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dennis100
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« Reply #270 on: December 07, 2018, 09:26:27 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing increase in seizures and pain on the life side of their body and also felt pain starting in their fingers and working its way up their left arm, back, and their leg. The physician ran diagnostics on the patient's device, and the reported diagnostics were within normal limits. The physician evaluated the patient for pain and stated that she does not believe the pain was related to vns since the pain does not coincide with vns stimulation or the placement of the vns device. The physician also explained to the patient that they magnet may not be able to able stop all seizures immediately, however it could help shorten the seizure. It was also stated that the physician does not believe that the patient has reached proper dosing levels. The physician decided to disable the patient's device in order to evaluate the complaints of pain and seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8103990
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dennis100
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« Reply #271 on: December 07, 2018, 09:27:12 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8071032
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dennis100
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« Reply #272 on: December 08, 2018, 01:55:18 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury   
Event Description
The patient's mother reported that the patient had been in the hospital due to vomiting, gagging, pain under each arm, hiccups and hypotension. The patient's vns was disabled for 24 hours in the hospital. When the device was off, there was no gagging and vomiting. When it was turned back on, the gagging and vomiting was less. The patient had reportedly lost 5 pounds since the vomiting started. After a full gi work-up, nothing but gastric irritation was found. The treating physicians in the hospital didn't think that the vns was the cause, but they wanted to further investigate and confirm this. The patient's mother reported that the treating physician said that her daughter was using the magnet too often. The patient was in the hospital for approximately 2 weeks. The patient's mother also reported that the patient was now experiencing pain at the generator site. When the patient saw another doctor for follow-up, he did believe that the patient's vomiting, nausea, pain at chest, under arms, hypotension and hiccups were related to the vns stimulation. He indicated that the patient's output current was too high at 2. 75 ma, so he decreased it to 2. 5 ma due to the vomiting and hiccups. No device error was noted by the physician. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8036490
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dennis100
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« Reply #273 on: December 09, 2018, 03:26:36 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Per clinic notes received for the patient's replacement, the generator is loose in the patient's anterior chest and migrated towards the left axilla causing pain in the left arm. It was also reported that the vns is causing shortness of breath at times. Therefore the patient was referred for surgery. Per the sales representative, the physician is new to vns and does not have opinions on the migration. No surgery has occurred to date. No additional relevant information has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8075978
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dennis100
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« Reply #274 on: December 14, 2018, 06:45:41 AM »

Model Number 105
Event Date 07/19/2013
Event Type  Injury   
Event Description
Additional follow up with the neurologist's office confirmed that the patient has still not reported the events to the office.

Event Description
The patient reported via (b)(6) that she had surgery seven days prior to replace her vns generator was still hurting. The patient later contacted the manufacturer and reported that the top of her incision appeared to be slightly opened. The surgeon was contacted; however, he stated that they had not seen the patient since surgery. On (b)(6) 2013, the patient reported that she was okay and was not complaining about pain or the device. She stated that she was in pain on the day of surgery for a while when the device was programmed, but now that she has healed more the stimulation is not as painful. The patient stated that the incision scar is still pretty painful when she does a lot of stretching of her arm, but that she knew this was part of the healing process from having surgery. Otherwise, the patient said she was fine and did not need to see her physician and only went on an emergency basis. The patient again clarified that she felt she was okay in the healing process and was not having issues with the device itself. Follow up with the physician's office indicated that the patient has not been seen since her pre-op visit. Follow up with the patient's other physician indicated that she was seen on the morning post-op the day after replacement surgery and has not been heard from since. It was stated that the patient has not reported any problems or complaints, so they were unaware of any issues. The patient's device was programmed on to previous settings at the post-op visit. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3330872
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dennis100
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« Reply #275 on: January 04, 2019, 09:26:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
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dennis100
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« Reply #276 on: January 04, 2019, 09:27:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859
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dennis100
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« Reply #277 on: January 05, 2019, 02:57:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8127177
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dennis100
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« Reply #278 on: January 11, 2019, 02:46:34 AM »

Type of Device:           Cyberonics VNS Pulse Generator
Device Brand Name:    Demipulse
Device Manufacturer's  Cyberonics
Name:
Date of this Report:     03/08/2011
(mm/dd/yyyy)
Describe the Event      Explantation of Cyberonics VNS Demipulse model 103 from left upper
or Problem:                anterior chest due to malfunction. Patient reported shock-like
                                 sensation on the site extending up to the neck and down to left arm and
                                 left upper abdomen. Patient did not experience permanent harm.
the device(s) may
have                          Minor injury to the patient or health care provider
caused or contributed
to:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=23991
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dennis100
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« Reply #279 on: January 15, 2019, 02:58:05 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.
 
Manufacturer Narrative

Event Description
It was reported that the explanted devices are not available for return to the manufacturer for analysis.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813078
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dennis100
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« Reply #280 on: February 09, 2019, 01:58:37 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury   
Event Description
The patient reported that they are having inflammation and are unable to turn their neck. The patient¿s neurologist was looking for a surgeon in order to have their device explanted. Clinic notes were received for the patient¿s explant surgery. Per the clinic notes, the patient has neck pain that she believes is due to the lead pulling on their nerve. The pain occurs intermittently and mild head turns can set off severe pain in her neck and in the muscles, and she limits her neck motion and arm motion to avoid pain. The patient¿s device was disabled for about two years. Programming history was reviewed for the generator. The generator normal mode was disabled on (b)(6) 2013, however magnet mode was left on. The patient¿s generator was completely disabled on (b)(6) 2015. No programming anomalies were seen. Information was received from the physician's assistant. It was unknown when the patient¿s pain began, and the patient had x-rays taken that appeared normal. The physician¿s assessment on the pain was unknown. The patient¿s device was disabled prior to her coming to their clinic, and the reason for disablement was unknown. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8272345
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dennis100
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« Reply #281 on: February 17, 2019, 06:19:58 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
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dennis100
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« Reply #282 on: March 08, 2019, 01:46:58 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8380159
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dennis100
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« Reply #283 on: March 21, 2019, 01:23:54 AM »

Model Number 302-20
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns system implanted in the patient was tested and system diagnostics returned high impedance with dcdc code 7 and neos no. X-rays were taken and sent to the manufacturer for review. The generator appears to be placed under the right arm in an abnormal arrangement. The filter feed-through wires appears to be intact. The insertion of the lead-pin connector could not be fully assessed due to the orientation of the generator in the x-rays and the quality of images, it appears to be not fully inserted. The electrodes appeared to be placed in abnormal arrangement, not in the neck. A strain-relief bend and a loop were not used. Only one tie-down was found holding the upper lead body. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. It was reported by the physician that the device was not switched off yet. No known surgical interventions have occurred to date. No patient adverse events were reported to date.
 
Event Description
Further information was received from the facility, indicating that the patient underwent full replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity and the generator was prophylactically replaced. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that the explanted devices will not be returned to the manufacturer as they were discarded. Therefore, no analysis results could be provided. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194237
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dennis100
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« Reply #284 on: March 21, 2019, 01:24:39 AM »

Model Number 103
Event Date 09/25/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was complaining of swelling and tenderness around the generator site. The swelling and pain was believed to be due to some scar tissue that had developed since implant that caused severe pain and irritation when the patient moved her arm. The patient underwent a generator pocket revision surgery on (b)(6) 2015 and a hematoma was identified at the generator site. It was reported that this was caused by the patient doing some lifting too soon after vns implant surgery. No migration had occurred. The hematoma was drained and the generator was re-sutured in place. Diagnostics following the revision were within normal limits. No additional relevant information has been received to date.
 
Event Description
The patient was seen in follow-up with the surgeon and it was noted that there was still swelling in the neck area. The surgeon ordered a laser treatment, but is certain he will need to proceed with another surgery. No additional surgical interventions have been performed to date.
 
Event Description
It was reported that the patient was seen by an ent who performed a laser procedure. It was found that there is a gland that is leaking and a procedure will need to be performed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5197508
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dennis100
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« Reply #285 on: March 23, 2019, 01:43:12 AM »

Model Number 104
Event Date 12/01/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 it was reported by the patient's mother that the patient has had recent unusual seizure activity that started over the last few months (that she thinks are simple partial seizures) and thinks are possibly related to the device function. She wants the patient to see the physician to check the vns device. The patient's mother went to the physician's office and reported that she wants the vns "worked on". Per the nurse, the mother did not report any change in the patient's seizures. The patient's mother later reported that the patient was having an increase in partial seizures and that the vns generator was not delivering the appropriate amount of therapy. She stated that she thinks the physician "switched the battery to save settings. " the mother feels that the increase in seizures is above pre-vns baseline levels. The patient's mother stated that there is a change in behavior; the mother described this as stiffening of arms and right side of body, quick arm and hand movements, incontinence, and unusual desire for excessive water. She said these were all things that were well controlled and are now occurring more frequently. The mother indicated that there has been no change in medication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5304878
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dennis100
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« Reply #286 on: April 06, 2019, 01:43:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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« Reply #287 on: April 16, 2019, 01:08:37 AM »

Model Number 304-20
Event Date 08/23/2016
Event Type  Malfunction   
Event Description
It was reported by the physician's office that high impedance was observed with the patient's vns device. It was noted that due to the high impedance, the output current delivered to the patient was less than the intended programmed settings. It was later noted by the physician's office that x-rays were taken an came back negative. The patient was referred for surgery; however, no known surgeries have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had both his lead and generator replaced on (b)(6) 2016 due to high impedance. After the patient was replaced, his vns was checked and it was confirmed that his device was working as intended with an impedance value of 1939. It was later confirmed by the physician that the patient's pain over the generator site was due to the high impedance observed prior to the vns revision. The device is not expected to be returned as the explanting facility will not return to the manufacturer.
 
Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.
 
Event Description
Clinic notes were received and it was noted the patient had voice alteration with stimulation; therefore, the settings were adjusted to try to resolve the voice alteration. The voice alteration appeared to begin at the same time as the high impedance occurred. Additionally, it was noted the patient was having a sharp pain over his generator periodically and sometimes with movement of his arm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965755
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« Reply #288 on: April 16, 2019, 01:09:21 AM »

Model Number 302-20
Event Date 09/01/2015
Event Type  Injury   
Event Description
It was reported that a patient had full revision surgery due to an unknown reason. Further information was received indicating that the full revision was done because the patient experienced pain in the left upper extremity, which, according to the surgeon, was due to the placement of the original lead. The cause of the pain was due to lead migration. However, the cause of the migration was unknown. The physician reported that the surgery was done for patient comfort and to preclude a serious injury. The explanted generator and lead were received on 08/10/2016. Analysis of the lead identified no anomalies. Analysis of the generator also identified no anomalies. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5962153
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« Reply #289 on: April 24, 2019, 02:33:44 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2017
Event Type  Injury   
Event Description
It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.
 
Event Description
The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain. The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.
 
Event Description
Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960601
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« Reply #290 on: June 02, 2019, 07:27:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury   
Event Description
A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope. The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns. Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down. Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times. According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias. The patient's resting heart rate was reportedly 54 beats per minute. Device diagnostics were performed and returned results within the normal limits. Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years. The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns. No further relevant information has been provided to date.
 
Event Description
Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin. The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits. The chest pain radiated to the patient's left arm and shoulder. The patient was noted to be bradycardic. X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day. Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits. The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia. The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers. The patient's medications were adjusted several times during the hospital stay. The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685193
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dennis100
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« Reply #291 on: June 04, 2019, 08:10:44 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2006
Event Type  Injury   
Event Description
It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure. The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out. The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".
 
Manufacturer Narrative
Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.
 
Event Description
It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures. It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever. Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness. The surgical notes indicated that the incision sites were irrigated with bacitracin solution.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma. (b)(4).
 
Event Description
The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent. It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle. It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender. The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture. It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6808989
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dennis100
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« Reply #292 on: June 09, 2019, 01:40:37 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was later reported that when the patient was having the wound healing issues the incision had opened and was infected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405
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dennis100
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« Reply #293 on: June 21, 2019, 12:46:42 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A patient reported that after implantation with vns, her left vocal cord had not been the same. It is unclear if the patient sustained a vocal cord injury during implantation with vns or after her device was explanted. The patient also reported that she had also experienced difficulty swallowing since explant. No additional relevant information has been received to date.
 
Event Description
The explanting physician's office reported that the patient's generator and a portion of the lead were explanted due to persistent left arm pain, both with and without stimulation. The explant surgery was not required to preclude a serious injury. It is unknown if the dysphagia and vocal cord injury that the patient reported were a result of this explant procedure. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7194052
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dennis100
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« Reply #294 on: June 27, 2019, 12:18:35 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737
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« Reply #295 on: July 04, 2019, 01:15:18 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient underwent repositioning surgery for a generator that ¿came loose¿. Follow-up from the provider clarified that the generator repositioning surgery was due to the generator ¿moving around¿ only during certain arm movements and the generator would pop out of the pectoralis muscle pocket. The physician stated she had a lot of soft tissue and it looked the initial pocket was maybe a little superficial to remain stable. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Device evaluated by mfr, corrected data: the device evaluation field was inadvertently marked incorrectly on the initial report. Additional manufacturer narrative and/or corrected data , corrected data: information regarding the use of code in device evaluated by mfr? was inadvertently not provided on the initial report. Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7706870
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dennis100
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« Reply #296 on: July 11, 2019, 01:37:23 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient was experiencing pain and was not tolerating magnet swipes. Clinic notes were provided and mentioned that the patient gets a left-sided pulling of her mouth and body twitching with every magnet swipe, along with headaches. This is said to have been going on for a few months. Clinic notes also mentioned that patient experienced an event where she was shaking, and her left lip was "drawn downward;" she was having difficulty using her left side upper extremities and her arm was painful. This was reported to have occurred after the magnet was used during diagnostics. The physician disabled the vns due to patient¿s episodes after magnet swipes. The patient stated that although the device was turned off, the "pulling" sensation on the left side of her face persisted, and she had tightness on the left side of her upper extremities. The patient was reportedly taken by ambulance to the hospital and admitted for one night. It was also mentioned in the notes that the patient is too afraid to use the magnet to abort seizures because of the mouth "pulling" sensation. The physician informed that the a surgery referral has been placed for patient comfort reasons. Additionally, the physician believes that the reported side effects may be related to the patient's pseudo seizures. The reason for the patient¿s hospitalization was not provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8676229
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« Reply #297 on: July 14, 2019, 04:33:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated. The patient explains the pain began in (b)(6). It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm. Impedance on (b)(6) 2018 showed impedance within normal limits. Follow-up from the provider indicated the patient states the vns had moved after being placed. Generator replacement surgery. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7747257
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dennis100
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« Reply #298 on: July 16, 2019, 11:21:31 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events were not related to the functionality of the device.
 
Event Description
It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted. She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes. The patient also stated that the generator moves when she moves her arm. She was looking to receive a smaller generator as the m103 generator gave her no issues. Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator. It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration. Attempts were made for follow-up with the psychiatrist's office. It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available. It could not be clarified if a model 103 device or model 105 device was implanted. It was stated that the patient was scheduled for explant surgery due to the reported events. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921428
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