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dennis100
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« Reply #240 on: January 07, 2018, 03:31:20 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7134281
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dennis100
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« Reply #241 on: February 01, 2018, 04:14:52 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2012
Event Type Injury
Event Description
Patient experienced ¿choreoathetoid movements¿ starting approximately in (b)(6) 2012. These are reported to be arm twitch movements. The neurologist stated that these are not seizures. The neurologist believed that these movements were related to the stimulation but were not associated with the stimulation (stimulation on time) because the movements did not coincide with the ¿on time¿ programmed on the vns. The device was not disabled to preclude a serious injury.

Event Description
It was reported that the patient had the vns device disabled for over 5 years now. The device was disabled due to an increase in "athetoid" style of seizures after generator replacement. The patient had an arm swing that was much more notable after device replacement and so the patient's device was disabled. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6284845
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dennis100
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« Reply #242 on: March 10, 2018, 02:38:22 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 12/23/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Report received that a patient experienced sharp pain in her neck with stimulation that started after she walked through security scanners at departments stores. The patient also reported feeling continuous stimulation for awhile after walking through these scanners. The patient did not feel as if her magnet stopped the feeling of stimulation. The patient was admitted to the er where diagnostics were taken. The results were within normal limits. The er staff was instructed to decrease the vns pulse width by the patient's neurologist. After this adjustment, the patient reported having painful stimulation in her arm that radiated from the shoulder. The next day, the er staff reported that the patient might have had brachial nerve issues related to vns which contributed to the arm pain. The patient was put on steroids but the patient continued to report having painful shocks up her neck and arm. The patient was admitted a few days later for a battery replacement. This replacement had been planned as prophylactic before the patient reported painful stimulation, but the surgeon indicated that he had hoped the replacement would resolve the painful stimulation. Before this replacement, the patient continued to report painful arm stimulation, but also reported that she experienced painful stimulation in the chest. Diagnostics were again taken before replacement and results were within normal limits. After the replacement, the surgeon noted observing a lot of dense scar tissue around the leads where they connect to the generator. Further information was received that the patient continued to feel painful stimulation after the new generator was implanted. The patient's neurologist decided to disable the device in hopes that the nerve would "settle down". X-rays were reportedly taken and looked "good" according to the neurologist. The patient continued to report painful stimulation even with the device off. The neurologist reported that the patient had psychogenic issues and may have reported this painful stimulation for attention. The explanted generator was returned to the manufacturer for analysis, but analysis has not been completed to date. Both the replaced generator and newly implanted generator passed all quality inspections and electrical tests prior to being released for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7251316
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dennis100
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« Reply #243 on: March 10, 2018, 02:39:29 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/27/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient had her device removed because the patient felt that she had left chest and arm pain from the device. The explanted devices were discarded after explant and are not available for analysis. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7245738
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dennis100
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« Reply #244 on: March 11, 2018, 01:39:56 AM »

Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002
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dennis100
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« Reply #245 on: March 19, 2018, 01:56:28 AM »

Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, the clinical specialist reported that she reviewed the patient's chest and neck x-ray report and they were abnormal with a possible disruption of the lead in the left neck. The physician recommended that a soft tissue neck report be performed. The neos flag was no for diagnostics and results of both the normal mode and system diagnostics were within normal limits. The soft tissue neck report indicated that the lead was intact. It was noted that each time diagnostics were performed, the system diagnostic's dcdc=3 and the normal mode dcdc=2 consistently. The patient has been experiencing shortness of breath within the last 6 months - 1 year and has had pain that runs down her arm and numbness when firing that also runs down her arm. There is no increase in coughing and the seizures are still monthly. The nurse practitioner had said that they ruled out cardiovascular and pulmonary issues with the shortness of breath. A battery life calculation was performed which showed 6. 37 years remaining until eri=yes. A/p and lateral x-ray images of the neck dated (b)(6) 2012 were received by the manufacturer. The generator was not able to be visualized due to the views in the x-rays provided. Therefore, whether or not the lead pin was fully inserted into the header of the generator could not be assessed. The electrode placement appeared to be normal and no lead discontinuities or acute angles were seen in the visible portions of the lead body. The patient later reported on (b)(6) 2012 that the device is causing her pain on and off throughout the day for about 5-6 plus hours a day. The patient was asked to be seen again regarding an evaluation of medications and vns. Good faith attempts for further information from the physician have been made but have been unsuccessful.

Event Description
On (b)(4) 2012, additional x-ray images were received, however these were the same x-ray images that had been provided by the physician earlier.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794888
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dennis100
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« Reply #246 on: March 29, 2018, 01:29:13 AM »

Model Number 102
Event Date 05/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.

Event Description
Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

Event Description
Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874197
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dennis100
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« Reply #247 on: April 04, 2018, 01:10:29 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410
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dennis100
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« Reply #248 on: April 07, 2018, 01:09:47 AM »

Model Number 10X
Event Date 12/29/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient had shown symptoms of autoimmune process which is appeared with subfebrile temperature, pains in joints etc, but the locus with generator is absolutely intact. The event began on (b)(6) 2012. The symptoms included high temperature, pain in the right knee and left elbow joints while moving, and swollen, hot joints. The patient was hospitalized with anti-inflammatory therapy. The antibiotics were applied successfully, and the patient left the clinic. The high temperature and pain began again on (b)(6) 2013. The locus of generator was intact. Anti-inflammatory therapy was continued. The number of seizures was increased almost to the pre-vns baseline (after vns implant, the patient experienced a 50% seizure elimination). Doctors did not determine the clear causes of the situation, but pediatricians tended to relate it to vns. The patient's heredity is free of distinctive features. The mix of antiepileptic drugs and vns parameters were not modified. The previous week, the patient left the clinic with satisfied status. The diagnosis was juvenile rheumatoid polyarthritis. The rheumatoid tests are negative. Cytostatics are not prescribed because the diagnosis is disputable. The generator was never disabled. No diagnostics are available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2976156
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dennis100
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« Reply #249 on: April 15, 2018, 12:36:03 AM »

Model Number 304-30
Event Date 12/10/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that per the physician's notes, the patient's electrodes and generator were removed but the surgeon felt that there was not enough space to reimplant new electrodes due to scar tissue and therefore did not reimplant the patient. It was also reported that the explanted generator would be returned to the manufacturer for product analysis. The explanted generator was returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.
 
Event Description
Good faith attempts for the return of the explanted products were unsuccessful.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the lead confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the patient's lead is broken and was referred for revision surgery. Because the patient has shunted hydrocephalus and no recent imaging, it was stated that prior to surgery a brain mri would be performed to make sure the patient's ventricles aren't enlarged. Clinic notes were received dated (b)(6) 2013 revealed that the week prior, the patient reportedly had 30 "small" seizures on the school bus. The patient normally has about 2 generalized tonic-clonic seizures per month and 1-2 smaller tonic-clonic seizures that affect upper extremities only. The patient's grandmother noticed that the patient has recently started looking upward and the left with left eye deviation and left arm flexion during the smaller seizures. The physician noted that there is no significant change on seizure amount as per family members. High impedance was noted that day during interrogation and "a broken wire was detected". The patient's settings were noted to be output=1. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=0. 8min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. Clinic notes dated (b)(6) 2012 indicate that for the last two weeks, the patient is presenting with sporadic jerking movements in the right shoulder during the night and the patient's guardian recounts a different type of seizure involving a shaking of the upper extremity that lasts one to two seconds and results in postictal dizziness. The patient underwent a full revision surgery on (b)(6) 2013. The hospital reported that the lead would not be returned to the manufacturer for product analysis. Attempts for the return of the explanted generator are underway but it has not been returned to the manufacturer to date. Good faith attempts for further information from the physician have been unsuccessful. The manufacturing records for the lead were reviewed and device met all specifications prior to distribution.
 
Manufacturer Narrative
Additional information was received which changes the event date from what was originally reported.
 
Event Description
Product analysis on the explanted generator was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The generator¿s internal memory showed that the impedance value increased from 1346 ohms to 10,000 ohms on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2985124
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dennis100
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« Reply #250 on: April 18, 2018, 01:20:27 AM »

Model Number 302-30
Event Date 03/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance on systems and normal mode diagnostics. The physician disabled the patient at a later appointment. Patient denies any manipulation or trauma. The patient has reported pain in her arm and neck for 3 weeks prior to the high impedance being visualized. It is unknown if the pain is occurring with stimulation or if it is related to the high impedance. The patient was referred for surgery. Surgery is likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date. The physician responded to attempts but did not address the question and only provided some programming history. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.
 
Event Description
Additional information was received that the patient had a generator and lead replacement and has been turned back on. Product return attempts have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3042434
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« Reply #251 on: April 24, 2018, 01:11:05 AM »

Model Number 103
Event Date 04/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient had an event that was not typical that involve the same jerking motion but it did not cluster. The patient's seizures typically occur in clusters. During the events, the patient will quickly jerk her arms and legs, typically pulling them in. Sometimes only one arm will pull upward and this can be at slow rhythm or quick, rapid jerks. A cluster of these events will last 7-10 minutes resolving in return to baseline. The second type of event has only occurred twice and involved the same extremity jerking but the patient holding her breath during the jerk. This event occurred three weeks prior to for the first time and lasted 7-10 minutes, like the jerking events. The third type of event involved staring straight forward, possibly slightly upward, while she is non-responsive. This occurred two weeks ago while the patient was hospitalized. The event last 40 seconds and involved arrested behavior including sucking on her pacifier. The device was reportedly at end of service no longer providing a charge. These events had increased over the last few months, likely correlating with battery failure on the vns. The patient was referred for generator revision. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to end of service. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis on the generator was completed on (b)(6) 2013. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118624
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dennis100
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« Reply #252 on: May 04, 2018, 01:24:44 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/19/2017
Event Type  Injury   
Event Description
It was reported by a vns patient that he got a new device and whenever he moves his arm his device moves around. He stated that this has never occurred with any of his previous devices and that he is in discomfort because of the movement of the device. The patient stated there were no traumatic injuries that could have resulted in the generator becoming loose and moving around. It was later reported that the patient was experiencing discomfort with the device and the patient feels the generator is too big. The patient was referred for surgery to receive a smaller device. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7472222
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« Reply #253 on: May 05, 2018, 12:33:56 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 10/07/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing pain in the chest area that goes down her arm, neck pain, tingling sensation in their arms, headaches, back pain, right shoulder pain, and paraesthesia in the upper and lower extremities. Due to the pain, it was also reported that the patient was experiencing sleep disturbances. Device diagnostics were performed and reported to be normal limits. Per the physician's assessment, the cause of the events is due to the surgeon nicking the nerve during surgery. The patient was referred for surgery due to the pain. No additional relevant information has been received to date. No surgical intervention is know to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445025
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« Reply #254 on: May 06, 2018, 01:39:32 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 12/14/2017
Event Type  Injury   
Event Description
It was reported that the patient was feeling pain in her chest and could feel her device move when she moved her arm. The patient was referred for generator repositioning surgery due to the pain and migration. The patient had surgery, and the generator was still sutured down in place from the implant surgery. The surgeon identified a mass of fluid around and below the generator. The seroma was drained, and the surgeon prescribed antibiotics. The generator was left in place, and the lead was not disconnected. Diagnostics were within normal limits, and the settings were not changed. The surgeon reported that the seroma caused an infection at the generator site. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7404008
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« Reply #255 on: May 12, 2018, 01:28:49 AM »

Model Number 304-20
Event Date 10/04/2013
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient office visits with his neurologist. Notes dated (b)(6) 2013 indicate that the patient had several breakthrough seizures since his last office visit with the most previous one occurring on (b)(6) 2013. The patient had one seizure at school consisting of generalized shaking of the extremities which appeared to slow or stop after magnet mode stimulation was activated. The patient's mother stated that the patient was having seizures throughout the night due to his drowsiness during the day. The patient continued to feel dizzy especially with physical activity. The patient had 2-3 head drops since his last office visit that occurred after having seizures while sleeping. The patient was able to feel when he was having a seizure and used the magnet frequently. The patient had different types of seizures over the past year: head drops lasting 10 seconds; generalized twitching of his extremities lasting 10-60 seconds; and clonic seizures lasting 15-30 seconds. The neurologist stated that overall the patient had an improvement sinc vns implant as the duration of his seizures had decreased significantly. The patient's device settings and medication was increased during the office visit. The neurologist stated that patient's wrestling with his siblings may have contributed to the high impedance observation. X-rays were taken during the office visit and were reported by the physician to be unremarkable. The patient's device was not disabled following the high impedance observation. Notes dated (b)(6) 2013 indicate that the patient had another seizure that lasted approximately one minute since his last office visit. The patient's device was tested during the office visit while the patient was sitting, lying, and turned his head. Diagnostic results from all the positions showed normal lead impedance. The neurologist stated that a microfracture may be a possible reason the high impedance observation at the previous office visit. Notes dated (b)(6) 2014 indicate that the patient had several seizures the week prior to his office visit. The patient's seizures were occurring at night. The patient's mother stated that the seizures would last approximately 10 seconds although she did not witness them. It was reported that magnet mode was activated but did not help in stopping the seizures. The patient's device had previously helped the patient reduce the duration of his seizures and postictal phase. The patient's medication was increased during the office visit. The patient's device was tested during the office visit and diagnostic results showed high lead impedance (impedance value >= 10,000 ohms). The patient's device was subsequently disabled. Notes dated (b)(6) 2014 indicate that the patient had three seizures in the past four weeks. The seizures were much milder and consisted of shaking of his entire body for 30-40 seconds. The patient also had 1-7 head drops that occurred throughout the day. The patient's device was tested during the office visit and diagnostic results showed high lead impedance. The patient's medication was increased during the office visit. Further follow-up revealed that the patient did not respond well to vns and the patient's seizures may be due to a combination of factors. X-rays were taken and were reported by the physician to be unremarkable. The x-rays will not be provided to the manufacturer for further review. The patient was seen prior to the his office visit in (b)(6) 2013 and diagnostics showed normal device function at the time. The patient was referred for replacement surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested at several positions and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
On (b)(6) 2013 it was reported that the patient was seen by the physician that day and upon running diagnostics, high impedance (impedance value greater than 6200 ohms) was observed. This was when the patient was in the upright position. The physician had the patient lie down and ran diagnostics again, which showed the device was okay with impedance value of 3200 ohms. The patient was again re-positioned into an upright position. Diagnostics performed while the patient was in the upright position again showed high lead impedance with impedance value greater than 6200 ohms. It was confirmed that the patient had no trauma, no falls, and no manipulation. The patient went to have x-rays taken and it was stated that the vns device would be disabled to 0ma that day. Additional information was received that the patient's mother reports that the patient had an increase in seizures over the last two weeks, but not above baseline levels. The x-ray results indicated that there was no fracture. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443991
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« Reply #256 on: May 21, 2018, 01:34:04 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
« Last Edit: September 01, 2018, 10:36:42 PM by dennis100 » Logged
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« Reply #257 on: June 08, 2018, 03:34:29 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain. The diagnostics were found to be within normal limits. It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns. The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient. The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns. The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children. The patient underwent vns explantation surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544133
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« Reply #258 on: June 09, 2018, 02:22:17 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/14/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to feeling constant pain at her generator site for an hour, which she believed to be continuous stimulation from the device, and she was also experiencing constant tingling in her arm. The physician stated that there were no reported traumatic events prior to the constant pain. The physician was educated on how to use the magnet to disable the device until it could be communicated with. It was reported later in the same day that the patient was feeling painful stimulation every 5-7 minutes. The patient had reportedly seen her neurologist and described her pain, but nothing was changed and the pain got worse so the patient went to the emergency room. The hospital staff called the next day to report that the patient was still having continuous stimulation, but they had not been using the magnet to disable the device as instructed. A company representative was able to communicate with the patient's device, and system diagnostics were within normal limits. The patient stated that she felt the stimulation when diagnostics were performed. The neurologist had come in the night before and programmed the device off. Since the device was programmed off. The painful stimulation resolved immediately after the device being programmed off. The patient had generator replacement surgery. The device has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7504920
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« Reply #259 on: June 09, 2018, 02:22:50 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 11/01/2004
Event Type  Malfunction   
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day. The patient also reported that his left arm felt heavy and numb. Follow up with the patient's neurologist revealed that the neurologist was unaware of the events. During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics. The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529711
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« Reply #260 on: June 09, 2018, 02:23:29 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/13/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's mother reported that her son was implanted last year and after the surgery he was not able to walk, lost control of his upper and lower limbs, and at times could not hold his posture. It was explained he continues to need help walking as the patient is very ataxic. The patient also sometimes needs help feeding himself and he no longer talks, walks independently, and interacts less. The patient was previously diagnosed with autism, but it has declined significantly since the vns procedure. It was noted the neurologist completed testing of the system to verify everything was working correctly, and it was. No one had an explanation for the patient's decline. It was also stated that the patient has been diagnosed with tuberous sclerosis which can contribute to developmental delays including physical ones. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7493765
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« Reply #261 on: July 06, 2018, 08:37:52 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain around the vns and going down her arm when lifting. The surgeon prescribed anti-inflammatory for a weeks and the pain did not resolve. The patient was referred for prophylactic vns replacement surgery. Follow up with the physician revealed that the patient reported no trauma to the area. No cause for the pain was found. 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=7577968
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« Reply #262 on: July 06, 2018, 08:38:24 AM »

Model Number 304-20
Device Problem No Information
Event Date 06/04/2018
Event Type  Malfunction   
Event Description
It was reported that this patient was referred for replacement due to lead issues and generator migration. It was noted that the device moves in their chest, and every time it moves, the patient gets a shock that travels down his arm. Diagnostics were taken several times and were all within normal limits. Additional information was received from the patient's surgeon that a silk, non-resorbable suture was used to secure the generator to the chest wall during the patient's previous implant. It was then stated that it looked like the suture was no longer attached to the chest wall indicating that the generator was no longer secured. Additional information was received from the neurologist¿s office stating that the patient¿s mother had stated that the patient's shocking sensations had occurred a long time ago and he was no longer experiencing any issues. The lead underwent product analysis and two sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. No discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The surgery facility is a no return site. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7645903
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« Reply #263 on: July 15, 2018, 03:20:03 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/19/2016
Event Type  Injury   
Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.
 
Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.
 
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received that the patient believed she had new issues with vns. Specifically, she complained of having "charlie horses in throat" on the left side vocal cord when she yawned or opened her mouth to sing. She also reported that she has experienced pain in the chest that extends down to her left arm. This pain was reportedly not constant (it "comes and goes"). The patient also reported having continued issues that were previously reported such as dysphagia, erratic stimulation, speech impediment, and ambulatory issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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« Reply #264 on: July 22, 2018, 02:19:09 AM »

Model Number 101
Event Date 06/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6), 2012 clinic notes dated (b)(6), 2012 were received from a vns treating physician. Review of the clinic notes revealed that the patient¿s mother stated the patient was recently hospitalized from (b)(6), 2012- (b)(6), 2012 due to a stroke and a hole in her heart told to her by cardiology. No outpatient cardiology has been set up at this time per the patient's mother. The patient has residual speech difficulty and right upper and lower extremities weakness. The patient has been provided with speech, occupational, and physical therapy. The patient is currently on asa 81mg per day. No new stroke-like symptoms have been reported since then. The patient's blood pressure was noted to be 124/76. The patient's assessment includes stroke/cerebral thrombosis with cerebral infarction. Attempts for further information have been made to the physician but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2665067
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« Reply #265 on: August 14, 2018, 12:47:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2018
Event Type  Injury   
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.
 
Event Description
Further information was received that despite the generator being disabled, the patient continued to experience the previously reported adverse events, specifically pain. It was stated that the paint occurred in the generator area and was associated with left upper extremity pain and some numbness. Because of this, the patient requested both the lead and generator be removed. The physician reportedly advised that the pain the patient was feeling was likely not from vns, but a definitive assessment was not made. No surgical intervention has occurred to date. No additional relevant information has been received.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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« Reply #266 on: September 23, 2018, 03:03:39 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The funeral home indicated that the device was explanted by the medical examiner and would be returned for analysis. The medical examiner's office indicated that the autopsy is pending, but would be provided when completed. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The autopsy finding were listed as clinical history of rett syndrome with a history of uncontrolled seizures, musculature atrophy of extremities, scoliosis; pulmonary congestion/edema; history that the decedent was found unresponsive in a prone position in bed. The conclusion was noted to be that the decedent died as a result of a seizure disorder associated with rett syndrome. The manner of death was listed as natural.
 
Event Description
Analysis of the generator was completed on (b)(6) 2015. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2015. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portion 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 portion were performed, during the visual analysis, and no discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4772129
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« Reply #267 on: November 10, 2018, 03:43:10 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/13/2018
Event Type  Injury   
Event Description
It was reported that the patient was scheduled to have the vns removed. Investigation determined that the removal was due to the patient experiencing pain and tenderness under her arm. The explanted generator was later received by the manufacturer. 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 device performed according to functional specifications, and analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8007544
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« Reply #268 on: November 24, 2018, 04:44:10 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

Event Description
The vns treating physician reported that high lead impedance was found during an office visit on (b)(6) 2013. The patient was last seen on (b)(6) 2012 at which time the lead impedance was within normal limits. The physician reported that an x-rays confirmed a distal fracture. The patient was for replacement surgery as soon as possible to prevent more seizures. Clinic notes from the patient's visit on (b)(6) 2013 were received which indicated the patient continued to do well. However, the patient had a breakthrough seizure earlier in (b)(6), followed by brief myoclonic jerks involving his upper limbs. Since then, he has not had any further seizures. He is seizure free on the ketogenic diet. Also on the last office visit, his seizure medications were being weaned off and had been over of seizure medications for about 8 months. The patient had breakthrough seizures that seem to be related to vns lead fracture. Given the good seizure control, the plan was to continue to wean the patient off of seizure medications. Attempts for additional information from the physician's office have been unsuccessful to date, including to obtain a copy of the x-rays. Although generator and lead replacement surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device failure occurred, and it was believed to have contributed to the patient's increased seizures.

Event Description
Additional information was received from the hospital reporting that the patient had generator and lead replacement surgery on (b)(6) 2013 and the explanted products were available for return. The explanted products were received by the manufacturer on (b)(6) 2013 for analysis. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. The implant card was also received and confirmed the date of surgery and indicated the reason for generator replacement as battery depletion with near end of service marked. Product analysis has not been completed to date.

Event Description
Operative notes from the patient's revision surgery on (b)(6) 2013 were received which indicated the diagnosis as placement of new lead due to fracture and generator secondary to end-of-life due to length of implant. The patient was doing well but began to lose efficacy with vns. Imaging was obtained which showed a fracture of the lead, explaining the device's 'failure to work. ' during the procedure, an incision was made over the old scar in the neck and dissection was carried down to remove the lead and the anchors. There was significant scar tissue surrounding the sternocleidomastoid, which was carefully dissected free by the surgeon. The lead dove directly posterior at this point, and the surgeon worked through the scar tissue to identify the connecting portion of the electrode. However, the nerve was scarred-in quite heavily, and the surgeon was unable to locate and free up all three of the components that held the nerve. The nerve was traced superiorly into the cicatrix and he tried to free up enough to again identify the previous electrodes, but the scar tissue was so heavy so the surgeon did not feel that he could 'safely dissect the nerve free without some type of injury to it. ' at this point, the surgeon felt that 'removal of the old electrode component was probably not worth the risk of injury to the nerve, and again try to free up as much nerve as possible, although the amount of exposure was very limited. ' the new set of electrodes were then successfully wrapped around the nerve. The surgeon felt that he had adequate contact of the two superior components of the lead, and the third electrode was able to be adequately wrapped around the nerve by laying it down inferiorly. Upon disconnecting the previous lead from the generator, a fracture was observed in the lead. The replacement lead was connected to the replacement generator which resulted in normal impedance upon diagnostics. He noted in the notes that the two electrodes appeared to have good relationships with the nerve. Attempts for additional information from the surgeon have been unsuccessful to date.

Event Description
The surgeon's office reported that there was noted to be scarring around the electrode and vagus nerve. However, the believed cause/relationship to vns was not provided. It may be reasonably assumed that it was related to presence of the electrode on the nerve.

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. 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 discontinuities, the condition of the returned lead portion 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000
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« Reply #269 on: December 07, 2018, 09:25:45 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/25/2018
Event Type  Injury   
Event Description
It was reported that after a patient underwent vns revision surgery, the patient suffered a stroke due to the patient's jugular vein being nicked at the time of surgery. The patient is also experiencing arm weakness which the neurologist attributes to have been caused by the stroke. The patient was reported as undergoing occupational and physical therapy for the arm weakness. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8072513
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