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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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