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dennis100
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« Reply #660 on: January 04, 2019, 11:15:31 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 #661 on: January 04, 2019, 11:16:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the vns was causing issues for the patient. It was later reported that the patient's vns was shut off due to hoarseness, dizziness, and blacking out. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190069
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dennis100
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« Reply #662 on: January 04, 2019, 11:17:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported by an emergency room physician that the patient's generator was continuously stimulating for several hours. It was reported that the physician attempted to disable the device using the vns magnet as well as a pacemaker magnet, but that the device continued to stimulate and the patient was admitted to the hospital. A company representative reported that the patient experienced neck pain and hoarseness that persisted despite the device being programmed off. The patient's device diagnostics were within normal limits. It was reported that the patient had recently had a seizure and had fallen and either hit her head or neck. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8178588
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dennis100
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« Reply #663 on: January 05, 2019, 03:42:56 AM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
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dennis100
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« Reply #664 on: January 07, 2019, 03:20:33 AM »

Model Number 302-20
Event Date 01/09/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 were received which indicate that the patient returned to the clinic for a consultation. Per the notes, since his last visit, the patient states he is experiencing increased seizures. The patient states that he no longer feels the vagal nerve stimulator when it activates. The patient denies any injuries to the head or neck. The patient stated that a few weeks ago, he developed a left frontal headache and hoarseness. The patient is tolerating his medications well. Per the notes, the vns device was interrogated and diagnostics were performed. Diagnostics demonstrated high impedances and inability to output current. X-rays will be ordered to assess for lead fracture. Notes dated (b)(6) 2013 indicate the patient has been having about one seizure every three weeks. The patient reports this is due to the fact that he has been spacing out his medications due to the risk of running short. Notes dated (b)(6) 2013 indicate the patient was having difficulty affording his medication and cut back on his does. Subsequently, he had four seizures. The patient's vns generator was replaced on (b)(6) 2014. Attempts were made for additional information; however, they were unsuccessful. The explanted device will not be returned to the manufacturer, as it has been discarded. No additional information has been received in regards to these events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3608421
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dennis100
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« Reply #665 on: January 07, 2019, 03:21:31 AM »

Model Number 304-20
Event Date 01/05/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device had high lead impedance. Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014. The vns device was programmed off to 0ma following the observation of the high lead impedance. The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward. The physician will not provide any additional information. Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block. Feed thru wires appear intact. Lead wires appear intact at the connector pins. The lead coils behind the generator before routing upward to the left neck. The portion of lead behind the generator cannot be assessed. The electrodes appear aligned. A strain relief bend is present and appears to be per labeling. No strain relief loop is present. Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead. No other information has been provided.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response. She indicated that depending on the slant of her head, she felt that the vns was more intense. In addition, the patient reported brain freezes when she had to take her medications with cold water. She believed it was possible that the vns was going off at that time and causing it. The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough. She said that she ended up getting pneumonia. The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance. The programming database and internal data of the patient's generator was reviewed. Per the data, it was found that the patient's generator was re-enabled. Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. 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=3622212
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dennis100
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« Reply #666 on: January 10, 2019, 02:07:16 AM »

Model Number 302-20
Event Date 01/15/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's device was programmed back on as there was no difference in the spasmodic dysphonia with or without vns stimulation. No further relevant information has been received to date.
 
Event Description
It was reported by the ent physician that the vns patient was seen in his office on (b)(6) 2014. Clinic notes were from the office visit were received indicating that diagnostic flexible fiberoptic laryngoscopy revealed left vocal cord paralysis possibly from a displaced lead. The notes also indicated that the patient recently went to the er where ct showed left vocal cord paralysis. The patient was having severe pain in her left throat and pain when swallowing. The ent physician suggests that the pain may possibly be due to a displaced lead, and advised the patient to have her generator programmed off. Additional information was received from the patient stating that she had been experiencing severe pain and had taped her magnet over her generator to disable stimulation. Whenever the magnet shifted out of place, the patient reported that she experiences a shock and the pain worsens. The patient was seen by a surgeon to discuss vns replacement. The surgeon believes that the patient does not have vocal cord paralysis but has irregular spasmodic movement of her left vocal cord which followed a severe upper respiratory tract infection. The surgeon stated that the patient¿s symptoms seem to worsen with vns stimulation. The surgeon does not believe that the reported event requires surgery, but suggested lowering the patient¿s settings. While the surgeon believes that the reported event is not due to vns, the neurologist believes there is a relationship with the reported event and vns. As suggested by the surgeon, the neurologist lowered the patient¿s settings. Review of the available programming and diagnostic history for the device did not reveal any anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3658670
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dennis100
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« Reply #667 on: January 11, 2019, 02:48:50 AM »

Model Number 102
Event Date 06/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain. Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well. The patient¿s device settings were increased during the visit. The patient presented with increased chest pain during an office visit on (b)(6) 2014. A chest ct was reported by the physician to be unremarkable. The patient¿s device settings were lowered during the office visit. The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014. The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation. The patient reported that she was still feeling electricity-like pain in her arm and palm. The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013. It was confirmed that the events are occurring continuously as well as with stimulation. She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously. Additionally, she was seizure-free for a while and had one seizure. At that time, diagnostics were normal and the battery was reported to be fine as well. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717363
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dennis100
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« Reply #668 on: January 12, 2019, 03:53:55 AM »

Model Number 303-20
Event Date 11/18/2013
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that this patient was evaluated by an ent on (b)(6) 2014 for continuous hoarseness. The visit report stated that the patient had "weakness of the left vocal cord" that was mild and would likely resolve. No interventions were taken. The patient had previously reported coughing and constant voice alteration following implant surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734895
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dennis100
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« Reply #669 on: January 14, 2019, 04:28:27 AM »

Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
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dennis100
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« Reply #670 on: January 15, 2019, 03:07:51 AM »

Model Number 304-20
Event Date 04/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed ct scans of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Ct scans reviewed by manufacturer, unable to assess lead continuity or lead pin insertion. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient's device was disabled on (b)(6) 2014. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. Due to the poor quality of the images, lead pin insertion and the filter feed-through wires cannot be assessed. The electrodes appeared to be placed in normal arrangement. Part of the lead was 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. Based on the images provided, the cause of the high lead impedance remains unknown.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc - 7). The patient¿s device was not programmed off following the high impedance observation. Ct scans were provided to the manufacturer for review but were unable to determine the integrity of the lead and whether the lead pin was fully inserted into the generator header. The last known good system diagnostic results were from the date of implant. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. Further follow-up revealed that the implant surgeon hit the patient¿s jugular as he tunneled from chest to neck. The patient was seen 15 days after implant surgery and presented with severe voice hoarseness. The patient¿s device was programmed on during an office visit on (b)(6) 2013. During the office visit on (b)(6) 2014, the patient¿s device settings were increased. A diagnostic test was subsequently performed and a warning message appeared indicating high impedance and limited output current. The neurologist misinterpreted the diagnostic results and increased the patient¿s device settings. A second diagnostic test was performed which revealed the high lead impedance. It was reported that the patient was doing well. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3823884
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dennis100
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« Reply #671 on: January 15, 2019, 03:08:33 AM »

Model Number 300-20
Event Date 04/19/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value = 10,000 ohms). The neurologist suspected fibrosis was causing high impedance as the patient was experiencing voice hoarseness with normal mode stimulation every five minutes. The patient was referred for generator and lead replacement surgery but no known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3810277
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dennis100
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« Reply #672 on: January 16, 2019, 02:35:23 AM »

Model Number 302-20
Event Date 04/19/2014
Event Type  Malfunction   
Event Description
The patient's generator product information was provided by the implanting hospital on (b)(6)2014.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The explanting facility does not return devices; therefore no analysis will be performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The neurologist suspected fibrosis was causing high impedance as the patient was experiencing voice hoarseness with normal mode stimulation every five minutes. The patient was referred for generator and lead replacement surgery but no known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808627
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dennis100
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« Reply #673 on: February 09, 2019, 03:39:19 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported via social media comment by the patient that she experienced vocal cord damage and permanent heart issues. The reported vocal cord damage was reported in mfg. Report #1644487-2019-00173. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8291615
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dennis100
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« Reply #674 on: February 09, 2019, 03:40:04 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2018
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient had passed away due to sudden unexpected death in epilepsy (sudep). The patient's mother indicated that the vns contributed to the patient's passing; however, the physician reported that was not the case. The physician indicated that the patient's death was not attributed to vns. The last system diagnostics known for the patient were within normal limits. The mother reported that on the day of the patient's death he had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours but he was eventually pronounced dead at 11 am. The patient's mother additionally reported that the patient's vns had been turned off for an mri a few weeks before the patient's passing and was turned on by a different neurologist. The mother reported that the son thought the neurologist had turned on the stimulation too high and wanted the generator explanted. She reported that the patient's generator would constantly turn on and off, and that it affected the patient's vocal cords. She reported that the patient's device was not helping him and that there was an increase in seizure frequency. She also reported that the patient had horrible heartburn and was agitated the day before he passed away. The patient's autopsy came back negative for any abnormal tests. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242124
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« Reply #675 on: February 11, 2019, 02:12:17 AM »

Model Number 302-20
Event Date 12/29/2014
Event Type  Injury   
Manufacturer Narrative
Event date corrected data to (b)(6) 2014.
 
Event Description
Additional information was received from the patient's treating physician. On (b)(6) 2014 his signal frequency was increased from 20 to 30hz and pulse width to 500 usec from 250. (he had tolerated these settings with his initial generator prior to battery depletion or replacement). The patient's therapy was lowered from signal frequency to 20hz and pulsewidth to 250 usec and the patient had immediate return of spontaneous vocalization.
 
Event Description
It was reported that following generator replacement the patient device settings were increased and the patient did not vocalize much since the titration. It was reported that the patient was previously non-verbal, but was now non-vocal which is abnormal for the patient. There was question as to whether or not the patient was experiencing vocal cord paralysis. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4495824
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« Reply #676 on: February 13, 2019, 02:58:55 AM »

Model Number 304-20
Event Date 01/03/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january. However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance. No known vns surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled. The patient's previous neurologist has no additional information to provide. No known surgical interventions have occurred to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (6592 ohms). Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms). X-rays were taken and did not identify any obvious discontinuities with the vns system. The generator was programmed off and the patient was referred to surgeon. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4516986
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« Reply #677 on: February 16, 2019, 02:57:27 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
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dennis100
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« Reply #678 on: February 21, 2019, 01:49:28 PM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient may have a broken lead as the patient¿s generator battery indication changed from 50% to 10% in 4 months. The generator was noted to be at ifi ¿ yes and the patient has been having a lot of seizures. Further follow up indicated that the patient¿ device diagnostics showed high impedance. Clinic notes were later received indicating that the patient had significant worsening in seizure duration and frequency. Patient is having complex partial seizures at the rate of 2-3 per day. Recent symptoms that patient experienced include: intermittent confusion, inability to talk, funny feeling in head, staring, and reporting that she was hot, staring spells, pausing at in appropriate parts of a sentence. Patient¿s compliance with treatment was reported to be good. Patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were not returned to the manufacturer per the explant facility policy.
 
Manufacturer Narrative
Available programming and diagnostic history were reviewed. Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4697733
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dennis100
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« Reply #679 on: February 24, 2019, 09:39:54 AM »

Model Number 303-20
Event Date 09/19/2016
Event Type  Injury   
Event Description
It was reported that vns patient implanted with vns system and still having dysphagia and dysphonia after 6 weeks from the implant. The physician knows that these adverse events are expected in the first weeks. The reported issues occurred with the stimulation on and also when the stimulation is off. The therapy was switched off on (b)(6) 2016 due to the reported issues. Follow up indicated that the dysphonia and dysphagia were observed since the vns implantation. It is likely that manipulation of the vagal nerve occurred during the surgery. No history of the reported dysphonia and dysphagia prior the implant of the vns system. It was also confirmed through the implant card that the vns system works fine after the implant (1242 ohms). No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4). Outcomes attributed to adverse event ; corrected data: the previously submitted mdr inadvertently provided an incorrect event outcome. Description of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event description. Brand name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Type of device, name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Model #, serial #, lot#, expiration date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that vns patient implanted with vns system and still having dysphagia and dysphonia after 6 weeks from the implant. The physician knows that these adverse events are expected in the first weeks. The reported issues occurred with the stimulation on and also when the stimulation is off. The therapy was switched off on (b)(6) 2016. Follow up indicated that the dysphonia and dysphagia were observed since the vns implantation. It is likely that manipulation of the vagal nerve occurred during the surgery. No history of the reported dysphonia and dysphagia prior the implant of the vns system. It was also confirmed through the implant card that the vns system works fine after the implant (1242 ohms).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6127156
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dennis100
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« Reply #680 on: February 26, 2019, 02:24:12 AM »

Event Date 03/06/2015
Event Type  Injury   
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently lacked the required evaluation codes. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that a patient with a partially explanted vns system (approximately 6 cm of lead remaining implanted) experienced a hot, painful sensation in the left side of the neck and was getting stuffy while having an mri performed on (b)(6) 2015. The scan was interrupted but then started back up again. After the mri was completed, the patient was hoarse and experienced coughing and choking for the next few days. The neurologist couldn¿t find anything that could be contributing to these events. The patient had an ent evaluation where it was found that the patient had decreased sensitivity of the larynx however; the vocal cord movements were intact. The ent evaluation was performed on (b)(6) 2015. It was concluded that there was significant heating of the vagus nerve during the mri. Follow-up revealed that the scan was performed according to the new vns guidelines however, the ¿old¿ low sar epilepsy protocol was followed. The gradients are increased quickly which may be the cause of the issues the patient experienced. The physician indicated there was a stimulation of the vagus nerve because a stream is going to run in the remaining leads under the influence of rapid changes in the diffusion gradient despite the short duration of the series (approximately 1 minute). It is suspected that perhaps the spatial gradient field may have exceeded 720 gauss/cm. No additional relevant information has been received to date.
 
Event Description
X-rays images were received by the manufacturer. Review of the images revealed a 6cm portion including the electrodes still implanted in the patient. Further information was later received indicating that the facility uses an mri rx/tx head coil which has been successfully used on vns patients previously.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4757324
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« Reply #681 on: March 08, 2019, 02:02:05 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
Patient reported that vns therapy did not decrease his seizures and had increased his seizures due to the stress from continuous voice alteration and not being able to sing with vns therapy. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8348790
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« Reply #682 on: March 09, 2019, 03:04:23 AM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/12/2000
Event Type  Injury   
Event Description
It was reported that the patient had lost their voice completely after vns implant. After a year of no voice, patient underwent vns removal surgery and later found out that vns wasn't put in correctly. Patient's voice issues resolved a week after vns explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8333909
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dennis100
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« Reply #683 on: March 10, 2019, 02:28:22 AM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/11/2001
Event Type  Injury   
Event Description
It was reported by the patient that their vns generator changed the sound of their voice every once in awhile and the patient had their generator explanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8337806
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dennis100
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« Reply #684 on: March 16, 2019, 02:03:17 AM »

Model Number 303-20
Device Problems Circuit Failure; Loss of Power
Event Date 09/07/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient had pain in the neck and throat, and swollen spot in the neck. It was reported that short circuit was suspected, as the dcdc value dropped from 6 to 5, to 3, to 2 and now 0. The generator was switched off. It was reported that the x-rays will be taken then sent to the manufacturer for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that both lead and generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Event Description
It was later reported that the vns patient had eating disorder, hoarseness, dysphagia and protrusion. Review of the available programming and diagnostic history received from the nurse showed normal diagnostic results through (b)(6) 2012. The x-rays were taken and sent to the manufacturer for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin seems to be fully inserted into the generator connector block. The electrodes placement seems to be normal. One tie-down, strain relief bend were used to secure the implanted lead but not as indicated in the labeling. Part of the lead was behind the generator. No lead breaks or sharpe angles were visible on the assessed lead parts.
 
Event Description
Further information received indicating that the patient underwent a full revision. The lead was replaced due to lead function issue (low impedance) and the generator was replaced likely due to battery depletion. No explanted devices return is expected at ths time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5123049
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« Reply #685 on: March 19, 2019, 01:36:10 AM »

Model Number 303-20
Event Date 06/24/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that a vns patient had been experiencing a persistent sore throat since the time of stimulation. The provider indicated that the patient's sore throat is experienced all the time but more so during vns stimulation. The patient's neurologist stated that device function was normal with normal diagnostics and vns stimulation had been turned on following the patient's surgery. A vocal cord video strobe performed by the patient's ear, nose, and throat physician revealed that the left true vocal cord is in the paramedical position and vibrates on phonation without adduction or abduction; the right true vocal cord works well. The assessment was that the patient was experiencing dysphonia and dysphagia secondary to vns implant. It was reported that normal lead impedances have been observed since implant with the latest measured lead impedance being 1,928 ohms (date of measurement unknown). No known further interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5238140
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« Reply #686 on: March 19, 2019, 01:37:17 AM »

Model Number 304-20
Device Problem Output Problem
Event Date 10/10/2014
Event Type  Injury   
Event Description
It was reported that the patient had tolerability issues since implant with vns stimulation due to painful stimulation in the neck electrode site and dysphagia with stimulation. Patient is not able to tolerate stimulation with settings greater than 0. 75 ma. Based on the adverse events, the physician suspects an lead break despite diagnostics reported to be within normal limits. Additional information was received that the patient also experienced coughing and voice alteration with stimulation. All of these adverse events were occurring since the implant of the device. Diagnostics are within normal limits and is 4246 ohms. Settings were reduced on (b)(6) 2015 for the stimulation related issues and the magnet was reported as too strong. Settings were further reduced in february and march, and the complaints above were reduced to "mild discomfort. " but patient continues to experience pain in the neck with 130 us. Patient's x-ray images of the neck and chest were received. There did not appear to be any gross fractures or discontinuities or other abnormalities that might explain the painful stimulation or dysphagia with stimulation. Additional information was received that the impedance value for the patient's device was around approximately 4000 ohms. The physician worried that the potential break in the lead near generator may be causing patient's side effects. Patient's settings were lowered to frequency of 20 hz and pulse width of 130 usec as patient was unable to tolerate stimulation 30 hz and 250 usec. Patient underwent lead revision surgery on (b)(6) 2015. The explanted lead has not been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: additional information was received that the explanted lead was suspected to be discarded. Information about the product disposition was inadvertently left out from the initial mdr. Evaluation codes (refer to coding manual) conclusions, corrected data: 70. Information about the product disposition was inadvertently left out from the initial mdr.
 
Event Description
Information was later received that the explanted lead was suspected to be discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5243003
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« Reply #687 on: March 22, 2019, 02:30:28 AM »

Model Number 103
Event Date 07/24/2015
Event Type  Injury 
Event Description
It was reported that a patient's generator was turned off for an unknown reason, and the patient was experiencing voice weakness even after the generator was turned off. Attempts for additional relevant info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024018
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« Reply #688 on: March 25, 2019, 01:54:56 AM »

Model Number 106
Event Date 07/08/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient that recently had generator replacement surgery ((b)(6) 2016) had high impedance about a month prior to the report (>10000ohms). The patient was then referred for surgery, but the surgeon performed diagnostics and no high impedance was present. The patient was referred back to the neurologist, and the impedance was 2200ohms and 3000ohms upon diagnostics. The patient then started to feel intermittent pain at the generator site. The patient was then referred to another surgeon. No surgical intervention has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient had a consult with a different surgeon, and it was believed that the lead pin was not fully inserted. The patient was experiencing painful stimulation in the chest and neck, trouble swallowing, and more voice alteration than he previously experienced. X-rays were performed. There were ap and lateral chest and neck x-rays from (b)(6) 2016. The x-rays showed that the lead pin was not fully inserted into the connector block, as the connector pin could not be visualized past the connector block. The generator was placed in the left chest per labeling, and the feedthru wires appeared intact at the connector block. No gross fractures were identified with the provided images. No sharp angles were noted. Additionally, a portion of the lead was identified to pass behind the generator and an assessment could not be made on this portion of the lead. There were no noticeable differences between the x-rays taken on (b)(6) 2016. No surgical intervention has occurred to date.
 
Event Description
The patient's generator was programmed off due to the intermittent high impedance, and the patient was referred to the surgeon for possible explant surgery. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965583
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« Reply #689 on: March 27, 2019, 07:06:55 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a prophylactic generator replacement. It was later reported that the referral was cancelled as the patient visited an ent and has larynx damage, and the ent scope showed too many complications for surgery. It was reported that at a consult with a vascular surgeon, the surgeon told the patient that the patient's inflammation in his larynx is due to the vns, and the patient wanted the device turned off. The patient wanted to test the efficacy to see if he still needed the vns therapy. The device was programmed off on (b)(6) 2015. The patient then reported that he has always had voice issues and hoarseness but did not mention whether it was constant or with stimulation. The patient was scheduled to visit with the implanting vns physician for the voice issues and full revision consult. No additional relevant information has been received to-date. No known surgery has occurred to-date.
 
Event Description
A message was received from the physician's office that the patient was healthy and able to fly with no foreseen problems and was written to inform of the vns placement. Additional relevant clarifying information has not been received to-date.
 
Event Description
Information was received from the physician (b)(4) 2016 providing that the inflammation was not caused by vns. The physician reported the patient developed hoarseness and was found to have a paralyzed vocal cord. However the vns was turned off 3-4 weeks prior with no changes. The vocal cord involved was on the right and the vns is on the left. The physician does not believe the voice alteration was due to stimulation or the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5348388
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