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dennis100
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« Reply #450 on: October 29, 2018, 11:06:30 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Death   
Event Description
It was reported by a physician that his vns patient had been diagnosed with esophageal adenocarcinoma. The physician had not made any medical assessment on the cause of the patient's condition. No known surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient had passed away. The cause of death was the previously reported esophageal adenocarcinoma. The physician did not believe the death was related to vns.
 
Event Description
The patient's treating physician stated that the esophageal adeconcarcinoma was thought to be related to the patient's comorbidity of barrett's esophagus. The physician also stated she was unsure if the lower esophageal sphincter relaxation led to the symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5937297
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dennis100
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« Reply #451 on: October 29, 2018, 11:09:07 AM »

Model Number 304-30
Device Problems Inappropriate Shock; Material Protrusion / Extrusion
Event Date 04/01/2015
Event Type  Injury   
Event Description
It was reported that the patient has been feeling 'shocks' in the neck at the electrode area for the last few months. X-rays were taken with no issues noted with the vns device. The vns device was tested by the physician with no issues noted. It was also reported that the patient had surgery on his esophagus on (b)(6) 2015, which has caused a 70 lbs. Weight loss and is causing the generator and lead to protrude. The 'shocks' started sometime after this procedure. It was reported that the pain doesn't happen all the time, but is often, and not with every stimulation. It was reported that the patient had the vns device diagnostics run while the patient was turning his head in multiple directions and there was no change in the impedance value. It was also reported that the 'shocks' stopped when the device was programmed off and the pain only occurs during stimulation. The output current was reduced and the off time was increased on (b)(6) 2015 to try to resolve the pain. The patient stated that the pain decreased but that the pain was still present. The patient was referred for generator replacement. No known surgical interventions have been performed to date.
 
Event Description
It was reported that the patient underwent a full revision surgery on (b)(6) 2015 due to reported pain and shocking sensations. It was reported the surgery was performed for patient comfort. It was also reported that the patient's new vns system was programmed on after surgery and the shocking sensation appeared to have resolved. Neither the lead nor the generator have been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4922369
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dennis100
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« Reply #452 on: October 30, 2018, 12:57:37 AM »

Model Number 103
Event Date 06/15/2016
Event Type  Malfunction   
Event Description
Additional programming and diagnostic data was received.
 
Event Description
Additional information was received that the patient only underwent generator replacement on (b)(6) 2016 due to neos - yes and that the lead was not replaced. Per the neurologist office, a system diagnostic test performed on (b)(6) 2016, showed normal impedance value of 3438 ohms. It is believed that the surgeon changed the generator first and did a system diagnostic test to see if there was a problem with the lead impedance. The high impedance likely resolved and so the lead was not replaced on (b)(6) 2016. Therefore the cause of the high impedance was likely due to an incomplete lead pin insertion.
 
Event Description
The physician couldn't say exactly on what date the patient experienced erratic stimulation but he feels strongly that the high impedance was a result of the procedure patient had on (b)(6) 2016. Patient underwent lead revision on (b)(6) 2016. The explanted lead will not be returned to the manufacturer.
 
Event Description
It was reported that the high impedance was seen for patient's device. System diagnostic test shows high lead impedance of >10,000 ohms. The current delivered was only 0. 25ma. The physician tried to lower the output current to 0. 25 and raised the pulse width to 500 per the instructions on the software alert, but the diagnostic test showed the same results. Patient also reported experiencing erratic stimulation. Patient did not report any blunt force trauma to the generator site or the neck, but said that she was out shooting a hand gun recently. Patient was referred for a full revision due to high lead impedance. Patient's vns was adjusted on (b)(6) 2016 (signal off time reduced to 1.08) no further seizures reported until after patient had a procedure done on (b)(6) 2016 (esophagus was dilated). Patient returned on (b)(6) 2016 to report breakthrough complex partial seizures and left sided cephalalgia (temple radiating to occiput). No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780640
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dennis100
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« Reply #453 on: November 10, 2018, 03:12:48 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8004870
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dennis100
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« Reply #454 on: November 10, 2018, 03:14:02 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient experienced a moderate increase in seizure frequency related to the implant procedure of the vns device. It was also reported that the day before the increased seizures, the patient experienced severe nausea and vomiting related to the implant procedure. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8009286
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dennis100
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« Reply #455 on: November 14, 2018, 09:17:22 AM »

Model Number 302-20
Event Date 12/01/2012
Event Type  Malfunction   
Manufacturer Narrative
The patient's increase in seizures is a serious injury/adverse event. The increase in seizures are related to the high impedance. Device failure is suspected and may have contributed to the patient's increased seizures.

Event Description
Reporter indicated that the diagnostic testing resulted in high impedance. It was reported that the device was programmed off to prevent damage to the patient's vagal nerve. It was also reported that the patient had projectile vomiting three times a day and that the patient was scheduled for surgery. The patient underwent generator and lead replacement on (b)(6) 2013. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Further follow-up revealed that the neurologist's notes indicated that the patient had experienced an increase in seizures since christmas; however, it was not noted whether the increase was above the patient's pre-vns baseline or what the physician's attributed the increase to. The notes indicated that the generator was at ifi = yes and there was high impedance >1000 ohms and that is when the patient was referred for surgery. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Analysis of the generator was completed on 09/30/2013. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In the pa lab, the device output signal was monitored for more than 24-hrs, showing showed no signs of variation in the pulse generator¿s output signal and demonstrating 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. However, further review of the ram and flash data, downloaded from the generator, shows high impedance had occurred during device implant. The data from the decoder spread sheet shows a change in impedance, the estimated occurrence was on (b)(6) 2013, from 12586 ohms (prior to explant) to 3993 ohms (explant date (b)(6) 2013). The combination of a high impedance value and output current (2. 00ma vns database) setting required a ¿vboost¿ compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v). Review of the electrical characterization report states that the longevity estimates are not guaranteed at compliance voltages greater than 10. 5v. This condition contributes to the disparity between the near neos condition and the % battery capacity that has been consumed, based on the device¿s internal eos projection system. This is a known, programmed event. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Further follow-up revealed that the generator and lead were discarded by the hospital and will not be returned to device manufacturer for analysis. An implant card was received indicating that both the lead and generator were explanted on (b)(6) 2013 due to "high lead impedance, battery depletion and abnormal diagnostics". The implant card listed the indication for use as "epilepsy and increased seizure frequency from baseline".

Manufacturer Narrative
Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description
Additional information was received that the generator was not discarded as reported to the manufacturer previously. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950752
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dennis100
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« Reply #456 on: November 26, 2018, 04:46:49 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that she has been having very bad digestion issues and difficulties swallowing since (b)(6) 2010. She stated that both issues started around the same time and said she has been to many specialists and physicians for the issue. The patient described the difficulty swallowing as "her food won't go down"; and confirmed that she was not vomiting her food back up, but was having a difficult time getting it to her stomach. Per the patient, solid foods will not digest at all and only liquids go down, but they go down very slowly. The patient stated that she has had many tests performed and has tried several different diets (e. G. The gluten-free diet, sugar free-diet, and dairy-free diet); however, nothing has worked and there has been no improvement. The patient explained that she has been diagnosed with gastroparesis and stated that several physicians believe her vagus nerve has been damaged. Per the patient, her physicians have stated that the vns device has caused nerve damage to her vagus nerve which has caused her to stop digesting food to her stomach. The patient's device stimulates for 30 seconds every 3 minutes, but the difficulty swallowing and digestion problems occur constantly and not just with stimulation. Per the physician's suggestion, the patient's device was turned off on (b)(6) 2013. Additionally, the patient stated that she has gained weight since (b)(6) 2012 as a result of the various diets she has been placed on. The patient stated that since this time she experiences shortness of breath with exertion that occurs all the time and not just with stimulation. Secondly, the patient began experiencing pain under her right rib which started when she gained weight in (b)(6) 2012. The pain was described as a constant pain that has gotten worse over time. This pain gets worse when the patient tries to eat or drink anything. At the time of this report, the patient stated that she had only had her vns device programmed off for a couple hours, but the pain has already lessened, though it was still present. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
On (b)(6) 2013 the physician reported that the patient had gastroparesis and laryngeal difficulty. Per the physician, the patient¿s entire vns system was removed in (b)(6) 2013 with nothing in the operative note indicating nerve damage.

Manufacturer Narrative
This device was implanted to treat fibromyalgia which is an unapproved indication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3096041
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dennis100
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« Reply #457 on: December 07, 2018, 10:38:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2018
Event Type  Injury   
Event Description
It was reported that a patient involved in the 'core vns' study experienced s seizure post vns surgery. The patient had previously been seizure free for the past year. As a result, of the seizure the patient experienced nausea and vomiting, and the patient was hospitalized for a day due to this event. The event was indicated as 'mild' in severity, and the patient has now recovered and the adverse events have resolved. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8059703
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dennis100
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« Reply #458 on: December 08, 2018, 02:39:16 AM »

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

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8036490
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dennis100
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« Reply #459 on: December 11, 2018, 12:29:23 PM »

Model Number 102
Event Date 06/30/2013
Event Type  Injury   
Manufacturer Narrative
Event description, correct data: previously submitted mdr inadvertently omitted that the patient had been experiencing some seizure but not more than before vns. This report is being submitted to correct this information.

Event Description
On (b)(6) 2013, it was reported that this vns patient had not been feeling stimulation for the past two months. As of the night of (b)(6) 2013, the patient did not feel any stimulation. The patient felt like the vns was working but not as well, like it was losing power. The patient settings were reported to be 30 second on time and a one minute off time. As of the previous thursday, the patient was diagnosed with gastroparesis. The patient had a history of cronhn¿s disease since 2009. The patient was to undergo a shoulder surgery. On (b)(6) 2013, it was reported that the patient was seen by his neurologist. The device settings were increased, and the patient could feel stimulation. Attempts for additional information have been unsuccessful. A battery life calculation was performed with results of 3. 44 years remaining until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3368808
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dennis100
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« Reply #460 on: December 13, 2018, 04:41:24 AM »

Model Number 302-30
Event Date 03/27/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the surgeon's office that the patient was scheduled for vns revision on (b)(6) 2013 for a lead fracture. Clinic notes dated (b)(6) 2013, indicate the lead test performed that day failed with battery indicate of about 90% and ifi = no, but lead impedance 9253 ohms. Notes dated (b)(6) 2013 state that the patient had fairly stable seizure control until three weeks ago when she had a total of seven seizures in one day associated with gastroenteritis. At her last office visit it was found that the vns lead was fractured; the parents elected at that time not to replace the vns. Now, they are reconsidering. The father feels that swiping the vns magnet is helpful in shortening the duration of a seizure and in reducing post-ictal lethargy. He is not convinced that the vns otherwise reduces the frequency of seizures; however, he feels the positive effect of the vns magnet is worth replacing the device. Review of the device manufacturing records indicate no unresolved non-conformance issues were found. Follow up indicated that no x-rays were taken in the neurologist's office. No patient manipulation or trauma is believed to have occurred that caused or contributed to the lead fracture. Replacement surgery was performed on (b)(6) 2013. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3346720
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dennis100
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« Reply #461 on: December 21, 2018, 09:47:06 AM »

Model Number 103
Event Date 10/16/2013
Event Type  Death   
Event Description
On (b)(6) 2013, it was reported that the vns patient passed away due to an unknown reason on an unknown date. The physician later reported that the patient passed away on (b)(6) 2013. No further information was provided by the physician as to the cause of death. The patient¿s obituary was found online which indicated that the patient passed away ¿at her home after a long battle with several illnesses¿.

Event Description
It was reported that the patient was cremated and there was no knowledge of the device being explanted. It was reported that if the device was explanted it would have been promptly disposed of post explant. The death certificate listed the immediate cause of death as epilepsy with other significant conditions contributing to death (but not resulting in the underlying cause of death) being intestinal malabsorption; possible fentanyl toxicity. The autopsy report noted that the death was consistent with a natural death. It was noted that the vns was explanted and the disposition of the device is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3468340
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dennis100
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« Reply #462 on: December 21, 2018, 09:47:47 AM »

Model Number 104
Event Date 04/01/2013
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes listed epigastric abdominal pain as one of the patient¿s current problems.

Event Description
On (b)(6) 2013, a patient¿s mother reported that her son developed gastroparesis in (b)(6) 2013. The mother stated that the physician had said they have no information on what it could have been caused by. The patient¿s device was last interrogated on (b)(6) 2013, and to the mother¿s knowledge, everything was ok. There were no noted events that preceded the gastroparesis. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3452684
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dennis100
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« Reply #463 on: January 04, 2019, 11:22:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2018
Event Type  Injury   
Event Description
It was reported that when the patient's device was interrogated, frequency was found to be set at 1hz. The most recent charting indicated that when the device was last checked on (b)(6) 2018, the frequency was set at 30hz. It was reported by the mother that the patient had been experiencing an increase in seizures over the last 2-3 months. Upon performing diagnostics, the patient experienced violent vomiting, coughing, and gagging. Settings were adjusted several times until the patient no longer experienced further side effects. Further titration was planned. The programming data was reviewed and it appeared that the device was intentionally disabled and programmed to the 1hz settings. At the same office visit, the output current was reprogrammed back on, but frequency was not adjusted and remained at 1hz. No apparent spontaneous change in settings occurred. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190809
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dennis100
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« Reply #464 on: January 05, 2019, 03:19:38 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Injury   
Event Description
It was reported that a patient underwent a prophylactic full revision surgery for the sentiva model. It was stated that since the reimplant surgery, the patient "has been going downhill", noting vomiting. The patient was sent to the emergency room 3 days after surgery and was unresponsive. The tc made a call to the surgeon who stated that the adverse events and emergency room visit were not due to the vns, but the anesthesia used for the surgery. The patient's device is currently programmed to the patient's original m104 device settings, with tachycardia detection on. Device history records were reviewed for both implanted devices. The generator and lead were both noted to have been sterilized and passed all quality inspections prior to distribution. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8159921
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« Reply #465 on: January 06, 2019, 11:04:59 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2018
Event Type  Injury   
Event Description
Clinic notes were received for a patient's battery replacement referral due to "low" battery. It was stated in the notes that after vns settings were decreased for tolerability issues and the patient was weaned off medication (felbamate), the patient's seizures worsened substantially and the patient was vomiting without warning. It was also stated that the seizure clusters were lasting "twice as long as they used to be". Diagnostics indicated that the device was functioning within normal limits. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141236
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« Reply #466 on: January 17, 2019, 03:05:47 AM »

Model Number 102R
Event Date 02/25/2011
Event Type  Death   
Manufacturer Narrative
Review of programming and diagnostic history performed.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2011. The patient¿s epileptologist did not have any information regarding the patient¿s death.
 
Manufacturer Narrative

Event Description
Follow-up with the medical examiner¿s office revealed that an external autopsy of the patient was performed. The cause of death was determined to be seizure disorder due to hydrocephalus with contributory causes of hypothyroidism and gerd. The manner of death was natural. It was not believed that the vns device was removed from the patient as only an external autopsy was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3895164
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« Reply #467 on: January 20, 2019, 03:28:14 AM »

Event Date 05/04/2010
Event Type  Injury   
Event Description
Reporter indicated that she had experienced gastroparesis for the last year and thought that her vns device may be a cause. Attempts for further information from the reporter's treating neurologist are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115008
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« Reply #468 on: January 21, 2019, 11:37:48 AM »

Model Number 102
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient experienced an increase in seizures while she was hospitalized in (b)(6) 2014. The reason for hospitalization is unknown. It was noted that the patient had undergone a urethral procedure. An end of service condition was observed during an office visit on (b)(6) 2014. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4130116
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« Reply #469 on: January 22, 2019, 05:15:37 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 12/10/2012
Event Type  Death   
Event Description
Reporter indicated the vns device was explanted and discarded.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was epilepsy, which was contributed by obesity, pneumonia, foreign body in respiratory tract, and inhalation of gastric contents. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of definite sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
All attempts for the autopsy results from the medical examiner's office have been unsuccessful to date.
 
Event Description
Reporter indicated the patient's death was not related to the vns, but the cause of the death is unknown and pending an autopsy. The death was not witnessed and no trauma occurred. The patient was noncompliant with taking his medications and did not keep regular office appointments. Attempts for the autopsy results are in progress.
 
Manufacturer Narrative

Event Description
Reporter indicated that a vns patient had died "peacefully in his sleep" on (b)(6) 2012. An online obituary noted the patient died at home as a result of his epilepsy. It is unknown if seizure activity preceded the death; as such sudep cannot be ruled out as a possible cause of the death. Attempts for additional information are in progress.
 
Event Description
An autopsy report for the patient was received to the manufacturer on (b)(4) 2013. Final autopsy diagnosis was "epilepsy, unspecified; oro-gastric aspiration, acute splenitis, pneumonia, hypoxic ischemic brain injury, subarachnoid hemorrhage, obesity, hepatic stenosis (mild), mild atherosclerosis of cerebral blood vessels, and superficial abrasions". The manner of death was natural. Blood tests did not detect any anti-epileptic drugs or illicit drugs. No significant injuries were present that caused the death. According to investigative reports, the decedent was found unresponsive after a seizure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2904662
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« Reply #470 on: January 23, 2019, 02:51:32 AM »

Model Number 104
Event Date 12/04/2010
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information received from the funeral home revealed that the patient passed away at the hospital. The patient died due to cardiorespiratory arrest due to chronic lung disease, encephalopathy, gi shutdown, and complete paralytic ileus. An internal sudep evaluation revealed that the death is unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3911273
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« Reply #471 on: February 02, 2019, 08:36:03 AM »

Model Number 102
Event Date 05/23/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed 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. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
It was reported that the vns patient was diagnosed with gastroparesis on (b)(6) 2014. The neurologist was unsure whether the patient¿s gastroparesis was related to vns. Diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3902559
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dennis100
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« Reply #472 on: February 08, 2019, 01:18:21 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Event Description
It was reported that post surgery, the patient had not been eating and had been vomiting. The patient also had a higher number of autostimulations than prior to their replacement. Further information received indicated that it was unknown if the patient¿s generator had died prior to replacement. The physician did not believe that the vomiting and weight loss is related to an illness or to compromised immune system post surgery. The patient saw a gastroenterologist, and had a v-tube and bypass to the duodenum and was placed on a feeding tube. It was indicated that there was a gastric issue; however, it is unknown if that is the sole cause of the nausea and vomiting, or if there was additional factors. The physician was concerned to disable the device because the patient is on many medications and has gone into status in the past. The physician also questioned if the patient¿s nerve had been pulled during the recent replacement surgery. The sales representative present at the surgery denied the surgeon having pulled on the nerve, and stated that surgeon believed the vomiting was unrelated to vns. The patient was hospitalized and his device was disabled. Per the physician, the patient immediately improved when the device was disabled. No additional or further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8222113
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« Reply #473 on: February 08, 2019, 01:18:55 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Event Description
Initial report was that the patient was referred for vns removal. Further information was received in clinic notes that the vns was "ineffective completely and, moreover, was associated with side effects which the parents believe consisted mainly of constipation. The device has been turned off. " the clinic notes indicate that the patient wishes to have the device removed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8250145
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dennis100
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« Reply #474 on: February 09, 2019, 03:00:43 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/19/2018
Event Type  Injury   
Event Description
It was reported by the patient that they have a higher heart rate and their stomach feels like it's fluttering when they lay on their stomach or left side of their body. This has been occurring for the past two months. The patient wore a heart monitor but has not heard the results of the exam yet. Programming history was reviewed for the generator, and only was available on the date of implant. No programming anomalies were seen. Attempts for further information have been unsuccessful to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8239369
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« Reply #475 on: February 09, 2019, 03:01:38 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/17/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was hospitalized due to difficulty swallowing. The patient has since been discharged and is doing better. The physician believed that the difficulty swallowing was most likely the result of anesthesia and intubation during vns surgery. Clinic notes were received dated 12/31/2018. After the patient¿s generator was replaced, the patient was admitted to the hospital due to vomiting and gagging and remained hospitalized for 11 days. The patient had an increase in seizures and severe constipation as well. Per the physician's assessment, the patient had a similar response to t&a so it is unknown if this was due to anesthesia or due to swelling in the neck following surgery. Attempts were made to the physician for more information. Per the physician, the patient's increase in seizures was believed to be due to missing medications due to vomiting. The increase in seizures was above pre vns baseline. The cause of the vomiting was unknown if it was due to constipation/discomfort from vns surgery/presumed neck swelling. The anesthesia and medications may have also contributed. The vomiting started the day after vns surgery. The patient had improved as quickly as it began. The constipation was a chronic condition that was made worse by surgery, likely due to anesthesia and was unrelated to the vns. The patient's swelling was only presumed based on symptoms. The swelling of the neck was from the vns surgery and began on the day of the vns surgery. The device history records were reviewed for the generator and lead. They passed all specifications prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8272311
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« Reply #476 on: February 09, 2019, 03:02:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient believed she experienced issues with her vagus nerve that caused stomach pain, pain in her neck that radiates down to the chest, migraines, and black out spells. The company representative indicated that the patient's generator system diagnostics were within normal limits. No known 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=8224067
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« Reply #477 on: February 09, 2019, 03:03:36 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that this is a new patient implant whose father reported that the patient had been hospitalized since the day after surgery because of coughing and vomiting and the patient would not eat or drink. The patient's device has not been turned on as this is a new patient. When asked if the patient has any risk factors that makes them more susceptible to coughing and or vomiting it was stated that the patient is severely disabled and has cerebral palsy, lennox gastaut, and lissencephalopathy. Per the physician the cause of the patient's coughing, vomiting and failure to eat or drink is unknown. The doctor reported no abnormalities or complications with the surgery. It was stated that the patient¿s primary care physician did not attribute the anesthesia to the patient¿s symptoms. It was stated that the patient¿s white and red blood cell counts were normal, and other tests that were performed could not pin point the cause of the patient's coughing. It was also stated that during the patient's stay in the hospital they had a significant decrease in seizures. But after they left the hospital, the patient's coughing and vomiting stopped, but their seizure activity returned to their previous baseline. No further relevant information has been received to date.

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« Reply #478 on: February 27, 2019, 08:38:23 AM »

Model Number 302-20
Device Problem Device Operates Differently Than Expected
Event Date 11/04/2014
Event Type  Malfunction 
Event Description
Patient's x-rays were received and reviewed. There was no image of the generator received. There are no obvious lead breaks identified in the visible lead portion. The electrodes appear to be inline on the patient¿s nerve. There was a spiral appearance of the lead after the tie downs in the lead body that does not continue through the length of the lead. The cause of the spiral appearance in the small potion of the lead is likely related to patient manipulation.

Event Description
High impedance with dcdc - 5 was observed for patient. The generator was turned to 0ma due to an ongoing issue of gastro-paresis caused by the vns (reported in manufacturer report # 1644487-2015-04996). The generator was turned back to therapeutic settings on (b)(6) 2015 with dcdc = 6 in system mode and at dcdc = 5 in normal mode diagnostics. A cervical spine x-ray has been taken and no obvious lead continuity issues were noted by the neurologist. No adverse events other than gastro-paresis were reported. The patient has not reported a fall or trauma to the site. The patient also has a portacast, a medication port, installed in their chest. It was implanted post vns within 4 inches of the vns therapy system but contains no electronic components. It has been present for "a while" and has not interfered with the vns in any way.

Manufacturer Narrative
Device manufacturing records and 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=4870962
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« Reply #479 on: March 03, 2019, 11:02:38 AM »

Model Number 303-20
Event Date 05/01/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that the patient was experiencing vocal cord paralysis which began on the date of vns surgery, (b)(6) 2015. The patient followed up with an ear, nose and throat physician who recommended surgery to address the vocal cord paralysis and the patient is reportedly considering this option. No known surgical interventions have occurred to date. The patient¿s treating neurologist reported that vns stimulation was turned on (b)(6) 2015 and is being titrated upward. The neurologist indicated there are no problems with the patient's vns system other than the patient being hoarse.
 
Event Description
Additional information was received indicating that the patient returned to the ear, nose, and throat physician and indicated she would like to move forward with the procedure, a left vocal cord injection procedure. It was reported that the patient was experiencing some gastro-intestinal issues at the time which required evaluation by a gastroenterologist before the left vocal cord injection procedure could be performed. No known procedures have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4928776
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