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dennis100
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« on: May 24, 2018, 01:11:08 AM »

Model Number 102R
Device Problem Energy output to patient tissue incorrect
Event Date 06/02/2017
Event Type  Malfunction  
Manufacturer Narrative

Event Description
It was reported by the physician that patient's device settings were changed following a defibrillation. The settings were changed back by the physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7402670
« Last Edit: June 13, 2018, 12:18:37 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 26, 2018, 01:11:41 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
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dennis100
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« Reply #2 on: May 26, 2018, 01:12:15 AM »

Model Number 302-20
Event Date 03/01/2008
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that patient was in the hospital for three weeks and in that time an external defibrillator was used. Subsequent diagnostics testing revealed high lead impedance, indicating a lead malfunction. Patient later underwent a full revision surgery. Explanted lead and generator were returned to manufacturer, however, that analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1037190
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dennis100
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« Reply #3 on: May 26, 2018, 01:12:50 AM »

Model Number 302-20
Event Date 06/01/2008
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Reporter indicated that after a vns patient received cardiac defibrillation at home, she developed stabbing, intermittent neck pain. Device diagnostics were normal. The vns was disabled and the patient was sent for a surgical consult. X-ray review by the manufacturer did not reveal any lead anomalies. The patient later underwent vns lead and generator revision surgery. The explanted devices have been returned and are currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1120737
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dennis100
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« Reply #4 on: May 26, 2018, 01:13:36 AM »

Model Number 102
Event Date 04/24/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that this vns patient went to the hospital after having a heart attack. After interventions took place to treat the patient, the generator could not be interrogated and may have been damaged by the medical actions taken. Prior to this date, it was reported that the patient's device was working fine. In order to troubleshoot, the wand battery was checked, and it was ensured that the handheld device was not plugged into the wall. On (b)(6) 2012, a battery life calculation was performed with negative results. On (b)(6) 2012, a physician reported that this vns patient experienced a cardiac arrest on (b)(6) 2012 and was revived with an aed. The physician stated that the patient's device could not be interrogated, and the physician was concerned that the patient's device had been damaged by the defibrillator. The physician was unsure of the relationship of the cardiac arrest to vns, but his impression was that the cardiac arrest event had nothing to do with vns. On (b)(6) 2012, it was reported that the patient was scheduled for generator explant on (b)(6) 2012. The lead was to be left in to prevent possible nerve damage and allow for the option for generator re-implant in the future. After explant the patient was to be sent to a facility for cardiac monitoring. Attempts for product return will be made. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, a neurodiagnostics coordinator at the explanting facility reported that the patient's vns was not explanted. The reporter stated that there was discussion between the hospital radiologist and the device manufacturer regarding explant of the vns because physicians wanted to do an mri; however, explant was not performed as they felt it would be unsafe to perform an mri of the heart because of the portion of the leads left on the vagus nerve.
 
Event Description
On (b)(6) 2012, the patient's physician responded that he was unable to provide additional information without reimbursement. Attempts for product return were performed. On (b)(6) 2012, information was received from the explanting facility that the individuals that processed device returns at the facility did not have the explanted device. No additional information was available.
 
Manufacturer Narrative
Explant date, corrected data: previously submitted mdr stated the explant date as (b)(4) 2012. Additional information was received stating that the device was not explanted so the explant date is not applicable. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584616
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dennis100
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« Reply #5 on: May 26, 2018, 01:14:09 AM »

Model Number 102
Event Date 01/16/2008
Event Type  Injury   
Event Description
Reporter indicated that a vns patient's seizures have become stronger in intensity following external defibrillation. Diagnostics after the onset of the event were reported to have been within normal limits. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1007373
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dennis100
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« Reply #6 on: May 26, 2018, 11:44:23 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.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4156771
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dennis100
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« Reply #7 on: May 26, 2018, 11:44:58 AM »

Model Number 102
Event Date 06/16/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized for five days on (b)(6) 2014 for rapid ventricular rate, atrial fibrillation and flutter. On (b)(6) 2014 the patient was admitted to the hospital for chest pain. The patient underwent transesophageal echocardiogram on (b)(6) 2014 and no clots were observed. The patient received cardioversion on (b)(6) 2014 and the heart rate returned to normal. The patient indicated that his inr was high and he had undergone pulmonary and gi testing. The patient's inr dropped below 2 and the patient underwent cardiac catheterization. The patient was released from the hospital on (b)(6) 2014. The relationship of the cardiac events to vns are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The patient's cardiologist reported that the patient has a history of mitral valve regurgitation with replacement and cardiomyopathy. There were no medication changes or other factors that could have caused or contributed to the arrhythmia. The patient also has a history of first degree av block and sinus bradycardia. The patient the patient experienced atrial flutter with a heart rate of 122 bpm. The patient experienced dyspnea and palpitations during the atrial flutter. The patient underwent tfe with cardioversion. The atrial flutter did not recur. The patient's neurologist indicated that there is no relationship between the atrial flutter and vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166277
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dennis100
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« Reply #8 on: May 26, 2018, 11:45:39 AM »

Model Number 103
Event Date 02/03/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient went to the er for a cardioversion. Following the procedure, the patient began experiencing bradycardia, pain, and syncope occurring with stimulation on-times which caused the patient to pass out. It was described that the patient¿s heart rate dropped for 30 seconds every five minutes which caused the patient to have pain and pass out. The patient¿s device was subsequently disabled. Diagnostic results showed normal device function. The patient did not have any issues with vns prior to the cardioversion. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554432
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dennis100
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« Reply #9 on: May 27, 2018, 01:32:10 AM »

Event Date 07/22/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had arrhythmia and was to undergo tee-guided cardioversion. It is unknown whether the patient¿s arrhythmia was related to vns. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the patient does not have the arrythmia due to vns. The physician indicated that the routine cardioversion is for an unrelated condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012875
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dennis100
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« Reply #10 on: May 27, 2018, 01:33:04 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 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
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.
 
Manufacturer Narrative

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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197
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dennis100
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« Reply #11 on: May 28, 2018, 02:07:56 AM »

Event Date 03/30/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated an unknown female vns patient had been defibrillated due to a ventricular tachycardia arrhythmia in a cardiac care unit of a hospital. The defibrillation was felt to have possibly damaged the vns, and it was reported the vns "was not working right". The malfunction event has been reported via mdr #1644487-2012-01067. The reporter declined to provide any additional information other than the treating neurologist's information. All attempts to the treating neurologist for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2547965
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« Reply #12 on: May 28, 2018, 02:08:34 AM »

Model Number 103
Device Problem Failure to shock or properly shock
Event Date 12/01/2013
Event Type  Injury   
Event Description
Further information was received indicating that the patient had undergone bi-phasic cardioversion in the morning with adhesive patches in anterior-lateral left position. The energy value used for the cardioversion was 100j. The generator's decoder spreadsheet was reviewed. On (b)(6) 2013 the patient underwent the first cardioversion treatment. On (b)(6) 2013 the battery voltage was 3. 440v and the lead impedance 3782 ohms. On (b)(6) 2013 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the patient underwent the second cardioversion. On (b)(6) 2014 the battery voltage was 2938v and the lead impedance 2401 to 2430 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.
 
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621
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dennis100
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« Reply #13 on: May 28, 2018, 02:09:15 AM »

Model Number 102
Device Problem Device operates differently than expected
Event Date 07/04/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that a patient had cardioversion performed and then starting having severe coughing every 90 seconds during stimulation. The nurse believed that the coughing was related to vns stimulation. The patient's magnet was placed over the generator to inhibit stimulation. The patient was then transported to another hospital, where he experienced bradycardia associated with stimulation. The patient's generator was disabled, which resolved the bradycardia. Attempts for further information have been made but no relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Monophasic cardioversion was performed at 100j with patches, one on the left-medial chest and one on the upper-middle of the back. According to the physician who performed the cardioversion, the patient was coughing during the procedure. After the cardioversion, the patient kept coughing and had repeated, regular asystole periods that were 14 seconds long. The physician who performed the cardioversion believed that vns stimulation led to ventricular tachycardia and asystole. Attempts for further information have been made, but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4950732
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« Reply #14 on: May 31, 2018, 02:21:47 AM »

Model Number 102R
Event Date 01/17/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient had a heart attack in (b)(6) and defibrillator paddles were used. The patient now sees a new physician however good faith attempts to obtain additional information from the physician have been unsuccessful.
 
Event Description
It was reported on (b)(6) 2012 that a patient implanted with vns in 2005 was going to be implanted with a defibrillator on (b)(6) 2012 due to arrhythmia. The patient presented in the er with arrhythmia and it was determined he needed a defibrillator implant. Good faith attempts to obtain additional information were unsuccessful as the physician has moved and his current residence is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438667
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« Reply #15 on: June 13, 2018, 12:19:20 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/29/2017
Event Type  Injury   
Event Description
It was reported by that patient underwent a cardioversion procedure. Following the procedure the patient¿s generator pocket appeared infected and the skin around the generator was breaking down which caused the generator to extrude. The physician was concerned that the cardioversion procedure could have contributed to the generator extrusion. The patient was referred for surgery due to the generator extruding from the body. The patient's generator was explanted and no replacement occurred at that time. A manufacturing review was performed which showed the generator and lead were sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
Further information was received from the physician that the patient did not have an infection at the generator site. The physician did not know what the cause of the extrusion was.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6552915
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« Reply #16 on: June 13, 2018, 12:19:54 AM »

Lot Number 567565
Device Problem Magnet failure
Event Date 01/16/2008
Event Type  Malfunction   
Event Description
Reporter indicated that a magnet was used to inhibit stimulation during external defibrillation. Following the event, the magnet was reported to not stop seizures like it had in the past. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810749
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« Reply #17 on: June 13, 2018, 12:20:39 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
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« Reply #18 on: June 13, 2018, 12:21:20 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
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« Reply #19 on: June 19, 2018, 01:18:05 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type  Death   
Manufacturer Narrative

Event Description
The patient was admitted to the hospital on (b)(6) 2017 due to increased seizures frequency and feeding intolerance. The patient had her medications were increased before the decision was made to induce coma. The patient was trialed on an anesthetic but developed a diffuse reaction, so she was then started on propofol infusion. On (b)(6) 2017 the patient developed severe acidosis and hypotension that resulted in cardiac arrest. The patient was then placed on life support where her kidneys began shutting down. The physician then attempted to improve the patient's electrolytes to help her heart cardiovert. However two attempts failed to cardiovert the patient. An electrophysiologist verified that the patent's heart would not likely recover. The patient's family then elected to remove the patient from life support. The explanted lead and generator were received for product analysis. Migration, wound dehiscence and infection are outside of the scope of product analysis. No anomalies were found with the generator that affected its functionality. Only a portion of the lead was returned and there was no noted discontinuity in the lead. No other relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was scheduled to undergo a replacement surgery. During the replacement surgery the surgeon found that the patient¿s generator had migrated further than the neurosurgeon had anticipated and so he explanted the patient¿s vns in order to allow the pocket to heal. Cultures were taken at the time of the patient¿s surgery to determine if an infection was present. Follow up with the surgeon¿s office indicated that the cultures confirmed infection and that there was skin dehiscence, wound breakdown, and pus observed when the physician opened the patient. The surgeon also noted that the was a bit of trauma that had occurred to the patient¿s skin recently. The patient was discharged after surgery but then came back to the hospital later that day because she was not feeling well. Ten (10) minutes after returning to the hospital the patient went into cardiac arrest where she was placed on life support. The patient¿s organs then began shutting down and the patient passed away. The neurologist ¿s notes were reviewed and there was no mention of attributing the death to vns therapy. The patient's explanted generator has been received and is undergoing product analysis. The surgeon also indicated that he did not use a non absorbable suture to anchor the patient's generator in the subcutaneous pocket. A design history record review found that the patient's generator was sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6292580
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dennis100
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« Reply #20 on: June 20, 2018, 12:52:42 AM »

Model Number 101
Event Date 11/11/2008
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The physician did not have any additional relevant information. The cause and date of death are unknown. The relationship of the cause of death to vns is unknown. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: this information was inadvertently left off of follow-up mfr. Report #01.
 
Event Description
Hospital records were received indicating that the patient's primary diagnosis was status epilepticus. The secondary diagnoses were listed as disseminated intravascular coagulation, cardiopulmonary arrest, seizure disorder, hydrocephalus, respiratory failure, mental retardation, and cerebral palsy. The patient's past medical history was listed as seizure disorder, hydrocephalus with vp shunt, (b)(6) status post decompression and mrcp. It was noted that the patient was found during sleep to have seizure activity and diastat was given with no improvement. The patient was brought to the emergency room with fever, increased heart rate to 200 and low blood pressure (74/42). Labs were taken and the patient had an increased pt, ptt and inr. Blood gases showed the patient was acidotic and having worsening respiratory distress including metabolic and respiratory acidosis so the patient was intubated. The patient became hypotensive and bleeding from the mouth. The patient developed large hematomas at multiple sites where blood was drawn. The patient received fresh frozen plasma and was placed on ventilator support. Metabolic acidosis continued and the patient was given sodium bicarb. The patient's heart rate dropped and the patient became pulseless. Cpr was initiated along with defibrillation. The patient's family requested withdrawal of support.
 
Event Description
The patient's online obituary indicated that the patient passed away at the hospital. Attempts to obtain additional relevant information have been unsuccessful to date.
 
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=4164211
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dennis100
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« Reply #21 on: June 20, 2018, 12:53:25 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
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dennis100
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« Reply #22 on: October 30, 2018, 01:16:46 AM »

Model Number 103
Event Date 08/26/2012
Event Type  Death   
Event Description
Additional attempts to the initial reporting physician regarding the bradycardia were unsuccessful as it was indicated that no further information would be provided. Additional attempts were performed to the medical records department of the hospital and a discharge summary was received. The summary reported that the patient was admitted to the hospital on (b)(6) 2012 due to tonic-clonic seizure; refractory to outpatient medications and vagal stimulator, recurrent ventricular tachycardia and/or supraventricular tachycardia, and leukocytosis. It was indicated in the note that the patient had epilepsy which was difficult to control and which resulted in frequent emergency room visits, worsening over the months prior. The patient was admitted due to severe epilepsy and developing status epilepticus. Upon admittance, she was intubated, mechanically ventilated and started on high doses of antiepileptics among other medication. During hospitalization, the patient also developed leukocytosis and fever and had blood cultures positive for staphylococcus epidermidis. She developed sepsis syndrome but responded to medication. This also resulted in the removal of her left subclavian line and the placement of a central line. The discharge summary noted that the patient developed several arrhythmias during hospitalization, some associated with seizures, but she had ventricular tachycardia and/or supraventricular tachycardia not related to her seizures. The patient was successfully treated with cardioversion for the ventricular tachycardia and the supraventricular tachycardia was managed with antiarrhythmics and changes in her vasopressors. There was no mention in the discharge summary of arrhythmia's related to vns stimulation. After three weeks of icu care, the patient's seizures persisted and the family requested withdrawal of care. The patient passed away shortly thereafter on (b)(6) 2012 at 1:45pm. The discharge diagnosis was status epilepticus, refractory to multiple medications in high doses, ventricular tachycardia and supraventricular tachycardia with aberrancy, and staphylococcus epidermidis sepsis. Follow-up was attempted with the hospital physician listed as the primary contact on the hospital discharge summary; however, it was indicated by his office that no further information regarding the patient's death would be provided. Attempts for additional information from the patient's treating vns neurologist have remained unsuccessful to date. The manufacturer was notified that the physician is semi-retired and rarely in the office. Additionally, the treating vns physician's nurses reportedly do not have any background on this patient. A review of in house programming history revealed that the date of disablement was (b)(6) 2012. Last available diagnostics from three months prior were within normal limits. Additionally, the battery status on the date of disablement was ok.
 
Manufacturer Narrative

Event Description
Attempts for additional information to the treating neurologist have been unsuccessful to date. Additionally it was indicated by the cremation facility that the generator was sent to a precious metals company and would not be returned. Follow up performed with the initial reporter indicated that the vns device did not contribute to the death as it had been turned off days prior to the death. It was indicated that the patient was very ill and that there were multiple medication changes prior to the death. However, she indicated that she was not at the hospital at the time of death, so she did not know the final cause.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported on (b)(6) 2012 that a patient recently passed away following an extended status epilepticus and other complications. While the patient was in the hospital it was indicated that she was experiencing bradycardia consistent with her vns stimulation on times. The device was disabled and the bradycardia subsided. Attempts for additional information are in progress.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2770952
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dennis100
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« Reply #23 on: October 30, 2018, 01:17:51 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes indicated that a patient went into cardiac arrest with associated respiratory arrest when he was given opioid pain medication shortly after his initial vns implant surgery. The medical team was administering the medication every 6 hours after surgery had occurred. Around midnight on the date of surgery, the staff noticed that the patient's breathing pattern had changed, leading to the cardiac arrest. An ambulance was called, and the patient was defibrillated. The physician concluded that the cardiorespiratory arrest was an adverse reaction to the pain medication and not caused by the placement of the vns. Clinic notes from later clinic visits indicated that the device was functioning properly. No additional relevant information has been received to date.
 
Event Description
The physician reported that the opioid painkillers were administered to the patient prophylactically. The physician also noted that the patient was non-verbal, so it could not be determined if or where the patient was experiencing post-surgical pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820596
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dennis100
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« Reply #24 on: November 10, 2018, 04:41:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/17/2018
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported the patient passed away. The cause of death was not reported however it was noted that the patient had undergone an autopsy. The company employee had the patient's explanted device and requested that programming data be reviewed to assess if a device malfunction had occurred. It was noted that the patient may have been exposed to defibrillation. Further follow-up with another company employee found that the patient's physician did not believe the cause of death was related to the device. However it was unclear why a device malfunction was suspected and if it was suspected to be related to the patient's passing. The programming data provided did not indicate a device malfunction was occurring. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7982384
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dennis100
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« Reply #25 on: November 13, 2018, 07:24:18 AM »

Model Number 302-20
Event Date 04/30/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

Event Description
The patient's explanted lead was not returned for analysis. Their explanted generator was returned. Their generator battery was at end of battery life and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. 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 hospital called and reported that they had a explanted generator which was replaced with m103 on (b)(6) 2013 due to a cardiac arrest in (b)(6) 2012 and the patient was resuscitated. The patient had their generator replaced prophylactically in case it was damaged. Their arrest was not vns related. During their generator replacement surgery it was noted that the patient had high lead impedance over 10,000ohms. The surgeon took the new generator off the lead and did generator diagnostics and it was all ok. The patient reported that his generator was working until about (b)(6) of last year and then it quit working meaning the battery was dead but he was not able to replace it because he had a cardiac arrest and had to be defibrillated and then had to recover before he could have his generator replaced. The pin was reinserted into the new generator and if it was past the connector block. The surgeon ran diagnostics and it was still high impedance. Their generator was not interrogated prior to explant to confirm battery status. Their lead was not replaced at this time on (b)(6) 2013. The patient went in for lead revision surgery on (b)(6) 2013. At this time their explanted lead has not been returned for analysis after good faith attempts have been made. It is not known if compressions were performed during the patient's cardiac arrest. The defibrillator was used.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2961920
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dennis100
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« Reply #26 on: November 19, 2018, 08:45:09 AM »

Model Number 103
Event Date 03/26/2013
Event Type  Injury   
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.

Manufacturer Narrative

Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3067719
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dennis100
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« Reply #27 on: Today at 01:34:21 AM »

Model Number 103
Event Date 01/28/2015
Event Type  Death   
Event Description
It was reported on (b)(6) 2015 that a vns patient has passed away of an apparent sudep (awaiting autopsy). It was noted that the paramedics refused to defibrillate the patient because of the 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4564779
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