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Author Topic: Misc. Cardiac  (Read 12076 times)
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dennis100
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« 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
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dennis100
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« Reply #1 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
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dennis100
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« Reply #2 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
« Last Edit: June 23, 2018, 12:31:50 AM by dennis100 » Logged
dennis100
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« Reply #3 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
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dennis100
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« Reply #4 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
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dennis100
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« Reply #5 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
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dennis100
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« Reply #6 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
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dennis100
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« Reply #7 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
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dennis100
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« Reply #8 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
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dennis100
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« Reply #9 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
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dennis100
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« Reply #10 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
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dennis100
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« Reply #11 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
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« Reply #12 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
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« Reply #13 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
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« Reply #14 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
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« Reply #15 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
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« Reply #16 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
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« Reply #17 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
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« Reply #18 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
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« Reply #19 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
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« Reply #20 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
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« Reply #21 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
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« Reply #22 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
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dennis100
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« Reply #23 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
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dennis100
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« Reply #24 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
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dennis100
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« Reply #25 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
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« Reply #26 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
« Last Edit: October 27, 2018, 04:56:59 AM by dennis100 » Logged
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« Reply #27 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
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« Reply #28 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
« Last Edit: October 27, 2018, 01:18:43 AM by dennis100 » Logged
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« Reply #29 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
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