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dennis100
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« Reply #330 on: January 05, 2019, 03:06:46 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via clinic notes received that the patient was referred for vns explantation surgery due to chest and jaw pain and the desire for mris. It was stated that the patient was seizure free for a year even with the vns disabled. Follow up revealed that the reason the vns was disabled was due to chest cramps experienced by the patient. The surgery to explant the vns was reported as both for the patient's comfort and to preclude serious injury as the patient had experienced pain and no longer used the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8163186
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dennis100
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« Reply #331 on: January 05, 2019, 03:07:22 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/08/2018
Event Type  Injury   
Event Description
Initial report was that a patient was referred for full device explant due to pain. Attempts for further information have been unsuccessful. No known surgical intervention has occurred. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8124372
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dennis100
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« Reply #332 on: January 06, 2019, 11:15:51 AM »

Model Number 304-20
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2014 it was confirmed that the patient underwent surgery on (b)(6) 2013 to remove the two lead tie-downs. Per the op-notes received, the pre-op diagnosis was that the two tie-down tabs were protruding into the skin with thinning of the skin over the tie-down tabs and concern for skin erosion. It was noted that the patient was hit in the neck by a ball recently and when this happened, these tie-down tabs became more prominent. The surgeon stated that the patient has very thin skin and the tie-down tabs were protruding through the neck and can be seen under the skin to the point where you can almost see the fact that they were white. There was no evidence of skin breakdown or infection during surgery. Diagnostics were performed before and after the removal of the tie-downs confirming lead impedance within normal limits. During removal of one of the tie-downs, scar tissue was removed as well from around the tie-down.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 note that the patient has lumps along the vagal nerve stimulator. The notes indicate that the lumps are the tie downs that secure the strain relief. It was noted that the patient's mother indicated that since the patient was hit in the neck with a ball that the tie downs have been more prominent. The mother indicated that the patient's previous physician performed diagnostics after the patient was hit in the neck with the ball and that diagnostics were within normal limits. The notes indicate that the patient will be referred for surgery to have the tie downs removed to prevent possible erosion through the patient's skin resulting in an infection. The notes indicate that the tie downs are painful to the touch and are nearly at the point of breaking through the skin. The notes indicate that the tie downs have definitely migrated and are protruding out through the skin. The patient was scheduled for surgical revision of the tie downs.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632097
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dennis100
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« Reply #333 on: January 06, 2019, 11:16:29 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 10/11/2018
Event Type  Malfunction   
Event Description
The patient was reported to have pain in their neck. The physician believes that there was curling of the lead and that the electrode is off of the nerve. The physician believed that the pain was due to the electrode coming off of the nerve. The pain was described as intense pain when laying on their left side or leaning their head to the left, and that it would resolve when the patient¿s head was turned to the right. Per an xray report received, there was some change in the lead configuration, but it was not specified what was different. No discontinuities were seen. X-rays were reviewed. The x-rays did not capture the generator and no assessment can be made on the position, lead wires, or feed through wires. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Based on the images provided, there is no obvious confirmation of the electrode coming off of the nerve. The device was interrogated and diagnostics were within normal limits. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8133204
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dennis100
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« Reply #334 on: January 08, 2019, 07:55:05 AM »

Model Number 102
Event Date 07/01/2013
Event Type  Injury   
Event Description
An implant card was received indicating that the vns patient underwent generator replacement on (b)(6) 2014 due to battery depletion. The explanted generator has not been returned to date.
 
Event Description
It was reported that the patient complained of pain in her throat that comes and goes. The patient was seen by an ent who found nothing wrong. The patient believes that the pain is from vns therapy. The patient reported that the pain has occurred for approximately 8 months. There was no trauma or any unusual occurrences that may have caused the pain. The physician believes that the device battery may be getting low and recommended generator replacement. Clinic notes dated (b)(6) 2014 note that the recurrence of seizures as well as the sore throat may be an indication of end of battery life, but that vns interrogation showed normal lead impedance and no end of battery life. It was noted that this may be preceded by end of effective stimulation when irregular stimulation may occur leading to more frequent seizures. It was noted that the patient would be referred to neurosurgery for generator replacement. It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3704897
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dennis100
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« Reply #335 on: January 10, 2019, 02:10:47 AM »

Model Number 103
Event Date 11/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was experiencing pain and swelling in the generator pocket up to the her clavicle. The pain and swelling began two weeks following replacement surgery and two days after the device was programmed on. The patient¿s pain and swelling progressed for over a month. The patient was unable to feel any stimulation 24 hours after the device was programmed on. The patient reported that no manipulation or trauma had occurred.
 
Event Description
An implant card was received indicating that the patient underwent generator implant on (b)(6) 2014. The lead impedance was marked ok (2592 ohms).
 
Event Description
It was reported by the neurosurgeon that the vns patient¿s generator was programmed on by the neurologist a couple weeks after her generator replacement surgery on (b)(6) 2013. The patient reported feeling stimulation and experienced some voice hoarseness with stimulation for about a day. Subsequently, the patient reported that she no longer felt any stimulation (including magnet activated stimulation) or any voice hoarseness. Additionally, the patient was having pain and swelling from generator site down her left arm. The patient¿s generator was explanted due to pain on (b)(6) 2014 and no replacement is planned at this time. The surgeon did not see any sign of infection except for small amount of swelling. No fluid or redness was observed. The explanted generator was returned to the manufacturer on (b)(6) 2014 and analysis was completed on (b)(6) 2014. Monitoring of the device output signal no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for additional information have been made, but no further details have been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3656770
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dennis100
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« Reply #336 on: January 10, 2019, 02:11:37 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 #337 on: January 11, 2019, 03:01:53 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed 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 patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3666903
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dennis100
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« Reply #338 on: January 11, 2019, 03:02:46 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 #339 on: January 13, 2019, 04:11:41 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed 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 patient underwent generator and lead replacement surgery. Pre-operative diagnostics showed high impedance (dc dc code - 7). During the surgery, a new generator was placed on the existing lead at which time device diagnostics were within normal limits. The patient's head was placed in four different positions with subsequent device diagnostics being within normal limits. The generator was moved and device diagnostics then resulted in high impedance (>10,000 ohms). The lead was dissected off of the patient's nerve and a new lead was placed. The surgeon reported that the lead appeared to be kinked when the generator pocket was opened. Device diagnostics with the new vns system was within normal limits. The generator and lead were received for analysis. Analysis of the lead was completed on 05/22/2014. Note the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. One of the quadfiler coils was kinked. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator is underway, but has not been completed to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient has been experiencing neck pain over the last two months and that device diagnostics approximately six months prior were within normal limits. Attempts to obtain additional information have been unsuccessful to date. It was reported that the patient was scheduled for system replacement, but surgery has not yet occurred.
 
Event Description
No anomalies were identified during the analysis of the patient's explanted generator.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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=3724366
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dennis100
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« Reply #340 on: January 14, 2019, 04:18:27 AM »

Model Number 102
Event Date 05/02/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was shocking the patient on (b)(6) 2014. The patient¿s device was tested on (b)(4) 2014 and diagnostic results revealed high lead impedance. The patient¿s device was subsequently programmed off. No patient trauma had occurred. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The patient was last seen on (b)(6) 2014 and there was no evidence of a device malfunction at that time; the patient's device settings were reported to be stable. The notes indicate that the patient¿s device was providing stimulation on an irregular basis and was dysfunctional but did not cause any seizures. The shocking from the device caused coughing and pain. The patient went to the emergency room on 05/02/2014. The magnet was taped over the patient¿s device. The patient felt one pulse of stimulation and the device reportedly stopped responding. The patient did not have any seizures while in the er but did have 2-3 auras. During the office visit, the physician noted a little lateral gaze nystagmus and the patient¿s device showed high impedance. With the magnet removed, the patient jumped whenever his device delivered stimulation which caused coughing and pain. The magnet was taped back over the device and the patient¿s medication was increased. X-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The complete lead connector pin insertion could not be assessed due to the poor quality of the images provided. 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. Incomplete lead pin insertion could be a possible cause of the high impedance. However, no definitive conclusions can be made with the images provided. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through 12/28/2010.
 
Event Description
Further information was received that the physician recalled that the patient also had continuous stimulation during the time the vns had high impedance. No further relevant information has been received to date.
 
Event Description
An implant card was received indicating that diagnostic results with the replacement generator and existing lead showed lead impedance within normal limits (impedance value ¿ 2644 ohms).
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838963
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dennis100
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« Reply #341 on: January 14, 2019, 04:19:15 AM »

Model Number 302-20
Event Date 01/11/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2014, it was reported that x-rays were taken, and the images showed a lead fracture. The patient was experiencing throat pain with no history of trauma. The patient¿s device was programmed off the next day. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient went to the emergency room on (b)(6) 2014 due to a breakthrough seizure and headache. Shunt malfunction was ruled out at the emergency room. The patient had her 2nd breakthrough seizure a week prior to her office visit on (b)(6) 2014. Both seizures were not convulsive. The neurologist stated that both seizures were extremely unusual for the patient. The patient had been seizure free since vns implant while using only one medication. The patient did not have any febrile illness or vomiting/diarrhea. The notes indicate that the diagnostic results showed that the battery was at end of service or near end of service. The neurologist stated that the battery was depleted and could not deliver the necessary therapy to prevent the patient¿s seizures. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through 11/11/2010. A battery life calculation using the available programming history showed approximately 3. 68 years until eri = yes.
 
Event Description
Additional information was received that the patient had lot of scar tissue seen during the lead and generator replacement. It is unknown if the leak break may have been a contributing cause of the scar tissue.
 
Event Description
Additional programming history was received indicating that device settings had been reduced in (b)(6) 2011. A new battery life calculation was performed with the new settings which showed approximately 5. 16 years remaining until neos - yes.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. 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=3828275
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dennis100
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« Reply #342 on: January 14, 2019, 04:20:04 AM »

Model Number 302-20
Event Date 04/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient was experiencing spasms and pain at the generator and lead sites prior to generator replacement surgery on (b)(6) 2014. The generator was replaced due to battery depletion.
 
Event Description
It was reported that the patient has had multiple issues including pain and decreased appetite since the lead was repaired with silicone. The pain in the neck area was intense, and the patient kept ice applied and took medication as a result. The patient had lead replacement surgery on (b)(6) 2014. The patient reported on (b)(6) 2014 improved adverse symptoms and feeling much better since the surgery. The explanted lead is not being returned to the manufacturer for analysis.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon repaired two large tears in the lead with silicone. Since the surgery, the patient was having difficulty turning her neck. When she turned her neck, the patient became nauseous from pain in her throat. The patient was unable to eat due to the nausea and had lost weight. The patient was also experiencing tinnitus with her head turned and having daily headaches. The patient¿s device was recently programmed on. The patient previously had a surgical consult on (b)(6) 2013 for a possible lead migration. The surgeon determined there was no lead migration and stated that the patient¿s device was working well. Diagnostic results showed normal device function as of (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through 11/23/2011. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient was going to be evaluated by another surgeon for a second opinion. The patient was referred for generator and lead replacement surgery. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator is not available to return to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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dennis100
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« Reply #343 on: January 14, 2019, 04:21:06 AM »

Model Number 103
Event Date 04/25/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s device was fine and that there were no issues. The patient¿s device settings were increased and the increased settings caused throat pain and voice alteration. The patient could not tolerate the higher settings. The settings were decreased and the patient was doing fine.
 
Event Description
It was reported that the physician was having issues interrogating the patient¿s device. The physician stated that the patient likely left his office visit on (b)(6) 2014 without having his device settings adjusted. The patient was scheduled to have his device settings lowered because he was having difficulty tolerating stimulation. It was reported that the physician had issues interrogating the patient¿s device in the past. The wand battery was replaced and confirmed to be functioning normally. The programming system was then able to interrogate a demo device. It was reported that the nurse always had the programming system was plugged in while interrogating patients.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3827885
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« Reply #344 on: January 15, 2019, 02:49:15 AM »

Model Number 102R
Event Date 01/23/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death was not provided. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The funeral home manager reported that there was no documentation indicating that the devices were explanted prior to burial.
 
Event Description
Additional information was received from the hospital where the patient passed away. The patient presented to the emergency room on (b)(6) 2014 with lower back pain and pleuritic chest pain. He was subsequently diagnosed with community acquired pneumonia and admitted. He was started on antibiotics and pain medication. When the patient was being moved to the nursing floor from the emergency department he became unresponsive with a heart rate in the 30s and blood pressure that could not be measured. He was given one dose of atropine, but the patient¿s pulse stopped and his skin grew cold. The patient was coded do not resuscitate so no further interventions were performed and he was pronounced dead. The cause of death was determined to be: 1) community-acquired pneumonia 2) bradycardia, hypotension, and cardiac arrest.

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« Reply #345 on: January 15, 2019, 02:50:36 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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« Reply #346 on: January 15, 2019, 02:52:32 AM »

Model Number 103
Event Date 04/20/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient was experiencing pain at her neck incision site. The patient¿s device was not programmed on following surgery. The next day, the patient had seven seizures and was admitted to the hospital. The patient¿s pain worsened extremely after experiencing multiple seizures. The patient expressed concern that her seizures may have caused her lead to migrate. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3815383
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dennis100
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« Reply #347 on: January 16, 2019, 02:50:02 AM »

Model Number 103
Event Date 03/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain in her arm in the beginning of (b)(6) 2014. Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014. The patient was having frequent nonconvulsive seizures until starting her medication in (b)(6) 2013. The notes indicate that the patient had good control with grand mal seizures in the past; however, the patient had three grand seizures in the past eight days with the second seizure occurring three days ago and the third seizure occurring the day as the office visit. The patient last grand mal seizure occurred in (b)(6) 2013. The patient¿s seizures occurred in the morning and lasted 1-2 minutes. The patient reported having good quality of sleep and a manageable stress level. The patient did not use her magnet and was tolerating stimulation well. The patient¿s medication was increased and her device settings were adjusted. The patient¿s device was tested during the office visit and diagnostic results revealed normal device function at the time. No programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. X-rays were taken and were reported by the physician to be unremarkable. The patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed normal device function at the time. The patient¿s side effects were inconsistent and not in common with the pain in her arm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3787965
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dennis100
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« Reply #348 on: January 16, 2019, 02:50:53 AM »

Model Number 105
Event Date 03/25/2014
Event Type  Injury   
Event Description
There were no adverse functional, mechanical, or visual issues identified with the returned generator. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. Other than typical wear and explant related observations, no product anomalies were identified in the returned lead portion. Note that since a significant portion of the lead (including the electrode array portion) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional information was received stating that the vns patient had not been re-implanted to date. The vns implant surgery was believed to have caused the infection. Patient manipulation or trauma is not believed to have caused or contributed to the infection. No external factors caused or contributed to the infection. Cultures were taken but the results were not provided. The patient was given an antibiotic regiment. Following the explant procedure, the patient¿s infection cleared but the patient may have developed vocal cord paralysis from a nerve injury during the explant procedure. The vocal cord paralysis was reported in manufacturer report # 1644487-2014-01440.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to what appeared to be an infection. The patient¿s device was programmed off two weeks before surgery because the patient had pain, redness, and swelling at the implant site. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. 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=3788012
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dennis100
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« Reply #349 on: January 16, 2019, 02:51:52 AM »

Model Number 303-20
Event Date 08/29/2013
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that the patient was going be seen by the physician again. No further information has been received to date.
 
Event Description
Initially, it was reported that the patient was having pain at the neck incision site related to implant surgery. It was later reported that the patient was undergoing generator replacement surgery. The relationship between the neck pain and generator replacement are unknown. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.
 
Event Description
It was observed that the patient¿s product information was inadvertently not reported on the initial report.
 
Event Description
On (b)(4) 2014 it was reported that the patient believes the pain is due to vns but the physician is not convinced. The physician would like to explore either turning the device off for a period of time or adjusting for a more comfortable setting to determine the cause.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: it was observed that the patient¿s product information was inadvertently not reported on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796494
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dennis100
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« Reply #350 on: Today at 02:57:48 AM »

Model Number 302-20
Event Date 06/03/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The explanted devices have not been received for analysis to date.
 
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 vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient reported having neck pain. It is unknown whether the pain was occurring with stimulation. Clinic notes were received indicating that the patient has not had any seizures since being admitted to the residential facility. The notes indicate that the patient was violent and had fights with the staff. X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3900473
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dennis100
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« Reply #351 on: Today at 02:58:36 AM »

Model Number 303-20
Event Date 05/09/2014
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized but identified abnormal placement of electrodes.
 
Event Description
It was reported that the vns patient would at times experience numbness under her chin and hot flushes in her left arm after her device was programmed on during an office visit on (b)(6) 2014. The patient¿s device showed lead impedance within normal limits (impedance value ¿ 2304 ohms) at the time. The patient was seen on (b)(6) 2014 and reported having some pain in her left arm after her device settings were increased. The patient¿s device showed increased lead impedance but still within normal limits (impedance value ¿ 4649, 4622 and 4701 ohms). X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. 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 appeared to be placed in an abnormal arrangement as they do not align with the spine but rather perpendicular to the spine. 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 reported events may be due to the abnormal placement of the electrodes. However, no definitive conclusions can be made. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899453
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dennis100
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« Reply #352 on: Today at 02:59:24 AM »

Model Number 102
Event Date 05/27/2014
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced a stinging sensation at the generator site. It was noted that the patient feels that the device is still working. It was noted that the patient's mother feels like the generator is slipping lower. It was noted that the vns is causing the patient pain for the last month and that it seems to be slipping down in her chest. X-rays were performed which showed the generator at the left heart border. Attempts to obtain additional information have been unsuccessful to date. No surgical intervention has been performed to date.
 
Event Description
The pain on the left side of the neck was reported to have started a year ago and is not occurring with vns stimulation. Patient was also reported to be wheel chair bound. It was noted that the patient would often turn the head to the right and stretch. X-rays were reviewed by the physician and the lead was observed to be coiled over the base of the left neck and in the mid left neck region.
 
Event Description
Further follow up indicated that the x-rays appeared normal and the vns device diagnostics were also normal. As the patient is hard to communicate with, the cause of the pain remains unknown and vns was not ruled out to be a possible factor. The x-rays were received and reviewed by the manufacturer. Two sets of electrodes were visualized in the neck region. The superior set of electrodes pertains to the current functional lead that was implanted on (b)(6) 2009 and the inferior set of electrodes belongs to the lead that was partially explanted on 09/10/2009. There did not appear to be any gross fractures or discontinuities that might explain the pain and painful stimulation.
 
Event Description
Additional information was received that the patient experienced neck pain and "intermittent buzzing", which started back in 2014. The buzzing sensation stopped when the patient's generator was replaced in 2014 but the neck discomfort continued to be present. The patient continues to have pain when turning the neck. It is unknown whether the neck pain is related to vns. It was reported by the patient's caregiver that it could be related to a muscle strain. No known interventions were taken regarding neck pain as patient has not consulted a physician regarding this yet.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to pain and repositioning of the generator pocket. The explanted generator was returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3900196
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dennis100
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« Reply #353 on: Today at 03:00:18 AM »

Model Number 103
Event Date 05/17/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient was experiencing tenderness in his left neck three days after vns implant. The surgeon found a hematoma that had developed around the patient¿s artery so the patient underwent surgery to suture the artery. During the procedure, the surgeon noted that there was blood around the patient¿s generator. Further follow-up revealed that the patient¿s device was programmed on during an office visit on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The surgeon reported that the wound was explored and the hematoma was evacuated and the bleeding was controlled. It was reported that the wound was healing at the patient's follow-up appointment. The surgeon reported that the bleeding and hematoma was not directly related to the vns. The hematoma appeared to be related to a bleeding subcutaneous blood vessel. The bleeding around the generator site was believed to be tracked down from the neck wound.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3889292
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