist later released the patient from his care due to behavioral issues. The neurologist did perform device diagnostics prior to releasing the patient and the results were said to be within normal limits however the exact test results were not provided to the manufacturer. 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=2005775


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:51:40 AM
Model Number 102
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the nurse that the pt was having some cardiac issues which she attributes to vns. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905621


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:52:28 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. Cardiac
Post by: dennis100 on June 13, 2018, 07:53:13 AM
Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
It was reported that the pt was having some "cardiac issues," but it was unk about the type of cardiac event that was occurring. There were no further details provided. The pt was referred to a cardiologist for consult, but no information has been provided regarding the outcome of the visit. Good faith attempts have been made to obtain additional information have been unsuccessful to date. The relationship of the device to the patient's event is unknown at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365869


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:53:52 AM
Model Number 102
Event Date 11/24/2010
Event Type Injury
Event Description
It was initially reported that a vns pt was "experiencing an extra heart beat with stimulation", which had been occurring for the past several months. The pt's medical professional was able to verify that an extra beat appeared with stimulation from vns. The stimulation events were also correlated to the pt's transient hoarseness from the vns therapy. Further info indicated that the pt had a prior heart condition, resting sinus tachycardia; however, there had been no cardiologist work-up prior to implantation with the vns. Settings at the time of the initial report were 1 ma/15 hz/130 microsec/7 sec/1. 8 min with no current diagnostic data available. There had been no changes in medications or settings to cause the onset of the event. Furthermore, the device was not disabled to see if the symptoms went away. Further info from the pt revealed that she had a "recent cardiovascular event" where "she felt she had an extra heartbeat". It was recommended to the pt that she see a cardiologist by her treating physician. Good faith attempts to gain further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005854


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:54:40 AM
Model Number 303-20
Device Problem Fluid leak
Event Date 01/01/2018
Event Type Malfunction
Event Description
The lead and generator were explanted due to cardiac issues which were previously reported in mfg. Report #1644487-2016-02764. During that investigation it was reported that diagnostics results were within normal limits while the cardiac events were occurring. Following surgery both the lead and generator were returned and underwent product analysis. Generator results are reported in mfg. Report #1644487-2016-02764. Analysis of the lead found that the lead was received in one portion. Setscrew marks were present on the connector pin, indicating that at one time there was proper contact between the generator and lead. A continuity check was performed on the lead portion and no discontinuities were observed. Abraded openings were observed in the lead's bilumen tubing and these openings appeared to have provided a pathway for bodily fluid to enter the tubing. It appeared that the abraded openings were potentially related to wear. It was previously reported that diagnostics were within acceptable limits during the device's implant when the cardiac events were occurring therefore it did not appear that the abraded openings and fluid ingress were related to the cardiac issues. The abraded openings are being reported in mfg. Report #1644487-2018-00239 and the cardiac events will continue to be captured in mfg. Report #1644487-2016-02764 as the malfunction and serious injury do not appear to be related.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7281330


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:55:22 AM
Model Number 102
Event Date 07/30/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:56:12 AM
Model Number 102
Event Date 09/19/2012
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that this vns patient experienced an arrhythmia during initial implant surgery that day. The patient was successfully implanted. An in-pocket system diagnostic was normal, and a final interrogation confirmed that the normal mode and magnet mode output currents were 0. 00 ma. During the first system diagnostic test, the surgeon noticed a heart arrhythmia during the vns stimulation period. He stated it was not bradycardia, just an abnormal arrhythmia. The system diagnostic test was repeated multiple times, all tests were within normal limits, and the arrhythmia was still present. Following each test, the surgeon attempted to re-position the coils on the nerve to maximize the distance between the coils and the cervical branch of the vagus nerve. He stated the arrhythmia was minimized but was still present after the repositioning of the coils. He stated this was likely due to the very small size of the patient and the short length of nerve he had to work. Attempts for additional information have been unsuccessful.

Event Description
A fax was received on (b)(6) 2012, from the patient's physician. The fax indicated that additional interventions included "cardiology consult and simultaneous". The patient did not have a previous history or family history of cardiac events. The patient's pre-existing conditions included neonatal cerebral abscesses, infantile spasms, intractable epilepsy, and global developmental delay. The patient experienced bradycardia. Prior to the event, the patient's heart rate was 109 bpm. During the event, the patient's heart rate was 104 bpm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2792641


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:57:04 AM
Model Number 103
Event Date 02/17/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Manufacturer Narrative

Event Description
The patient's generator was identified as having been affected by a manufacturing error that led to the generator remaining programmed on to a high output state for about two months as a result of an incomplete final electrical test at time of manufacturer. During the time that the device remained programmed on, the generator is believed to have used a significant amount of battery capacity. The calculated projected life accounting for the time that the device remained on did not meet the design requirements for battery longevity. This issue does not affect the actual performance of the device. However, it does result in reduced battery life. The physician was notified via field action notice letter. It was reported on (b)(6) 2016 that the patient was referred for replacement. The physician believes that the device was nearing end of service. It was later reported on (b)(6) 2016 that the patient passed away on (b)(6) 2016 due to lungs and heart issues; the vns device is not believed to have been related to the patient's cause of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498233


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:57:51 AM
Model Number 106
Event Date 02/17/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that it was known prior to implant surgery that the patient had severe cardiac issues before implant, but the patient was still implanted due to the vns benefits outweighing the risks. However, the physicians had a suspicion that the patient may have some issues after the surgery. When the case manager called the patient's girlfriend on (b)(6) 2016 to follow-up on the appointment, it was reported that the patient was still in the hospital due to clotting issues. The patient was hospitalized three days before the implant due to heparin bridging. The day after implant on (b)(6) 2016, the patient had surgery to drain the generator incision site. The neck site was also swollen and was noted that it would probably need draining also. She stated that it is not infection. It was indicated that this is not due to the vns, but because of the clotting issues that patient has due to the heparin bridging. The patient was seen on (b)(6) 2016, and the device was turned on. The patient tolerated activation well. The clotting issues had appeared to resolve, and the patient appeared to be fine. It was clarified that the fluid was in the neck, and was since absorbing after the procedure. The physician thought that the clotting was blood. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5505080


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 07:59:14 AM
Model Number 102
Event Date 08/03/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a pacemaker company's representative reported that the vns patient was going to implanted with a pacemaker because the patient has an arrhythmia. The representative did not know the relationship of the arrhythmia to vns. Clinic notes dated (b)(6) 2011 were received from the vns treating physician. The clinic notes revealed that the vns patient was being referred for prophylactic battery replacement. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet pulse width=250usec/magnet on time=60sec. The physician reported that four months ago, while she was in a pain clinic, the patient was found to have bradycardia. Since then, the patient has had multiple presyncopal and syncopal episodes characterized by diaphoresia, light headed and sometimes brief loss of consciousness. The patient was noted to have a prior medical history of mild sleep apnea. The patient is scheduled to have a pacemaker implanted the next week. On (b)(6) 2011, the manufacturer's consultant reported that the vns patient was having their vns battery replaced as well as having a pacemaker implanted that day. The reason for the pacemaker was the patient had a sic sinus syndrome. The battery was programmed to output =1. 75ma/signal frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's pacemaker was placed on the right side of the chest and was greater than 8 inches away from the vns generator. Good faith attempts for additional information from the patient's physician regarding the sleep apnea and arrhythmia have been to no avail thus far. Attempts for the return of the explanted generator will be made. When additional information is received, it will be reported.
 
Manufacturer Narrative

Event Description
On (b)(6), 2011 additional information was received when it was discovered that the patient's generator had been replaced on (b)(6), 2011 for prophylactic reasons. The lead impedance was ok after surgery. Good faith attempts were made for the return of the explanted generator but the hospital discarded it. If additional information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2224215


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:00:25 AM
Model Number 106
Event Date 01/07/2016
Event Type Injury
Event Description
It was reported that the patient has been sick since device was placed. The physician thought it was the medications and changed her medications. Patient stated that she was in the hospital for septic shock from (b)(6) and was in the hospital on (b)(6) 2016. Patient experiences shocking sensations despite holding the magnet over the device. The tape over the magnet is peeling her skin since she has had the magnet in place for 3 weeks and that when she changes the tape it peels her skin. Per the neurologist and primary care physician, patient has permanent ekg changes and electrical conductive problems w/ her heart that is related to the vns device. The patient had a chemical stress test and was in vtach. Patient was given medication to slow her heart rate. Patient would like tc to visit and turn off vns but tcs need physician's written consent to do so and patient has not yet seen their neurologist. Patient was seen by a different neurologist on (b)(6) 2016. Per the nurse at the office, the vns was not evaluated at that time and the device was believed to be off. Additional relevant information has not been received to date.

Event Description
The explanted generator was returned to the manufacturer. Analysis is underway but has not been completed.

Event Description
Additional information was received that the patient underwent surgery to have vns generator removed on (b)(6) 2016. Per the surgeon, patient did not have a history of any heart issues or risk factors that makes them more susceptible to heart issues prior to vns implantation. The patient reported that the sepsis was not related to vns therapy. The explanted generator has not been received to date. No other relevant information was received.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative
(b)(4).

Event Description
Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5975296


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:01:29 AM
Model Number 103
Event Date 09/05/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The patient was very ill and the physicians decided to stop the patient's medication. The cause of death was not provided; however, vns is not suspected to have caused or contributed to the death. System diagnostic results showed lead impedance within normal limits (impedance value ¿ 1675 ohms) and an ifi condition. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Further follow-up revealed that the patient's response to vns therapy was a reduction in seizures. The patient was receiving vns therapy at the time of death. The believed cause of death is multi organ failure. The vns was not explanted. It was reported that the death was not related to vns therapy. No autopsy was performed. The death was witnessed. The patient died in the hospital icu from multi organ failure. There was no history of drug or alcohol abuse and the patient had a history of cardiac and respiratory problems (chest infections).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4130340


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:02:34 AM
Event Date 04/27/2008
Event Type Injury
Event Description
Reporter indicated a pt's vns was disabled due to constant voice hoarseness and difficulties swallowing which had not resolved despite programming changes. Four days after the vns was disabled, the pt developed an elevated blood pressure and had dizziness. No pathological reason for the elevated blood pressure or dizziness has been found. Attempts for further information from the attending physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053271


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:04:50 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
Updated settings were provided. An updated battery life calculation did not support that the device was depleted in (b)(6) 2016. No further relevant information has been received to date.

Event Description
The patient reported that her device had been off for years, but it was unclear if the device was programmed off or if it depleted. No further relevant information has been received to date.

Event Description
The physician stated that the patient's device had depleted normally. No surgery has occurred to date.

Event Description
It was reported that the patient was informed by her cardiologist that she did not need vns, so she stopped seeing her neurologist to manage her device. The patient's device reportedly depleted around (b)(6) 2016, and the patient had an increase in seizures. The patient went back to her neurologist and was referred for generator replacement surgery, as the neurologist believed that the vns was necessary. A battery life calculation did not support that the patient's device would have been depleted at that time. Attempts for further information were unsuccessful to date. A blc was performed, which resulted in 3. 8 years until neos=yes. The last known settings were from (b)(6) 2012: 1. 75ma/20hz/250us/30sec/3min.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600157


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:05:43 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 06/19/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a patient passed away. The patient's neurologist reported that the patient's death was not believed to be related to vns as the physician believed the patient had a heart condition. The physician did not know of the patient's cause of death as he recently learned of the patient's death. The patient was last seen 3 months prior to his death and was not having any problems with the vns device when he was last in the physician's office. No settings or diagnostics were available from the last time the patient was seen. The patient's death certificate did not indicate a cause of death, but indicated that the patient died at his place of residence. An autopsy was performed, but results of the autopsy have not been received to date. The patient's death is classified as probable sudep. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6544443


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:06:52 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. Cardiac
Post by: dennis100 on June 13, 2018, 08:07:36 AM
Model Number 102
Event Date 08/19/2011
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient had syncope and general arrhythmia. The physician feels that both events were related to dehydration but the role vns played in the event was not addressed. When the patient experienced the suspected syncope the patient had not eaten or kept himself hydrated. Good faith attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received that the patient's cardiac issues were not related to vns, and that the patient did not really have any cardiac issues. No comment was made on the syncope. The physician will not be providing any additional information as he is very hipaa sensitive.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2460592


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:08:20 AM
Model Number 102
Event Date 03/09/2012
Event Type Injury
Event Description
It was reported on (b)(6) 2012 that the vns patient was going to be implanted with a cardiac recorder device. Additionally it was reported that the patient is pre-syncopal likely due to atrial fibrillation. Attempts to obtain additional information have been unsuccessful to date. At this time it is unknown what is the relation of the arrhythmia to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2512933


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:09:04 AM
Model Number 103
Event Date 12/12/2014
Event Type Malfunction
Event Description
Called to the operating room (or) to test the vagus nerve stimulator (vns) equipment. Generator model 103 with serial number (b)(4) and lead model 304 was tested and high impedence was reported. Device disconnected from lead and the generator was tested with the pin and still high impendence was obtained. New generator model 103 with serial number (b)(4) was tested and the patient information was programmed prior to placement by neurosurgery. After placement lead test was performed, heart rate ranged from 93 to 87 during the lead test. No bradycardia was noted and the lead test was ok.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4384729


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:09:53 AM
Model Number 102
Event Date 02/27/2012
Event Type Injury
Event Description
It was reported that following a vns battery replacement, the patient had a seizure. Their magnet was used and 2mg of versed and the patient's seizure was aborted. However, the patient continued to seize and was admitted to neuro critical care. The patient had a pacemaker replaced the previous week and the same incident occurred post operatively. Good faith attempts are underway for further details about the reported event. Their device tested well and was programmed to. 25/30/500/30/3. 0/. 50/60/500.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2499861


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:10:46 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.

Event Description
Additional information was later received that the physician does not think that the events are related to vns. Device diagnostics were performed and are within normal limits. No vns interventions were taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817109


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:11:58 AM
Model Number 102
Event Date 12/01/2008
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2008 revealed that the pt was recently hospitalized for a seizure, incision drainage, and aspiration pneumonia. The pt reported on this day that the incision had healed without complications. Her pneumonia resolved and she was going to follow-up with her cardiologist in (b)(6) to consider a pacemaker. The relationship of these events to vns is unk. Attempts for add'l info have been unsuccessful thus far. The pt had recent vns reimplantation surgery in (b)(6) 2008, and she had lumbar surgery in (b)(6) 2008. The pt had an infection and wound drainage that resulted from the lumbar surgery. However, it is not clear that the incision drainage reported in the clinic notes is in relation to the lumbar surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2391360


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:12:57 AM
Model Number 102
Event Date 03/24/2011
Event Type Injury
Manufacturer Narrative
Corrected data: initial report inadvertently reported the incorrect generator model and serial number.

Event Description
It was reported via clinic notes that the pt had previously seen a cardiologist for syncope and orthostasis however the relationship of the events to vns is unk. The clinic notes also noted that diagnostics were normal at the pt's last visit on (b)(6) 2011. Attempts for additional info have been unsuccessful to date. The pt's generator has been replaced prophylactically and it is undergoing analysis.

Event Description
Analysis of the explanted generator has been completed. The generator performed to specifications and no anomalies were found however it was noted that the "elective replacement indicator (eri)" was set to "yes"; this indicates that the device was nearing end of service and has a battery voltage less than 2. 6 volts. The battery voltage found during analysis indicated 2. 573 volts. The depleted battery is not expected to have result in the reported syncope.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267795


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:13:38 AM
Model Number 103
Event Date 10/15/2010
Event Type Injury
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953518


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:14:50 AM
Model Number 102
Event Date 10/02/2012
Event Type Injury
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that the increase in seizures was first observed on (b)(6) 2012. The patient¿s current settings were noted to be output=2. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=500usec. The physician stated that the vns is nearing end of service so the increase in seizures could possibly be related to that. The patient has been referred to a neurosurgeon for battery replacement. The physician was unsure as to the relationship of the increase in seizures to vns as the patient has been implanted with vns for a number of years. The patient has an increase of petit mal seizures. The patient stated that she has been experiencing ¿dizzy spells¿ and forgetting things more; the patient¿s mother thinks it may be due to an increase in stress. Primarily stress has preceded the onset of the increase in seizures. The physician is going to increase the patient¿s medication and send to neurosurgeon for battery change consult. It was clarified that the ¿weird signal¿ that the patient¿s mother reported that the physician had observed during a recent appointment was only the elective replacement indicator flag. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(4) 2013 when it was discovered that the patient underwent generator replacement on (b)(6) 2012 due to battery depletion and that the generator could not be interrogated due to battery depletion. The hospital reported that it is against their policy to return explanted medical devices to the manufacturer, therefore the explanted generator could not be returned for product analysis.

Event Description
Additional information was received on (b)(6) 2013 when a battery life calculation was performed which showed 0 years remaining until eri=yes.

Manufacturer Narrative

Event Description
On (b)(6) 2012 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 revealed that the patient has been experiencing a lot of petit mal seizures. The patient is having dizzy spells and is forgetting things more. The patient's mother reported that the patient has been under stress. The patient's vns was noted to be nearing eos. The patient's settings were output=2. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time-1. 8min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=500usec. System diagnostics showed the device to be functioning properly with dcdc=2. The patient was referred for surgery due to the vns battery nearing end of service. Although surgery is likely, it has not occurred to date. The patient has probable ongoing occasional absence seizures. The patient's mother later reported that the patient is going to be re-implanted with an insulin pump. She further mentioned that the patient was getting a generator replacement because of a 'weird signal' her neurologist saw on a recent appointment. The patient's mother also stated that the patient had a stroke prior to vns which is partially causing the seizures. The patient does have grand mal seizures, which the vns has helped tremendously for. The patient was noted to have cardiac and respiratory issues due to her many seizure types which the mother again said that because of the vns and subsequent seizure reduction, these have improved significantly and are in no way believed to be related to vns according to the cardiologist. The patient's mother also stated that the patient isn't experiencing an increase in seizures, but is experiencing an increase in severity with all her seizure types, which is still below her vns baseline. The mother suspects that the increase was due to the recent heat wave where they live, but the physician suspects that the battery could be contributing.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2806070


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:15:45 AM
Model Number 102
Event Date 09/24/2009
Event Type Injury
Event Description
It was initially reported that the patient recently had a seizure, which was uncommon for him as he has been more controlled recently. It is unclear what his current seizure frequency is to that of his pre-vns levels. The patient was said to have been admitted to the er and hospitalized for 24-hours, due to "breathing and cardiac issues. " the patient's settings were said have been changed. 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=1514065


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:16:34 AM
Event Date 01/11/2001
Event Type Injury
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 patient experienced a decrease in the respiratory sinus arrhythmia (rsa) magnitude. This patient's rsa magnitude varied from the baseline by a factor of -1. 4651 +/-1. 7972. The decrease started and ended abruptly with the onset and end of vns. The decrease in the rsa magnitude was concomitant with a transient decrease on heart rate in this patient. 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 of afferent 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 physiological 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 respiration 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. This patient was also included in an article by the same author titled "vagus nerve stimulation therapy induces changes in heart rate of children during sleep", which was reported in manufacturer report # 1644487-2009-01956.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471017


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:17:27 AM
Model Number 102
Event Date 10/06/2008
Event Type Injury
Event Description
Reporter indicated a vns therapy patient is experiencing pain that goes up her neck and up the skull. The patient "has been fainting quite often so she would fall. " according to the patient, the physician said the fainting is "related to her bp levels. " she stated that her bp will sometimes shoot really high and her pulse will drop really low. 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=1225765


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:18:13 AM
Model Number MODEL 250
Event Date 08/20/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6), 2012 it was reported that on (b)(6), 2012 the patient had his vns checked and when the wand was against the device and diagnostics were performed, it transmitted two times of the programmed output. The patient stated that he doubled over, stopped breathing, and his heart stopped for about a minute. While driving home the patient stated that it did it again and at home one other time before he returned to the physician who had it fixed and re-programmed the patient to the correct settings. The patient noted that he had his magnet taped over his device until he was able to see his physician again to get the settings corrected. The physician later clarified that the patient is very sensitive to parameter changes and when the physician performed the system diagnostics, which runs at higher settings than the patient is used to, the patient immediately had painful stimulation and reacted badly so the physician aborted the test. Instead of stopping the test by pressing cancel on the screen, he removed the wand from the patient's generator. The physician did not do a final interrogation prior to the patient leaving the clinic visit. Later that day the patient returned reporting that his vns wasn't set to the correct settings and when the physician interrogate the patient, the patient was set to output=1ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min which are the settings that the system diagnostics test runs at. The physician then corrected the patient's settings by programming the patient back down to an output of 0. 5ma and adjusted the other settings appropriately, settings not provided. The physician also stated that the patient only felt painful stimulation, there was no asystole or syncope experienced by the patient during the visit and the physician feels that the reports were likely exaggerated by the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2746524


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:19:18 AM
Model Number 103
Event Date 03/29/2016
Event Type Injury
Event Description
It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016. Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia. A ct scan was obtained, which showed a pericardial effusion. The patient was then emergency transported to another hospital for exploration surgery. During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery. The vns magnet was placed over the device during this surgery. After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation. The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur. The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016. Diagnostics were performed, and the results were all within normal limits. The arrhythmias and painful stimulation no longer occurred after the device was programmed off. The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized. It was also reported that the patient had a history of mild bradycardia prior to this event. No further relevant information has been received to date.

Manufacturer Narrative

Event Description
Data was received from 03/29/2016 and 03/30/2016. No anomalies were noted - the data indicated that the device was functioning within normal limits. It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47. 0% change) on (b)(6) 2016, 5:57:24 (estimated). The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i. E. Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury). It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:20:05 AM
Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing dizziness, headache, and decreased blood pressure with stimulation. The device was disabled which resolved the events. Per physician, the events are believed to be related to the vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947554


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:20:56 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/27/2017
Event Type Injury
Manufacturer Narrative

Event Description
A patient called and reported that she went to the emergency room due to an arrhythmia and a panic attack. The patient stated that her vns device was "going crazy" while she was in the hospital, meaning it was stimulating a lot. Attempts to obtain additional information were made to the physician, but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6508647


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:22:15 AM
Model Number 103
Event Date 04/17/2012
Event Type Injury
Event Description
Additional information was received form the surgeon's office indicating that they had not heard of any heart rate or arrhythmia issues during the implant surgery. The site also checked the operative report which indicated no issues and everything was normal. The operative report specifically noted "complications: none. " the surgeon's office indicated that it is likely that the patient's mother likely misheard the anesthesiologist. All diagnostics were normal during the surgery per the operative report.

Event Description
It was reported by the vns patient's mother that during the initial implant surgery, she overheard the anesthesiologist comment about a problem with the patient's heart rate during the procedure. The patient's neurologist reportedly was not aware of the issue. A company representative was present at the implant surgery however she was not notified of the issue. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2781634


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:23:10 AM
Model Number 102R
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type Injury
Event Description
It was reported by a patient that she has been considered to possibly be having "skip beats" /arrhythmia, for the past few years, but has not been confirmed on 30 day holter monitoring. Revision surgery occurred due to high lead impedance (previously reported in mfr report#1644487-2018-00225). The hospital would not return the explants to the manufacturer. Additional relevant information has not been received to-date.

Event Description
Follow-up from the treating neurologist provided they did not know if the arrhythmia was related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7283787


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:23:54 AM
Model Number 102
Event Date 05/12/2011
Event Type  Injury   
Event Description
It was reported by the pt that her seizures were worsening and were "bad. " later, the pt stated that she had been to the emergency room on (b)(6) 2011 for seizure activity, on (b)(6) for chest pain, and on (b)(6) to have her vns' functionality tested. The pt was reported to have a history for cardiac problems. The pt's neurologist was contacted. The site stated that the pt's stitches were bothering her, so a meeting with the surgeon was being coordinated. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129997


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:24:44 AM
Model Number 103
Event Date 01/01/2011
Event Type Injury
Event Description
It was reported via clinic notes received that the pt has obstructive sleep apnea, asthma, and a previous electrocardiogram indicated an arrhythmia. It was noted on the clinic notes that a recent electrocardiogram showed a "sinus arrhythmia"; however, it is not known if this is the same arrhythmia or a separate one. The relationship of these events to vns is not known. Diagnostics dated (b)(6) 2011 indicated normal device function. Attempts for additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316734


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:25:32 AM
Event Date 09/08/2011
Event Type Injury
Event Description
It was reported by the nurse that the pt had been implanted with a cardiac pacemaker. It was not known if the cardiac issues were unrelated to vns, but the site inquired into how to check the vns following his surgery. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276566


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:26:27 AM
Model Number 104
Event Date 09/01/2012
Event Type Injury
Event Description
It was reported on (b)(6) 2012 that the patient was scheduled for surgery. The generator replacement surgery occurred on (b)(6) 2012. Attempts for product return are in progress, but the explanted device has not been received by the manufacturer to date.

Event Description
The implant card was received confirming the generator was explanted on (b)(6) 2012. It was reported that the ifi flag = yes and that the lead impedance was ok following generator replacement. Further follow-up revealed the generator was discarded during the surgery and will not be returned to manufacturer for analysis.

Event Description
The patient was referred for generator replacement, and clinic notes from the neurologist dated (b)(6) 2012, indicated the patient had experienced an increase in seizures. It was indicated that after interrogating the generator, it showed it was ifi=yes, indicating the battery was nearing end of service. (previously on (b)(6) 2012, the ifi=no and no vns setting changes were made. ) it was indicated that the physician would first check for infection, and then the generator would be replaced. Then on (b)(6) 2012, it was also noted that the patient was having some days with several seizures on the same day. Then, the patient was ill which caused an increase in seizures. Of note, portions of the clinic notes were illegible. In addition, the clinic notes were stamped to be from a cardiovascular center. The clinic notes also mention an increase in seizures on (b)(6) 2012, however this will not be investigated as the physician attributes it to a change in medication. Attempts for additional information from the neurologist regarding the increase in seizures in (b)(6) 2012 have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2812159


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:27:50 AM
Model Number 102
Event Date 03/21/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, clinic notes from a vns treating physician's assistant were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the vns patient has a pacemaker. The clinic notes did not state the type of arrhythmia the patient was experiencing nor the relationship of the event to vns. Good faith attempts for further information were made to the patient's cardiologist but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2545757


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:29:03 AM
Model Number 103
Event Date 08/25/2013
Event Type Death
Manufacturer Narrative

Event Description
On (b)(6) 2013, a physician reported that this vns patient had died the previous month. The patient was implanted in (b)(6). The death was sudden in for unknown cause, no autopsy was done. The generator and lead were explanted for return to device manufacturer. An online search showed the date of death to be (b)(6) 2013. The explanted lead, generator, and three magnets were returned on (b)(6) 2013. Analysis is underway, but has not been completed to date.

Event Description
Additional information was received stating that the patient experienced a reduction in seizures with vns and was receiving vns therapy at the time of death. The patient had recently undergone a cardiac stress test apparently for a borderline ekg and a family history of cardiac death. The cause of death is unknown but believed to be unrelated to vns. The patient passed away suddenly at his home on the morning of (b)(6) 2013 and was found on the floor after experiencing a fall and hitting his head. The patient was not convulsing and later stopped breathing. The patient¿s caretakers stated that the patient appeared fine that morning except for some blinking so the patient was given medications approximately 20 min prior to the death. It was noted that the patient developed an infection following vns implant surgery which had fully recovered. The physician indicated that the patient may have had cardiac arrest. Based on the available information about the patient¿s death, an internal classification has determined that the death may be probable sudep.

Event Description
Generator analysis was completed on (b)(4) 2013. 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) 2013. 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. Analysis of the three magnets was completed on (b)(4) 2013. The three magnets returned are functioning within specification and function properly, initiating a magnet response from the pulse generator. The cracks noted in the case of magnet 3 did not have an adverse effect on the device performance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3430836


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:30:08 AM
Model Number 102
Event Date 05/21/2012
Event Type Injury
Event Description
Additional information was received from the explanting facility reporting that they no longer have the explanted generator, and therefore, it will not be returned to the manufacturer for analysis.

Event Description
Clinic notes dated (b)(6) 2012 revealed that the patient has experienced several seizures since her prior visit on (b)(6) 2012. Clinic notes dated (b)(6) 2012, revealed that the patient has been experiencing an increase in seizures. Additionally, it was noted that the patient suffered a fall during a seizure on (b)(6) 2012, which resulted in a fracture of the distal radius. The physician believes that the device may be nearing end of service and has recommended the patient follow-up with the cardiologist for an ekg prior to device replacement. The patient has a history of arrhythmia as referenced in mfr report # 1644487-2012-03150.

Event Description
The implant card was received which reported the patient had prophylactic generator replacement on (b)(6) 2012. Attempts for product return have been unsuccessful to date.

Manufacturer Narrative

Event Description
The patient has been referred for generator replacement surgery, however the surgery has not occurred to date. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852882


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:31:07 AM
Model Number 102R
Event Type Injury
Event Description
It was reported that a vns patient has a pacemaker implanted. The implant date or the relationship of their cardiac event to their vns device is not known at this time. The patient's physician who was following the patient at the time has passed away. Good faith attempts are underway for further details about this event. The patient does not currently have a treating vns physician.

Event Description
No interventions are planned for the patient at this time. They will be monitored for a while and followed with a new neurology team. No further information has been received in regards to their pacemaker and their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023497


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:33:16 AM
Model Number 102
Event Date 07/29/2012
Event Type Injury
Manufacturer Narrative

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

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:34:21 AM
Model Number 103
Event Date 04/25/2013
Event Type Death
Manufacturer Narrative

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

Event Description
On (b)(6) 2013, it was reported by the patient's mother that the patient had developed an infection and would be undergoing a heart procedure as soon as possible. Per the mother, the physicians were concerned that the infection may have attached to the vns device (one of several devices implanted in the patient), and they wanted to explant the vns system while they repaired the patient's heart valve. It was stated that the patient's vns had been programmed off for about a year. Follow up found that the patient had been in the hospital for two days after getting the infection from a cardiac surgery related to a cardiac device. The patient had been in surgery two weeks prior to (b)(6) 2013, and it was stated that there was some sort of blood infection near the generator found. It was clarified that there were two procedures being referred to. One in which the artificial heart valve was placed and the infection developed, and the second was the upcoming surgery to remove the device. It is unknown if the removal of the artificial valve ever took place as the patient's mother only stated that the physicians were considering it. Follow up with the patient's neurologist found that the patient had not been seen since (b)(6) 2012, and no information on the cardiac surgery or infection were known. Follow up with the medical records department of the cardiac facility found that the patient passed away from cardiac arrest on (b)(6) 2013. It was stated that the patient experienced cardiac arrest and was sent to the emergency room where the patient passed away. Attempts were made to the treating surgeon and the hospital staff for additional information; however, they were unsuccessful. The surgeon's office stated that they had not seen the patient in the office and could not provide information. The hospital stated that they were bound by confidentiality not to give information. No additional information was provided.

Event Description
The patient's obituary was searched which found the location of the patient's funeral services. Follow up with this site found that the patient was buried with the device, as the funeral home was unaware that the patient had been implanted at the time. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129960


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:35:21 AM
Event Date 06/24/2013
Event Type Injury
Event Description
Attempts for additional information from the initial reporter have been unsuccessful. No additional information was provided.

Manufacturer Narrative

Event Description
During routine case management discussion with a mother who is considering vns implant for her child, the mother related a concern she heard about vns. A friend told her that her niece reportedly had stunted growth of the carotid artery and heart issues following implant of vns. No patient information or physician information was provided. Attempts for additional information from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232904


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:36:12 AM
Event Type Injury
Event Description
On (b)(6) 2014, it was reported that the patient had cardiac issues for some time (prior to vns). The physician requested information on bradycardia and vns; however, he did not provide any additional information on the patient's identity or cardiac events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3600861


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:38:08 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/01/2017
Event Type Injury
Event Description
Patient reported that vns device is causing a cardiac issue initially. Patient was checked out by cardiologist and neurologist and they don't believe device is an issue and didn't see a cardiac issue with patient in a work up. Additional information was received from the neurologist that the patient was experiencing nausea and sweating, which led them to think there was a cardiac issue. The neurologist does not think there is any relationship between patient's cardiac issue and vns therapy. Patient again reported that his vns is not functioning correctly because his head is pounding, he can¿t have bowel movements and is nauseous. Patient was advised to disabled vns temporarily using the magnet until he could see a medical professional. Patient also reports that a neurologist mentioned that vns is affecting his heart. He currently has the magnet taped over the device but reports that it did not disable the stimulation.

Event Description
The headache and constipation were reported to have been observed? more than 6 months ago. Patient is getting follow up workup for nausea and chest discomfort. Patient does have a history of the headache and constipation prior to vns implantation. There were medication changes or other events that could have caused or contributed to the headache and constipation. The physician does not think that the headache and constipation is related to vns. The patient's heart was not affected by the vns per the physician and patient does not experience any cardiac issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7206856


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:39:07 AM
Model Number 102
Event Date 10/09/2012
Event Type Injury
Event Description
Information was received from the patient's currently treating physician reporting that they cannot provide additional information as they just started treating the patient on (b)(6) 2012. Attempts for information from the previously treating physician were unsuccessful as the physician is no longer practicing.

Manufacturer Narrative

Event Description
A health history form dated (b)(6) 2012 indicated that the patient has or had the following symptoms within the past year: irregular heart beat, rapid heart, and fainting. The relationship to these events and vns was not indicated. Of note, the patient also has a history of high blood pressure, high cholesterol and chest pain. It is unknown what interventions have been taken. Attempts for additional information have been unsuccessful to date. The form also indicated the patient has or had cancer within the past year, as reported in mfg report number: 1644487-2012-03443.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:40:07 AM
Model Number 103
Event Date 01/11/2013
Event Type Injury
Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Event Description
Follow up with the patient's mother indicated that the physician is talking about either programming the vns device off for a trial run or having it explanted because he feels that the vns is not covering the type of seizures that the patient has. Attempts have been made for additional information; however, they have been unsuccessful. No other information has bene provided.

Event Description
Additional information was received that product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the patient was hospitalized on (b)(6) 2013 after having two grand mal seizures. The patient's mother reported that the patient had not experienced a grand mal seizure in five years. It was reported that while the patient was hospitalized she began to experience irregular heart rhythms after the second grand mal seizures. The patient's mother explained that the patient's heart rate would decrease when the patient stood up and would increase upon lying down. During the hospitalization the patient also began to experience shortness of breath. The patient's mother indicated that the patient's physician "blew off" the issue. Attempts to obtain additional information are underway; however, no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026508


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:41:35 AM
Model Number 302-20
Event Date 06/28/2011
Event Type Malfunction
Event Description
Additional information was received indicating no x-rays were taken to evaluate for a lead fracture. The physician confirmed that the high impedance is believed to be a result of damage incurred during open heart surgery. The patient has had increased seizures since the time of the surgery that was originally believed to be related to the surgery however the increased seizures did not resolve after some time leading to the physician suspecting an issue. The seizures were noted as slightly improved following surgery and the overall increased seizure frequency was noted as being below the pre-vns baseline. The physician disabled the patient's vns when the high impedance was discovered on (b)(6) 2012.

Event Description
The patient had full revision surgery on (b)(6) 2013, and their explanted products have at this time not been returned for analysis.

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

Event Description
The explanted generator and lead will not be returned for analysis.

Event Description
It was reported that the patient's vns is indicating high lead impedance. The physician believes the vns may have been damaged during cardiac surgery for valve replacement and aneurysm repair on (b)(6) 2011. However, the vns had not been checked since (b)(6) 2011. Both of the cardiac events are reportedly not related to vns therapy. Attempts for additional information have been unsuccessful to date. Surgery to replace the vns lead and generator is likely. No adverse events have been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2650301


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:42:43 AM
Model Number 102
Event Date 01/09/2013
Event Type Death
Manufacturer Narrative

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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986302


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:43:31 AM
Model Number 302-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
On (b)(6) 2012 a vns treating neurologist reported that the vns patient was seen that day for follow-up and high impedance was observed during a system diagnostics test; output=limit/lead impedance=high/dcdc=7. The patient has not felt any stimulation with vns for a month. The patient's device was disabled due to the high impedance and the patient was sent for x-rays. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. The x-rays were reviewed and based on the views provided no cause for the report of high impedance could be found, however, the presence of a micro-fracture or lead fracture in the portion of the lead that could not be assessed, cannot be ruled out. In the x-rays it was noticed that the patient was implanted with a cardiac device; however, the physician reported that the patient's arrhythmia is not related to vns. The type of arrhythmia was not provided.

Manufacturer Narrative
Analysis of programming history. 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=2624335


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:44:46 AM
Model Number 103
Event Date 11/02/2011
Event Type  Injury   
Event Description
It was reported by vns patient's parent that the patient experienced increased seizures, arrhythmia, voice alteration, coughing, vomiting, lack of efficacy, and pupillary miosis. The patient's parent also reported that the use of the magnet did not help abort the patient's seizures. The patient's voice was reported to be suppressed and sometimes presented vomit after coughing. The patient's mother indicated that a physician in (b)(6) tried to increase the frequency but it led to overstimulation for the boy, and the doctor switched the frequency back to 0,75 ma. The patient was reported to have been implanted in the us and now resides in (b)(6) where the patient is not being treated.
 
Event Description
Additional information was received from the area representative indicating the physician confirmed the reported increasing seizures were due to lack of ramping the patient up. The dosing is being determined now and the patient is being followed up. Moreover, the physician confirmed the arrhythmia event had not occurred.
 
Manufacturer Narrative
 
Event Description
Further information was received from the area representative indicating that a new physician saw the patient. The physician indicated he calibrated the generator and now is able to see improvement in the patient's clinical status. The physician indicated the patient's increase in seizures was due to normal disease progression. No arrhythmia was found on the patient in accordance to the physician. The reported lack of efficacy was due to sub-optimal programming of the vns hence not achieving optimal therapy. No interventions have been planned at the moment as the patient is doing well clinically. No further information was received regarding the other events as it was unknown if they were related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353606


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:45:38 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/03/2016
Event Type Injury
Event Description
It was reported by the patient that she had been hospitalized four times since being implanted with a model 106 generator due to device overstimulation. The patient believed that her heart defects may have caused the overstimulation from autostimulation. Two of the four hospitalizations lasted longer than eight days. The patient's device was disabled by the magnet and she said she felt a little better. The symptoms from overstimulation were not reported. Follow up with the patient's neurologist found that the patient had been admitted to the hospital due to passing out episodes with an unknown etiology, but suspected to be due to dysautonomia. The physician indicated that it was unclear if the vns was related to the patient's symptoms. It was indicated that the patient's symptoms did not get better with magnet mode disablement. She indicated that a possible cause was heart problems and it was unclear if the autostimulation feature was playing a role in these symptoms. Reportedly, the patient's current generator's settings had not changed from the previous generator's setting besides the addition of the autostimulation feature. The patient's generator was disabled to see if the patient's symptoms improved. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6283389


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:46:39 AM
Model Number 304-20
Event Date 01/27/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns patient reported that she has been experiencing constant pain to the back of her neck since vns implant surgery on (b)(6) 2012. The patient stated that the pain was so severe the night before that she could not sleep and could not wear her cpap mask because the strap increased the pain. The patient felt that the pain was a 7 on a scale from 1 to 10 but that the pain has decreased after taking 600mg of ibuprofen 30 minutes ago. The patient also reported that there is a burn like marking on the left side of her neck but no redness, swelling, or abnormal drainage. The patient stated that she has called the neurologist and surgeon but has not received a call back. Prior to being implanted with vns, the patient was cleared by her cardiologist. Good faith attempts for further information from the physician were made but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2462385


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:47:24 AM
Model Number 103
Event Date 07/19/2012
Event Type  Injury   
Event Description
The explanted generator and a portion of lead were returned to the manufacturer on 04/29/2016. Analysis of the returned generator indicated that the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). This was successfully verified in the product analysis lab. The battery shows an ifi=no condition. The data in the diag accum diagaccumconsumed memory locations revealed that 9. 140% of the battery had been consumed. Measured battery voltage and consumed capacity parameters are as expected. There were no performance or any other type of adverse conditions found with the pulse generator. The returned portion of the lead containing the manufacturing id tag was not returned thus the model and the serial number of the returned lead portion cannot be verified. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
Further information was received indicating that the patient underwent generator explant surgery on (b)(6) 2014. As reported by the nurse, the device was explanted due to the following reasons: "device failed to demonstrate any benefit as regards seizure improvement, and patient's suspicion that nocturnal seizures may have been made worse". It was reported that no replacement was performed. The return of the explanted generator is expected but it has not been received to date.
 
Event Description
On (b)(6) 2012, it was reported that this patient's seizure activity had changed: the patient was beginning to experience nocturnal seizures when the device was programmed on. When the device was disabled, the events stopped. The patient believed that vns was affected seizure activity. The device was to be disabled on (b)(6) 2012. The patient had previously been experiencing chest pain. The device was disabled when the chest pain was initially reported, and the patient did not experience additional chest pain. Once the device was programmed back on, the pain returned. The chest pain was first observed on (b)(6) 2012. The pain was not believed to be related to vns. An ecg did show changes but there were no changes in pulse. The pain was not limited to the generator site. A cardiology appointment was scheduled, but the event was not believed to be related to vns. Systems diagnostics from (b)(6) 2012 indicated 2421 ohms. The chest pain began coincided with a settings increase to 0. 50 ma. The pulsewidth was lowered to 250 usec. The device remained on until (b)(6) 2012, at which point, the output current was 1. 0 ma. At this time, the patient began to complain of worsening nocturnal seizures. Looking back, her seizures had become troublesome at 0. 5ma, but the patient's settings were increased with the hope of settling the seizures. On (b)(6) 2012, the patient disabled the device with the magnet and requested that the device be programmed off. The device was disabled for a month, and the patient reported that she did not have any seizures (nocturnal) and she had not had any chest pain. On (b)(6) 2012, the device was programmed on to 0. 5 ma. On (b)(6) 2012, the patient reported that the night seizures had returned and that she had experienced one episode of chest pain. The device was disabled. The patient's seizures were reportedly back to pre-vns.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently provided an incomplet event description.
 
Event Description
Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. The explanted generator and a portion of lead were returned to the manufacturer on 04/29/2016. Analysis of the returned generator indicated that the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). This was successfully verified in the product analysis lab. The battery shows an ifi=no condition. The data in the diagaccum consumed memory locations revealed that 9. 140% of the battery had been consumed. Measured battery voltage and consumed capacity parameters are as expected. There were no performance or any other type of adverse conditions found with the pulse generator. The returned portion of the lead containing the manufacturing id tag was not returned thus the model and the serial number of the returned lead portion cannot be verified. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2893543


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:48:07 AM
Model Number 102
Event Date 08/27/2003
Event Type  Injury   
Event Description
It was reported that the patient wants to have the device explanted due to gastric issues. It was reported that the patient has lost 70 pounds and it is still being considered that the vns could be the cause of the gastric issues which resulted in the weight loss. It was reported that the surgery would be for patient comfort and not to preclude a serious injury. No surgical intervention has been performed to date.
 
Event Description
It was reported by the vns patient that she has not had a seizure in a "very long time" but has been having chronic gastritis for years. She indicated that her gastroenterologist suggested she have her vns disabled and explanted. The gastritis was reportedly not attributed to vns however the physician indicated that it might impede improvement with digestion. The patient indicated that her heart rate has increased with stimulation since her vns was first turned on. The patient stated this takes her breath away and the increased heart rate was observed on an ekg. The patient indicated that she has not had her vns checked in a long time. The patient indicated that the vns has been beneficial so she would like to avoid turning the vns off but may pursue vns disablement if it is necessary to help resolve the digestion issues. The patient also indicated that her generator may have migrated due to weight loss and her chest is now more uncomfortable as a result. She indicated that she also sleeps on the same side as her generator is implanted on and that may be contributing to the discomfort. The patient is considering having her vns disabled and/or removed however she had not discussed with a physician. Attempts for follow-up have been unsuccessful to date. Although the patient indicated she may be pursuing intervention, no interventions appear to be planned at this time.
 
Event Description
Additional information was received that the patient had their generator turned off and that the patient was having the vns system explanted due to needed mri for osteo-arthritis. The imaging center will not do the mri with the system implanted. Another call was received the same day that stated that due to the other issue the patient has had with vns the patient would not be re-implanted.
 
Event Description
Additional information was received that the patient was explanted. The hospital required as sign authorization to have the explants sent to the manufacturer for evaluation, so the lead and generator will not be returned to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2682077


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:49:00 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2018
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported by the medical examiner that the patient had passed away. The cause of death was provided as seizure disorder with dilated cardiomyopathy as a contributory condition. The manner of death was provided as natural. The medical examiner did not suspect the death to be related to vns. The lead and generator were returned for analysis. Product analysis was performed on the lead. Setscrew marks were found on the lead connector pin providing evidence of good mechanical and electrical connection was present at one point in time. Continuity checks were performed and no discontinuities were identified. There was no evidence to suggest an anomaly with the returned portion of the device. Product analysis was performed on the generator. The pulse generator diagnostics were as expected for the programmed parameters. The device output signal was monitoring for more than 24 hours in a simulated body temperature environment. No signs of variation in the generator¿s output were shown. 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. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707242


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:49:46 AM
Model Number 105
Event Date 01/06/2015
Event Type Malfunction
Event Description
A voluntary medwatch was submitted to the fda and received by the manufacturer with the report number mw5062653. It was reported that after the patient's second vns implant, which occurred on (b)(6) 2015, that the patient had permanent damage which could end the patient's life. This damage was not specified. It was also noted the patient had nerve damage, permanent sensitivity to touch, damaged nerve/pain, heart problems, and scar tissue. The patient also stated the neuropathy could result in death. The patient also reported that the manufacturer called and stated the surgery never should have been done. No specifics regarding any of the reported information were provided. The manufacturer';s internal databases were reviewed; however, the patient information was unable to be identified based on the lack of information reported on the voluntary medwatch. Additional information related to a previously implanted vns is captured in mfr. Report # 1644487-2016-01518.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5772238


Title: Re: Misc. Cardiac
Post by: dennis100 on June 13, 2018, 08:50:37 AM
Model Number 102
Event Date 11/10/2008
Event Type Injury
Event Description
It was reported a vns therapy patient passed away. The patient experienced cardiac adverse events 4 months prior to the patient's death. Follow up with the medical professionals did not reveal an exact cause of death as no details of the patient's passing were provided by the patient's family; however, the treating physician stated it was "probably not related" to vns therapy. Follow up with the county medical examiner's office did not know the cause of death as an autopsy was not performed. Manufacturer reviewed available programming/diagnostic history and the most recent device diagnostic test was performed in early 2007, at which time the results were with in normal limits. A battery life calculation revealed the patient's generator was 6. 01 years until the elective replacement indicator read "yes". Good faith attempts to obtain the cause of death listed on the patient's death certificate, as well as the patient's vns therapy system for analysis, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1398522


Title: Re: Misc. Cardiac
Post by: dennis100 on June 14, 2018, 12:47:36 AM
Model Number 302-20
Event Date 04/16/2012
Event Type  Injury   
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.
 
Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2818913


Title: Re: Misc. Cardiac
Post by: dennis100 on June 14, 2018, 12:48:08 AM
Model Number 102
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was reported to the manufacturer that the vns pt experienced syncope that led to cardiac events. The pt was hospitalized for the reported events. The pt's device was temporarily programmed off with the use of a magnet, but it is unk if this resolved the reported events. The relationship between the reported events and vns therapy is unk at this time. It is unk if the pt has a medical history of these events. Good faith attempts to obtain add'l info regarding the reported event are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656291


Title: Re: Misc. Cardiac
Post by: dennis100 on June 19, 2018, 01:19:51 AM
Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after her prophylactic generator replacement surgery, she developed an allergic reaction to antibiotics prescribed by neurosurgeon as a precaution. The pt was hospitalized for 3 days ((b)(6) 2011). Also, while she was hospitalized, she was told that her ekg was abnormal which necessitated referral to cardiology, capture in mdr #1666487-2011-00976. Pt also reports hand tremor, cognitive issue and memory problems since the generator replacement. Good faith attempts to obtain more information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082998


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:34:03 AM
Model Number 302-20
Event Date 02/16/2011
Event Type  Malfunction   
Event Description
Reporter indicated that a vns pt had a cardiac ablation procedure performed and since then had been experiencing painful stimulation in the throat, and felt the vns was not functioning properly. Attempts for further info from the treating neurologist about what type of arrhythmia the pt was experiencing and vns function are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2031212


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:34:36 AM
Model Number 103
Event Date 02/02/2012
Event Type  Injury   
Event Description
It was reported that a vns pt had two cardiac ablations done and developed a blood clot in her lung. She is on anticoagulant therapy, but it was reported that her vns is doing well. The reporter did not indicate any of the events were related to vns. However, attempts for add'l info from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2465252


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:35:11 AM
Model Number 302-20
Event Date 07/23/2007
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, a pt was experiencing magnet failure as the magnet would not stop the device from stimulating. Also the pt was experiencing continuous stimulation that lasted for 3-4 hours after a magnet stimulation. Due to the continuous stimulation, the pt was experiencing muscle spasms. The pt reported increased seizures. The nurse practitioner in the physician's office stated, the reported issues were not related to vns therapy. She stated, the pt was experiencing high anxiety and cardiac issues that caused the "perceived issues". The np re-educated the pt on swiping the magnet and what the intended results would be and has scheduled the pt for a cardiac cath.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476458


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:35:53 AM
Model Number 102
Event Date 01/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Further review of the event reported revealed that the patient's cardiac condition is unrelated to vns. The cardiac condition is in reference to the wpw (wolff-parkinson-white) syndrome which is a congenital condition that results in tachycardia. Based on this information, the patient's cardiac condition is unrelated to vns therapy or surgery.
 
Event Description
Clinic notes dated (b)(4) 2014 reported that the patient has a ¿history of seizure disorder as well as cardiac condition with history of wpw syndrome. ¿ attempts for additional information on the cardiac condition and relationship to vns have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639494


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:36:30 AM
Model Number 103
Event Date 05/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2013 it was reported that due to the patient's experience with irregular heart rhythms the cardiologist did an ablation. Following the ablation the patient began to have a low heart rate and a pacemaker was implanted. After having the pacemaker implanted the patient started to become dizzy, sleepy, with trouble eating (weight loss), and vomits with dizziness. It was also reported that the patient experienced their shoulder and neck tightening up when they swiped the vns magnet across the generator. Good faith attempts are currently being performed.
 
Event Description
Follow up with the physician found that he was not under the impression that the patient's complaints of experiencing irregular heart rhythms, dizziness (which led to vomiting), sleepiness, inability to eat (leading to weight loss), or tightening of shoulder and neck area were related to the patient's vns. The physician stated that the patient has had extended periods in which he was asymptomatic with his device turned on, and, conversely, he has reported the above symptoms with his device disabled. It is the physician's understanding that the patient is currently undergoing a cardiac workup to explore a cardiovascular etiology for his complaints. Lastly, the physician stated that as he believes none of the patient's problems are caused by his vns, he is unable to provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3212285


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:37:28 AM
Model Number 102
Event Date 04/17/2008
Event Type  Injury   
Event Description
Reporter indicated that a vns patient implanted for 2 years, now experiences a prolonged q-t interval. The patient was reported to have a family history of cardiac problems and further testing is planned to determine if vns is a factor.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1047219


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:38:03 AM
Model Number 103
Event Date 02/22/2013
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to shortness of breath. It was reported that the device settings were decreased; however, it was not known if this resolved or improved the patient's shortness of breath. It was reported that the shortness of breath started three days prior after device settings were adjusted to previous settings. The patient's treating neurologist does not believe that the shortness of breath is related to vns therapy; however, a cardiologist at the hospital evaluated the patient and is concerned that the device may be stimulating the patient's phrenic nerve. The patient's pharmacist reported on (b)(6) 2013 that the patient was hospitalized due to the patient experiencing fluctuations in heart rate following device setting adjustments. The pharmacist reported that the patient's heart rate increases when the patient stands up and decreases when the patient lies down. The pharmacist reported that the treating neurologist does not believe that the heart fluctuations are associated with vns therapy. Additionally, the pharmacist indicated that the patient's device was programmed off approximately a week prior to see if this would help, but that the patient's symptoms have continued. (b)(6) 2013 the patient's aunt reported that the patient has been having problems breathing with stimulation. The patient's aunt indicated that the treating neurologist does not believe the difficulty breathing is related to vns therapy and that the neurologist will not discuss this with the family and that they are becoming concerned. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
The physician reported that he believes there is no relationship of the shortness of breath and fluctuations in heart rate to the vns therapy. The shortness of breath and fluctuations do not occur with device stimulation. The physician noted that the vns was programmed off and the patient experienced a change in symptoms and that now the vns therapy is back on and the patient is doing well. The physician noted that the patient did not have a medical history of shortness of breath prior to vns therapy. The patient was seen by a cardiologist and did not have any clinically significant arrhythmias to the physician's knowledge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3017923


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:38:41 AM
Model Number 103
Event Date 03/26/2013
Event Type  Injury   
Event Description
A vns consultant was asked to go to a local hospital and check a patient's device. The patient was in the hospital and the patient had his magnet taped over the device. She was told that if they remove the magnet the patient has asystole with stimulation. The patient's device was not checked as they did not want to have an asystole occur. Good faith attempts are underway for further details.
 
Event Description
External cardiac defibrillator paddles were used on patient in the er and also had a ct scan. Asystole started/noted in er when admitted. He has a condition called wolff-parkinson-white syndrome and has had arrhythmias associated with that. There for no prior recent vns programming changes prior to events. System diagnostic testing performed in icu: 1410 ohms/ok. Device programmed to zero output current/zero magnet output current (b)(6) 2013. In er/icu - events were believed by the attending physicians to be attributed to vns stimulation and occurred during stimulation but did not occur when the magnet was in place over the generator. The patient's treating neurologist did not believe these events were due to vns and will be following the patient until further assessment takes place. The attending physicians did believe the vns was contributing to their cardiac events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3067719


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:39:24 AM
Model Number 102R
Event Date 08/31/2012
Event Type  Injury   
Event Description
Additional information was received indicating generator replacement surgery has occurred. The explanted generator was returned and underwent analysis. The generator performed to specifications and no anomalies were found.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was being referred for prophylactic battery replacement and the patient was experiencing an increase in seizures. No further information was provided. Follow-up with the physician's office found the patient has been experiencing difficulty with medications however the relationship of this to the increased seizures was not specified. The site also indicated that the patient was being referred to a cardiologist for prolonged qt syndrome. The relationship of this syndrome to vns was not specified. The patient's vns was previously disabled on (b)(6) 2010, due to an unknown reason. It is unknown if the patient's vns has been re-enabled since then. Attempts for additional information have been unsuccessful to date. Surgery to replace the patient's generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766296


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:40:59 AM
Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
A letter was received from the treating vns physician who reported that the physician is not aware of any evidence implicating that the patient's vns caused a cardiac dysrhythmia. The patient had structural abnormalities (as described in her ep study) that responded well to the ablation procedure on (b)(6) 2013. Since he is not convinced that there is a correlation between her cardiac rhythm and her vns, he was unable to provide additional information.
 
Event Description
A cardiologist reported that the vns patient was going to undergo a cardiac ablation to correct an arrhythmia. She indicated that the arrhythmia may be related to vns but it also be related to the patient's seizures. She was not certain. Follow-up was performed with the cardiologist following the cardiac ablation. Clinic notes dated (b)(6) 2013 reported current diagnoses of seizures with epilepsy, syncope and collapse, and palpitations. The patient was noted to have ongoing problems with seizures progressing so the treating vns physician contacted the cardiologist. The patient was evaluated by the physician and cardiologist in the hospital and had a monitor. In spite of all of the efforts, she has was having ongoing seizures. She also was having palpitations on an almost daily basis which last up to 30 minutes. She had a treadmill stress test on (b)(6) 2013 and it did not show any evidence of ischemia. She did have questionable atrial arrhythmias on the treadmill at maximal stress. On her event monitor last summer, she had episodes of underlying sinus rhythm and she did have repeated episodes of atrial arrhythmias with atrial cycle lengths around 200 ms, some of which looked like flutter and some more looked like atrial fibrillation. Her rate would be in the 100-120 range. She said she was not taking anything at the time including an episode where her heart rate went to 150, and she says that she was absolutely not doing anything that would have caused that from a physiologic standpoint. Her echocardiogram last (b)(6) showed normal left ventricular function with no significant abnormalities. The vns physician indicated to the cardiologist that if nothing can be offered from a cardiac standpoint, she will need to see a neurosurgeon to resolve the issue. Review of the ecat strips, which the vns physician has performed on his patients who have underlying sinus bradycardia, with rates in the 60s and then tachycardia with rates around 100-120 with a:a intervals at times that look consistent with atrial flutter or atypical coarse atrial fibrillation. The patient has no previous history of significant trauma, and no previous interventional or invasive cardiology procedures. The patient had an event monitor in (b)(6) 2012, echocardiogram (b)(6) 2012, treadmill test (b)(6) 2013; left ventricular ejection fraction: via echo. Cardiac analysis shows regular rhythm, s1 and s2 normal, no s3 or s4, apical impulse not displaced, no murmurs, no gallops, and no rubs detected. The cardiologist's impression indicated atrial arrhythmias, possible atrial flutter, and palpitations. The patient had a scheduled electrophysiology study and possible ablation scheduled for the next week. The cardiologist suspected that the patient may have a tendency to atrial fibrillation. The patient had (b)(4) study for atrial arrhythmias, possible atrial flutter, syncope, seizures, palpitations, normal lv fxn, and vns. She had successful ablation for avnrnt and aflutter. Follow up was indicated for patient to have a 24 hour holter monitor in 2 months with office visit to follow in 3 months. Additionally, the cardiac cath report dated (b)(6) 2013 was received. She was "referred as she was having clinical events of tachycardia related to her seizure medications. At this point intervagal nerve stimulator at this point. She is also having recurrent symptoms that are concerning for possible arrhythmia, and monitors have shown abnormalities including tachycardia consistent with an arrhythmia, possibly atrial flutter. If there is not an arrhythmogenic component to her symptoms, then it is felt that she would be facing neurosurgery to try and address the focus of her seizures. Subsequently, after discussion and documentation of arrhythmias, she has elected to proceed with ep study and possible ablation. It is felt that if there is no arrhythmias induced, then the following consideration would be anatomical ablation of atrial flutter". During the ablation procedure, "atrial tachycardia was seen that had rates of 140 beats per minute. Due to this uncertain clinical scenario as it should not be reinduced. The patient underwent successful ablation for two forms of psvt (avnrt and aflutter). The cardiologist indicated in the notes that it is believed the patient was having both of these arrhythmias clinically and would benefit from ablation. The patient's medications were continued at that time. Attempts for additional information regarding these events to the treating vns physician have been unsuccessful to date. The relationship of the arrythmia, increased seizures and syncope to vns are unclear to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018075


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:42:00 AM
Model Number 101
Device Problem No Information
Event Date 09/06/2010
Event Type  Death   
Event Description
Additional information was received from the treating physician indicating that the patient's death was due to cerebellar degenerative disorder and was not believed to be related to vns. Additionally, it was indicated that the generator had previously been disabled.
 
Event Description
Follow up with the funeral home's director found that the patient was cremated and the device was not removed at the time. The director stated that typically explanted devices are destroyed after being removed. Attempts for a death certificate were unsuccessful as the state will not provide the information to the manufacturer. Additionally, attempts for information from the treating neurologist have remained unsuccessful to date.
 
Manufacturer Narrative

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died from causes of atherosclerotic heart disease, essential (primary) hypertension, and cardiac arrhythmia, unspecified. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported on (b)(6) 2012 that the patient passed away. The initially reporter was not able to provide any additional information at that time. A search of the social security index revealed that the date of death was (b)(6) 2010. Attempts for additional information and product return have been unsuccessful to date.
 
Event Description
The death event was reviewed on (b)(4) 2012, and with the available information has been determined to be possible sudep. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a cause of death. Programming history was reviewed on (b)(4) 2012. No diagnostic history was available. No anomalies were observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662130


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:42:56 AM
Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Event Description
The psychiatrist was wondering on (b)(6) 2012 if the patient's device could be disabled, as the patient desired for the device to be turned off. However, the device has not been turned off. It appears that the patient desires for the device to be disabled due to her programmed settings which have been low throughout the implant history.
 
Manufacturer Narrative
The initial report inadvertently did not include that the patient wanted the device turned off.
 
Event Description
It was reported that apatient now has a pacemaker implanted. The patient can reportedly no longer use the vns magnet to stop stimulation or it "stops the pacemaker. " the patient planned on following up with her psychiatrists. It is unclear when the patient's arrhythmia first occurred, and the relationship to vns is unknown with the information provided. Attempts for additional information from the psychiatrist have been unsuccessful to date. A review of the patient's programming/diagnostic history was performed with the history available in the in-house database, however there were no diagnostics available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2552987


Title: Re: Misc. Cardiac
Post by: dennis100 on June 23, 2018, 12:43:42 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/04/2006
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A patient reported periodic bradycardia approximately 3 weeks after implant surgery. The arrhythmia reportedly was not present prior to vns implant; however, vns had not been turned on at the time the arrhythmia was first identified. The patient was evaluated by a cardiologist, who determined that the events were not related to vns, but to her neurological medications since the vns had not been enabled. The patient was given a cardiac work-up, which came back negative. The neurologist noted that the patient's heart rate was in the high 30s and she was also experiencing hypotension (blood pressure 70/30) and syncope. The patient had been hospitalized for these issues, which the physician reported began prior to stimulation being enabled. The neurologist reported that the vns was programmed to low settings to evaluate the patient's response to stimulation and mitigate the frequency of the bradycardia episodes in the event that they occurred with stimulation. The patient's heart rate reportedly increased by 8-10 beats per minute during stimulation. Impedance was within the normal limits. A company representative reported that the patient had a preexisting pulmonary embolus, which required clearance prior to vns implantation. The surgeon later evaluated the patient and reported that the bradycardia did not appear to occur with stimulation. The surgeon reported that he implanted the vns electrodes below the cardiac branches of the vagus nerve. The generator had been turned off several weeks after the initial occurrence of bradycardia, and the surgeon did not believe that the bradycardia was related to vns as the bradycardia did not stop after stimulation had been disabled. Over a decade after the initial report of bradycardia, the patient reported to the manufacturer that her vns caused her to go to the er constantly with severe chest pain and arrhythmias. The patient reported that her blood pressure and heart rate would plummet, nearly requiring the use of a pacemaker. The patient reported using a magnet to relieve some of the pain, but much of it persisted. She also reported experiencing an increase in seizures. The patient was in intensive care often due to the reported events. The patient eventually underwent vns lead and generator explant surgery. The patient reported that the arrhythmias resolved after explant, but a bundle block remained. The patient reportedly still experienced problems trouble regulating her heart rate and blood pressure. The manufacturer's database of programming history was reviewed for the patient's generator. Diagnostics performed on the date of implant confirmed proper device function. A significant portion of the programming history was unavailable for review; however, stimulation was observed to be enabled at a clinic visit 10 months after implant. The vns was then programmed off. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7372277


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:24:23 AM
Model Number 103
Event Date 09/22/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a study patient was hospitalized due to worsening of heart failure. It was reported that the worsening of heart failure was not related to vns implant , but probably related to device stimulation. The patient was managed with diuretics, ace inhibitors, beta blockers and other medications. The patient was discharged on (b)(6) 2013 in hemodynamically stable condition. It was noted that the patient recovered without sequelae.
 
Event Description
It was later reported that the worsening of heart failure was not related to device stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3429783


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:25:00 AM
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient is going to get a pacemaker due to complete heart block. The cardiologist indicated that the patient was implanted in (b)(6) 2011 and had a left bundle branch block prior to implant, but was unsure if the condition has been exacerbated by vns therapy or if it is a natural progression of the disease process. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3432870


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:25:41 AM
Event Date 06/24/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
During routine case management discussion with a mother who is considering vns implant for her child, the mother related a concern she heard about vns. A friend told her that her niece reportedly had stunted growth of the carotid artery and heart issues following implant of vns. No patient information or physician information was provided. Attempts for additional information from the reporter have been unsuccessful to date.

Event Description
Attempts for additional information from the initial reporter have been unsuccessful. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232904


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:26:22 AM
Model Number 102R
Event Date 01/24/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that a patient had a prolonged seizure and was taken to the hospital. The patient felt the seizure coming on and attempted to take depakote and went in to generalize tonic/clonic seizure. It was noted that it may have been a few seizures back to back rather than a single seizure but this has not been confirmed. While that the hospital the patient was experiencing atrial fibrillation with rapid ventricular rate. The ekg report documented atrial flutter with variable av block. He has had sinus tachycardia with his seizure before and has heart palpitations, and there is no history of cardiac pathology as far as they can tell. The following day the patient was back to baseline and ready to go home. There was no relationship to vns provided for the prolonged seizure or arrhythmia. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician that the patient is very non-compliant. The patient has not reported any adverse events to her so she had no information. The physician has not information to provide on the seizures or arrhythmia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156815


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:26:55 AM
Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported that a patient developed cardiomyopathy. The device was programmed off and the patient was given lisinopril and coreg as a result. In 2008, the patient began to notice shortness of breath and decrease in energy. In 2009, the patient had an echocardiography which was abnormal and at that point, the patient was diagnosed with cardiomyopathy. The patient was diagnosed with ankylosing spondylitis and is taking methotrexate and endbrel for this condition. The patient is also morbidly obese and has hypothyroidism. The patient had ecg in 2005 that showed a nonspecific t wave abnormality and this procedure was repeated the next day with results that the nonspecific t wave abnormality improved. The device has been programmed off so that further testing can be performed. It is unk whether or not the cardiomyopathy is related to the device. The patient will follow up with the physician in 2010 at which time, the echocardiogram will be repeated. Good faith attempts to obtain additional information are in process.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:27:31 AM
Model Number 102
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that she was experiencing pain in her hand every five minutes and wanted to know if being implanted with a pacemaker has any interference with the vns implant to cause the pain. The patient was referenced to her physician. Follow up with the patient's physician found that she had no information on the patient's cardiac events and why the patient was implanted with pacemaker. The physician stated that she would try to look into finding out more about the patient's events; however, no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3197467


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:28:13 AM
Model Number 101
Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was diagnosed with a cardiac myopathy which her physician feel is related to hypoxia. The cause of the hypoxia cannot be determined. The patient began noticing symptoms of hypoxia approximately 12 months prior to the report. On (b)(6) 2012, the patient went to the emergency room because the symptoms were sever and was formally diagnosed with hypoxia. Follow-up with the physician's office indicated that the physician had just left on a 6 month leave. The patient had their generator turn off per patient's request following the report to the manufacturer. The nurse said that the physician would be the only one that would be able to address questions regarding vns. The physician was sent questions to be addressed when he returned.
 
Event Description
Additional information was received that the patient requested to have her vns turned off due to ongoing issues they she was having due to smoking with chronic obstructive pulmonary disease (copd). The copd is not related to vns or made worse by the vns the patient just request off as she was having issue with oxygen saturation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3037982


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:28:48 AM
Model Number 102
Event Date 09/28/2011
Event Type  Injury   
Event Description
Reporter indicated a vns patient was diagnosed with cardiomyopathy in (b)(6) 2011, and that this is under good control. Attempts for further information are in progress.
 
Event Description
All attempts to the reporter for further information have been unsuccessful to date.
 
Event Description
Reporter indicated the patient's cardiomyopathy is due to an unknown cause. Interventions for the cardiomyopathy included wellbutrin and lamictal medications, and the vns output current was decreased from 3. 0ma to 2. 5ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2429007


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:29:34 AM
Model Number 102
Event Date 03/28/2012
Event Type  Injury   
Event Description
It was reported through clinic notes that were received on (b)(6) 2012 and dated (b)(6) 2012, that the patient has a cardiac conduction problem that runs in her side of the family. The name of the cardiac disorder is currently unknown. While it appears that this issue is hereditary in nature, the physician indicated that he wanted to obtain more information on the issue so that he could ensure that the patient's medication and vns therapy would not affect the condition. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744290


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:30:19 AM
Model Number 104
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative
Pt ag: age at time of event: the initial report inadvertently reported the age incorrectly. Date of event: the initial report inadvertently reported the event date incorrectly. The physician reported the patient developed the congestive heart failure over the past few years.
 
Manufacturer Narrative

Event Description
Follow-up with the physician revealed that the device was disabled on (b)(6) 2015. The physician stated it was unknown whether it will be re-enabled at a future date. The patient reports that dyspnea decreased after disabling. The patient stated they feel better overall after disabling. The device was turned off to prevent serious injury related to the report of tachycardia.
 
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: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:31:04 AM
Model Number 102
Event Date 10/27/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was admitted to the hospital due to atrial flutter. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4273777


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:31:43 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an atrial flutter and it was suspected to be related to vns therapy. Follow up with the medical professional revealed the patient had an atrial flutter 2:1 and tachycardia about 130 beats per minute, or bpm. Ecgs were performed with the vns on, autostim off, and the vns disabled with no change in the readings. Further follow up with the medical professional revealed that they were unsure of the relation of the atrial flutter and vns, but that it was possible sympathetic rebound after stimulation. It was stated that no change in ecg was possible as the readings were taken in a short period of time and cardiac rhythm had no sufficient time to restore. It was reported that they were looking into long term side effects of aeds, but felt this was an unlikely cause. The patient's autostim mode was disabled upon observation of the atrial flutter. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7557819


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:32:17 AM
Model Number 102
Event Date 01/18/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient has a history of congestive heart failure and a cerebrovascular accident (cva). The relationship of these events to vns was not provided. Additional information has been requested from the neurologist but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2465307


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:33:02 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 note that the patient has a past medical history of possible heart attack. A pre-anesthesia evaluation dated (b)(6) 2013 noted that the patient has a history of myocardial infarction (2008), coronary artery disease and congestive heart failure. The notes indicate that the patient recently received cardiac clearance. The relationship of the patient's cardiac history to vns is unknown. Attempts to obtain additional information will be made, but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3458127


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:34:02 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. Cardiac
Post by: dennis100 on June 24, 2018, 04:34:44 AM
Model Number 102
Event Date 01/10/2013
Event Type  Injury   
Event Description
The patient reported that she developed congestive heart failure while on vns therapy and that her physician believes that the vns is causing her heart issues. The patient had made a similar report in 2013 however her treating physician at the time denied that vns was causing the congestive heart failure. The previous physician has not seen the patient recently. The identity of the patient's current physician is unknown. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The identity of the patient's current physician was confirmed. However no additional relevant information has been received to date in regards to the patient's congestive heart failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6182955


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:35:17 AM
Model Number 102
Event Date 06/23/2009
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2009 from congestive heart failure. The relationship between the patient's death and vns is currently unknown, and attempts for additional information have been unsuccessful to date.
 
Event Description
Additional follow up was performed with the patient's funeral home who indicated that the device was unavailable for return; however they were uncertain if it was explanted or discarded. Attempts for additional information regarding the patient's death have remained unsuccessful.
 
Event Description
Additional information was received from the physician's office indicating that they had lost the patient's medical history during a move and would be unable to provide any more information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2485449


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:35:56 AM
Model Number 102
Event Date 12/01/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death and its relationship to vns are unknown. No further information relevant to the patient¿s death has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient did not have any concurrent illnesses or diseases at the time of death. The patient was receiving vns therapy at the time of death. The patient died (b)(6) 2014. The generator was explanted after death. The believed cause is suspected sudep and cardiomyopathy (dilated) found on autopsy. The death is thought to be unrelated to vns therapy. The patient was found in bed 1 week after he died and his body was in a position suggestive of a seizure. The patient¿s cardiac issues were only made aware to the neurologist after the autopsy. The patient was compliant with aeds. The obituary states that the patient passed away from natural causes at his home in wa. Obituary states there will be no funeral so no funeral home is listed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4403674


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:36:40 AM
Model Number 102
Device Problem No Information
Event Date 09/27/2011
Event Type  Death   
Event Description
It was initially reported that the patient passed away. The physician reported that the patient had been in hospice care in (b)(6) 2011 and they had not heard from the patient since then. The reason the patient was in hospice was unknown by the office. Search of the social security death index revealed that the patient had passed away. The physician's office was unaware of this. This death event has been reviewed and with the available information has been determined not to be sudep. The patient was under hospice care at the time of death due to an undisclosed terminal illness. As the patient was in a poor state of health at the time of death, the death was likely not unexpected. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2011 due to causes of other forms of chronic ischemic heart disease; other forms of chronic ischemic heart disease; unspecified mental retardation; atherosclerotic heart disease; ischemic cardiomyopathy; atrial fibrillation and flutter; congestive heart failure. Underlying cause of death was provided as major cardiovascular disease. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: inadvertently not provided in follow-up report #01. The received date for follow-up report #01 was 03/03/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2516883


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:37:13 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 02/26/2013
Event Type  Death   
Event Description
It was found through a search of candidates that may need battery replacement that this patient had passed away in a hospital. Prior to death, the patient had a stroke and was diagnosed with congestive heart failure. The patient's neurologist indicated that the cause of death was probably old age. The cause of death and its relationship to the vns device is unknown. The patient's available programming history was reviewed. System diagnostics were within normal limits and no anomalies were found. No additional relevant information has been received to date. The product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6323845


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:37:57 AM
Model Number 102
Event Date 02/23/2016
Event Type  Death   
Event Description
It was reported by the physician's office that the husband had called a few days after the patient's death and stated the patient had gone to the hospital for a few days and had passed away. The reason for the hospitalization is still unknown. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
It was reported the patient had been sick and hospitalized prior to passing away. A reason for hospitalization is currently unknown. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Date of event; corrected data: the information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received from the medical records department of the hospital where the patient had reportedly passed away. In the notes, it was reported the patient arrived to the emergency department on (b)(6) 2016 due to a fall and labored breathing. It was noted the patient was on hospice and had been having complaints of worse coughing and breathing over the last few days. The patient was diagnosed with bronchitis chf (congestive heart failure) exacerbation, pneumonia, and uti (urinary tract infection). The patient was discharged back home via ambulance with instructions for taking medication for the uti. No interventions for the chf were noted. No further information on the cause of death or the exact date of death was given. There was no allegation against vns noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549235


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:38:34 AM
Model Number 103
Event Date 09/19/2012
Event Type  Injury   
Event Description
It was reported by the physician that the vns patient was complaining of 'heart racing' and 'chest pain' over the past two weeks. The physician ordered a holter monitor to confirm if an arrhythmia was present. The relationship of the events to vns is unknown. Last known diagnostics were taken on (b)(6) 2010 and were normal. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received that a faxed response was received from the physician. None of the questions were addressed but clinic notes were attached. In the clinic notes it reported that the patient had central apnea and obstructive sleep apnea. Additional follow-up indicated that it was unknown if the apneas were related to vns. The patient has vns placed prior to the sleep study that resulted in the formal diagnosis of the apnea but the patient has had a history of snoring and sleep disturbances prior to vns and is suspected that the patient has apnea prior to vns. The patient had large tonsils that contributed to obstructive component of the apnea and once those were removed her "scores" got better.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:39:17 AM
Model Number 102
Device Problem No Information
Event Date 09/27/2011
Event Type  Death   
Event Description
It was initially reported that the patient passed away. The physician reported that the patient had been in hospice care in (b)(6) 2011 and they had not heard from the patient since then. The reason the patient was in hospice was unknown by the office. Search of the social security death index revealed that the patient had passed away. The physician's office was unaware of this. This death event has been reviewed and with the available information has been determined not to be sudep. The patient was under hospice care at the time of death due to an undisclosed terminal illness. As the patient was in a poor state of health at the time of death, the death was likely not unexpected. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2011 due to causes of other forms of chronic ischemic heart disease; other forms of chronic ischemic heart disease; unspecified mental retardation; atherosclerotic heart disease; ischemic cardiomyopathy; atrial fibrillation and flutter; congestive heart failure. Underlying cause of death was provided as major cardiovascular disease. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: inadvertently not provided in follow-up report #01. The received date for follow-up report #01 was 03/03/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2516883


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:39:58 AM
Model Number ASKU
Event Date 07/04/2005
Event Type  Death   
Event Description
Additional information was received on (b)(6) 2012 when the physician stated that the device was not related to vns and the device was not explanted after the patient died. The physician has not seen the patient in a while so he did not have any additional information to provide. Good faith attempts to obtain a copy of the death certificate were unsuccessful as the state does not does not provide without family consent. A sudep evaluation was performed and the death was determined to not be sudep.
 
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2012, that a vns patient passed away. The patient's family stated the patient died of cardiomyopathy however the physician who reported the event stated the patient did not have any cardiac issues that he was aware of. The physician believes the patient died due to a seizure because the patient went to the er due to a seizure and then wandered out of the room. The patient was later found dead in the hospital stairway. The physician was not able to confirm the cause of death and did not have any more information to provide. The physician stated that he if became aware of any additional information, he would reported it to the manufacturer. Good faith attempts to obtain additional information are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2527899


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:40:46 AM
Model Number 103
Event Date 03/31/2014
Event Type  Death   
Event Description
The physician reported that the patient experienced a reduction in seizures with vns therapy. The patient was receiving vns therapy at the time of death. The generator was explanted after the patient's death. The believed cause of death was cardiac arrest - cardiomegaly. The death was reported to not be related to vns. An autopsy was performed which revealed the circumstances of death as seizure followed by cardiac arrest. The patient had a history of cardiac problems. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
The coroner reported that the cause of death was heart failure and epilepsy, right ventribular hypertrophy and transposition of great arteries. It was reported that although the death could be categorized as sudep, the degree of cardiac abnormality was considered to have been significant and likely caused an arrhythmia leading to cardiac arrest. Analysis of the lead was completed on 06/24/2014. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on 07/08/2014. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient passed away. 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=3767233


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:41:22 AM
Model Number 103
Device Problem No Information
Event Date 10/05/2012
Event Type  Death   
Event Description
Good faith attempts have been made and no further information has been attained.
 
Event Description
Cause of death information obtained from the (b)(4) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was cardiomegaly which was contributed by unspecified anxiety disorder and other, unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
A vns treating physician reported that one of his patient passed away. No further information has been received from the patient's treating physician. It was reported in their obituary that they died peacefully in their sleep. It is unknown if the patient passed from sudep and at this time given all the information available a probable sudep. Good faith attempts are underway for further information surrounding this patient's cause of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075128


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:42:08 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 09/01/2015
Event Type  Death   
Manufacturer Narrative

Event Description
Follow up with the servicing funeral home showed that the patient was buried, and per their policy that buried patients do not have devices removed, the patient¿s device was unavailable to be returned. Follow up with the office of the treating physician showed the last available settings and diagnostics prior to the patient¿s death, which were within normal limits. Follow up with the hospital tending to the patient at the time of death showed that the patient was admitted for acute respiratory failure. The patient appeared to die from the failure and suspected septic shock from a respiratory source. The respiratory failure was believed to relate to chronic congestive heart failure. The patient was on ventilation until palliative care was initiated. The patient continued to be in respiratory distress of varying degrees until his death. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient had passed away. An online obituary search revealed the date of death, but no other relevant information was stated. The generator and lead device history records were reviewed and found that all specifications were met prior to distribution. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6207787


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:43:04 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 10/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that a patient passed away in the hospital due to an unknown reason. The patient's device was not explanted. Programming history showed that the device was functioning properly approximately two weeks prior to the death. No further relevant information has been received to date.
 
Event Description
The records from the patient's hospitalization and subsequent death were received. The patient presented in the emergency department with cardiac arrest. The patient had a history of chronic heart failure, tracheostomy, and a g-tube. An x-ray of the chest was performed, and there was total opacification of the right lung and lower left lung, which could have been due to pneumonia, effusion, or post-obstructive atelectasis. Labs were performed, and the results indicated hyperkalemia, acute renal failure, and metabolic acidosis. The official cause of death was primarily hyperkalemia and secondarily acute renal failure, anemia, cardiac arrest, metabolic acidosis, respiratory acidosis, respiratory failure, and septic shock. The death was not attributed to the patient's vns in any way.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6342620


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:43:44 AM
Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
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) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:44:26 AM
Event Date 01/12/2010
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away. The patient's neurologist reported that he had no information regarding the patient's death. An online obituary stated that the patient passed away at home. The funeral home reported that the death certificate indicated that the cause of death was valvular heart disease. The relationship of the death to vns is unknown. The funeral home reported that the patient was buried and the device was most likely not explanted. It was reported that the facility only explants devices for cremations. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3915049


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 04:45:12 AM
Model Number 103
Event Date 01/07/2013
Event Type  Death   
Event Description
On (b)(6) 2013, the patient was admitted to the hospital for implantation of the device. Pre-surgical clinical findings included patient complaint of mild chest pain with dyspnea, left shoulder pain, and right lower limb pain and numbness. The patient underwent general anesthesia and implantation of a left vns therapy system on (b)(6) 2013 with model 103 generator serial number (b)(4) and model 304-20 serial number (b)(4) on the left vagal nerve. Per the operative notes, the patient's neck vessels were severely engorged, but there was reportedly no severe bleeding during surgery. (of note, the patient was on anti-platelet medications which inhibit thrombus formation). Two normal mode diagnostic tests were performed intra-operatively per labeling which were within normal limits. The vns system was not programmed on, that is there was no stimulation, at any other time during or after the implantation procedure of (b)(6) 2013. After completing the operation on (b)(6) 2013, the patient did not regain consciousness and was found to have lateralizing neurological signs. An initial ct scan of the head on (b)(6) 2013 revealed a non-hemorrhagic left fronto-tempero-parietal-occipital infarction and evidence of intra-cerebral swelling. The patient was treated with anti-edema measures and pulmonary ventilation was continued post-operatively. Treatment included iv drugs piracetam, mannitol, citicoline. However, the patient's neurological condition deteriorated. A second ct scan of the head on (b)(6) 2013 revealed hemorrhagic transformation of the large infarct. In response to this event, the patient underwent neurosurgery for decompression craniotomy of intra-cerebral swelling. As of (b)(6) 2013, the patient was placed on a ventilator and was haemodynamically stable with worsening renal functioning. The patient was appropriately managed by intensivists, neurologists, neurosurgeon, and cardiologist. In spite of the efforts, the patient was declared expired and was removed from the ventilator on (b)(6) 2013. Per the death certificate, the cause of death was acute left internal carotid artery infarct with haemorrhagic transformation with cerebral edema and dilated cardiomyopathy, acute respiratory failure, peripheral vascular disease, tricuspid heart dysplasia, old anterior wall myocardial infarction leading to cardio-respiratory arrest. In the opinion of the investigator, the relation of the death to the implant procedure was determined to be probable; however, there were clinical factors that likely contributed to the death. The patient had significant coronary and peripheral vascular disease that consisted of severe, three-vessel coronary artery disease and severely impaired left ventricular systolic function, carotid atherosclerosis, bilateral claudication with total infra-renal occlusion of the aorta. The patient also had pre-existing severe mitral regurgitation. The overall impression of the clinical event adjudication committee was that the patient was severely compromised as a result, with risks factors for general anesthesia complications that included previous myocardial infarction, severe ischemic cardiomyopathy, ongoing heart failure, severe mitral insufficiency, total aortic occlusion, and renal insufficiency, and risk factors for thromboembolism that included severely compromised left ventricular function including left ventricular dyskinesis, mitral insufficiency, carotid atherosclerosis, and renal insufficiency. The death is not believed to be related to vns stimulation, as the device was not turned on following implant. Implantation surgery has known potential risks, complications, and side effects identified in both the investigator's brochure and the device labeling. The generator was explanted on (b)(6) 2013. Product return to the manufacturer is expected, but the generator has not been received to date. The lead was not explanted prior to the patient's cremation.
 
Event Description
It was reported that the patient had prolonged hospitalization.
 
Manufacturer Narrative
Describe event or problem: patient (b)(6) male was enrolled in (b)(4), a randomized, multi-site, open-label feasibility study designed to collect data on patients with stable symptomatic heart failure ((b)(6) functional classification class ii/iii) implanted with the model 103 and model 304 vns therapy system from baseline through 34 weeks post-baseline. The clinical trial is being conducted in (b)(6) and has been approved by (b)(6). The vns therapy products used are the same products used in commercial distribution. The patient was randomized to cervical vns implantation on the left vagal nerve. Common device name: product code nke (congestive heart failure) is an unapproved indication.
 
Event Description
The explanted generator was receieved by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated the device was returned due to 'acute ica left infarct with heamorrhagic transformation with cerebral edema leading to death. ' explant date was also listed as (b)(6) 2013.
 
Event Description
Product analysis was completed on the explanted generator. The returned model 103 generator performed within all specifications during electrical testing. There were no adverse functional, mechanical, or visual issues identified with the generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to manufacturer functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2939332


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:44:17 AM
Model Number 103
Device Problem No Information
Event Date 03/08/2012
Event Type  Death   
Event Description
It was reported that the vns patient passed away. Further follow-up revealed that the date and cause of death are unknown as the care residence no longer had the patient's records at the facility. The relationship of the vns to the cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The death certificate was received on 01/06/2015 and reported date of death as (b)(6) 2012. The patient passed away as an inpatient in a hospital. Cause of death was respiratory failure (3 days) due to (or as a consequence of) pericardial effusion (2 weeks) due to (or as a consequence of) pleural effusions (2 weeks) due to (or as a consequence of) myocardial infarction (one month). No autopsy was performed.
 
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) 2012 and the patient's cause of death was major cardiovascular disease with other forms of chronic ischemic heart disease, pericardial effusion (noninflammatory), pleural effusion, not elsewhere classified, pleural effusion, not elsewhere classified, and respiratory failure, unspecified. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of not 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=4051482


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:44:53 AM
Model Number 103
Event Date 06/02/2012
Event Type  Death   
Event Description
Additional information was received as a copy of the death certificate that indicated the cause of death was complications from epileptic seizures with a secondary cause of hypertensive cardiovascular disease. The patient's manner of death was noted as natural. The patient's body was cremated and follow-up with the funeral home found the vns was not removed and likely remains with the body or was discarded. No autopsy was performed.
 
Event Description
It was reported by the neurologist that the vns patient had passed away "due to a seizure. " the patient was receiving vns therapy at the time of death however the patient only began receiving vns therapy on (b)(6) 2012 and had reportedly missed some appointments. The site reportedly is not able to provide any further information. Attempts for additional information have been unsuccessful to date.
 
Event Description
A sudep (sudden unexpected death in epilepsy) evaluation was performed and assessed within the (b)(6) which determined that the death met criteria for classification of possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2712596


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:45:38 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 08/31/2012
Event Type  Death   
Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2012 due to unknown reasons. Diagnostic results did not indicate any device malfunction. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report #s of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: initial report inadvertently listed the incorrect date of system diagnostic results. Implant date, corrected data: initial report inadvertently listed the incorrect implant date.
 
Manufacturer Narrative

Event Description
According to the patient's autopsy report, the patient died at home due to epileptic seizure disorder. Other pathological diagnoses were obesity, hypertensive heart disease, and lymphocytic thyroiditis. The patient had electrocardiograph pads on his left arm and both legs, had a bite on his tongue, and had multiple anti-epileptic drugs in his system at the time of death. The relationship of the death to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256305


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:46:26 AM
Model Number 102
Event Date 03/12/2016
Event Type  Death   
Event Description
In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the (b)(4) lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.
 
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.
 
Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.
 
Manufacturer Narrative

Event Description
The explanted devices were received for analysis on 05/02/2016. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator is underway and has not been completed to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.
 
Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549413


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:47:09 AM
Model Number 102
Device Problem No Information
Event Date 10/28/2012
Event Type  Death   
Manufacturer Narrative

Event Description
Additional information was received via cdc national death index where the patient¿s underlying cause of death was listed as ¿congenital malformation, unspecified¿ with record axis of ¿hypertensive heart disease without (congestive) heart failure,¿ and ¿other and unspecified convulsions. ¿.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2012. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Further information was received that the patient's generator had been explanted and was to be returned. The explant was in the possession of the medical examiner which indicated it was likely explanted after the patient passed away. The generator and lead were returned to the manufacturer for analysis which also indicated the lead had been explanted after the death. Product analysis has not been completed to date on either the lead or generator. The medical examiner indicated the patient's cause of death was "intractable seizure disorder". No additional relevant information has been received.
 
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) 2012, and the patient's cause of death was unspecified congenital malformation, contributed to by hypertensive heart disease without (congestive) heart failure, contributed to by other and unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible 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=3903250


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:47:42 AM
Model Number 102
Event Date 06/27/2007
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) 2007and the patient's cause of death was cerebral cysts, including hypertensive heart disease without (congestive) heart failure, atherosclerotic cardiovascular disease, and other and unspecified convulsions. 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 definite 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=5293346


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:48:22 AM
Model Number 103
Device Problem Device operates differently than expected
Event Date 08/02/2011
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) 2011 and the patient's cause of death was due to major cardiovascular disease, hypertension and unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep.
 
Event Description
A sudep reconciliation was performed by the national death index (ndi). This information was reviewed by the manufacturer. Per the updated sudep reconciliation, this death was provided as definite sudep.
 
Manufacturer Narrative
Describe event or problem; corrected data: the patient¿s cause of death was hypertensive heart disease without (congestive) heart failure. Previous supplemental mdr # 1 inadvertently listed the incorrect cause of 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) 2011 and the patient's cause of death was due to hypertensive heart disease without (congestive) heart failure.
 
Event Description
It was reported by the pt's physician that the pt had passed away. The pt had been "doing great", but her mother found her deceased. The physician stated the pt had passed away due to cardiac issues. The pt did not have a pre-vns cardiac issue. The pt had a tia prior to vns, though, and was very obese per the physician. The physician stated the pt did use her magnet many times before her death and wondered if this could have contributed. Further info indicated that the pt's device had been enabled on (b)(6) 2011, and the pt used her magnet "very frequently. " the pt was then seen on (b)(6), and then on (b)(6) when the signal frequency was reportedly increased. The pt canceled her visit for (b)(6) and then found dead on (b)(6). Post-mortem eval showed "old heart disease" and possible heart attack. The pt's cardiac risk factors were obesity and occasional smoking. Also, the pt had a greater than 50% seizure reduction with the vns sys. The vns was not explanted, and the physician did not know the relationship between the vns and the death. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234298


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 05:49:18 AM
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. Cardiac
Post by: dennis100 on June 24, 2018, 05:49:59 AM
Model Number 102
Event Date 11/21/2008
Event Type  Death   
Event Description
Manufacturer performed a death sweep and it was noted the patient had died. The patient's cause of death was reported per their coroner to be hypertensive cardiovascular disease and listed as natural. The patient had not eaten anything for three days prior to their death and was drinking liquids. The patient was discovered deceased at home in their bed. No trauma was noted. No suicide note. The patient's vns that was explanted at the time of death was discarded therefore will not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1398527


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 06:00:34 AM
Model Number 102
Event Date 08/04/2006
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626



Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 12:46:39 PM
Model Number 105
Event Date 03/04/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away from cardiac failure. No additional relevant information was available. It is unknown if the vns therapy was related to the cause of death. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4644856


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 12:47:21 PM
Model Number 102
Event Date 01/15/2011
Event Type  Death   
Event Description
Follow-up with the funeral home showed that the patient was cremated and the device was explanted and disposed. The cause of death was stated per the medical examiner as hypertensive cardiovascular disease. An attempt for the death certificate was made but is unavailable since the state of death does not provide the death certificate to the device manufacturers.
 
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that this vns patient is deceased. The patient's psychiatrist is also deceased, so further follow-up is not possible. Obituary searches revealed that the date of death was (b)(6) 2011. The patient was a resident of (b)(6). Attempts for the patient's death certificate have been made but no further information regarding the patient's death has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4683650


Title: Re: Misc. Cardiac
Post by: dennis100 on June 24, 2018, 12:48:13 PM
Model Number 102
Event Date 09/26/2007
Event Type  Death   
Event Description
Reporter indicated a pt's death was possibly due to exacerbation of a lethal ventricular arrhythmia by vns therapy and severe underlying cardiac disease. The pt was implanted on the right vagus nerve. The pt was buried with the vns and no autopsy was performed.
 
Manufacturer Narrative
Clin auton res (2007), exacerbation of electrical storm subsequent to implantation of a right vagal stimulator. Doi 10. 1007/s10286-007-0440-1. Shalaby, a, et al.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1006210


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:18:36 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 10/03/2012
Event Type  Death   
Event Description
It was reported by the patient's mother-in-law that the vns patient passed away on (b)(6) 2012. Follow-up with the patient's last known treating physician was performed. The physician had not seen the patient since (b)(6) 2008, and therefore, he was unable to provide an assessment on the relationship of the patient's passing to vns. The patient died due to 'failure to thrive,' per the obituary, so the physician reported that it was unknown if it was sudep related. The patient had a seizure reduction from vns therapy, but it was unknown from the physician if the patient was receiving vns therapy at the time of death. The patient had a history of concurrent illness/diseases; sick sinus syncope, pacemaker, and atrial fibrillation as reported in mfg report number: 1644487-2013-00363. The death was reviewed by the manufacturer in-house nurse. It was reported that the patient died from failure to thrive. Since a cause of death was reported sudep is not suspected to be the cause of death. Follow-up with the funeral home manager revealed that the vns devices were not explanted prior to burial.
 
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) 2013 and the patient's cause of death was: unspecified dementia (record axis 1) and other lack of expected normal physiological development (record axis 2). 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=2955761


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:19:21 AM
Model Number 103
Event Date 10/31/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that the vns patient was experiencing an ectopic heartbeat that began on (b)(6) 2012, and resolved that same day. The patient recovered without sequelae. The patient was noted to have premature ventricular contraction and this ectopic heartbeat was moderate in severity. It was reported to not be related to the vns implant but the relationship to stimulation was probable; at the time of stimulation, the ectopic heartbeat was appearing. It was intermittent. The pulse width was reduced to 130usec and the output current was increased to 0. 5ma but the patient had frequent coughing and therefore the patient was kept at an output of 0. 25ma and pulse width of 130usec. It was also reported that the patient was experiencing a burning sensation in their eyes that began on (b)(6) 2012, and resolved on (b)(6) 2012. It was reported that the burning sensation in the patient's eyes was not related to the vns implant but possibly related to vns stimulation. The event was continuous. No actions were taken for the event and the patient recovered without sequelae. The patient had mild severity of burning sensation in both eyes and itching at the time of sensation. There was no decrease in vision at the time of the event and there was no gritty sensation, redness, watering, or discharge either. The patient did not go for consultation for this event but the patient used cineraria maritin schuade eye drops for two times at the time of burning sensation from (b)(6) 2012. It was later reported that patient also experienced giddiness and weakness that began on (b)(6) 2012, and resolved on (b)(6) 2012. These events were not related to vns implantation but were possibly related to vns stimulation and both events were mild. These events were continuous. No action was taken for the events and the patient recovered without sequelae. The patient was not subject to any consultation with doctors regarding the giddiness. No action was taken regarding the events. It was reported that on (b)(6) 2012 the patient had his second titration visit where the patient was increased to 0. 5ma but experienced a cough and the current was decreased back to 0. 25ma; the cough then disappeared. The patient was kept at an output of 0. 25ma. From the next day, (b)(6), 2012, the patient started having burning sensation in the eyes, giddiness, and weakness. No consultation was taken with an ophthalmologist, neurologist, or physician for the adverse events. The patient has a past medical history of dilated cardiomyopathy, mild mr, severe lv dysfunction (lvef-30%), acute decompensated heart failure (nyha class ii). The patient has no history of shortness of breath even on exertion and no history of chest pain, syncope, or giddiness. The patient had a coronary angiography in (b)(6) 2006 which showed normal coronaries. A 2-d echo cardiography dated (b)(6) 2012 showed a dilated lv, global hypokinesia of lv, severe lv dysfunction (lvef-31%), moderate mr/mild tr, mild pah/no clots. A chest x-ray dated (b)(6) 2012 had noted cardiomegaly. Additional information has been requested but no further information has been received to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vpcs were too frequent so the ectopic heartbeat was moderate. The ectopic heartbeat was determined to be not related to vns stimulation.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when the physician reported that diagnostics were within normal limits. The patient's settings were noted to be output=1ma/frequency=10hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=0ma/magnet on time=60sec/magnet pulse width=500usec. The patient was noted to have a history of dilated cardiomyopathy, severe lv dysfunction, no "ccf", and "nyha class ii".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870871


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:20:05 AM
Model Number 103
Event Date 03/29/2016
Event Type  Injury   
Event Description
It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016. Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia. A ct scan was obtained, which showed a pericardial effusion. The patient was then emergency transported to another hospital for exploration surgery. During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery. The vns magnet was placed over the device during this surgery. After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation. The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur. The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016. Diagnostics were performed, and the results were all within normal limits. The arrhythmias and painful stimulation no longer occurred after the device was programmed off. The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized. It was also reported that the patient had a history of mild bradycardia prior to this event. No further relevant information has been received to date.
 
Event Description
Data was received from 03/29/2016 and 03/30/2016. No anomalies were noted - the data indicated that the device was functioning within normal limits. It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47. 0% change) on (b)(6) 2016, 5:57:24 (estimated). The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i. E. Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury). It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:20:52 AM
Model Number 102
Device Problem Insufficient Information
Event Date 11/12/2012
Event Type  Death   
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted leads and generator. Portions of the outer silicone tubing including the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. In the product analysis lab, the generator 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. The physician reported that the patient's risk factors for sudep include his multiple aeds and early onset epilepsy. It was also reported that the patient had lennox gastaut syndrome. There were no concurrent illnesses or diseases. There was no change in response to vns therapy. The patient was receiving vns therapy at the time of death and was programmed to output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min. The physician stated that the believed cause of death was unknown as well as the relationship of the vns to the patient's death. It was stated that no recent laboratory reports or findings considered relevant to the cause or presumed cause of death were available. An autopsy was performed. The death was not witnessed. Copies of the death certificate were not provided. The patient was "found dead". The patient was (b)(6) at epilepsy onset and had a history of nocturnal seizures. The patient did not have a history of febrile seizures. The patient had 2nd generalized and complex partial seizures (2-3/week). The patient never underwent resective epilepsy surgery. The patient did not have a history of drug or alcohol use. The patient did have a history of cardiac or respiratory problems; however, the patient did have mild sleep apnea. The patient was taking depakote, levecturacetam, and lorazepam at the time of death. The patient was compliant with aeds; last known drug levels were not available.
 
Event Description
On (b)(6) 2012, a vns treating physician reported that the vns patient had passed away on (b)(6) 2012 from sudep and that it was not related to vns. The patient's lead and generator was explanted and returned to the manufacturer for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed. Additional information has been requested from the physician, but no further information has been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received when it was reported that the neurologist had stated that the patient's death was due to sudep however the neurologist later stated that she actually does not know the cause of death. According to the department of vital records in the state the patient passed away in, the manufacturer of the patient's medical device is not eligible to obtain a copy of the death certificate.
 
Event Description
The 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) 2012 and the patient's cause of death was epilepsy, unspecified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860509


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:21:36 AM
Model Number 103
Event Date 11/04/2011
Event Type  Injury   
Event Description
The physician reported that she had a patient who was complaining of dizziness, nausea and trouble sleeping. The patient was sent to a cardiologist and an arrhythmia was identified. The physician indicated that, while the patient's normal resting heart rate is 100bpm; the patient was experiencing occurrences where his heart rate dropped to 60bpm. The physician was uncertain if this event could be related to vns, and it is unknown if these drops in heart rate are associated with stimulation. The physician indicated that they attempted to lower the output current from 2. 25ma to 1. 75ma. The physician also stated that the patient was currently set to 30sec on and 1. 8 minutes off. The physician indicated that she may try a more rapid cycle; however no other information was provided at that time. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2355594


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:22:12 AM
Model Number 102
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was reported that the vns patient experienced a bradycardic episode after increasing output current from 1. 5 ma to 1. 75 ma. The patient's heart rate dropped from 86 beats/min to 63 beats/min. Patient's output current was reduced back to 1. 5 ma and this was the only intervention taken to preclude a serious injury. It is unknown if the patient had a medical history of bradycardia pre-vns. The neurologist does believe the event is related to vns. The event resolved after setting changes and did not reoccur. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698091


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:24:41 AM
Model Number 102
Event Date 07/01/2010
Event Type  Injury   
Event Description
It was initially reported by the pt that she is having issues with her vns which started about a year ago. She notices, her heart races with stimulation. It does not occur with every stimulation cycle, but it does occur at least once a day. She has trouble breathing and then her heart races and feels like "her heart is going to jump out of her chest. " no changes in medication were made but symptoms started right after her vns settings were increased. Good faith attempts to obtain additional info have been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1817869


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:25:39 AM
Event Date 04/01/1998
Event Type  Injury   
Manufacturer Narrative
Article reference: zaaimi b, grebe r, berquin p, patrick b. "vagus nerve stimulation therapy induces changes in heart rate of children during sleep" epilepsia 48: 923-930. 2007.
 
Event Description
It was reported in a scientific article that study patient #1 showed change in heart rate while receiving vagus nerve stimulation. It was indicated that the change in heart rate was related to vns therapy. There was a decrease in heart rate noticed for this particular child patient. 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. This patient was also included in an article by the same author titled "vagus nerve stimulation induces changes in respiratory sinus arrhythmia of epileptic children during sleep", which was reported in manufacturer report # 1644487-2009-01969.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471024


Title: Re: Misc. Cardiac
Post by: dennis100 on June 25, 2018, 03:26:50 AM
Model Number 102
Event Date 07/01/2009
Event Type  Injury   
Event Description
It was initially reported that the pt was experiencing a lower pulse rate (53s), but it was unclear by the physician if this was related to the device settings change a few weeks prior to the onset of the lower pulse rate. The pt visited the er, but her pulse rate never dropped low enough to be considered an arrhythmia. The physician later indicated that use of the magnet to disable the device did not relieve the symptoms. The pt's settings were last changed 6 months prior to the recent change with no adverse events. Diagnostics were last performed 6 months ago and all were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date. Review of previous history on pt resulted in a reported fall approximately a month prior to the onset of the symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1436717


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:03:50 AM
Model Number 103
Event Date 01/25/2014
Event Type  Injury   
Event Description
Information was received that clarified the events. The patient was admitted to hospital with history of loss of consciousness. On further observation and investigation, it was diagnosed as ventricular tachycardia which was not believed to be related to vns therapy.
 
Manufacturer Narrative
Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.
 
Event Description
It was reported that the vns patient who is enrolled in the (b)(6) clinical study presented with syncope which required hospitalization. The treating physician believes the syncope event is probably related to stimulation of the vns device. The patient was implanted with the device in (b)(6) 2012, and the syncope events began on (b)(6) 2014. During hospitalization, the patient regained consciousness in about five minutes without any episode, but had sudden onset of loss of consciousness on the same day, while still in the hospital. The patient regained consciousness and an ecg showed intermittent atrial fibrillation. The ecg also revealed sustained monomorphic ventricular tachycardia. The physician does not believe that the tachycardia event is related to vns stimulation. An electrophysiologist advised for aicd (automatic implantable cardioverter defibrillator) implantation which was done on (b)(6) 2014. The patient was hemodynamically stable during and after the procedure. The patient was discharged in a stable condition on (b)(6) 2014. To note, this patient is enrolled in the (b)(6) clinical study sponsored by the manufacturer and the patient has a known medical history of hypertension & coronary artery disease and moderate left ventricular dysfunction (35%). In addition the patient presents with history of shortness of breath functional classification iii as of the prior 2 ¿ 3 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3647069


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:04:31 AM
Model Number 102
Event Date 05/28/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 reported that the patient has been having numerous problems, including a stroke. The patient fell and developed a subdural hematoma and underwent surgical evaluation. The notes do not indicate the relationship of the stroke to vns. The patient has a chronic history of coronary artery disease, hypertension, and peripheral neuropathy. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the treating physician who reported that the patient's stroke occurred on (b)(6) 2013 and was not related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3249014


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:05:05 AM
Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. The clinic notes dated (b)(6) 2012 revealed that over the years the severity and frequency of the patient's seizures have gradually increased. The patient reports two different types of seizures; the first type he reports feeling confused and may lose balance and fall. These episodes are relatively short, lasting seconds to a few minutes. The second type of episodes represents secondary generalized convulsions, which also last only a few minutes. The patient continues to have approximately 1-3 seizure episodes per week. The clinic notes list the patient's medical history consisting of coronary artery disease, hyperlipidemia, and coronary atherosclerosis of native coronary artery. The patient experiences hiccups and voice alteration with vns stimulation. The patient was prescribed baclofen for his hiccups. The physician indicated that when the patient has his vns replaced, they may seek a lower target dose in the hopes of avoiding hiccups which the patient associates with his vns settings. A battery life calculation was performed which showed 5. 46 years remaining until eri=yes. Attempts for further information from the physician have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2657377


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:05:43 AM
Model Number 102R
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient has congestive heart failure and cerebral hematoma. It is unknown if these events were related to vns.
 
Manufacturer Narrative

Event Description
Good faith attempts for more information were unsuccessful. Follow-up with the physician's office indicated that they did not feel comfortable commenting regarding the patient's events and did not provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2394303


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:06:15 AM
Model Number 102
Event Date 01/18/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient has a history of congestive heart failure and a cerebrovascular accident (cva). The relationship of these events to vns was not provided. Additional information has been requested from the neurologist but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2465307


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:06:57 AM
Model Number 104
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative
Pt ag: age at time of event: the initial report inadvertently reported the age incorrectly. Date of event: the initial report inadvertently reported the event date incorrectly. The physician reported the patient developed the congestive heart failure over the past few years.
 
Manufacturer Narrative

Event Description
Follow-up with the physician revealed that the device was disabled on (b)(6) 2015. The physician stated it was unknown whether it will be re-enabled at a future date. The patient reports that dyspnea decreased after disabling. The patient stated they feel better overall after disabling. The device was turned off to prevent serious injury related to the report of tachycardia.
 
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: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:07:36 AM
Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported in clinic notes that the patient had irregular and rapid heartbeat, not relationship to vns provided. The clinic notes are from the patient current neurologist. The patient's previous neurologist reported that a past cardiologist of the patient felt the arrhythmias were related to vns but he did not feel the arrhythmias were related to vns as the patient had a history of arrhythmias prior to vns. It is currently unknown who the patient's current cardiologist is or their assessment on the relationship of the arrhythmias to vns. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was provided that the currently treating physician has no information to provide regarding the reported arrhythmias.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2873111


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:08:12 AM
Model Number 102
Event Date 06/23/2009
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2009 from congestive heart failure. The relationship between the patient's death and vns is currently unknown, and attempts for additional information have been unsuccessful to date.
 
Event Description
Additional follow up was performed with the patient's funeral home who indicated that the device was unavailable for return; however they were uncertain if it was explanted or discarded. Attempts for additional information regarding the patient's death have remained unsuccessful.
 
Event Description
Additional information was received from the physician's office indicating that they had lost the patient's medical history during a move and would be unable to provide any more information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2485449


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:08:56 AM
Model Number 102
Device Problem Low impedance
Event Date 12/07/2012
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently omitted the new conclusion code per receipt of information relating to cause of 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) 2012 and the patient's cause of death was unspecified infantile cerebral palsy, which was contributed by unspecified septicemia, congestive heart failure, unspecified pneumonia, unspecified coma, other and unspecified convulsions, foreign body in respiratory tract (part unspecified), and inhalation and ingestion of other objects causing obstruction of respiratory tract. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2012 due to unknown reasons. Programming history suggested low impedance, but there were no patient adverse events to suggest that the death was related to the low impedance in any way. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report numbers of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.
 
Event Description
The patient died from pneumonia. There was no indication that the pneumonia was related to vns in any way. The device was buried with the patient, so no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256308


Title: Re: Misc. Cardiac
Post by: dennis100 on June 26, 2018, 03:09:43 AM
Model Number 102
Event Date 11/20/2011
Event Type  Death   
Event Description
Additional information was received on (b)(4) 2013 when the physician reported that there is no relationship between the cardiopulmonary arrest, atrial fibrillation, and congestive heart failure to vns. The events did not occur with stimulation. No causal or contributory programming or medication changes preceded the onset of these events. The physician stated that he believes the patient had a pre-vns medical history of atrial fibrillation and congestive heart failure. The patient had a previous risk factor of "l/v smoking and hypertension" which may have predisposed the patient to myocardial infarctions according to the physician.
 
Event Description
Additional information is received on (b)(4) 2013 when the physician reported that it is unknown when the patient passed away and the relationship of the patient's death to vns. A copy of the patient's death certificate was requested from the department of vital records in the state the patient passed away in but it has not been received to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient has passed away on (b)(6) 2011. Additional information has been requested from the patient's physician but no further information has been received to date. Based on the information received to date, the patient's death is possibly sudep at this time.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when the patient's death certificate was received. The patient passed away on (b)(6) 2011 and the immediate cause of death was noted to be cardiopulmonary arrest, congestive heart failure, atrial fibrillation, and aortic stenosis. The approximate interval between the onset of these events and death was minutes for the cardiopulmonary arrest and years for the congestive heart failure, atrial fibrillation, and aortic stenosis. An autopsy was not performed and the manner of death was stated to be "natural". Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2892949


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:44:35 AM
Model Number 103
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported by the pt that after the pt was turned up to 0. 50ma, she began to experiencing voice alteration and feelings that her "heart was racing," but have since resolved. The pt reports that she is still having grand mal seizures, but her postictal period is improved from 4 days of headaches to only 1. 5 days. The pt has since lost her insurance and has been unable to visit with a neurologist on her vns management. Her previous neurologist was unaware of the reported issues so they were unable to comment. The pt also has a history of refusing to take her paxil, so it is not clear if this may be a contributory factor. 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=1905610


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:45:24 AM
Model Number 103
Event Type  Injury   
Event Description
It was reported that a vns pt experienced an arrhythmia described as av block type ii as a side effect from vns therapy. Further information was received from the treating physician indicating the pt did not have any prior history of cardiac events and the av block occurred post operatively. Moreover, the physician indicated the arrhythmia did not correlate with the on time of the programmed device settings and did not occur while performing diagnostics. However, the av block occurred after a setting change as the output current was increased from 1 ma to 1. 5 ma. The treating physician believes vns exacerbated the av block and determined to be related to stimulation. At the moment, interventions taken were to program vns off and monitor the pt as the event recurred after vns was off. The treating physician would like to continue vns therapy while maintaining the pt under cardiac monitoring. 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=1641397


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:48:02 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. Cardiac
Post by: dennis100 on June 27, 2018, 01:48:45 AM
Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
"type of report, corrected data: inadvertently did not include "30-day report" on initial report. ".
 
Event Description
On (b)(6) 2012 additional information was received when it was discovered that the patient had generator replacement surgery that day for prophylactic reasons. The explanted generator was returned to the manufacturer for product analysis on (b)(4), 2012. Product analysis is still underway and has not yet been completed.
 
Event Description
On (b)(6) 2012, a vns treating neurologist reported that the vns patient was admitted to a local hospital for cardiac catheterization in (b)(6) 2012 and that during the intubation process prior to the cardiac catheterization, the patient's heart stopped for 45 seconds or so. The doctors gave him cpr and brought him back. The neurologist stated that the doctors in the local hospital were concerned about whether the vns could contribute to his cardiac arrest. The neurologist did not believe that the vns played the single major role in the patient's cardiac arrest. The neurologist stated that the patient went for a second trial of cardiac catheterization and had a stent for his coronary artery (70% stenosis). The neurologist said that he promised the patient that he will turn off the patient's vns temporarily for his future elective surgeries. The patient has been referred to a surgeon for replacement of his vns battery, which was already planned prior to the cardiac arrest. Since the cardiac arrest in (b)(6) 2012, the neurologist stated that patient's voice has become very hoarse with vns stimulation and he has started to feel pain occasionally with vns stimulation. The neurologist reported that they already suspected his vns might be close to the time of end of life but the vns diagnostics did not show that. The neurologist stated that the patient's leads need to be inspected and possibly revised as well. Additional information was requested from the neurologist but he stated that he did not wish to provide any further information. Although surgery is likely, it has not yet occurred. A battery life calculation was performed with the programming history available which showed negative years until the elective replacement indicator reads as yes.
 
Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The septum of the generator 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. The elective replacement indicator (eri) was set; the battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2503387


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:49:35 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the patient¿s grandmother that the patient has had multiple adverse events that she believes are related to vns therapy. She stated that the adverse events first began after the device was implanted in 2015. She reported increase in heartbeat and chest pain (patient is non-verbal and it was stated that she grabs at her chest). It was also reported that the device was disabled about two months ago but the issues persisted. She has not seen the neurologist lately but she reported that the patient has been hospitalized multiple times due to the heartbeat problems. Per the primary care physician that the patient was seeing, there was no arrhythmia to detect or report. This physician does not believe that the patient's reported adverse events are related to vns therapy since they have persisted past the disablement two months prior. However, it's not clear if there was never an arrhythmia or just not one at that appointment. Follow-up was also made to the patient¿s neurologist. The patient had not been seen in the office since (b)(6) 2016 and at that time the device was programmed on except autostim was off. The patient has not been seen back since. Therefore the office has no comments currently on the reported issues. The sales rep then noted that while he was in the office, the np noted that the patient was currently at sacred heart hospital complaining of heart issues. The patient was seen later on (b)(6) 2017 by the neurologist¿s nurse. The vns settings were turned down. Attempts were made for more information but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7026660


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:50:17 AM
Model Number 103
Event Date 04/18/2014
Event Type  Other   
Event Description
I have the vns for seizure. This is made by cyberonics. It was put in me in (b)(6) 2013. The doctor centrals it with his hand held device and i use a magnet at home on myself when i have a seizure. In 2013, i was fine on the lowest setting that there is. Then in 2014, my doctor was ready to raise the setting on the vns. Once he started to raise and lower the setting on the vns, my ears, jaw, and neck would hurt, then my neck started to burn like it was on fire. I have not been able to be around any loud noises of any kind, it hurt the magnet. I feels like electricity is going straight to the magnet when loud noises are near by. Now in 2016, the magnet is shocking me all the time and it hurts non stop causing my heart to race really fast. Everytime i see the doctor, he says he has never heard of this happening, so he won't take the vns out. I have told the doctor several times, cyberonics several times, and the surgeon who put the magnet in about what has happened. They keep saying they have never heard of this, so they won't do anything about it. All they will do is play with the medicines on having it go up and down in its doses. Cyberonics vns therapy patient essentials.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5620358


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:50:54 AM
Model Number 102
Event Date 01/17/2012
Event Type  Injury   
Event Description
It was reported by the pt that he felt like his heart rate was faster than normal on a previous date. No increase in seizures, medication changes, or trauma was reported. Pt indicated that he would follow up with his physician on (b)(6) 2012 regarding this issue. Good faith attempts to collect add'l info have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2467128


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:51:42 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.
 
Event Description
Further follow-up was received from the company representative that the physician had called him and stated patient¿s mother had called with an ¿urgent¿ message saying her son has been having issues breathing because of the vns. The physician stated that the mother reported that the issues have been on-going for 2-3 weeks but the mother thought it was urgent and wanted the vns turned off. The device was turned off on (b)(6) 2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6199949


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:52:26 AM
Model Number 102
Event Date 06/07/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the vns patient has a first degree av block. No further information was provided. Good faith attempts for further information from the physician were made but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3201140


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:53:17 AM
Model Number 104
Event Date 01/05/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Date received by manufacturer (mo/day/yr) corrected data: omitted date from follow up report 01. Should have been (b)(4) 2012.
 
Event Description
Product analysis was completed on the returned explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Diagnostic values indicated that the output current reported low (2. 5ma) with the device programmed to 3. 0 ma. However, the measured output signal amplitude (both prior to and after the monitoring test) demonstrates that the generator is able to deliver the programmed 3. 0 ma despite the warning message of a low output condition. The near end-of-service (n eos) was set at bench testing. Results of diagnostic testing indicated the device was operating properly with n eos yes. The data in the (b)(4) memory locations revealed that 116. 680% of the battery had been consumed. The battery voltage value stored within the generator (2. 427 volts reported during final electrical testing) suggests an n eos, battery partially depleted, condition. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
A patient was sent for generator replacement due to end of battery life. Preoperatively, the patient went for a baseline ekg. It was noted the following: abnormal ecg with unconfirmed diagnosis and first degree av block. It is unknown the relationship to their vns device. Good faith attempts have been made and no further information attained. The explanted generator is at the manufacturer pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2467550


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:54:03 AM
Model Number 106
Event Date 06/29/2016
Event Type  Injury   
Event Description
The patient's surgeon reported with a clinical assessment following the patient's vns and pacemaker implant procedures. The patient had an atrioventricular conduction block that was impacting cardiac function. The physician assessed that this was not related to vns. At the time of the follow up appointment on (b)(6) 2016, the patient's pulse rate and rhythm were assessed to be normal. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient started having several bradycardia and asystole events soon after a full vns replacement surgery. The patient was admitted to the hospital in relation to these events. The vns generator was confirmed to have been enabled after the replacement surgery. There were no cardiac issues noted during the implant or testing. Post-operative diagnostics were reported to be within normal limits. The vns magnet was placed over the device to inhibit stimulation and the cardiac events did not resolve. The treating physician concluded that the cardiac events were not related to vns stimulation. The relation between the cardiac events and vns surgery has not been clarified to date. The patient was subsequently evaluated for a pacemaker implant, and the case was completed. Attempts for additional pertinent information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). Initial report inadvertently listed wrong expiration date. Initial report inadvertently listed wrong device manufacture date. Initial report inadvertently listed wrong udi.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817715


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:56:11 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:56:51 AM
Model Number 105
Event Date 01/01/2014
Event Type  Injury   
Event Description
The patient reported that she has experienced a recent exacerbation of cardiac arrhythmia. The patient attributes this to vns and reported that she is on low settings. The patient indicated that she has a history of arrhythmia for which she is followed by a physician. The patient reported that experienced five straight days of severe arrhythmia, but that it is not as bad anymore. The patient reported that she was originally diagnosed with premature ventricular contraction two to three years ago. The patient indicated that she had a feeling vns therapy affected it. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient was briefly hospitalized in mid-(b)(6) 2014 after experiencing a blackout. The treating physicians attributed the blackout to either bradycardia, cva or a clotting disorder. The patient¿s description of the event suggested that the event was not arrhythmia but an absence seizure. The patient was last seen by her neurologist on (b)(6) 2014 so the neurologist is unable to provide any feedback regarding the event. The patient has not been seen by a medical professional to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: additional information indicates that the patient was hospitalized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3688946


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:57:53 AM
Model Number 102
Event Date 07/06/2006
Event Type  Injury   
Event Description
A vns patient indicated that he was experiencing dizzy spells which prompted him to visit the emergency room. In the emergency room, an ekg was performed and the results indicated a normal sinus rhythm without stimulation and sinus arrhythmia with occasional premature ventricular complexes during stimulation. It was also indicated that the patient may have possible left atrial enlargement. The patient's device was subsequently disabled with his magnet reportedly causing him to slip "back into depression again. " the patient did indicate that he has a pre-existing history of bradycardia and that he wears a pulse oximeter monitor to alert him when "it hits 39. " follow-up with the patient's cardiac surgeon, who had performed a cardiac exam a month after the patient's initial report, revealed that the patient showed no evidence of arrhythmia or heart enlargement. The patient indicated that he received surgical consult from another cardiac surgeon who reportedly did not diagnose him with any "major" heart condition. Later the patient indicated that he had failed a stress test and that his condition has "gotten to be severe bradycardia". The patient is now seeking surgical consult for the implant of a pacemaker. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1393198


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:58:35 AM
Model Number 103
Event Date 08/27/2010
Event Type  Injury   
Event Description
It was initially reported that the recently implanted pt pvc that occurred about once per month. The pt has a cardiac diagnosis of perimembranous ventricular septal defect, small and restrictive with infrequent pvcs, the pt is not on any cardiac medication and was last seen by a cardiologist on (b)(6)2009. The pt was implanted the week prior to the report. The pt is said to be having pvcs "a little more frequent" over the three days since implant, but was not daily or with stimulation on-time. The pt also has depression and anxiety. The nurse practitioner has recommended a holter monitor for 72-hrs. If there were no issues seen, the pt would continue the monitor for 30-days. The site wanted to confirm there was an increase in pvcs and the relationship to the therapy/surgery or other external issues/stressors. The nurse was unable to rule out the device as a contributory factor at this time. No diagnostics were immediately available of the pt's device. Info received from the company representative present during the implant surgery indicated that the anesthesiologist noted some "cardiac changes" during administering the anesthesia prior to the start of surgery. These issues were said to have resolved after the pt fell asleep. The anesthesiologist felt it was anxiety related at that time since she was awake. Diagnostics performed on the device during surgery were said to be within normal limits, and there were no cardiac issues noted when the pt was turned to 0. 25ma. The nurse later reported that the family refuses to disable the device so the pt will have a holter monitor at this time. Since the pt is known to have a lot of anxiety, the decision may be to be slower titrations of her therapy. No further details have been received on the issue. 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=1858494


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 01:59:24 AM
Model Number 103
Event Date 03/01/2016
Event Type  Malfunction   
Event Description
The patient did not show up to his consult appointment and did not return phone calls to reschedule. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported to cts that this patient wants to have his device explanted for an unknown reason. Good faith attempts to obtain the reason for wanting the device explanted were unsuccessful. The patient reported on (b)(6) 2016 that he is having spasms locally around the vns site left chest and neck area and vocal stimulation. He thought his vns was not functioning any longer. It was noted he also has svt with pvc cardiac issues. The patient scheduled a consult for vns removal. The patient stated his vns was turned off at the er visit and that there were no issues but was told it was most likely scar tissue causing pain. The patient noted he still does not have a neurologist but the surgeon will remove his vns without neurology approval. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5563700



Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:00:01 AM
Model Number 101
Event Date 10/01/2008
Event Type  Injury   
Event Description
It was reported that a vns pt was admitted to the hosp due to a massive increase in seizures. Several medications were administered to the pt in order to address the seizure activity which only had transient effects. The pt was transferred to an intensive care unit for the application of thiopental. The reporter indicated that prior to administering the thiopental for status epilepticus and mechanical ventilation, a cardiac arrhythmia was observed. The reporter stated that a complete heart block was recorded on ecg in addition to event of asystole lasting approx six seconds with a spontaneous recovery. The pt's vns device was programmed off and add'l arrhythmia events reportedly recorded. The reporter indicated that vns therapy settings had remained unchanged prior to the event and that at this time they have been unable to tell whether there was an exact time correlation between the pt's arrhythmia and device stimulation. The reporter also indicated that the pt's device would remain disabled until they were "100% sure, that there is no logical connection possible between the vns-stimulation and that event. " the cause of the arrhythmia event and its relationship to vns therapy is unk. Good faith attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1281061


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:02:38 AM
Model Number 102
Event Date 06/18/2010
Event Type  Injury   
Event Description
Although vns explant surgery is likely, it has not occurred to date.
 
Event Description
On (b)(4) 2013 information was received from the reporter that a case study was being published on this patient and event and that an abstract for the article had been received for the article. The article is ¿late-onset advanced heart block due to vagal nerve stimulation¿ by a. Schevchuck and m. B. West, published in the american journal of therapy on june 21, 2013. Figures #1 and #2, which display ekgs of the patient¿s normal sinus rhythm and sinus rhythm during vns stimulation showing advanced atrioventricular block, respectively, are figures not received in the past.
 
Manufacturer Narrative

Event Description
A nurse practitioner at a neurologist's reported on (b)(6) 2012, that a patient was experiencing bradycardia with vns stimulation, and the patient will likely have his device removed as a result. The patient is also being monitored by a cardiologist who has noted that the patient has second- and third-degree heart block during stimulations. She also indicated that he was having a drop in blood pressure during these bradycardia events causing syncope. Due to the adverse events, she expects the device to be explanted, but they are waiting for the cardiologist evaluation to be completed. They first confirmed the bradycardia and syncope on (b)(6) 2012, but she suspects that this has been an on-going issue since the patient was turned on ((b)(6) 2010). The patient is noted as being a poor historian due to issues with alcohol abuse and appointment compliance, and she feels that he cannot tell the difference between a seizure and a syncopal event, which is why she feels that this has been an issue since after implant. She does not feel that the device is malfunctioning, but the placement of the electrodes is the likely cause. She mentioned that they were able to induce an event with the magnet activation, which is how they confirmed the events occurring with stimulation. When asked if the events are occurring with normal mode stimulation, she said that she believed so, which is why there is question about the previous seizures possibly being syncopal events. The events were not occurring with every normal mode activation. The patient's device is now disabled and is wearing a holter monitor to further determine if this event is occurring without stimulation. An ecg/cardiology monitor report was received indicating the patient's average heart rate is 64 bpm. The minimum heart rate was measured as 27 bpm, and the maximum heart rate was 101 bpm. The study concluded that the patient has complete heart block on (b)(6) 2012, at one point. A cardiology consult was placed for the electrophysiologist. The arrhythmia questionnaire was received from the neurologist's office reporting that the patient does not have a prior history of cardiac events nor does his family. The patient does have pre-existing medical conditions of tuberous sclerosis, sleep apnea, and major depression which are unrelated to vns. The patient has experienced 2nd degree type 1 and type 2, in addition to 3rd degree heart block. The patient's normal heart rate is about 64 bpm, but during the bradycardia it dropped to 27 bpm. This did not occur intraoperatively. No traumatic events, medication changes, or vns settings changes were experienced prior to the arrhythmia. The bradycardia occurs with the on time of vns stimulation but not during diagnostics. The neurologist's office believes the arrhythmia is related to vns stimulation. The patient has not been hospitalized for this event. Since the device was disabled, the patient reports that the bradycardia has not occurred again, but they are awaiting the holter monitor results.
 
Manufacturer Narrative
Article citation: american journal of therapy; 2013 jun 21. [epub ahead of print]; late-onset advanced heart block due to vagal nerve stimulation. Schevchuck a, west mb. Department of internal medicine, division of cardiology. (b)(6).
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not include this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2728697


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:04:14 AM
Model Number 102R
Event Date 04/13/2011
Event Type  Injury   
Manufacturer Narrative
Corrected data: the correct patient age is provided. Only the birth year was provided by the reporter. Suspect medical device: the correct device information is provided per the reporter. Implant date, corrected data: the correct implant date is provided. Device manufacture date, corrected data: the correct manufacturing date is provided.
 
Manufacturer Narrative
Case report: vagal nerve stimulation and late onset asystole. Rhit shankar, victor oluwaseyi olotu, nicholas cole, heather sullivan, caryn jory. Seizure 2012 jan 2 pii:s1059-1311(12200332-9. Doi 10. 1016/j. Seizure 2012. 12. 011.
 
Event Description
Additional information was received. The full article was provided. This case report is a case of a (b)(6) man with intellectual disability who about 8 years later developed an iatrogenic ventricular asystole presenting as recurrent cardiogenic syncope following vns which was initially misdiagnosed as his seizure worsening. His vns workup did not reveal any cardiac problems. His vns was fitted following usual procedures. The required intraoperative tests were performed and no complications were noted. Following his vns being fitted his seizure frequency and intensity of both seizure types improved significantly. Approximately 8 years later there was an increase in what seemed to be atonic seizures which started occurring on an almost daily basis, which given his history. Were considered to be his seizure worsening. The aed treatment he was on at the time which included levetiracetam 3000 mg/day and pregabalin 300 mg/day were adjusted and his vns was checked and titrated but there was no improvement in his seizures. A detailed description of these events suggested that these attacks were different from previous episodes and pointed at a cardiac cause. An assessment of his cardiac status was then requested. There was suspicion that the vns was causing symptomatic bradycardia and a 24 hr cardiac monitor was arranged. It showed recurrent episodes of recurrent ventricular standstills, pauses and runs of complete heart block. At this point the vns was deactivated. A repeat cardiac monitor show sinus rhythm throughout. Approx 2 months after vns was deactivated his seizures worsened despite aed treatment. Following another discussion with family, his family made a decision to reactivate the vns again, approx 4 mo after it was disabled. Vns was turned on at lower settings than previous unfortunately sustained recurrent syncope returned with confirmation on the cardiac monitor. The vns was again turned off. The patient remained deactivated after this. Article sites (b)(6) article described a case report of interoperative bradycardia and asystole ((b)(4)/medwatch report number 1644487-2008-01907) another event addressed in file (b)(4) medwatch report number:1644487-2008-03112.
 
Event Description
Additional information was received from an abstract that was discussing this patient's event. Reported that vns is a treatment option in patients with refractory epilepsy unsuitable for other surgical options. Vns helps in intractable cases with an average decrease in seizure frequency by 40%. It involves an operation to implant under the skin a generator with coils wrapped around the left vagus. Vns is well tolerated and safe though there have been cases reported of bradycardia occurring intraoperatively and clinically. Parasympathetic hyper stimulation of the right vagus predisposes to bradycardia. The left vagus when hyper stimulated predisposes to atrioventricular (av) blocks. There has been no cases that we are aware of reporting av blocks post vns. We report a case of iatrogenic ventricular asystole presenting as drop attacks following vns which initially was misdiagnosed as seizure worsening. A (b)(6) man with intellectual disability and treatment resistant intractable epilepsy (generalised seizures including drop attacks) had a vns fitted. There were no intraoperative complications. The vns workup did not reveal any pre cardiac problems. His seizures improved. Two years later there was an idiopathic increase in drop attacks which was, given his past seizure history considered to be seizure worsening. There was no improvement to anti-epileptic medication and vns titration leading to a review of his cardiac status. A 24hr ecg showed recurrent episodes of ventricular standstills, pauses and runs of complete heart block corresponding with vns stimulation. No other cause could be found to explain this occurrence. Vns was turned off. Subsequent ecg was unremarkable. Two months later all forms of his epilepsy worsened prompting a patient choice of switching on the vns under 24hr ecg monitoring. The ecg after switch on showed continued p wave activities but runs of ventricular asystole after vns stimulation. The longest asystole was 9. 79 seconds. This led to the vns being turned off again. The abstract reported that the vns is considered a safe option in epilepsy management. Unfortunately it can cause side effects of iatrogenic asystole and misdiagnosis of seizure worsening. Awareness of this rare but late onset, life threatening side effect of vns is important.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reporter indicated the vns generator was disabled due to asystole occurring with vns stimulation. The vns stimulation was lowered to 0. 75ma, but the patient again experienced asystole, so the vns was disabled. The reporter has declined to provide additional information at this time.
 
Event Description
It was reported to our country manager in (b)(6) that they had a vns pt implanted with a model 101 which has been implanted for 9 yrs, and is an extremely good vns responder. Over the past 6 months, the pt had reported to his general practitioner that they were having "odd" turns, which their physician initially attributed to focal seizures. However the pt had a cardiological review also, and the ecg showed that he was having 12 second pauses at the time of stimulation. On =30secs, off = 3 mins, so every 3 mins, there was a 12 second pause. The cardiologist contacted our country rep to ask her to switch the device off but unfortunately, the pt had recently left (b)(6) for a six week holiday in (b)(6). The nurse is attempting to make contact through family members to contact the pt and find a vns treating physician in (b)(6). There is also a query as to whether the pt could have a cardiac pacemaker implanted alongside their vns, because they do not want him to lose his therapy. The pt does not have a medical history of this prevns implantation. Once the pt returns from their vacation they will be admitted to hospital for some cardiac monitoring to plan the next course of action. If further info is attained another report will be sent.
 
Event Description
Additional details were provided by the reporter, including the correct vns implant information. The plan of care is to keep the vns disabled for now. The vns was disabled on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096034


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:05:08 AM
Event Date 01/01/2004
Event Type  Injury   
Manufacturer Narrative
"complete heart block with ventricular asystole during left vagus nerve stimulation for epilepsy. " epilepsy & behavior 5 (2004) 768-771. See scanned pages.
 
Event Description
It was reported in an article that during initial vns placement, an intraoperative system diagnostic test resulted in a 9-s period of ventricular asystole with hypotension. A pre-operative ecg had shown first-degree heart block. Subsequent cardiac eval was unremarkable. The device was left in place, and subsequent activation of the vns device did not result in any significant problems. Review of the pt's medical records did not reveal any evidence of previous cardiac disease. 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=1120741


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:05:54 AM
Model Number 102
Event Date 05/27/2009
Event Type  Injury   
Event Description
A vns pt's cardiologist indicated that he noticed that the pt was having intermittent heart block (p wave, but no qrs wave) for duration of three to four seconds recently. The cardiologist indicated that he did not know if the issue was related to vns therapy and added that pacemaker implantation would likely occur. Good faith attempts for additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1408615


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:06:45 AM
Model Number 102
Event Date 03/28/2011
Event Type  Injury   
Event Description
It was reported that the vns pt has been experiencing 3rd degree av heart block and bradycardia. The physician has stated that the pt has been hospitalized and will likely need a pacemaker. The physician has stated that the arrhythmia occurs even when vns stimulation has been disabled. The physician still feels however, that there may be a partial relationship of the vns stimulation to the arrhythmias. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082984


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:07:41 AM
Model Number 103
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
This event was previously reported in manufacturer report number # 1644487-2011-02834.
 
Manufacturer Narrative

Event Description
A pacemaker vns case study was reviewed which showed that a vns patient was found to have frequent episodes of atrial fibrillation on the ecg telemetry. The emergency room physician ordered a holter monitor which detected not only many short episodes of atrial fibrilation, but also frequency episodes of sinus bradycardia associated with 2:1 av block. The patient was referred for cardiology consultation. It was noted that review of the holter tracing revealed more episodes of sinus bradycardia with 2:1 av block during the night time than the day time. In contrast, there were more episodes fo af during the day time than the night time. Analysis of the holter tracings suggested possible correlation of the arrhythmias with vns stimulation because of the intermittent nature of the arrhythmias. It was noted that the patient adamantly declined further alteration to her vns. The patient was implanted with a pacemaker because of the well-documented symptomatic bradycardia. It was noted that the patient's symptoms resolved with pacemaker implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3905904


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:08:41 AM
Model Number 103
Event Date 02/11/2012
Event Type  Injury   
Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.
 
Manufacturer Narrative

Event Description
Reporter indicated the patient had no history of cardiac events. The patient's father did have a myocardial infarction at age (b)(6). The patient does have pre-existing hypertension. The patient experienced bradycardia during the event. The heart rate prior to the bradycardia was regular, and during the event was irregular. The blood pressure prior to the event was 133/110; during the event it was 90/40. The date of the bradycardia event was (b)(6) 2012. The patient did not have any symptoms, but "did not feel well in general". The patient did not experience any traumatic events prior to the bradycardia, and had no trigger events. The bradycardia did not occur after a medication change. The bradycardia did not correspond with the vns stimulation on time, did not occur during vns diagnostics testing, and did not occur following a setting change. Electrocardiography information was not provided as it was not available. The bradycardia event is not felt to be related to the vns, and it is not felt to have exacerbated or co-currently contributed to the bradycardia. The patient was hospitalized as an intervention, and experienced a myocardial infarction which required the placement of two cardiac stents. The vns generator is currently programmed on, with settings of 2ma output current, 30hz, 250 pulsewidth, 30 sec on, 5 min off. The arrhythmia event has not recurred.
 
Event Description
It was reported by a physician that a vns patient experienced bradycardia/ av block and was sent to the hospital. The patient did not experience pain and reacted abnormally along with having low blood pressure. The patient was later dismissed with normal vital functions, but severe swallowing problems. Treating physician does not believe the event is related to vns. An increase in seizures was also reported, but this was below pre-vns levels. At the moment, good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603911


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:09:30 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 06/09/2017
Event Type  Injury   
Event Description
It was reported that when a vns patient¿s device is on it had an effect of av node block. Systems diagnostics were reported to be fine. The physician lowered the stimulation on time in the hope of resolving it. The physician then turned the device off and that resolved the symptoms. When the device was turned back on the problem returned. A holter monitor was used and seems to confirm that when vns is on there's a cardiac response. The device was left off to see what happens. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating provider indicated the patient is doing ok.
 
Event Description
Follow-up from the provider indicated the vns is believed to be causing the cardiac symptoms. The specific effect of the av node block was bradycardia as the patient¿s heartrate went down to 30 beats per minute. The patient was placed on an ekg/event monitor and was referred to cardiology. They dynamically adjusted the vns parameters guided by the ekg.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685430


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:10:38 AM
Model Number 102
Event Date 03/11/2016
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear. Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear. Her generator site was hurting and her brain was foggy. The patient then visited the nurse practitioner on (b)(6) 2016. During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before. Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation. The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation. So the magnet pulse width was decreased down to be the same as normal stimulation. Diagnostics were performed and were within normal limits. X-rays were taken afterwards and no issues were observed. Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016). Since the shock with the magnet, patient felt that her heart would beat really fast. This happens about once a day at different times of the day and can last 10-30 min. This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse. She never had this happen before and there are no triggers that patient could find. Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.
 
Event Description
Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation. No known causes or contributory factors were present. Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation. The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation. Per the medical profession, there was no device migration as she could not perceive any movement of the generator. The pain in the chest was not due to presence of device or migration. Patient has had her generator replaced since then on (b)(6) 2016 and is doing well. The explanted device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549412


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:11:28 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 11/30/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a patient that with vns, her seizures have changed and increased. The patient also states that when her heart rate rises, she has increased seizures and states that the device works up her heart rate. No surgical intervention has taken place to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140631


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:12:03 AM
Model Number 102
Event Date 04/30/2008
Event Type  Injury   
Event Description
It was reported via clinic notes dated (b)(6) 2008 that "the patient reports intermittent rapid heartbeat. " no other information given regarding event. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2301701


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:12:37 AM
Event Date 01/01/2001
Event Type  Injury   
Manufacturer Narrative
Zaaimi, b. , grebe, r. , berquin, p. , patrick b. "vagus nerve stimulation therapy induces changes in heart rate of children during sleep". Epilepsia 48: 923-930. 2007.
 
Event Description
It was reported in a scientific article that a study patient showed change in heart rate while receiving vagus nerve stimulation. It was indicated that the change in heart rate was related to vns therapy. There was an increase in heart rate noticed for this particular patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471019


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:13:13 AM
Model Number 102
Event Date 01/07/2011
Event Type  Injury   
Event Description
Mfr received a report from a vns pt that after vns device magnet was swiped, her heart raced and she started coughing which lead her to shortness of breath. The review of mfr's programming history database showed that sys diagnostics results performed on the day of surgery, (b)(6) 2010, were within normal range. Mfr suggested the pt to see her treating neurologist. Good faith attempts to obtain more info from pt's treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979704


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:13:52 AM
Event Date 10/16/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient's father that the patient had 10 violent seizures the night of (b)(6) 2015 in which he had to give her emergency diastat in order to clam her. The father reported the following day the patient had a very high heart rate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5227121


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:14:35 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/06/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient developed edema at the electrode site and a rapid heart rate following a generator replacement. The physician programmed the device off. Information was obtained from the physician that the cause of the rapid heart rate was due to the body's reaction to the surgery. It was also stated that the patient was developing an infection at the generator site due to patient picking. The physician is treating the site before beginning therapy. The device history records of the generator and lead were reviewed, and the devices were sterilized according to procedure prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7390605


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:15:15 AM
Model Number 101
Event Date 01/01/2004
Event Type  Injury   
Event Description
It was reported in a scientific article that a vns patient experienced palpitations the day after having vns implantation surgery. The patient was taken to the emergency room and telemetry studies showed intermittent runs of atrial fibrillation, atrial flutter, and frequent premature atrial complexes. The patient was hemodynamically stable during the arrythmia. The patient had no history of dysrhythmia or other cardiovascular disease. The patient's generator was programmed off, but the patient continued to have paroxysmal runs of atrial flutter and fibrillation for 24 hours, but thereafter remained in sinus rhythm. The device was turned on at a later date and the arrhythmia did not recur. Currently, the relationship of the arrhythmia to vns therapy is unknown as good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Article: srinivasan, balaji, and ashish awasthi. "transient atrial fibrillation after the implantation of a vagus nerve stimulator. " epilepsia (2004): 1-1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1402706


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:16:15 AM
Model Number 303-20
Device Problem No Information
Event Date 04/13/2012
Event Type  Injury   
Event Description
The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.
 
Event Description
The patient called and provided additional information that she had undergone surgery due to the previously reported vocal cord paralysis. Her surgery involved removing one of her vocal cords, reportedly. She stated that she was continuing to have an increase in seizures as previously reported. The patient's diagnostics with the new model 106 generator were all within normal limits. No further relevant information has been received to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental mdr #7 inadvertently had the wrong date under. The date should have been 02/14/2017.
 
Event Description
The physician reported that device diagnostics were within normal limits. The patient was encouraged to use the magnet more. The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.
 
Event Description
The patient reported that she is still experiencing issues with her new generator. The patient reported that she is uncomfortable and it still hurts sometimes. The patient reported that she feels like it "jumps" around sometimes. The patient complained to the physician's office regarding erratic stimulation. The patient reported that vns isn't working. The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The patient reported that she was scheduled to see the surgeon for consult. She indicated that she needs two procedures at the same time. The patient reported that the other procedure she requires is cardiac related for possible stent placement. The patient reported that she had an abnormal ekg, but it may be related to her vns. The patient underwent surgical consult and was referred to a cardiologist. No known surgical interventions have been performed to date.
 
Event Description
A patient reported that she had experienced a weight loss of approximately 150 pounds since being implanted with her vns device in (b)(6) 2012. Follow-up with the patient's physician showed that the weight loss was related to vns and was due to experiencing left vocal cord paresis following the implant in (b)(6) 2012. Per the neurologist, the vocal cord paresis may have caused aspiration and thus diminished oral intake, resulting in weight loss. The family was reportedly well compensated as of (b)(6) 2016. The majority of the clinical symptoms reported are related to bodily structures near the lead site ( voice alteration, dysphagia, nerve damage, and vocal cord paresis ). Additionally, the reported events were not alleviated after generator replacement occurred on (b)(6) 2016. Diagnostics have reportedly been within normal limits with both generators. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The patient underwent generator replacement. The explanted generator has not been received for analysis to date. The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality. The physician believes a 3d echo was performed. It was reported that the ekg was ok.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:17:24 AM
Model Number 102
Event Date 06/04/2008
Event Type  Injury   
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.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:17:58 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that a patient was experiencing a rapid heart beat. Follow up with the patient's treating physician revealed that the cause of the increased heart rate was unknown. However, diagnostics showed that the patient's device was functioning properly. The physician has turned off the patient's device to see if the issue resolves.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1237258


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:18:44 AM
Model Number 103
Event Date 01/01/2008
Event Type  Injury   
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153329


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:19:23 AM
Model Number 105
Event Date 05/08/2015
Event Type  Injury   
Event Description
It was reported that the patient experienced an increase in heart rate associated with vns stimulation. The physician elected to turn down the output current from 1. 5ma to 1. 25ma to see if this would result in a decrease in heart rate. It was also noted by the patient that the stimulation on times made the patient feel anxious. The physician thought this could be related to the heart rate increase. Good faith attempts for additional, relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Suspect device udi, corrected data: the initial report inadvertently did not report this information. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789594


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:19:58 AM
Model Number 103
Event Date 02/01/2010
Event Type  Injury   
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1641399


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:20:45 AM
Model Number 102
Event Date 11/08/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had a battery replacement surgery on (b)(6) 2011. The explanted generator was returned for product analysis on (b)(4) 2011 that has not yet been completed.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include all the relevant information on supplemental report #3. Inadvertently put "after further investigation, the event is believed to not be related to vns. " on supplemental report #3 instead of "after further investigation it was discovered that the patient had both mitral valve prolapse (mvp) and mitral regurgitation (mr) and that these events are believed to not be related to vns. ".
 
Event Description
After further investigation it was discovered that the patient had both mitral valve prolapse (mvp) and mitral regurgitation (mr) and that these events are believed to not be related to vns.
 
Event Description
Additional information was received on (b)(4), 2012 when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
On (b)(6) 2011, clinic notes were received from a vns treating neurologist. Review of the clinic notes from that day revealed that the patient has had a slight increase in seizures over the past 2 months. The physician stated that the patient can have anywhere from 1 to 5-6 seizures per month but that the patient has already had 2 seizures in (b)(6) already. The patient's seizures are partial or generalized. The magnet was reported to be used for the seizures with good benefit. The patient was referred for prophylactic battery replacement. A system diagnostics test performed on (b)(6) 2011 showed results within normal limits, with normal lead impedance, a dcdc of 2, and end of service= no. The patient's settings were output current: 3. 0ma/pulse frequency: 30hz/pulse width: 250us/on time: 3. 0 sec/off time: 1. 8 min/magnet output current: 3. 25ma/magnet on time: 60 sec/magnet pulse width: 500us. In the patient's medical history listed in the clinic notes it states that the patient has an implantable cardiac defibrillator (icd) but does not mention any arrhythmias. Additional information has been requested from the physician but no further information has been received to date. A battery life calculation was performed which showed 1. 09 years until eri = yes. Although surgery is likely, it has not yet occurred.
 
Event Description
After further investigation, the event is believed to not be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2354649


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:21:25 AM
Model Number 102R
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported by the cardiac physician's assistant that they wanted someone to interrogate and possibly disable the patient's generator to see if it was affecting the patient's heart rate. The pa indicated that the patient was bradycardic, typically with a heart rate in the 40s, but it had dropped down to the 30s with a junctional rhythm. The patient had been bradycardic for the past several months but it had worsened and she had presented at the er with dizziness and lightheadedness. The patient had a history of coronary heart disease and had a heart attack less than a year prior. The patient was described as having a complicated medical history. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569457


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:23:18 AM
Model Number 102
Event Date 04/30/2008
Event Type  Injury   
Event Description
Reporter indicated a vns pt was "admitted to the er in 2008, for chest pain and severe sinus bradycardia. She has a history of chest pain due to mitral valve prolapse, irregular heartbeat and episodes of bradycardia. See attached medical records. " good faith attempts to obtain add'l info have been unsuccessful to date.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:24:05 AM
Model Number 10X
Event Date 06/02/2010
Event Type  Injury   
Event Description
It was reported to the manufacturer that the vns patient experienced an episode of syncope associated with low blood pressure on (b) (6) 2010. The patient's resting blood pressure was 120. After this episode, the blood pressure was re-checked and it was observed to be at 70/42. It was brought back up to 90 at the hospital. It was indicated that the patient has a medical history of mitral valve pro-lapse. The patient was advised to see a cardiologist. It is unknown at this time if the event has been determined to be related to vns therapy. It is unknown if interventions have been taken for the event. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1749838


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:24:59 AM
Model Number 103
Event Date 05/03/2010
Event Type  Injury   
Event Description
A vns pt called and reported that she had been at the hospital on (b) (6) 2010 because the device had been choking her. She had been admitted to the hospital on (b) (6) 2010 because after using her magnet, she felt like her heart was racing. She reported, the hospital treated her like a cardiac pt because they thought she was having a heart attack and believed the vns was the cause. Additionally, she reported that after her initial implant she was unable to eat. Good faith attempts thus far have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1716183


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:25:42 AM
Model Number 103
Event Date 12/20/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient was implanted with vns for heart failure on (b)(6) 2014. The patient had a history of hypertension and non-critical coronary artery disease. The patient was extubated in the operation room, and then she was transferred to the post-operative ward. While there, she developed sudden bradycardia and hypoxia. The patient was intubated again and was treated with atropine and kept on a ventilator for 3 minutes. The patient was subsequently extubated and kept on an oxygen mask. Mannitol was administered, and vitals were monitored. The patient was transferred to the cardiac intensive care unit and was discharged on (b)(6) 2014. The physician attributed the hypoxia and bradycardia to premature extubation following the vns implantation surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5546490


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:26:45 AM
Model Number 303-30
Event Date 11/01/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.
 
Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.
 
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:27:27 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 03/08/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was seen by a cardiologist who noted the patient had a widened qrs complex and believed this was related to the vns. The patient's device was disabled at the time of the visit due to high impedance found on the lead. The high impedance is reported on mfr. Report # 1644487-2018-0031. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7386238


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:28:21 AM
Model Number 102
Event Date 08/11/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(4), 2012 clinic notes from a vns treating physician were received by the manufacturer. Review of the clinic notes dated (b)(6) 2011 stated that the patient has been seizure-free for quite some time and has also developed some coronary artery disease and had a coronary artery bypass graft. However clinic notes dated (b)(6) 2011, list the patient's seizure number from (b)(6) 2011 indicating that the patient was only seizure free in (b)(6) 2011 of that time frame; (b)(6)- 2 seizures, (b)(6)- 2 seizures, (b)(6)- 0 seizures, (b)(6)- 2 seizures, (b)(6)- 1 seizure, (b)(6)- 2 seizures, (b)(6)- 2 seizures, (b)(6)- 1 seizure, (b)(6)- 0 seizures. It is unclear if the patient experienced an increase in seizures at a point during this time frame since the clinic notes dated (b)(6) 2011 state the patient has been seizure free for quite some time and then the clinic notes dated (b)(6) 2011 indicate that the patient was in fact having seizures. Attempts were made to the physician for further information but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2663614


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:29:18 AM
Model Number 302-20
Event Date 04/15/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient has been referred for a full revision surgery. Although surgery is likely, it has not occurred to date.
 
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 it was reported that the patient was scheduled for a full revision surgery. The patient underwent a full revision surgery on (b)(6) 2012. System diagnostics after replacement showed results within normal limits of 1145 ohms and 1242 ohms. The device was let programmed to an output of 0ma. The leads had been replaced due to high impedance with an impedance greater than 10,000 ohms and the generator had been replaced for prophylactic reasons. Attempts for the return of the explanted lead and generator to the manufacturer for product analysis have been made but the products have not been returned to date.
 
Event Description
On (b)(6), 2012 clinic notes were received from the (b)(6), 2012 clinic visit. The clinic notes report that the physician thinks there is a breakage in the wires. The patient has a history of depression and mitral valve prolapse. The patient was noted to continue to be having occasional breakthrough seizures. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the explanted lead and generator were received by the manufacturer for product analysis. It was noted that after surgery the lead impedance was "ok", with an impedance value of 1242ohms. Product analysis on the generator was completed on (b)(6) 2013. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccum consumed memory locations revealed that 4. 648% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis also revealed that the impedance value went from 3748ohms to 11612ohms on (b)(6) 2011. The patient's programming history was reviewed and on (b)(6) 2011 the patient's vns was disabled. The patient was then programmed back on to output = 0. 5ma/frequency = 20hz/pulse width = 250usec/on time = 30sec/off time = 5min later that day and then was disabled on (b)(6) 2011. System diagnostics showed results within normal limits on (b)(6) 2011 from but on (b)(6) 2011 high impedance was observed on a system diagnostics test; output = ok/lead impedance = high/impedance value 10,000ohms. Product analysis on the lead is still underway and has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2011, a vns implanting surgeon reported that the vns patient went for generator replacement surgery on (b)(6) 2011, and that during surgery, the impedance was at 4000 ohms. The surgeon took out the lead pin from the generator header and then re-inserted the pin and made sure to tighten it. The impedance then showed 2900ohms. After surgery, system diagnostics revealed high impedance of >10,000 ohms. The generator was programmed to 0ma due to the high impedance and the patient was referred for x-rays. Ap and lateral chest and neck x-ray images were received by the manufacturer on (b)(4) 2011, and reviewed. The connector pin appeared to be fully inserted into the connector block. There did not appear to be any gross fractures, discontinuities, or any sharp angles in the lead body. There was a portion of the lead body coiled behind the generator that was unable to be assessed. There could be micro-fractures that may not be able to be visualized in the x-ray that could be the cause of the patient's high impedance. Additional information was requested from the patient's physician; however, no further information has been received to date.
 
Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted leads. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the ends of both the (+) connector ring and (-) connector pin quadfilar coils appeared to be broken past the electrode bifurcation. Scanning electron microscopy was performed and identified the areas as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the marked 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 other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2100458


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:30:09 AM
Model Number 101
Event Date 01/05/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012, that the patient had an ekg performed on (b)(6) 2011, which revealed sinus bradycardia, with a rate of 57. The notes also suggest that the patient has a pacemaker. It is unknown at this time if the bradycardia is related to vns, however it was documented that the patient also has a history of coronary artery disease.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856566



Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:30:51 AM
Model Number 102
Event Date 08/06/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a medical status form for the patient was received dated (b)(6) 2012. It reported that the vns patient suffers from some neuropathy that is ongoing. It was also noted that the patient has ongoing heart rate irregularities and syncope. The syncope was stated to be sometimes in response to vns. The patient was also experiencing ongoing mitral valve prolapse (mvp), major depression, gastrointestinal disorder sometimes, gad (generalized anxiety disorder) with panic disorder, and a new onset of chronic pain/pain syndromes. Attempts for additional information have been made to the physician but no further information has been received to date. A battery life calculation was performed which showed 7. 38 years remaining until eri=yes.
 
Event Description
On (b)(6) 2012, the physician's nurse reported that what the patient meant by "heart rate irregularities" was that the patient had a mitral valve prolapse which she has had for over 15 years. The nurse then sent a form which stated that the patient had tachycardia (part of the mitral valve prolapse event). The patient's heart rate prior to the event was 80-90 bpm and the blood pressure was 120/80. The mitral valve prolapse was found during an ekg and started 15 years go. The patient does not have any symptoms of an arrhythmia. The patient experienced increased depression prior to the arrhythmia and had caffeine intake prior to the arrhythmia. The arrhythmia did not correlate with the on time of the programmed device. The physician does not believe the arrhythmia is related to vns and he feels that it is anxiety related. The patient has had such episodes in the past. No interventions have been taken and the arrhythmia event has not recurred. The physician reported that the patient is unsure when the syncope first started. The physician feels it is related to dehydration and he had the patient hydrate. The syncope is not associated with stimulation and no causal or contributory programming or medication changes preceded the onset of the syncope. The patient has a medical history of syncope prior to vns. No further information was provided regarding the nerve damage.
 
Event Description
On (b)(6) 2012, the physician reported that the nerve damage was not related to vns stimulation or surgery. It was also clarified that the syncope was related to dehydration and not vns. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2722352


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:31:39 AM
Model Number 102
Event Date 11/15/2013
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2013 due to inhalation and ingestion of food causing obstruction of respiratory tract. Patient also had dementia and chronic ischemic heart disease.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4933194


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:32:24 AM
Model Number 103
Event Date 01/09/2012
Event Type  Death   
Event Description
The patient's death certificate was received from the state vital records department which reported the cause of death as cardiac arrest, respiratory failure and pneumonia. Other significant conditions contributing to the death but not resulting in the underlying cause was coronary artery disease. No operation was performed for any condition. The date of death was confirmed as (b)(6) 2012. Follow-up was performed on (b)(6) 2013 to the treating hospital facility for additional information regarding the cause of death and the relationship to vns. However, additional information could not be provided without patient spouse/caregiver written consent. This death event was reviewed by the manufacturer's nurse and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was due to cardiac arrest, respiratory failure, and pneumonia. The patient died in the hospital, indicating he was likely not in a reasonable state of health at the time of death, and the death was likely witnessed.
 
Manufacturer Narrative

Event Description
During an in-house device audit call, it was reported by the physician's office that the patient had expired on (b)(6) 2012. The office did not have any record of the vns device(s) being explanted. No additoinal information was provided, and attempts for additional information have been unsuccessful to date. The physician is no longer a practicing at the office.
 
Event Description
This death event has been reviewed by the manufacturer's nurse, and with the available information has been determined to be possible sudep. The patient died and had epilepsy, and also had bladder and prostate cancer but the cause of death is unknown at this time. As such, sudep cannot be ruled out as a possible cause.
 
Event Description
The patient was last seen by the treating vns physician on (b)(6) 2011, and there is no mention of the patient's death in his medical chart. The last note reported that he also had prostate and bladder cancer. The relationship of these events is unknown. No diagnostics were recorded in the chart. Attempts for additional information have been unsuccessful to date. Attempts for the death certificate are in progress, but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816451


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:33:00 AM
Model Number 102
Event Date 02/02/2015
Event Type  Death   
Event Description
No autopsy was performed, and the death was not witnessed. The patient was found face down in bed with blood on the pillow and sheet. The age of epilepsy onset was 2 yrs, and he had a history of 2nd generalized and complex partial seizures. The patient also had premature ventricular contractions and trigeminy post-seizures. The patient had been on the following anti-epileptic medications: lecosamide, levetiracetram, oxcarbazepine, carbamazepine, valproates, phenyloin, topiramate, lamotrigine, gabapentin, lorazepam, and aption. He was on lamotrigine and vimpat at the time of death and was compliant with medications.
 
Event Description
It was reported that a patient who had been implanted with a vns device passed away on (b)(6) 2015. The patient's physician reported that the death was due to sudep. The physician also stated that the death was not related to the vns device. The device was explanted prior to cremation and discarded by the funeral home.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682131


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:33:44 AM
Model Number 102R
Device Problem No Known Device Problem
Event Date 10/16/2009
Event Type  Death   
Event Description
The death certificate was received, and the cause of death was listed as seizure disorder of unknown etiology and focal moderate atherosclerotic coronary artery disease. The patient passed away at home, and an autopsy was performed. The manner of death was natural. A sudep evaluation was performed, which classified the death as probable sudep. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Analysis on the generator was approved. Analysis found that the device had reached an end of service condition; 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 concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was also approved. Note that the lead assembly (body) including a portion of the connector boot and the electrode section was not returned; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. No further relevant information has been received to date.
 
Event Description
It was reported that a patient passed away in 2009 due to unknown reasons. The patient's devices were explanted and returned for analysis. No further relevant information has been received to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not list the patient's death date. Date of event, corrected data: initial report inadvertently did not list the event date. Explant date, corrected data: initial report inadvertently did not list the explant date of the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6363429


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:34:21 AM
Model Number 102
Event Date 07/07/2014
Event Type  Death   
Event Description
Analysis of the lead was completed on 08/01/2014. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output attempting to deliver therapy through an open electrical load - cut leads). Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The physician reported that the death is does not appear to be associated with the vns. There was no believed relationship of the death to vns. The cause of death was reported to be atherosclerosis heart disease. An autopsy was performed. The patient was found unresponsive in bed. Heart disease was found at the autopsy.
 
Event Description
It was reported that the patient passed away and the device was explanted and ready to be returned for analysis. The cause of death was unknown. The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found. Analysis of the lead is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3973702


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:35:05 AM
Model Number 101
Event Date 02/05/2012
Event Type  Death   
Manufacturer Narrative

Event Description
A sudep evaluation was also performed and indicated that the patient's death was likely not sudep.
 
Event Description
It was reported that the patient passed away. At the time, the reporter did not know the cause of death or when the patient passed. She did not comment on the relationship between the patient's death and vns. A search of the social security index revealed that the date of death was (b)(6) 2012. Attempts for additional information have been unsuccessful to date.
 
Event Description
The physician indicated (b)(6) 2012, that the cause of death was unknown; however, it was not believed to be related to vns. The physician stated that the patient had a history of cad (coronary artery disease) and cabg (coronary artery bypass graft). Attempts have been made for a copy of the patient's death certificate, and have been unsuccessful to date. The patient's device will not be returned for product analysis as the director of the patient's funeral home stated that the patient had been cremated and the device was disposed of.
 
Event Description
The death certificate was received on (b)(6) 2012. The cause of death was not provided on the death certificate however it did state that the manner of death was natural. Additionally the patient passed away in hospice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662335


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:35:51 AM
Model Number 105
Event Date 11/07/2013
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
New information received indicates that the patient's death occurred on (b)(6) 2013.
 
Event Description
An autopsy report was received that stated the patient¿s death was due to coronary heart disease. Toxicology showed therapeutic levels of the prescribed anti-epileptic drugs making epilepsy an unlikely primary cause of death; however, the possibility that an epileptic seizure placed undue strain on the compromised heart leading to a heart attack cannot be excluded. There was no evidence of a drug overdose or excess alcohol.
 
Event Description
It was reported that the patient passed away. The clinician's opinion was sudep. A death follow-up form was received which indicated that the cause of death was unknown and that it was possible sudep. The generator and lead were explanted after the death. It was reported that the patient was found death in bed and that he had nocturnal seizures. The patient had no history of drug abuse or cardiac history. It ws reported that an autopsy was performed, but no copy was available. The explanted devices have not been received for analysis.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the lead was completed on (b)(4) 2014. A short circuit condition was identified on the lead coils as result of the coils being exposed. Based on the appearance of the returned lead this was most likely caused at the explant procedure. Scanning electron microscopy images of the positive and negative coil ends verified that the coils were torn (due to tensional forces exerted on the lead) at explant as indicated by the appearance of the coil wires. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497820


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:36:39 AM
Model Number 102R
Event Date 05/02/2013
Event Type  Death   
Event Description
It was reported that the patient passed away approximately 3-4 months ago. The cause of death is not know at this time. It was reported that the patient had a pacemaker and known cardiac issues which was previously reported in mfr. Report # 1644487-2013-00834. Attempts to obtain additional information will be made, but no information has been obtained to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The device was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. There is no evidence to suggest an anomaly with the returned portions of the lead. During the visual analysis, the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the ribbons from coming in contact with the vagus nerve. With the exception of the tissue-covered (+) white and (-) green electrodes, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Note that since a large portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received stating that the vns patient¿s device was at end of service on (b)(4) 2010.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient passed away on (b)(6) 2013. The patient was found dead on his bed in a supine position. The patient device¿s was disabled at the time of death and was not explanted. It was reported that the patient¿s death was not related to vns. An internal review of the available information determined that the patient¿s death was possible sudep.
 
Manufacturer Narrative
Additional information indicates that the patient¿s dob was (b)(6) 1946.
 
Event Description
Additional information was received stating that the vns patient was born on (b)(6) 1946, not (b)(6) 1949 as initially reported. The patient¿s death certificate was obtained. The death certificate listed the immediate cause of death as cardiopulmonary arrest with probable acute coronary syndrome and probable coronary artery disease as sequential conditions that contributed to the death. The patient had other significant health conditions may have contributed to the patient¿s condition. Nurse¿s notes regarding the patient¿s death were received. The notes indicate that the patient was being closely monitored due to treatment with continuous positive airway pressure (cpap). It was noted that the patient¿s cpap mask had be adjusted frequently. No issues were noted with the patient when he was evaluated at 11:00 pm on (b)(6) 2013. At 11:45 pm, the notes indicate that nurse required assistance adjusting the patient¿s cpap mask because the patient kept removing it. At midnight, nurse reported that the patient was pale, warm to touch, breathless, non-responsive, and pulseless. Cpr was immediately initiated and the paramedics that arrived approximately ten minutes later continued cpr until the patient was pronounced dead at 12:33 am on (b)(6) 2013. Follow-up with the nurse revealed that the patient was not having a seizure at the time of death the patient¿s seizure record indicated that the patient experienced several seizures from (b)(6) 2013 which consisted of stiffening, jerking, some forward head drops, flinging of the arms. The patient¿s postictal periods were uneventful with good recovery. With the available information, an internal classification determined that the death was unlikely sudep. The patient¿s body was donated to science and the patient¿s devices were explanted. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3506710


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:37:15 AM
Model Number 102
Event Date 04/07/2010
Event Type  Death   
Event Description
Company rep became aware that epileptic vns patient passed away on (b)(6), 2010. F/u with funeral home revealed that vns device was buried with the deceased. The cause of death in the death certificate was mentioned as: sepsis/septic shock (48 hours), gangrenes left foot (1 week), atherosclerotic peripheral vascular disease (aspvd) (1 year). Also, no autopsy was performed. Good faith attempts with the pt's treating neurologist have been unsuccessful to date to question the relationship of death to vns device. Sudep eval was conducted by mfr and based on the available info, it has been determined not to be sudep since the death was not sudden or unexpected. The dhr for the lead and generator were reviewed and sterility prior to shipment was confirmed.
 
Manufacturer Narrative
Eval, method: device mfg records were reviewed. Results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938703


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:38:25 AM
Model Number 103
Event Date 07/05/2012
Event Type  Death   
Event Description
Programming history was reviewed. Diagnostics from the date of implant are within normal limits. The device was implanted in (b)(6) 2012, and the device was programmed to deliver therapy on (b)(6) 2012. Settings were increased on (b)(6) 2012 and again on (b)(6) 2012.
 
Event Description
With the available information the patient's death is a possible sudep.
 
Event Description
Additional information was received that the cause of death was due to seizure disorder with other significant contributing factors of atherosclerotic cardiovascular disease, diabetes mellitus, hypertension history and thyroid disorder. The manner or death was natural.
 
Manufacturer Narrative

Event Description
Additional information was received from the physician on (b)(6) 2012. It was indicated that the relationship of the patient's death to vns was unknown as was the cause. An autopsy was performed; however, the physician did not have a copy to send to the company. Additionally per the physician, vns had not helped the patient's seizures. Follow up with the patient's funeral home found that the patient was cremated and device explanted; however, as they no longer had the device, they assumed it was discarded. A request has been made to obtain a death certificate; however, per (b)(6) the cause of death is not yet available. No further information is known at this time.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported that a patient who was recently implant in (b)(6) 2012, passed away on (b)(6) 2012. The cause of death is unknown, however it was indicated that the death was sudden. Attempts for additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2690445


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:39:09 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 09/29/2012
Event Type  Death   
Event Description
It was reported on (b)(6) 2015 that this patient passed away from atherosclerotic cardiovascular disease on (b)(6) 2012 per the patient's death certificate.
 
Event Description
Based on the report of this event which was only defined as atherosclerosis there is no evidence to suggest that vns caused or contributed to this event.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data, initial mdr inadvertently omitted that the death is likely unrelated to vns therapy. Corrected data, evaluation codes added that the death is unrelated to vns (no device failure).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4925673


Title: Re: Misc. Cardiac
Post by: dennis100 on June 27, 2018, 02:39:52 AM
Model Number 103
Event Date 05/05/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away in her sleep on (b)(6) 2014. The physician suspected sudep. The patient¿s device was not explanted prior to cremation.
 
Manufacturer Narrative

Event Description
A copy of the autopsy report was received where the cause of death was listed as atherosclerotic cardiovascular disease (hardening of the arteries of the heart) and a seizure disorder. At autopsy, there were focal areas of myocardial fibrosis indicating that the deceased had suffered multiple myocardial infarctions (heart attacks) in the remote past. The deceased also suffered from a seizure disorder which also contributed to her death. The manner of death was listed as natural. An internal sduep evaluation was performed and it was determined that the death was unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840356


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:46:03 AM
Model Number 300-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description
It was reported that a vns pt was scheduled to have total revision surgery due to a lead fracture. The physician also indicated the pt experienced pain, and diagnostics showed a device malfunction. However, the revision surgery was postponed because the pt was experiencing heart flutter. It is unk if the heart flutter event is related to vns therapy. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1028856


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:46:40 AM
Model Number 102
Event Date 10/18/2011
Event Type  Injury   
Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.
 
Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:47:23 AM
Model Number 105
Event Date 06/25/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported by the physician that the patient was admitted to the hospital the night prior due to a cardiac block. It was stated that the patient was recently implanted and evaluated by an ear nose throat doctor who gave approval for the device to be turned on for the first time on (b)(6) 2013. The output current was programmed to 0. 25ma and diagnostics indicated everything was ok with a lead impedance of 4092 ohms. The patient was programmed on and observed for 20 minutes. The patient tolerated the stimulation. The magnet output current was programmed to 0. 5ma, and the patient tolerated the magnet swipe as well. Additional information was received that the patient experienced cardiac arrest and had a pacemaker placed in the intensive care unit (icu). Aside from the fact that the patient had experienced a couple events where his heart rate increased with his seizures, no information was given on if the patient experienced arrythmia events prior to vns implant. It was found that the patient may have an underlying cardiac condition. Moreover, the patient's seizure frequency has increased (above pre-vns baseline levels) since the vns was implanted. The physician believes that there are a few factors that could have possibly contributed to the events. He believes the patient may have epileptic syncope and an underlying arrhythmia, but is unsure if the seizures are bringing on the cardiovascular events or vice versa. The physician also believes vimpat could be a possible contributor, so the patient was taken off of this medication on (b)(6) 2013. Lastly, the physician thinks that the connection on the nerve may have been a contributing factor, especially if the patient had a pre-existing condition. The patient's device is off at this time and the patient had a stent placed. Vns explant is likely, but surgery has not occurred to date. Follow up found that the patient had an asystole event at the time of diagnostics during implant surgery. No other information has been provided.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently reported this data incorrectly. This outcome was not included on the initial report. The patient's device was turned off, patient was taken off one medication and cardiac intervention was taken. Type of reportable event, corrected data: the initial report inadvertently reported this data incorrectly.
 
Manufacturer Narrative

Event Description
The treating physician reported the patient has not had more events since the pacemaker placement since time of report. The physician reported that the patient's seizures and cardiac events were both not controlled previously.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3309437


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:48:04 AM
Model Number 101
Event Date 04/15/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received that the event reported was not vns related. Chest pain heart flutters. Start date of event was (b)(6) 2013. Device was off at the time related to being at or near end of battery life. The patient heart flutters were related to the patient having a low potassium level that caused a palpitation. No cardiac ischemia their chest pain resolved and was not vns related.
 
Event Description
It was reported that a vns patient reported that she was in the hospital with a heart attack 2 weeks ago. When questioned further, she reported that she just had chest pain. She stated that she has severe anxiety and her heart flutters sometimes. Good faith attempts are underway for further details about the reported event.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:48:56 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
Vns pt is experiencing a heart block. Pt's physician feels it may be related to vns. Pt will have cardiological tests and device will be temporarily turned off during tests. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1074562


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:50:11 AM
Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, information was requested regarding vns and atrial fibrillation. The patient is treated for refractory major depression. The patient recently had the vns unit replaced due to battery depletion. The previous week, the patient presented to the physician's office to have her device programming and indicated that she had felt palpitations. Upon examination, the patient had an irregular pulse. An ecg earlier confirmed that the patient had atrial fibrillation. Follow-up with the patient's physician showed that the patient was a (b)(6) woman who suffers from refractory major depression. She was not responding to antidepressants, and was implanted with vns for the first time three years prior with good response to vns therapy in the treatment of the depression. In november 2012 the patient communicated that she was going to move to (b)(6) due to her husband's job and requested information to her doctor on how to proceed with vns. The physician interrogated the device and found it to be at eos. On (b)(6) 2013, the patient had her device replaced. Shortly after revision, the patient's settings were increased to half of her pre-revision settings. Normal hoarseness was noted. No diagnostics were run. During the week of (b)(6) 2013, the patient presented for a dosing appointment. The patient stated that she had palpitations. The patient had not presented a previous history of such; however, the patient was unsure whether she might have had palpitations before. The device was programmed off at that visit. Two days after the appointment, another medical professional reported that the patient was presenting atrial fibrillation detectable even 48 hours after the device was disabled. The patient was moderately obese and was treated for hypertension with amlodipine. The physician believed that it was possible that the present atrial fibrillation was related to the patient's hypertension and not vns, but this is still being investigated. The patient was seen by a cardiologist; however; no outcome from the cardiology study was available. No intervention is planned or taken so far. The atrial fibrillation is asymptomatic so far. It was detected by means of an ekg 48 hours after the device switch-off. The patient's antidepressants had not been modified. Of note, two months prior to revision, the patient underwent an ekg for a routine health check and anomalies were noted; however, these were regarded as technical problems of the ekg equipment.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 that the clinical concerns about this patient seemed to have diminished / resolved. The initial suggestion that the patient had atrial fibrillation was incorrect, and the patient had been deemed medically fit by a cardiologist. The patient has atrial ectopics that are considered to be of no functional or pathological significance, and not related to her vns. The vns was restarted a couple of weeks ago without incident. Diagnostics were satisfactory.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2986119


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:51:01 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
Reporter indicated that vns therapy pt experienced an episode of heart block which lead to the pt going to the emergency room. The treating physician's assessment of whether or not this event is related to vns therapy is unk to mfr at this time. Good faith attempts for further info are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1001049


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:51:57 AM
Model Number 102
Event Date 01/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679922


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:55:35 AM
Model Number 102
Event Date 01/11/2008
Event Type  Injury   
Event Description
Reporter indicated that a vns patient was experiencing 30 second periods of heart block associated with stimulation on times and subsequent arrhythmias. The patient has a prior history of syncope and heart rate irregularities. Diagnostic testing showed the device to be functioning properly. Ekg strips were evaluated and showed that the patient was experiencing a ventricular standstill. The device was programmed off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992788


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:57:13 AM
Model Number 102R
Event Date 03/03/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. The cause of death was unknown by the physician's assistant. The funeral home director indicated that the patient was buried with the device and that the immediate cause of death was heart failure due to atrial fibrillation >3 years, due to or as a consequence of atrial fibrillation >3 years, due to or as a consequence of sleep apnea >5 years. The death certificate noted other significant conditions contributing to death, but not resulting in the underlying cause was serious anemia. No autopsy was performed. The manner of death was listed as natural, and tobacco did not contribute to the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641033


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:57:52 AM
Model Number 102
Event Date 11/30/2009
Event Type  Death   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
Outcomes attributed to adverse event: death, corrected data: the initial report indicated the date of death was (b)(6) 2009 however, it was (b)(6) 2009. The information has been corrected in this report. Date of event, corrected data: the initial report indicated that the date of the event was (b)(6) 2009 however it was (b)(6) 2009. The information has been corrected in this report.
 
Event Description
Additional information was obtained and it was found that the patient¿s date of death was actually (b)(6) 2009 and the patient passed away at the hospital. The patient was admitted to the hospital on (b)(6) 2009 with acute atrial fibrillation with fast response, hypotension, and probable pneumonia. The history of present illness details that the patient had serial life threatening problems over the last two months which included an intracerebral hemorrhage with resulting hemiparesis and marked cognitive and physical deficits. A feeding tube was placed a week prior to the hospital stay because of dysphagia and recurrent aspiration. The patient had an acute mi, pneumonia, svt, and blood pressure difficulties prior to placement. Tachycardia at a rate of 180 led to him being sent to the er. The svt proved quite difficult to control as he was found to have a large intraventricular clot that they did not anticoagulate because of the intracerebral hemorrhage. The physician wished to move the patient to hospice due to the poor prognosis, but his brother wanted gentle care. In a progress note addendum, the physician convinced the patient¿s family to move the patient to hospice care because ¿his prognosis is essentially zero. ¿ the patient had another mi while in the hospital, but the patient's heart rate and blood pressure somewhat stabilized. The patient was eventually discharged on (b)(6) 2009, the date of death.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2009. The cause of death is unknown. Review of the available programming and diagnostic history showed normal diagnostic results through 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3673246


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:58:33 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was experiencing cardiac syncope. The syncope was provided to be mild. The relationship to the implant procedure or vns stimulation is unknown and the adverse event had not resolved at the time of the report. The stimulation was not turned on at the time of the event. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7809373


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:59:09 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.

Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.

Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 12:59:48 AM
Model Number 102
Event Date 06/06/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's device was unable to be communicated with. The physician used two different programming systems that had been working without issue, but the generator was still unable to be communicated with. The patient's generator was able to be palpated and was closer to the midline than in an axillary position. The patient had been cardioverted on (b)(6) 2016 due to atrial fibrillation (not related to vns), and the patient immediately stopped feeling stimulation after the procedure. The patient's generator was implanted on (b)(6) 2016 and programmed on during the surgery without issue. The generator had not been communicated with since implant. Troubleshooting was performed, including ensuring the wand battery was not depleted, the handheld was not plugged into the wall, and two generator hard resets. However, the generator was still unable to be communicated with. The company representative also attempted to communicate with the patient's device on (b)(6) 2016, but was unsuccessful. Another hard reset was performed, but the device was unable to be communicated with. The physician's programming system was confirmed to be functioning properly with a demo generator. Further information was received clarifying that the patient had cardioversion performed on (b)(6) 2016 and also had heart attack (not related to vns) on (b)(6) 2016 with subsequent cardiac catheterization that showed no blockage. System diagnostics showed good lead impedance and proper functionality of the device during implant surgery on (b)(6) 2016. The patient was referred for generator replacement. No surgical intervention has occurred to date.
 
Event Description
The patient had generator replacement surgery due to the generator not communicating. The explanted generator was discarded. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5847816


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:00:27 AM
Model Number 103
Event Date 06/28/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, a physician's office reported that a recently implanted patient stated that she had a seizure the previous night ((b)(6) 2012) and felt as if her heart skipped a beat. The reporter noted that the patient was not a good historian. Additional information was received from the patient on (b)(6) 2012. The patient stated that she felt her heart was fluttering before a big seizure. The patient had not experienced a "big" seizure in a while and did not know if the fluttering was associated with the "big" seizure. The patient provided her current settings and said that she was last seen on (b)(6) 2012. Attempts for additional information have been unsuccessful.
 
Event Description
Follow-up with the physician on (b)(6) 2012 revealed that the heart fluttering was not related to vns. The patient's settings were also provided. No external factors preceded the onset of the heart fluttering or big seizure. There was no history of heart fluttering listed; however, the patient reported that the heart fluttering occurred from time to time. The physician was unaware of the patient's big seizure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2673459


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:01:01 AM
Model Number 102
Event Date 05/02/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:01:38 AM
Model Number 103
Event Date 11/21/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was seen at the hospital and was experiencing atrial fibrillation, it is unknown if this is related to vns. The patient is planning on seeing a cardiologist. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2372880


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:02:20 AM
Model Number 103
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a vns patient's caregiver that the patient had atrial fibrillation and received cardioversion for the atrial fibrillation (b)(6) 2016 which was successful, however the procedure was reported to have caused his vns therapy to stop working. The vns was reported to have reduced the frequency and severity of the patient's seizures, however the seizure frequency and severity were reported to have increased since the vns stopped working. After surgical consult, generator replacement surgery was scheduled as the device was found to be at near end-of service. Lead impedance was reportedly okay after diagnostics. The device was interrogated and the output current was 1. 5ma and had not been found to be disabled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Event Description
Generator replacement surgery occurred on (b)(6) 2016. The explanted device has not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5577796


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:03:04 AM
Model Number 105
Event Date 05/10/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
Initially, it was reported that the patient was scheduled for explant due to unknown reasons. It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012. It was noted that the patient experienced dysphonia with device activation and dysphagia to pills. The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain. It was noted that the symptoms continued after programming the device off. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent vns explant. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5526231


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:03:39 AM
Model Number 103
Event Date 04/28/2015
Event Type  Injury   
Event Description
It was reported that the vns patient was scheduled for prophylactic generator replacement surgery on (b)(4) 2015. The patient was put under anesthesia and subsequently experienced a drop in heart rate from 40-50 bpm to 0 bpm. The patient was given epinephrine to restore the heart rate. It was noted that the patient had number health issues and was normally taking blood thinner medication but was not on the medication the day of surgery. The surgery was aborted and the patient¿s device was not replaced. Follow-up revealed that the patient had a prior history of bradycardia and atrial fibrillation. The event is not believed to be related to device stimulation on-times. The patient¿s device remained programmed on and the cardiac events have not reoccurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4795612


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:04:42 AM
Model Number 102
Event Date 05/04/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient is experiencing very severe bradycardia with no evidence of asystole. This was diagnosed on (b)(6) although it may have started earlier. The patient is showing signs of atrial fibrillation followed by bradycardia as low as 20bpm. The device was deactivated with a pacemaker magnet and the patient showed no bradycardia after the magnet deactivation. The patient's device was then disabled to 0ma.
 
Event Description
The patient's following physician is aware of the situation and that the device was turned off by the icu. The patient has not seen the patient since the event and is unwilling to provide any additional information. Therefore, attempts for additional information have been made but no relevant information 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=4802826


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:05:39 AM
Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:06:22 AM
Model Number 103
Event Date 09/04/2014
Event Type  Injury   
Event Description
It was reported that during sinus surgery on (b)(6) 2014 unrelated to vns, the patient had atrial fibrillation. The patient received a cardiogram at that time and was stabilized. Follow-up revealed that no issues were seen with the patient¿s device and normal mode device settings. It is unknown if the patient¿s device was disabled for the procedure. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received indicating that the vns patient underwent gallbladder removal surgery and not sinus surgery as initially reported. Three hours following surgery, the patient reported experiencing shooting pain up on the left side of her neck and coughing. Additionally, a lump was located in her left breast below the generator.
 
Event Description
Clinic notes were received stating that the vns patient had been hospitalized the week prior to her office visit on (b)(6) 2014 due to atrial fibrillation and underwent cardioversion in the or. Three hours following surgery, the patient experienced coughing due to shooting pain up the left side of her neck. The magnet was used to temporarily disable the device. The patient¿s device settings were increased following the cardiac events. There was concern that the cardioversion may have somehow altered the patient¿s device settings. The patient subsequently experienced throat irritation at the higher device settings which resolved when the settings were reduced.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4156771


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:07:07 AM
Model Number 102
Event Date 03/13/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the physician lowered the patient's off time that day to 1. 8min and thinks the patient is having atrial fibrillation. No further information was provided. Good faith attempts for further information from the physician have been unsuccessful. Good faith attempts for the patient's implanted product information have also been made but have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2013 when the patient's implanted product information was provided by the hospital.
 
Manufacturer Narrative

Manufacturer Narrative
Inadvertenly listed the date as (b)(4) 2013 on follow-up report #1, the date should have been (b)(4) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3037242


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:07:47 AM
Model Number 102
Event Date 05/01/2006
Event Type  Injury   
Manufacturer Narrative

Event Description
A cardiologist called and asked for labeling on the vns and cardioversion. She had a patient who had a vns implanted, hospitalized in icu that was in afib and she needed to cardiovert them before putting a pacemaker in. The patient was having cardiac pauses as well and she did not think it was related but was not sure. Actual start date of event unknown. Said that it occurred during the off time so that she did not think so. She said that the patient was elderly so most likely related to that but could not be 100% sure. It was asked if she had tried to disable the device to rule out the vns and she said no, since she was not having it during the on time. She felt that she did not need to do that and that it was most likely related to her age. Patient was set to 7 secs on time 3 mins off time. The patient had sick sinus syndrome with severe bradycardia requiring their pacemaker placement (b)(6) 2006 in the right chest area. No interactions with their vns were reported. During this time frame, the patient was also found to have paroxysmal atrial fibrillation and was placed on coumadin. After implant with their pacemaker, the vns device and pacemaker are reportedly were working well and the patient doing fine as well. The patient had been implanted since (b)(6) 2005, and there is no indication that this event coincides with vns stimulation. No further information will be provided in regards to their cardiac event from their physician's office. It was later reported in (b)(4) 2013 that the patient had died. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972148


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:09:07 AM
Model Number 102
Event Date 07/27/2009
Event Type  Injury   
Event Description
A medical student called to report that he had a vns patient who had atrial-fibrillation that had developed since being implanted. Per the student, the atrial-fibrillation is occurring with stimulation according to the patient's 30/5 duty cycle. The patient has not had any seizures since being implanted with the vns. The event did not occur during vns testing. Good faith attempts are being made for further details and thus far have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1788757


Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:09:41 AM
Model Number 102
Event Date 01/25/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was scheduled for battery replacement due to an end of service condition, but was then postponed due to atrial fibrillation. There was no indication that the issue was related to the vns therapy, but no further details have been made available at this time. 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=1616532



Title: Re: Misc. Cardiac
Post by: dennis100 on July 03, 2018, 01:48:14 PM
Device Problem No Known Device Problem
Event Date 01/18/2018
Event Type  Injury   
Event Description
It was reported that a vns patient experienced ventricular fibrillation when the output current was increased. The output was then programmed back to the original settings and the issue was resolved. It was reported that the patient has never had v-fib before. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7266921


Title: Re: Misc. Cardiac
Post by: dennis100 on July 04, 2018, 12:32:06 AM
Model Number 103
Event Date 07/23/2013
Event Type  Death   
Event Description
It was reported that the vns patient died the month prior. No other information was provided. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: this date on follow-up mfr. Report #01 was inadvertently reported incorrectly. The date should have been 09/15/2014 rather than 09/16/2014. The report was submitted within the 30 day deadline with the date change.
 
Event Description
Additional information was received stating that the patient¿s immediate cause of death was ventricular fibrillation arrest and aspiration pneumonia with a contributory condition of dvt¿s (deep venous thrombi). No autopsy was performed. The patient¿s body was cremated and the device was not explanted prior to cremation. Approximately one month prior to the patient¿s death, the patient went to the er on (b)(6) 2013 due to increased lethargy and being unaroused. The patient improved during his work-up at the er, and it was the medical opinion that he was ¿most likely suffering from a postictal state that is recovering slowly. ¿ he was not admitted to the hospital and was released to return to his home with continuation of his baseline medications. The clinical impression was ¿altered mental status ¿ resolved¿. On (b)(6) 2013, the patient developed a high fever at the group home facility, seemed lethargic to caregivers, and was having a lot of coughing. The patient was experiencing respiratory failure with low oxygen saturation, a urinary tract infection, and evidence of pneumonia on a ct scan. He was given antibiotics based on his high risk for aspiration due to swallowing difficulty. An endotracheal tube was placed to facilitate oxygenation that markedly improved. The patient was admitted to the icu on mechanical ventilation and was in critical condition at the time of admission. Medical records of the hospitalization indicate that the patient was admitted with fever and subsequently diagnosed with pneumonia (aspiration related). The patient required intubation, he self-extubated , and was then re-intubated. It was decided by a caregiver to avoid extraordinary procedures and to offer comfort only support and he died a few days later due to sudden ventricular fibrillation and cardiac arrest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3342878


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 07:46:12 AM
Model Number 103
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported by the patient that he was recently hospitalized, due to some heart problems. Patient also stated that he has other health issues such as sleep apnea. Patient was scheduled to see his psychiatrist for follow up. Follow up with the implanting surgery revealed that they haven't seen the patient since surgery and they are not following up with the patient anymore. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845936


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:25:21 AM
Model Number 102
Event Date 08/04/2006
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:25:58 AM
Model Number 102
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 were received, which indicate the patient has a heart murmur. There was no additional information listed on the notes about the event. Attempts for additional information are underway; however, they have thus far been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3396783


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:26:50 AM
Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
Clarification was received from the nurse at the physician¿s office who reported that she does not see how ¿vns had any relation to the sleep apnea and heart murmur or anything of that nature. ¿.
 
Event Description
Clinic notes dated (b)(6) 2012 and (b)(6) 2013 reported that the patient's medical history included sleep apnea and heart murmur. The relationship to vns is unknown, and attempts for additional information to date have been unsuccessful to date. It is unknown if interventions were taken for these events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3182811


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:27:46 AM
Model Number 102R
Event Date 06/12/2009
Event Type  Injury   
Event Description
Reporter indicated that when her vns generator would stimulate, she would experience a "bubbles in the chest" sensation which she stated was a cardiac arrhythmia. The reporter stated her physicians were aware of the sensation. The reporter stated she has a heart murmur with slight enlargement of the left ventricle. All attempts to the pt's family practice physician and vns physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1414554


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:28:38 AM
Model Number 102
Event Date 01/21/2009
Event Type  Injury   
Event Description
Follow-up on (b)(6) 2012 showed that the patient was seen on (b)(6) 2012. The swelling on the back of the patient's head was an irritation. The patient had a seizure at school, hit the back of her head, and the back of the head was swollen. There was no mention of the sleep apnea or arrhythmia in the patient's chart; therefore, no assessment regarding these events was available. The patient had recently had some dental work, and the physician wondered if the impaired healing of the dental work was related to the vns. The patient was also having seizures again; however, when asked, it was stated that this was not an increase. The patient's device was disabled, but no changes were noted, so the device was turned back on. The patient was now on vimpat and doing better.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, this vns patient's mother reported that the patient had a tooth extracted as it had decayed, and she began experiencing seizures where she 'migrates' to where the tooth was, as she experiences pain in that area. After the patient's replacement (due to end of service), the patient experienced this complication in addition to sleep apnea and a heart murmur. It was also stated that the patient experiences a swelling on the back side of her head after her seizures, which hadn't happened before. Programming history is available for (b)(6) 2012. A battery life calculation indicated 4. 25 years remaining attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860590


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:29:15 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/10/2016
Event Type  Injury   
Event Description
A patient was seen at the physician's office and desired to have his device explanted as he believed the vns was making his seizures worse. At the office visit, the physician temporarily disabled the patient's vns and scheduled to see the patient again in a few months to test the device's efficacy. Diagnostics indicated the device was performing as intended. Follow-up with the company representative present at the office visit indicated that the patient stated vns never controlled his seizures. The physician had noted that the patient has a heart murmur that may have factored into the patient's increased seizures, although it was unclear if the patient had a history with cardiac issues or if the arrhythmia was related to vns. It was noted that the physician had only recently begun seeing the patient and had disabled the device as he was unsure what may be causing the increased seizures. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7402922


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:45:52 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
Initial rptr indicated that she was implanted with the vns and "it was really bad for her". She reported "she had been "suicidal and wanted to have the vns device removed". The vns was disabled per the pt's request. The pt's treating physician reported that the pt "always had some problem with her, each time something different. She didn't know whether to believe her or not and whether they were related to vns or just due to the pt. " the physician reported pt reported the vns lowered her heart rate, so the physician lowered her vns dose. Pt reported her mind works slower and reported that she had "suicidal ideations in the past at higher doses", so the physician lowered dose again. Pt later reported "that the suicidal ideations are much better now". The treating physician was wanting to keep the vns at the lower dosing, but the pt is adamant for the device to be turned off, so physician turned device off. The physician reported being confused the "pt denied having suicidal ideations in the first place, but then came back and said they were better. " diagnostic testing was within normal limits. The pt per physician 'is adamant on getting the vns removed. " good faith attempts have been made for add'l info that have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009718


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:46:27 AM
Model Number 103
Event Date 10/19/2016
Event Type  Injury   
Event Description
A patient alleged that vns almost killed her, stating that it electrocuted her vagus nerve and the connected organs. The patient believed that her vns malfunctioned and contributed to years of pain and damage, leading her to have the device explanted 1 month prior to her report; however, no device malfunction has been identified to date. A review of programming history for the patient's device available from the date of implant through the next 2. 5 years indicated that the device functioned properly throughout the available history. The programming history indicated that the device was programmed off in march 2015. A physician who followed the patient in 2016 indicated that the device was programmed on in february, and programmed off again in october. The physician could not assess the cause of the patient's reported adverse events since the physician had only seen her twice in his clinic. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A call was received from a physician stating that a patient was reporting that their lead neck site was "heating up" and the vns was causing pain at the chest wall. The patient was also experiencing jaw pain which stimulation, and her heart slowed down when the vns was stimulating. The patient stated that she was supposed to receive stimulation every 5 minutes but she was feeling the device go off every 30 seconds. A review of the available programming history showed that the patient's settings from (b)(6) 2012 had a 5 minute off time. The physician was told to use a magnet to inhibit stimulation for the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096084


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:47:03 AM
Model Number 103
Event Type  Injury   
Event Description
It was initially reported by the physician's office that a pt mentioned that it seems that her pulse rate seems to drop at night. It was unk if this was occurring with stimulation. The pt was going to be referred for further evaluation on the issue. No further details have been made available on the issue. Good faith attempts to obtain additional info on the issue have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1671547


Title: Re: Misc. Cardiac
Post by: dennis100 on July 05, 2018, 08:48:00 AM
Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient has some episodes of a slow heart rate in the 50¿s ever since the vns was turned on a couple of weeks ago. The patient had no reported heart issues prior to vns. There was no report of cardiac issues on diagnostics during implant. The patient¿s current settings were noted to be output=0. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 75ma/magnet on time=60sec/magnet pulse width=500usec. The patient was taken to the er but everything was fine so he was not admitted into the hospital. They have not diagnosed the patient to have bradycardia. Since the patient has only had episodes, they have not seen a direct correlation to vns or stimulation. Good faith attempts for further information from the physician have been made but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3485598


Title: Re: Misc. Cardiac
Post by: dennis100 on July 06, 2018, 11:34:56 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 05/31/2018
Event Type  Injury   
Event Description
It was reported that during the lead replacement surgery for high impedance, which is reported in mfg. Report #1644487-2018-01042, an erratic heart rate was observed when the vns was programmed to the pre-op settings. The in-pocket vns diagnostics were within normal limits and heartbeat detection was verified within 1 beat per minute, or bpm, at 70 bpm. It was stated that there was slowing and increasing of the heart rate. The surgeon stated that this was likely the result of stimulation on a "fresh" portion of the nerve. It was decided to disable the vns and allow the patient's physician to titrate the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7626459


Title: Re: Misc. Cardiac
Post by: dennis100 on July 06, 2018, 11:35:43 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to low heart rate. The cardiologist stated that the low heart rate correlated with magnet mode. However, the neurologist believed that the low heart rate was not caused by vns but could have been exacerbated by vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594811


Title: Re: Misc. Cardiac
Post by: dennis100 on July 16, 2018, 01:42:53 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. Cardiac
Post by: dennis100 on July 25, 2018, 06:09:07 AM
Model Number 102
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient went to the er due to choking, shortness of breath, chest pain and an accelerated heart rate. The er physician placed the magnet over the device and the events resolved. Patient visited his treating physician after that and his device was disabled and patient was referred for removal surgery. Physician stated that the patient had no history of heart problems. Physician stated that the patient was set at 01/30/1000/60/180. Additional information received stated that the patient underwent a vns explant surgery. Explanted products were returned to manufacturer for analysis. Analysis is currently in progress for the explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888980


Title: Re: Misc. Cardiac
Post by: dennis100 on August 10, 2018, 04:16:47 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient had a defibrillator put in. The patient was having atrial fibrillation. The neurologist didn't think the vns was the cause of the atrial fibrillation and thought the patient had atrial fibrillation before being implanted with vns. A cardiologist though wanted the device disabled. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726058


Title: Re: Misc. Cardiac
Post by: dennis100 on August 20, 2018, 03:41:57 AM
Model Number 105
Event Date 09/01/2010
Event Type  Injury   
Event Description
Cyberonics vns - for epilepsy patients. Two surgeries. Two separate devices, worsening, depression. Device malfunction could be fatal. First vns - implant constantly malfunctioned left scar tissue caused death/resuscitation in operating room. Caused stroke 2 times, caused permanent damage to heart/body, second device caused permanent damage and could be end by death to my life. Nerve damage, permanent sensitivity to touch, damaged nerves/pain, heart problems, scar tissue. Neuropathy could result in death. Cyberonics recently called, and they stated the surgery never should have been done. Pt id: (b)(6). Chart # at operating room: (b)(6). Surgeon: (b)(6). Surgical operating room/extended adm: (b)(6) 2015. Csn: (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5700328


Title: Re: Misc. Cardiac
Post by: dennis100 on August 21, 2018, 08:51:24 AM
Model Number 102
Event Date 03/15/2006
Event Type  Injury   
Event Description
It was reported by the pt that she was having a lot of gastric reflux problems and thought it may be due to her vns. She also reported a pain in between her vagus nerve and esophagus. The pt did want the vns explanted as it had not been beneficial for her. The device had been turned off due to the pain, but the pain was still present when she eats. Furthermore, the pt claimed to have an irregular heartbeat, which she did not know if it was related to vns. All of the pt's problems supposedly began after she was implanted. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141185


Title: Re: Misc. Cardiac
Post by: dennis100 on August 25, 2018, 06:08:52 AM
Model Number 102R
Event Date 07/01/2008
Event Type  Injury   
Event Description
It was reported to mfr that the vns pt was experiencing an irregular heartbeat. The pt reported that when the physician attempts to increase the device settings, the arrhythmia occurs and the physician has to turn the settings back down. The pt reported that follow up was performed with a cardiologist, who attributed the irregular heartbeat to vns therapy. Attempts to obtain additional info from the treating physician are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1098147


Title: Re: Misc. Cardiac
Post by: dennis100 on August 27, 2018, 11:32:30 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Event Description
It was reported that the patient was having chest pains. It was unclear if the pain was due to the vns. The patient was taken in an ambulance and abnormal ecg was observed. The patient had no past abnormal ecgs. It was recommended to the patient to contact her neurologist to run diagnostics. Follow up with the physician's office revealed that the patient had contact the office. It was reported that they were aware of the event, but did not have information. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6684184


Title: Re: Misc. Cardiac
Post by: dennis100 on September 05, 2018, 08:26:16 AM
Model Number 103
Event Date 03/01/2016
Event Type  Injury   
Event Description
On (b)(6) 2016 it was reported that the patient was scheduled for prophylactic generator replacement on (b)(6) 2016. The clinical reason is that his seizures have increased in number and severity with the current generator. The surgeon has noted heart rate variability in this patient and suggested this new generator model as the "next step". The patient underwent the generator replacement on (b)(6) 2016. The lead impedance for the new implant was ok, 1618ohms. The explanted generator cannot be returned for product analysis per the hospital.
 
Manufacturer Narrative

Event Description
The surgeon stated that the increase in seizures and increase in severity of the seizures were not related to vns. They were believed to be due to the patient¿s medicine, drug regimen, and disease progression.
 
Event Description
On (b)(6) 2016 it was reported that the patient has been having "multiple breakthrough seizures" and the physician is considering implanting him with a model 106 generator as he thinks it may help with the patient's seizures, though it was noted that this would be considered a prophylactic replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5570936


Title: Re: Misc. Cardiac
Post by: dennis100 on September 07, 2018, 11:42:33 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2018
Event Type  Injury   
Event Description
It was reported that during the patient's generator replacement surgery, following the removal of the old device and implant of the new device, the new device was interrogated and diagnostics were performed, which were ok. The device was then turned back on to the previous device¿s settings. After programming was complete, the patient experienced heart block. The anesthesiologist monitored the patient and when the generator cycled again, and the patient again experienced heart block. The timeline of this was confirmed by the anesthesiologist who reviewed the cardiac monitor after the completion of the case. The surgeon turned the generator off and the anesthesiologist monitored the patient¿s heart rate for approximately 5 - 10 minutes. No abnormalities were observed during this time period. The device was turned back on, but at a lower output current of 1. 00ma for normal and magnet mode. After turning the device back on at this lower current, her heart rate was monitored for approximately 10 minutes, again no abnormalities were observed and the surgeon contacted the patient¿s neurologist office and they collectively decided to leave the device at the lower output current. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7738864


Title: Re: Misc. Cardiac
Post by: dennis100 on September 08, 2018, 01:22:21 AM
Model Number 102
Event Date 01/18/2013
Event Type  Injury   
Event Description
It was initially reported that a patient had and ekg done which demonstrated concerns for atrial fibrillation. There was no relationship to vns provided. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156370


Title: Re: Misc. Cardiac
Post by: dennis100 on September 13, 2018, 02:25:07 AM
Model Number 102
Event Date 12/07/2009
Event Type  Injury   
Event Description
On november 7, 2011 clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2009 revealed that the patient had her pacemaker interrogated that year and that the patient has obstructive sleep apnea. No relationship between the patient's arrhythmia and the obstructive sleep apnea to vns was provided in the clinic notes. Good faith attempts for additional information from the physician have been made but no further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2350933


Title: Re: Misc. Cardiac
Post by: dennis100 on September 13, 2018, 02:25:51 AM
Model Number 103
Event Date 08/05/2011
Event Type  Injury   
Event Description
It was reported by the pt that she had experienced an arrhythmia while in the hosp for her vns initial implant. She did not specify what kind of arrhythmia it was but only stated that it "was not there before. " it was not clarified if it occurred during the surgery or post-implant. F/u with the neurologist's office found that the site had not heard of any adverse events and the pt was doing well at the visits following vns implant. Per the site, the pt's vns is functioning normally however specific vns diagnostics were not provided. A staff member at the surgeon's office said she was not aware of any of the events but would confirm with the surgeon. The pt also reported hotness and swelling at the wound site, nausea, visual disturbance, difficulty swallowing, and choking following surgery as well however none of these events were able to be confirmed with the neurologist or surgeon at this time. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2249204


Title: Re: Misc. Cardiac
Post by: dennis100 on September 19, 2018, 01:42:02 PM
Model Number 102
Event Date 12/07/2011
Event Type  Injury   
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Reporter indicated that a vns patient was having increased depression and was waiting for a heart transplant. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2428146&pc=MUZ


Title: Re: Misc. Cardiac
Post by: dennis100 on September 20, 2018, 10:45:57 AM
Model Number 1002
Event Date 07/01/2011
Event Type  Injury   
Event Description
Reporter indicated that she began having some "heart related issues", where it feels like her heart is skipping beats, and her blood pressure drops, which started occurring about 6 months ago. The reporter questioned if this may be related to her vns device. Attempts for additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2423087


Title: Re: Misc. Cardiac
Post by: dennis100 on September 26, 2018, 06:23:39 AM
Model Number 102
Event Date 08/29/2011
Event Type  Injury   
Event Description
Additional information was received from the surgeon who reported that the patient's reported additional health problems are not related to vns. The patient has been referred to a vascular specialist, but the patient has not followed up.
 
Manufacturer Narrative
The supplemental report #1 inadvertently did not include that the patient now reportedly has seven blood clots.
 
Event Description
It was reported that the patient has seven blood clots and has swelling in the legs and left arm, and the patient did not have these blood clots and swelling prior to vns. Attempts for additional information from the surgeon's office have been unsuccessful to date.
 
Event Description
It was reported that the patient had the generator and lead explanted on (b)(6) 2014. The explanted products have not been received by the manufacturer to date.
 
Event Description
The patient reported that the patient wants to the vns device explanted because it caused him to have blood clots. The patient indicated that he has had the device disabled 'for a period of time. ' the patient is reportedly now on coumadin, and continues to report that his health has declined with vns. He plans on reducing coumadin in anticipation of vns explant. Attempts for additional information on the device disablement have been unsuccessful to date.
 
Event Description
It was reported by the explant hospital that the explanted products were discarded.
 
Event Description
Additional information was received from the epileptologist's office which revealed that they are unable to provide an assessment regarding the relationship of the patient's heart conditions to vns. It was noted that the patient's vns system has been working properly and no changes have been made to the patient's medication or the vns settings. They are unaware if any interventions have been planned or if the patient had a medical history of blood clots or heart problems. The surgeon's office reported that the patient's blood clots, swelling and heart valve problems are not related to vns. The patient has been referred to a vascular specialist regarding these events. No causal or contributory medication changes precede the onset of these events, and the patient does not have a medical history of these events. Patient manipulation or trauma may have occurred to have caused/contributed to the swelling. No additional information was provided by the surgeon. The patient further reported that he has seven blood clots, and has swelling in his legs and left arm, which he didn't have before vns. The patient says that with vns, he is having more health problems than what he wants. Attempts for additional information from the surgeon have been unsuccessful to date.
 
Manufacturer Narrative
Date of birth, corrected data: the initial report inadvertently reported the date incorrectly. Date received by manufacturer, corrected data: the supplemental report #7 inadvertently reported the date incorrectly. It should have reported the date as 10/24/2014.
 
Event Description
It was reported that a vns pt had swelling in his arms and legs around the time of vns implant on (b)(6) 2011 through (b)(6) 2011. The pt went to the er in (b)(6) 2011, and the physicians found that he had a blood clot in his arm and one in his leg. He was hospitalized at that time. During this hospitalization, the pt was diagnosed with one of his heart valves not opening. The pt indicated that he thinks these events are all related to vns. The pt has reportedly not had his vns checked in a while and probably will not until the blood clots and heart valve problem resolve. Attempts for add'l info from the physician have been unsuccessful to date.
 
Event Description
Information was received from the neurologist¿s office that in clinic notes dated (b)(6) 2012, it was documented that the device was off. The nurse was unable to find when it was first turned off. An additional attempt for information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465251


Title: Re: Misc. Cardiac
Post by: dennis100 on September 26, 2018, 06:24:46 AM
Model Number 102
Event Date 06/13/2014
Event Type  Injury   
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3927782


Title: Re: Misc. Cardiac
Post by: dennis100 on September 27, 2018, 10:26:08 AM
Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after she allergic reaction to antibiotics prescribed by neurosurgeon, captured in mdr# 1644487-2011-00975, she was told by hospital physician that she has an abnormal ekg. She was referred to cardiologist but the name of cardiologist was not provided. Good faith attempts to obtain additional information from pt's neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082987


Title: Re: Misc. Cardiac
Post by: dennis100 on September 30, 2018, 12:22:52 PM
Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
All attempts to the reporter's treating neurologist for further information have been unsuccessful to date.
 
Event Description
Reporter indicated that since his vns settings were increased in (b)(6) 2012, he had been experiencing dyspnea and "heart racing. " the reporter was advised to follow up with his physician. Manufacturer follow up with the treating physician revealed the reporter had not notified the physician about the reported issues. The physician will attempt to follow up with the reporter. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2507314


Title: Re: Misc. Cardiac
Post by: dennis100 on October 03, 2018, 07:27:18 AM
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2018
Event Type  Injury   
Event Description
A research article hypothesized the risk factors to determine a relationship between vns and clinically-significant arrhythmias. The case study central to the article discussed a patient who was admitted to the facility with symptomatic bradycardia associated with vns stimulation. The patient's medical history was reviewed. It was noted that the patient did not exhibit heart rate changes related to vns stimulation during the vns implant procedure; however, 3 years after implant, the patient occasionally exhibited loss of consciousness initially presumed to be related to a change in seizure type. It was later determined that the patient experienced momentary bradycardia, av block, and a brief cardiac arrest during sleep. The patient was implanted with a cardiac pacemaker, which resolved the bradycardia. Previous literature was also reviewed in the context of this article. The literature review identified 21 patients documented across 14 studies exhibited arrhythmias presumably induced by vns. Several of these events are discussed in the following mfr. Report #s: 1644487-2014-01653, 1644487-2006-00148, 1644487-2008-01907, 1644487-2008-01792, 1644487-2008-01919, 1644487-2009-01201, 1644487-2008-01648, 1644487-2008-03112, 1644487-2009-02887, 1644487-2011-01081, 1644487-2011-01081, 1644487-2012-02233, 1644487-2012-00993.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7779058


Title: Re: Misc. Cardiac
Post by: dennis100 on October 05, 2018, 01:17:12 PM
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's mother reported via social media that her son's vns had caused him to have heart problems. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7900685


Title: Re: Misc. Cardiac
Post by: dennis100 on October 06, 2018, 06:37:36 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/17/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient felt that her heart was "skipping beats" and that this worsened with stimulation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7887874


Title: Re: Misc. Cardiac
Post by: dennis100 on October 06, 2018, 06:38:23 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2018
Event Type  Injury   
Event Description
It was reported by a patient through social media that she was the first live patient for the surgeon implanting her vns and now had "heart blockage". The patient further stated that she had vns implanted in (b)(6) 2015 and was having heart problems attributed to the vns by (b)(6) 2018. She stated she was seeking vns explant. Programming history was reviewed, however data was only available from the date of implant up to (b)(6) 2016, which noted no device issue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7889910


Title: Re: Misc. Cardiac
Post by: dennis100 on October 08, 2018, 01:55:46 PM
Model Number 102
Event Date 08/15/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was seen by the neurologist and it was determined that the cardiac event has no relation to vns.
 
Event Description
It was reported that the vns patient was diagnosed with heart disease. The patient¿s cardiologist stated that vns may be affecting the patient¿s heart. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4085358


Title: Re: Misc. Cardiac
Post by: dennis100 on October 09, 2018, 01:30:29 PM
Model Number 104
Event Date 10/04/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
No further information has been attained after good faith attempts have been made.
 
Event Description
It was reported that the patient continues to have left shoulder pain with stimulation. The patient¿s caregiver would like to have the patient¿s lead replaced. She reports that the patient saw the surgeon a year ago about the pain and other events, and the surgeon reported to them that the patient did not need replacement.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Additional information was received from a company representative indicating the patient was to undergo surgery as a piece of a foreign object was detected under the patient's shoulder area and believed to be associated with initial vns surgery. Moreover, the patient was reported to have an increase in seizures. Interventions taken were to increase the medication doses. At the moment, attempts to obtain further information regarding the foreign object have been unsuccessful to date.
 
Event Description
It was reported by a patient's mother that the vns patient had recently undergone generator replacement surgery and since then, the patient has experienced an increase in seizures, started having cardiac issues, and constant left shoulder pain. The patient's mother did not know if the reported increase in seizures was above pre-vns baseline, but did mention the patient underwent medication and parameter changes to reduce the seizure frequency. At the moment the relationship of the reported cardiac issue, pain, and increase in seizures to vns therapy is unknown as good faith attempts to obtain further information from the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2540783


Title: Re: Misc. Cardiac
Post by: dennis100 on October 10, 2018, 03:38:56 AM
Model Number 102R
Event Date 05/03/2011
Event Type  Injury   
Event Description
Reporter indicated via clinic notes received to the manufacturer on (b)(6) 2012 that the patient had increased seizures on (b)(6) 2011. The patient had been seizure-free for two years, and then had 3 seizures on (b)(6) 2011 that were suspected to be drop seizures. Vns diagnostics were within normal limits and the vns was not at end of service. The patient had ans testing (study of the sympathetic and parasympathetic nervous system) performed, which was abnormal. Attempts for further information regarding the increased seizures have been unsuccessful to date.
 
Event Description
Reporter indicated via clinical notes received to the manufacturer that a vns patient had a possible arrhythmia. The patient was prescribed a holter monitor for use at home to analyze his heart rhythm on (b)(6) 2011. All attempts for additional information from the reporter regarding the possible arrhythmia have been unsuccessful to date.
 
Manufacturer Narrative
Information from the reporter was inadvertently omitted from the initial mdr report.
 
Event Description
Reporter indicated the patient did not have a pre-vns history of an arrhythmia, but an arrhythmia was not confirmed. The reporter referred all additional questions to the treating surgeon. All attempts for further information regarding the possible arrhythmia from the surgeon have been unsuccessful to date.
 
Manufacturer Narrative
Information from the reporter regarding the increased seizures was inadvertently omitted from the initial mdr report.
 
Manufacturer Narrative

Event Description
Additional information was received to the manufacturer from the treating surgeon. Per the treating surgeon, the patient did not have an arrhythmia. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2556909


Title: Re: Misc. Cardiac
Post by: dennis100 on October 10, 2018, 03:39:40 AM
Model Number 102
Event Date 04/28/2008
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported on (b)(6) 2012, that a patient has felt a ringing in his left ear since surgery and indicated it interferes with his hearing. He has a scar at the generator site which is sensitive and painful. The scar at the generator is large and there is no scarring at the neck site. The patient is experiencing an irregular heartbeat with stimulation. He stated his heart has been observed as "skipping a beat" and states the device affects his memory in that he is unable to remember some things. He can also feel stimulation in his leg at times. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the neurologist's office reported that they have not seen the patient since 2008 so they would not be able to comment on the events reported by the patient. It is unknown who the patient will see at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2581381


Title: Re: Misc. Cardiac
Post by: dennis100 on October 11, 2018, 07:00:15 AM
Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a pacemaker company representative reported that the vns patient will be having a pacemaker implanted due to sick sinus syndrome. It was unknown when the event first started. Good faith attempts were made to the physician for further information but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2602866


Title: Re: Misc. Cardiac
Post by: dennis100 on October 12, 2018, 04:53:01 PM
Model Number 101
Device Problem Insufficient Information
Event Date 06/23/2012
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was acute myocardial infarction (unspecified), atherosclerotic heart disease, and heart failure (unspecified). There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that a vns patient was going to be referred for generator replacement surgery. The patient died prior to their surgery consult. No information is known surrounding the cause of their death or the circumstances around their death. Their neurologist does not have any further details at this time. Sudep has not been ruled out. Good faith attempts are underway for further details.
 
Manufacturer Narrative

Event Description
Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2664669


Title: Re: Misc. Cardiac
Post by: dennis100 on October 12, 2018, 04:53:53 PM
Model Number 103
Device Problem Insufficient Information
Event Date 02/27/2012
Event Type  Death   
Manufacturer Narrative
Death, date of event; corrected data: additional information was received regarding the date the patient passed away.
 
Manufacturer Narrative
Outcomes attributed to adverse event; corrected data: this information was inadvertently left off of supplemental 03 mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received on (b)(4) 2012, when a sudep evaluation was performed over the information received thus far which was determined to be possible sudep. The patient's neurologist reported that she passed away on (b)(6) 2012 and the last time he saw her was on (b)(6) 2012. They had no information on the cause of her death. Additional information was requested from the patient's primary care physician regarding the patient's death but no further information has been received to date.
 
Manufacturer Narrative
 
Event Description
On (b)(6), 2012 a vns treating neurologist reported that the vns patient has passed away in (b)(6) 2012. No cause of death was provided. The patient had switched neurologists and the neurologist that the patient was seeing at the time of her death is unknown. Attempts for further information are underway.
 
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) 2012 and the patient's cause of death was unspecified and cardiogenic shock. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
Additional information was received on (b)(6) 2012, when the office of vital records in the state passed away in reported that a copy of the patient's death certificate will not be provided as the company of the patient's medical device is not eligible to obtain a death certificate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2668852


Title: Re: Misc. Cardiac
Post by: dennis100 on October 14, 2018, 12:55:01 PM
Model Number 103
Event Date 07/27/2012
Event Type  Injury   
Event Description
Additional information was received from an epilepsy specialist nurse that she was not sure of the conclusion from the cardiologist but initially their treating physician did not feel that her symptoms were cardiac. An initial ecg and bloods were unremarkable. It was planned for the patient to have an echocardiogram and 24 hour blood pressure. Unknown if this has occurred. As additional information is attained it will be sent to the manufacturer.
 
Event Description
It was reported that a patient in (b)(6) who was implanted two months ago is presenting with an abnormal electrocardiogram. The patient was going to be followed by a cardiologist. The patient also had complaints of chest pain and she has a history of cardiac problems. Their chest pain was determined to not be vns related. Further investigation is underway in regards to their abnormal electrocardiogram.
 
Manufacturer Narrative
Suspect medical device corrected data:. Labeling was attained and not added to the initial mdr report.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on October 14, 2018, 12:55:54 PM
Model Number 102
Event Date 06/08/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacture data, corrected data: an incomplete manufacture date was inadvertently provided on the initial mdr report. The complete manufacture date is provided.
 
Event Description
Additional manufacturer follow-up identified the patient's treating neurologist; however, the neurologist has not seen the patent since (b)(6) 2011 and was unaware of any cardiac events and has no information regarding the arrhythmia or syncope events. Additional manufacturer follow-up with the pacemaker surgeon revealed he had no information and declined to discuss the events further. Vns diagnostics were within normal limits during the pacemaker surgery on (b)(6) 2012.
 
Event Description
It was reported by a surgeon that a vns patient would be implanted with a pacemaker due to the experienced events of syncope and 3 second delays in heart rhythm. The surgeon had no additional information regarding the patient's medical history. Additional information was received through the area representative who indicated he was present at the time of the pacemaker surgery. The representative indicated that he was able to successfully interrogate the patient's vns prior to surgery. At the moment good faith attempts to obtain further information regarding the reported 3 second delay and syncope have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2637436


Title: Re: Misc. Cardiac
Post by: dennis100 on October 14, 2018, 12:57:06 PM
Model Number 102
Event Date 06/27/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for a vns patient reporting that the patient has a history of seizure-like spells which appear to be associated with episodes of syncope, tonic-clonic activities. The patient has episodes of syncope after standing for two minutes, and it was unclear if it was related to orthostatic hypotension or cardiac dysrhythmias. He was referred to be evaluated by cardiology. The physician noted the patient would benefit from coumadin for secondary stroke prevention due to the atrial fibrillation. The physician turned off the vns device on this visit, (b)(6) 2012, as the patient requested. Additional notes were received indicating the patient has two types of spells which he passes out, and the vns indications are not clear. This was the first appointment with this physician. The patient however has not had any recent seizures, but feels the vns may need to be explanted. Follow up with the physician's office confirmed that they do not know the relationship of the arrhythmia and syncope events to vns as the patient was first evaluated on (b)(6) 2012. They disabled the device on (b)(4) 2012 because they do not know if the patient's seizures are epilepsy related to related to alcohol. Therefore, they turned it off to see if the seizure frequency increases without vns. There were no notes to indicate that diagnostics were taken prior to the device being disabled. There was no strong indication why the patient feels the generator should be explanted. However, per the notes, the physician indicated that he will not suggest to have it explanted until the etiology of the patient's seizures are clear. It is unknown to date if the device disablement will be permanent or temporary. The office was unable to provide additional information. Although the patient is requesting explant, the physician suggested turning the device off first and monitoring his symptoms. Although surgery may occur in the future, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2720145


Title: Re: Misc. Cardiac
Post by: dennis100 on October 14, 2018, 12:57:48 PM
Model Number 102
Event Date 04/10/2012
Event Type  Injury   
Event Description
Attempts to the treating physician for additional information have remained unsuccessful.
 
Event Description
Clinic notes received on (b)(6) 2012 and dated (b)(6) 2012 reported that the patient is implanted with a pacemaker. The patient's specific heart condition, as well as its relationship to vns is unknown at this time. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715954


Title: Re: Misc. Cardiac
Post by: dennis100 on October 18, 2018, 02:40:09 AM
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported the company rep that the pt had a recent ekg that contained an abnormality, unk if related to vns or if the pt has a history of cardiac events. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953497


Title: Re: Misc. Cardiac
Post by: dennis100 on October 19, 2018, 12:00:46 PM
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. Cardiac
Post by: dennis100 on October 27, 2018, 01:19:43 AM
Model Number 102
Event Date 03/21/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, the manufacturer was called by a pacemaker company's representative requesting pacemaker precautions for a vns patient. The representative did not know what type of arrhythmia the patient is experiencing. The representative was informed of the pacemaker and electrocautery precautions for vns patients. Good faith attempts have been made to the patient's neurologist and cardiologist; however, no further information has been received. If additional information is gained, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2044885


Title: Re: Misc. Cardiac
Post by: dennis100 on October 27, 2018, 05:56:56 AM
Model Number 102
Event Date 10/01/2014
Event Type  Death   
Event Description
It was reported that a vns patient had passed away. The patient had a heart attack in 2014, no exact date given, and passed away. The patient reportedly had chronic heart problems. A review of the manufacturer's in house programming history identified the patient's last known settings in (b)(6) 2014. All diagnostic results available were within expected limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5987277


Title: Re: Misc. Cardiac
Post by: dennis100 on October 27, 2018, 06:00:20 AM
Model Number 103
Event Date 03/07/2015
Event Type  Death   
Event Description
It was reported that the patient had passed away recently and had experienced increased seizures prior to death. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The patient was reported to have been buried by the funeral home. Attempts made for additional relevant information regarding patient's death were unsuccessful. A copy of the death certificate is being requested. Attempts were made for the patient's vns products but they have not been received to date.
 
Event Description
Additional information was received that the patient¿s cause of death remains unknown as the medical examiner¿s office is performing toxicology tests to see if it might be drug overdose and have not determined the cause of death. An autopsy was performed on (b)(6) 2015 but the results will not be released until all tests are completed. Additional attempts made for the autopsy report were unsuccessful to date. The explanted generator and lead were returned on 4/7/2015. A large portion of the lead assembly (body) including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure and no obvious anomalies were noted. Analysis of the returned generator is underway but has not been completed.
 
Event Description
Patient's death certificate was received stating that the cause of death was atherosclerotic cardiovascular disease. Patient had this disease for years along with medically significant obesity. Patient's manner of death was natural and patient died at home.
 
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4656704


Title: Re: Misc. Cardiac
Post by: dennis100 on October 27, 2018, 06:01:06 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/14/2017
Event Type  Death   
Event Description
The patient was reported to have passed away in hospice due to congestive heart failure. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563117


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:51:27 AM
Model Number 104
Event Date 09/25/2012
Event Type  Death   
Event Description
The physician reported that he did not know the cause of death, but did not think that the death was sudep or related to vns therapy. The death certificate was received and listed the immediate cause of death as acute cardiopulmonary collapse (approximate interval between onset and death: immediate) due to coagulopathy. Other significant conditions contributing to death, but not resulting in the underlying cause given was listed as infection, epilepsy, chronic encephalopathy and ataxia. The physician reported that he does not feel the patient's infection was related to vns therapy. The physician declined to provide any additional information.
 
Manufacturer Narrative
 
Event Description
A funeral home called to return a explanted lead and generator from a vns patient who had passed away. No further details were provided surrounding the patient's cause of death and relationship to their vns. It was reported the patient had their products explanted in the last month but exact date of death not provided. Exact explant date not known. Analysis was performed on their explanted lead. The generator analysis is pending completion. An analysis was performed on the returned lead portions. Note that portions of the marked and unmarked connector boots, including a portion of the serial number tag was not returned therefore; it was not possible to verify the serial number during this analysis. The lead assembly (body) including the electrodes was also not returned; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since portions of the marked and unmarked connector boots, the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
The generator pa was completed on (b)(4) 2013. Analysis of the generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder found that a high impedance condition existed prior to explant. This is reported in mfr report # 1644487-2013-02260.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3180767


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:52:14 AM
Model Number 102
Event Date 07/16/2013
Event Type  Death   
Event Description
On (b)(4) 2013, it was reported that the patient passed away at home few days earlier ((b)(6) 2013) due to myocardial infarction. Attempts have been made for additional information, but they have been unsuccessful. No additional information has been provided.
 
Event Description
The national death index from the cdc website listed the patient's causes of death as drowning and submersion while in swimming pool, atherosclerotic cardiovascular disease, drowning and nonfatal submersion, and other ill-defined heart diseases.
 
Manufacturer Narrative
 
Event Description
Further follow-up revealed that the physician indicated that the device had been programmed off and therefore the death was not related to vns therapy. The physician indicated that the patient had parkinson's disease and suffered a heart attack and that the death was not related to vns therapy. The device disablement was previously reported in mfr. Report # 1644487-2010-01378.
 
Event Description
The explanted product and a product return form were received by the manufacturer. The cause of death was listed as drowning. Additional circumstances surrounding the death were listed as atherosclerotic cardiovascular disease. Analysis of the explanted lead and generator did not reveal any anomalies or performance issues however, the entire lead was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3298712


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:52:59 AM
Model Number 102
Event Date 06/04/2012
Event Type  Death   
Event Description
On (b)(6) 2012, a vns patient's son reported that the vns patient had recently passed away. The son reported that the death was not related to vns. An online obituary search showed that the patient's date of death was (b)(6) 2012. On (b)(6) 2012, follow up with the funeral home and physician's office was performed. Follow up with the associated funeral home revealed that the device was explanted prior to burial and discarded. It was also stated that the cause of death was cardio-respiratory failure. The physician's office stated that the patient had not been seen for some time. A battery life calculation was performed on (b)(6) 2012 with 9. 18 years to eri=yes. Attempts for additional information have been unsuccessful.
 
Event Description
This death event has been evaluated and with the available information the death has been determined to be possible sudep. Even though the funeral home reported the cause of death was cardiorespiratory failure, this is very vague and ultimately all deaths occur as a result of cardiorespiratory failure in some manner. The circumstances of the death, the general health of the patient, location of the death (inpatient or at home), and if seizures were involved with the death are all still unknown. As such, sudep cannot be ruled out as a possible cause of death.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, the patient's death certificate was received. The certificate indicated that the patient passed in a natural manner. The underlying cause was cardiorespiratory failure (few days), septic shock with multi-system organ failure, and chronic liver disease with (b)(6). Follow-up with the patient's physician showed that no information was available regarding the patient. A sudep evaluation was performed with the new information. This death event has been reviewed and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was cardiorespiratory failure, septic shock with multi-organ failure, and chronic liver disease with (b)(6). Although the location of the death is not listed on the death certificate, it is likely the patient died in a hospital setting due to the reported event of septic shock and multi-organ failure. The patient was likely in a poor state of health at the time of death, and the death was likely witnessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2672168


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:53:40 AM
Model Number 103
Event Date 02/17/2010
Event Type  Death   
Event Description
On (b)(6), 2012, a physician reported that this vns patient had passed away. The physician believed that the patient died of seizures but did not have any additional information. An obituary determined the date of death to be (b)(6), 2010. On (b)(6), 2012, follow up with the mortuary associated with the patient's death revealed that because the device contained a battery, it would have been removed and disposed of properly in 2010; therefore, return of the device for product analysis is not possible. Additional follow up with the physician was conducted, and no information was available; however, another physician's name was provided as a potential source of information. Follow up with the suggested physician on (b)(6), 2012 revealed that the patient's cause of death was a cardiac arrhythmia due to an epileptic seizure. The relationship of the patient's death to vns was unknown, and no additional information was provided.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2617074


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:54:28 AM
Model Number 102
Event Date 12/02/2014
Event Type  Death   
Manufacturer Narrative

Event Description
Attempts for the vns products were made and it was reported that the funeral home will not return medical devices as the patient¿s family might want it later on in the future. It is unknown if the patient¿s device was explanted or not. Death certificate indicates that the patient's cause of death is due acute myocardial infarction, secondarily due to coronary heart disease, diabetes and chronic obstructive pulmonary disease. Patient was cremated and an autopsy was not performed. Tobacco use did contribute to death. An internal sudep evaluation was performed by the manufacturer which determined the death to be unlikely sudep.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns are unknown. It was noted that the patient had numerous medical issues. The patient was last seen by the neurologist over a year ago and diagnostic results showed normal device function at 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=4443657


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:55:13 AM
Model Number 102
Event Date 12/09/2010
Event Type  Death   
Event Description
A copy the death certificate was received where it states that the immediate cause of death was probable cardiac dysrhythmia due to angiomyolipomas of the heart in association with tuberous sclerosis. An autopsy was performed.
 
Event Description
Additional information was received indicating that the vns patient¿s device was not explanted after passing away. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
It was reported that the vns patient passed away from status epilepticus. The patient¿s obituary stated that the patient died in the hospital on 12/09/2010 and faced lifelong medical challenges of tuberous sclerosis. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3715018


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:55:53 AM
Model Number 102
Event Date 08/22/2013
Event Type  Death   
Manufacturer Narrative
 
Event Description
Additional information was received from the vns treating physician that the patient's death was unlikely related to vns therapy. The patient's death was sudden and was thought to be cardiac. The patient slumped over in front of the mother in the daytime, and she did not think it was a seizure. The patient was taken to the er and was unable to be resuscitated. The patient had a family history of sudden death in a relative. The patient had reduced seizures with vns and was receiving therapy at time of death. There was no prior history of cardiac or respiratory problems. Analysis of the generator and lead was completed. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was reported that the vns patient passed away and the explanted device was available for returned. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date. The cause of death is unknown. The relationship of vns to the cause of death are 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=3913891


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:56:34 AM
Model Number 101
Event Date 05/20/2008
Event Type  Death   
Manufacturer Narrative

Event Description
The funeral home indicated that the cause of death was cardiopulmonary disease and the manner of death was natural. There was no other information available. The physician indicated that the patient was last seen on (b)(6) 2007 and he does not have an opinion on the death.
 
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns is unknown. No additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410520


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:57:12 AM
Model Number 102
Event Date 04/21/2007
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. The relationship of the death to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
A copy of the patient's death certificate was received where the cause of death was documented as acute fatal cardiac arrhythmia due to or a consequence of the patient¿s seizure disorder. A review of the programming history revealed that the device was performing as intended.
 
Manufacturer Narrative
Review of programming/device diagnostic history performed. Date of event, corrected data: the initial report indicated the date of death was (b)(6) 2007 however it was actually (b)(6) 2007. The information has been corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3939064


Title: Re: Misc. Cardiac
Post by: dennis100 on October 28, 2018, 12:58:02 AM
Model Number 103
Event Date 05/04/2013
Event Type  Death   
Event Description
It was initially reported that the patient passed away due to unknown causes and the relationship of the death to vns was not provided. The funeral home reported that the patient was buried with the generator and lead, so it will not be available for return to the manufacturer for evaluation. The cause of death was later determined to be cardiac arrhythmias due to insecure medications below therapeutic levels. Following-up with the physician did not provide any additional information about the patient¿s death.
 
Manufacturer Narrative

Event Description
It was reported that the physician did not think there was anything wrong with the patient's device.
 
Event Description
Additional information was returned from the physician that the patient¿s death was not believed to be related to vns. It was unknown if the patient had a pre-vns history of cardiac arrhythmias.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156826


Title: Re: Misc. Cardiac
Post by: dennis100 on October 29, 2018, 11:25:33 AM
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported in an article that a patient died due to a heart disease. No other information regarding the event is available in the article. Attempts for further information from the authors of the article were unsuccessful. Therefore the relationship between the patient's death and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1631948


Title: Re: Misc. Cardiac
Post by: dennis100 on October 30, 2018, 01:07:00 AM
Model Number 103
Event Date 01/31/2012
Event Type  Death   
Event Description
On (b)(6) 2012, correspondence with the user facility's autopsy director revealed that the patient was in status epilepticus, and the generator was implanted as an intervention. It was believed that the death was not related to vns. The autopsy report was provided to the manufacturer. The autopsy report indicated that the patient was healthy until (b)(6) 2012, when she developed high fevers, without other symptoms. On (b)(6) 2012, antibiotics were started for a throat infection but the fevers persisted. On (b)(6) 2012, the patient was lethargic, and during the night, she was found unresponsive with muscle stiffness and her eyes open. The patient was intubated at an emergency department. The patient was transferred to another facility and admitted directly to intensive care. The cerebrospinal fluid had 4 neutrophils/ml and normal numbers of lymphocytes; the glucose was elevated. An mri showed localized edema of the hippocampi and fornical column, probably postictal edema. An extensive infectious disease workup on the blood and csf was negative, looking for bacteria, including bartonella, viral encephalitis viruses, adenovirus, and herpes simplex virus. The acylcarnitine profile, blood amino acid screen and urine organic acids were negative for metabolic disease, and a paraneoplastic work-up was negative. Pulse steroids were given for a possible autoimmune encephalitis. From admission, the patient had persistent seizure activity in spite of multiple antiepileptics. A pentobarbital infusion did not stop seizure activity despite burst suppression; when pentobarbital was stopped because of possible propylene glycol toxicity, a versed infusion was given, also without effect. A series of therapeutic apheresis procedures was started. On (b)(6) 2012, inhaled sevoflurane was started, also without effect on the seizures; epinephrine was required for hypotension and lasix for volume overload. The latter was subsequently replaced by hemofiltration. The vns device was placed on (b)(6) 2012. Despite all measure, status epilepticus continued. An echocardiogram on (b)(6) 2012, showed mildly decreased left ventricular function, and a follow-up on (b)(6) 2012, showed severe right and left ventricular systolic dysfunction and pericardial effusion, which did not respond to treatment with pressors. Care was redirected at the parents' request and death occurred on (b)(6) 2012. Per the autopsy report, significant autopsy findings included global ischemic encephalopathy with astrogliosis involving multiple areas of the brain. These findings are consistent with the effects of status epilepticus; inflammation or other findings indicating an etiology of the patient's initial high fevers and status epilepticus were not identified in the brain or in the other organs. Features of cardiac failure and dilation were evident, but aside from minor preterminal ischemia, the myocardium was histologically unremarkable. Based upon the autopsy report, the principle diagnosis of the death was global ischemic encephalopathy and gliosis with features of cardiac failure. Cardiac failure occurred; however, the cause or causes of the fevers, seizures, and terminal cardiac failure were not identified during the clinical course or at autopsy; in particular, there was no anatomic indication of an infectious disease, an inflammatory process, or an intrinsic abnormality of the brain. Possible etiologies include a late-presenting mitochondrial disorder, another metabolic or hereditary disease, or an unknown acquired disorder of the central nervous system. The autopsy also did not determine how or whether the neurologic condition and the cardiac failure were related to each other, and an anatomic cause of the cardiac failure was not identified.
 
Event Description
On (b)(6) 2012, a hospital reported that a vns patient had passed away. The patient's generator and lead were explanted by the funeral home. The date of death was provided as (b)(6) 2012; however, no additional information was available. The patient's explanted generator, with lead still attached, was returned on (b)(6) 2012 and is currently undergoing product analysis. Programming history from the date of surgery shows that the device not programmed on. Two system diagnostics from the date of implant indicated normal results. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Review of programming history.
 
Event Description
Generator product analysis was approved on (b)(6) 2012. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The generator was returned programmed on to deliver therapy. The lead assembly was returned. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. A fax from the surgeon on (b)(6) 2012, indicated that the surgeon was unaware, and no additional information was provided. Attempts to contact the pathology, neurology, neurosurgery, and medical records departments at the facility where the patient was implanted have been unsuccessful, but are still underway. Contact with the initial reporter corrected that the device was not received from the funeral home. Attempts to obtain information from the funeral home are in progress. A manufacturer's consultant present at the patient's implant surgery noted that the that the patient was a four-year-old admitted for cold symptoms two weeks ago and began having seizures have were uncontrolled with medications. The patient developed a phb (phenobarbital) toxicity. The patient was an inpatient; therefore, the neurologist was unknown. Diagnostics from the implant surgery were also provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769865


Title: Re: Misc. Cardiac
Post by: dennis100 on October 30, 2018, 01:08:23 AM
Model Number 103
Device Problem Insufficient Information
Event Date 06/24/2011
Event Type  Death   
Event Description
It was initially reported that the patient passed away in her sleep. The cause of death and the relationship to (b)(6) is unknown. Good faith attempts for more information and product return have been unsuccessful to date.
 
Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2011 and the patient's cause of death was unspecified cardiac arrhythmia, accompanied by other and unspecified convulsions. 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
A response was received from the physician that indicated that there was an autopsy that was performed by it will not be provided. No further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2188653


Title: Re: Misc. Cardiac
Post by: dennis100 on October 31, 2018, 02:17:23 AM
Model


Title: Re: Misc. Cardiac
Post by: dennis100 on October 31, 2018, 02:18:06 AM
Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2012, revealed that the patient has a history of cardiac arrhythmia. Additionally, it was noted that the patient was experiencing left chest pain (relationship not reported). The physician has recommended that the patient follow-up with the cardiologist for an ekg prior to undergoing generator replacement, for which is being reported in manufacturer report #: 1644487-2012-03152. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates: the initial report inadvertently reported the system diagnostic results incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852443


Title: Re: Misc. Cardiac
Post by: dennis100 on November 02, 2018, 08:48:39 AM
Model Number 102
Event Date 09/13/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away and was undergoing an autopsy. It was later reported that the patient passed away in her sleep and was found the next morning. The cause of death is pending the final death certificate completion. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was buried with the patient; therefore, no analysis can be performed. The death certificate listed the cause of death as sudden cardiac arrest subsequent to dilated cardiomyopathy. Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.
 
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=4193323


Title: Re: Misc. Cardiac
Post by: dennis100 on November 04, 2018, 02:04:26 AM
Model Number 102R
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient has congestive heart failure and cerebral hematoma. It is unknown if these events were related to vns.
 
Manufacturer Narrative

Event Description
Good faith attempts for more information were unsuccessful. Follow-up with the physician's office indicated that they did not feel comfortable commenting regarding the patient's events and did not provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2394303


Title: Re: Misc. Cardiac
Post by: dennis100 on November 05, 2018, 11:41:26 AM
Model Number 102
Event Date 01/10/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The identity of the patient's current physician was confirmed. However no additional relevant information has been received to date in regards to the patient's congestive heart failure.
 
Event Description
The patient reported that she developed congestive heart failure while on vns therapy and that her physician believes that the vns is causing her heart issues. The patient had made a similar report in 2013 however her treating physician at the time denied that vns was causing the congestive heart failure. The previous physician has not seen the patient recently. The identity of the patient's current physician is unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6182955


Title: Re: Misc. Cardiac
Post by: dennis100 on November 09, 2018, 03:21:31 AM
Model Number 102
Event Date 07/19/2011
Event Type  Injury   
Event Description
Clinic notes were received to the manufacturer from the reporter for a vns patient indicating the patient had heart trouble, but this was not specified other than the cardiac status is unchanged throughout the clinic notes. Manufacturer follow up with the reporter revealed the reporter declined to give any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2428068


Title: Re: Misc. Cardiac
Post by: dennis100 on November 10, 2018, 04:39:12 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a physician that a patient was interrogated and found to be set to 0 milliamps for all output currents unexpectedly. The patient underwent an ekg about a week prior to visiting the doctor and it was stated that the ekg electrodes were placed over the device. The patient's parent reported an increase in seizure activity and the physician believes that a generator reset occurred. A review of the downloaded data was performed and it was identified that generator hardware resets had occurred on the device on (b)(6) 2017, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018 and the output current had been set to 0 milliamps. The cause for the reset could not be determined from review of the data. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939028


Title: Re: Misc. Cardiac
Post by: dennis100 on November 10, 2018, 04:39:43 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient is experiencing asystole when the magnet is activated for 15 seconds after the magnet swipe. The patient is reported to be diagnosed with aortic stenosis and rheumatic heart disease. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7980947


Title: Re: Misc. Cardiac
Post by: dennis100 on November 15, 2018, 08:59:16 AM
Event Date 02/27/2013
Event Type  Injury   
Event Description
It was reported that the patient has a defibrillator implanted. It is unknown to date if the defibrillator is related to the vns or if it is a separate event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026370


Title: Re: Misc. Cardiac
Post by: dennis100 on November 16, 2018, 08:44:07 AM
Model Number 102
Event Date 02/11/2013
Event Type  Injury   
Event Description
It was initially reported that the patient felt that his heart rate was very slow. It is unknown if the slowed heart rated was related to vns. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001730


Title: Re: Misc. Cardiac
Post by: dennis100 on November 16, 2018, 08:44:40 AM
Event Date 10/01/2009
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt was experiencing palpitations. The pt has been seizure free and had placed a magnet over her vns device for the past 1. 5 years. According to treating neurologist, the pt has long q-t interval but hasn't seen a cardiologist. The physician did not know if pt's cardiac symptoms have subsided since he just inherited the pt from another physician. Good faith attempts to obtain more info regarding pt's adverse event have been unsuccessful to date.

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


Title: Re: Misc. Cardiac
Post by: dennis100 on November 18, 2018, 09:26:51 AM
Model Number 102
Event Date 08/01/2011
Event Type  Injury   
Event Description
It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261210


Title: Re: Misc. Cardiac
Post by: dennis100 on November 27, 2018, 08:28:50 AM
Model Number 102
Event Date 06/21/2011
Event Type  Injury   
Event Description
It was reported in clinic notes received on (b)(4) 2012 and dated (b)(4) 2011, where it was stated that the patient had cad (coronary artery disease). Additional clinic notes were received on (b)(4) 2012 and dated (b)(4) 2011 where it was stated that the patient had cad, cva (cerebral vascular accident - stroke) and cardiomyopathy. The generator was programmed to 2/30/130/60/3/2/250/60 and the patient was to follow up in six months. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that the patient did not have a history of stroke or cardiomyopathy prior to being implanted with vns however he did not indicate a relationship between these events and the patient's vns device. Diagnostic results were provided which indicated normal device function however the date the diagnostics were performed was not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2515621


Title: Re: Misc. Cardiac
Post by: dennis100 on November 29, 2018, 03:21:32 AM
Model Number 302-30
Event Date 05/05/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

Event Description
Neurology reported that they had a vns pt that could not longer feel stimulation (magnet and normal mode) and had increased seizures, below pre-vns baseline. System diagnostics testing was performed and yielded 7 / limit / high. The pt's vns programming physician wanted to disable the device related to their high lead impedance but pt did not want him to. The pt has been referred to their surgeon for revision surgery. At this time no surgical date has been set as pt is status post cardiac stent placement and on plavix. The pt did not recall having any trauma to the site prior to their high impedance being attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1720407


Title: Re: Misc. Cardiac
Post by: dennis100 on November 29, 2018, 03:22:14 AM
Model Number 102
Event Date 11/13/2012
Event Type  Injury   
Event Description
On (b)(4) 2013 clinic notes were received dated (b)(6) 2012 which indicated that the patient has a history of open heart surgery. No further information was provided as to why the patient had open heart surgery and the relationship to vns. During this clinical visit the patient denied any chest pain, chest tightness, or chest pressure. The clinic notes indicate that the vns output was set at 2. 5 ma and the magnet output was set to 2. 75 ma. Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167280


Title: Re: Misc. Cardiac
Post by: dennis100 on November 29, 2018, 03:23:56 AM
Model Number 102
Event Date 01/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 information was received by the reporter at a physician office visit that the patient had his device disabled in (b)(6) 2012 due to pain he was experiencing. Attempts for additional information are still in continuation.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2013 information was received from the reporter that the patient¿s pain had first been observed on (b)(6) 2012 and was categorized as pain and shortness of breath. It was determined that the pain occurred whenever stimulation occurred or whenever the magnet was swiped. It was also noted that the patient had a cardiac stent implanted several days prior to the onset of pain. No further interventions have been taken or are planned since the device was disabled. No causal or contributory programming or medication changes preceded the onset of the pain. A manufacturer's review of the programming history database showed that programming history data is available from (b)(6) 2006 (date of implant) to (b)(6) 2009. Follow-up also provides data from (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167203


Title: Re: Misc. Cardiac
Post by: dennis100 on November 29, 2018, 03:24:37 AM
Model Number 102
Event Date 09/05/2007
Event Type  Malfunction   
Event Description
Reporter indicated the patient has experienced "life changing side effects" from the vns therapy system. The "patient reports a number of non-specific complaints including not feeling well, blood pressure fluctuation, intermittent chest pain, having been in the hospital on several occasions, including receiving a coronary stent. The patient also states the device has not helped his seizure disorder. " the patient elected to have the vns therapy system explanted. Good faith attempts are being made to obtain additional information, but have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959423


Title: Re: Misc. Cardiac
Post by: dennis100 on November 30, 2018, 12:23:17 PM
Model Number 102
Event Type  Injury   
Event Description
Good faith attempts for additional information were made and have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was noted from clinic notes received in regards to a vns patient that they were positive for: irregular heartbeat, tachycardia. The relationship to their vns is unknown. Good faith attempts are underway for further details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144910


Title: Re: Misc. Cardiac
Post by: dennis100 on December 02, 2018, 02:11:22 AM
Model Number 106
Event Date 04/26/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was implanted on (b)(6) 2016 and there were no issues during the implantation; however, while running a system diagnostics (1ma output current, 500c pulse width and 20hz signal frequency), the patient developed an irregular heart rhythm that went into a bundle branch block. This spontaneously resolved within a few minutes. After a while, a second system diagnostics test was performed (while the patient was still under anesthetic) and the same event occurred. Once this was resolved, they programmed the normal mode to 0. 25ma output current, 30hz signal frequency, 250 sec pulse width, 30sec on time and 5min off time. Then an output current of 0. 5ma went fine as well. An output current of 0. 75ma caused a slight arrhythmia which was resolved. At 1ma output current, the patient had the same reaction of an irregular arrhythmia followed by a bundle branch block, which spontaneously resolved. It was reported that the patient has no cardiac history, and the cardiac exam before surgery (in pre-operative assessment) was normal. Vns has been left switched off. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Further information from the nurse indicated that the patient's device has been switched on and turned up to 1. 25ma output current with no repetition of the previous events, on (b)(6) 2016. The patient is currently under cardiac investigation and vns was switched off again. It was reported that the patient was hemodynamically stable during the arrhythmia. An ecg was performed and reviewed by a cardiologist who noted the transient 2:1 av block. His baseline heart rate was 60 - 70bpm. Following stimulation there was a transient 2:1 block followed by a sinus tachycardia with left bundle branch block (hr 95). At no time did the patient go into atrial fibrillation. This lasted 5-10min with no hemodynamic compromise. He reverted back to a normal qrs complex; when the stimulation was tested again there was a transient bradycardia and then he became more tachycardic (hr 90) then sinus rhythm again with a bundle-branch block. This settled again after 5 minutes. It was reported that at emergence the nurse reversed residual neuromuscular blockade with neostigmine and glycopyrrolate which put his heart rate up to 110 bpm (side-effect of the glycopyrrolate) and he moved from a narrow complex to a bundle branch block. The patient was reviewed in recovery by a consultant cardiologist who feels there are 2 things going on here: firstly, he has rate-related bundle branch block with appears to occur above a heart rate of 80. In recovery it was very apparent to see when his heart rate dropped below 80 his qrs complexes were normal. When it rose above 80 he had a broad-complex. Secondly, on the periods immediately following stimulation, he appears to go into a very short-lived (5 seconds or so) 2:1 av block. It was reported that the anesthetics used and their dosage are: induction (intravenous propofol (200mg), fentanyl (200mcg) and atracurium (45mg)); maintenance (inhalational desflurane (end-tidal desflurane 6. 2), incremental fentanyl for analgesia (50mcgs total), intravenous paracetamol (1g)). No further information was provided to date.

Event Description
Further information was received from the nurse indicating that the patient spent 10 days in the hospital undergoing tests by the cardiologist. According to the nurse, the patient indicated to her that his results were normal but the cardiologist suggested to not switch vns on. It was reported that the nurse has finally performed another diagnostic test (which set off the arrhythmia in theatre) and nothing happened. She decided to switch the device on and increased the output current to 1. 25ma, and still no arrhythmia or av block as the day before.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5659529


Title: Re: Misc. Cardiac
Post by: dennis100 on December 05, 2018, 01:39:35 AM
Model Number 103
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 noted that the patient has a past surgical history of cardiac surgery. It is unknown if the cardiac surgery occurred prior to vns therapy or the relationship to vns therapy. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3301479


Title: Re: Misc. Cardiac
Post by: dennis100 on December 06, 2018, 01:47:05 AM
Model Number 102
Event Date 03/11/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's current treating physician indicated that there is no concern about the vns system.

Event Description
Clinic notes dated (b)(6) 2103 indicated that this patient¿s device was disabled in 2011 because it was felt that it was making her heart rate drop. It was turned on except for the fact that she was able to swipe the magnet whenever she felt a seizure coming on. The patient was not receiving a continuous daily stimulation. When the vns and medication were discontinued, the patient did well. Review of programming history showed that the device was disabled on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3262884


Title: Re: Misc. Cardiac
Post by: dennis100 on December 07, 2018, 11:42:53 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has a left bundle branch block, enlarged left ventricle, and the vns device was switched off. The physician was inquiring into if there has been long term cardiac problems from prolonged stimulation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8061848


Title: Re: Misc. Cardiac
Post by: dennis100 on December 08, 2018, 02:52:20 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury   
Event Description
The physician's assistant (pa) reported that the patient presented with left neck pain so pain injections were attempted, which did not resolve the issue. The patient was then sent for x-rays. Per the x-rays the pa believes the generator migrated due to potential chest compressions at an er visit and the er visit was unrelated to vns. It is not "know" when the patient was in the er. The pa believed the migration caused the neck pain due to the lead tightening. The patient was referred for surgery to suture the generator higher. The pa stated the diagnostics were normal. X-ray images were assessed by the manufacturer as well. Based on the images provided, the generator was placed normally in the left chest. Due to the poor quality of the image, nothing further could be assessed concerning the generator. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. Due to the poor quality of the image, nothing further could be assessed concerning the lead. Based on the images provided, there is no obvious cause for the reported pain and generator migration. Additional information from the pa reported that the surgery will be for patient comfort and to preclude serious injury. The settings were initially turned off after the pain to see if there would be a reduction in pain, which there was not. The settings were later turned back on to lower settings. The physician later decided to replace the generator because it was already 2 years old instead of just performing a revision. No additional relevant information has been received to date.

Manufacturer Narrative
"device evaluated by manufacturer": device evaluation is not necessary as the reported events are not related to device functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8034826


Title: Re: Misc. Cardiac
Post by: dennis100 on December 16, 2018, 05:08:55 AM
Model Number 102
Event Date 09/01/2013
Event Type  Injury   
Manufacturer Narrative
Corrected data: supplemental report #1 did not indicate that attempts for return of the explanted generator were unsuccessful. The information has been included in this report.

Event Description
Clinic notes dated (b)(6) 2013 note that the patient's mother has noticed a decrease in heartrate into the low 60s and upper 50s. The notes indicate that the patient's heartrate is usually upper 60s and that it may be due to the vns. Clinic notes indicate that the device is near end of service. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Follow up with the physician found that the patient successfully underwent generator replacement on (b)(6) 2013 due to end of service. Since replacement, the patient is no longer vomiting and that all other issues previously mentioned have been resolved.

Event Description
Good faith attempts to for return of the patient's explanted generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3415683


Title: Re: Misc. Cardiac
Post by: dennis100 on December 17, 2018, 04:28:39 AM
Model Number 103
Event Date 07/15/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient did not have a history of dyspnea or heart conditions prior to vns implantation and had no risk factors that made the patient more susceptible to these conditions. It was reported that there were medication changes or other factors that caused or contributed to the patient¿s event, but these changes or factors were not specified. The patient had no prior history of cardiac events and no reported family history of cardiac events. It was noted that the patient did not experience any of the following: bradycardia, tachycardia, and asystole.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3408210