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dennis100
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« Reply #570 on: February 25, 2018, 01:37:21 AM »

Event Date 04/01/2010
Event Type Malfunction
Event Description
It was reported in manufacturer report # 1644487-2012-00029 that a vns patient had a history of seizures and began to have an increase in seizures following implant of the vns lead and generator. The pt reportedly went to the physician and met another pt with similar issues. This report is to address the pt with similar issues as noted in manufacturer report # 1644487-2012-00029. The original pt's report indicated he or she experienced hoarseness and passing out after seizures; however, it is unk if the "similar issues" includes these events as well as the increased seizures. It is unk if any interventions have been taken. This information was reported to the fda in april 2010; however, it was not believed that this event had been passed on to the manufacturer. Attempts for further information are not possible as the pt and physician information were not available.

Manufacturer Narrative
Initial reported listed the event as a "serious injury" however it is a "malfunction". The information has been corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403802
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dennis100
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« Reply #571 on: February 26, 2018, 02:03:29 AM »

Model Number 302-20
Event Date 06/21/2007
Event Type Injury
Event Description
It was reported through a clinical study that a vns patient experienced transverse cutaneous nerve of neck neuropathy post-vns implantation, decreased sensitivity over cervical scar post-vns implantation, and voice hoarseness with stimulation. The severity of the transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation events in accordance to the study coordinator/nurse were mild and had a definite relationship to vns implantation. The events of transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation were noted on (b)(6) 2007 and were noted to be ongoing at the end of study. Moreover, the events were described as not serious adverse events and no intervention was taken for the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2463092
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dennis100
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« Reply #572 on: March 08, 2018, 02:31:07 AM »

Model Number 102
Event Date 05/16/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. It was indicated that the initial reporter had not seen the patient back as she was only there for a follow up for a brain tumor that she had prior to being implanted. Per the reporter, she was the one who was attempting to interrogate the patient and she got "nothing" from the device and they were unable to perform the mri. She indicated that they are having no problems at all with their programming system and that it is functioning as intended. They have not seen the patient again as she only follows up every year or so only for this mri. Follow up was then performed with the patient's treating neurologist, who indicated that the device was last interrogated in (b)(6) 2010. She did indicate that the patient was seen again in (b)(6) 2012. Interrogation was not attempted at that time, however she felt that the vns was working as the patient was still experiencing cyclical voice alterations with stimulation. The neurologist indicated that she feels the generator has reached end of service and that is the reason that it could not be communicated with. No additional information was provided.

Event Description
It was reported by an mri technician that while trying to disable the device, they were receiving a failure to communicate message and were unable to interrogate the generator. Multiple programming systems were used and troubleshooting steps, including checking the wand battery and making sure that the programming system was unplugged from the wall were performed, however, the device could not be interrogated. The patient indicated at the time that she was unsure of the last time her device was checked stating that it may have been in 2009. A rough estimation of battery life was calculated based on available programming history which indicated that the device may be at or nearing end of service. However, end of service has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2614735
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dennis100
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« Reply #573 on: March 08, 2018, 02:32:25 AM »

Model Number 302-20
Event Date 04/18/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to death or serious injury.

Event Description
An analysis was performed on the returned lead portions. During the visual analysis the green (-) electrode quadfilar coil appeared to be discolored and broken in several areas. Visual analysis was performed and identified the areas as being thin, with pitting which prevented identification of the coil fracture type and evidence of electro-etching. One of the coil break areas was identified as being mechanically damaged which prevented identification of the coil fracture type with evidence of electro-etching. During the cleaning process the green (-) electrode ribbon, spot-weld / slug and coil became detached. This most likely occurred due to the vibration of the sonicator used in the cleaning process. Visual analysis was performed on the spot-weld / slug and identified evidence of where the quadfilar coil had been mounted on the slug. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Additionally it was observed there was outer and inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the slice marks observed on the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative
Date of event: corrected data to (b)(6) 2012.

Event Description
It was reported that a vns patient was seen in clinic and they had high lead impedance. In addition, the patient has has reported hoarseness since reimplant last year. The patient has been referred to a surgeon for lead revision surgery. Because of scheduling the patient will not have the surgery until (b)(6) 2012. Their output current was initially decreased but his seizures increased significantly so they have turned him back up to his previous settings and this has got his seizures back under control. Good faith attempts are underway for further information.

Event Description
The patient had full revision surgery and their explanted products are at the manufacturer for pending analysis completion. Their surgeon decided to prophylactically replace their generator. No further information has been attained about their reported events.

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

Event Description
Further diagnostic history was reviewed. Unknown date of actual event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2622788
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dennis100
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« Reply #574 on: March 08, 2018, 09:45:49 AM »

Event Date 06/03/2011
Event Type Injury
Event Description
It was reported that the vns patient has been experiencing "vocal cord issues" since implant. The patient was seen by an ent physician who indicated that he believes the lead was implanted too close to the vocal cords. It was also noted that the patient has not seen much efficacy since implant. The patient was reportedly going to see the implanting surgeon for further evaluation however the surgeon's office indicated that the patient has not been seen or made an appointment. Attempts for further information from the neurologist's office have been unsuccessful to date. Attempts for the product information were unsuccessful.

Event Description
Additional information was received indicating the patient's vocal cord issue has resolved.

Event Description
On (b)(6) 2012, additional information was received indicated that the patient had hoarseness and awakening at night with vns stimulation noted in (b)(6) 2011. It was confirmed that vocal cord issues were related to electrodes being placed too close to the larynx. No hoarseness was noted (b)(6) 2011. On (b)(6) 2011, the hoarseness was intermittent but then constant on in (b)(6) 2011. A note indicated the hoarseness appeared to have resolved following the thyroidectomy. The thyroid issues were not believed to be related to vns.

Manufacturer Narrative

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

Manufacturer Narrative
Event date, corrected data: previously submitted mdr indicated an incorrect event date. The patient's physician believes that the vocal cord issues are related to the electrodes being placed too close to the larynx at the time of implant; therefore, the event date is the date of implant: (b)(6) 2011. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603575
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dennis100
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« Reply #575 on: March 09, 2018, 03:32:03 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/01/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the physician observed high impedance with no output current delivered on the patient's device. The physician noted that the patient was experiencing no discomfort, increase in seizures ant that the patient was still experiencing voice alteration with stimulation. 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=7297630
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dennis100
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« Reply #576 on: March 09, 2018, 03:32:50 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/06/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through a study adverse event form that a patient's vns was disabled due to laryngospasms. The severity of the laryngospasms was marked as severe and life-threatening. No clarification as to why the event was considered life-threatening has been received to date. As a result of this event, the patient discontinued the study. After the vns was disabled, the problem resolved. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7290396
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dennis100
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« Reply #577 on: March 10, 2018, 02:12:59 AM »

Model Number 300-20
Device Problem Fracture
Event Date 01/01/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
Per nurse practitioner, the patient reported feeling intense stimulation recently to the point of waking him up at night and bouts of severe cough and unable to speak intermittently. System diagnostic with high impedance 6113 ohms was detected. Prior to these recent changes the patient reported not detecting stimulation and no voice strain with 0. 75 milliamps and 1. 0 milliamps magnet activation. The patient also reports no blunt trauma to the area around the generator and/or neck area. Patient does bowl on a regular basis and reports these intense stimulations during sleep, laying down, during bowling, standing and other times in the day as well. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7268872
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dennis100
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« Reply #578 on: March 10, 2018, 02:13:44 AM »

Model Number 304-30
Device Problem No Known Device Problem
Event Date 06/05/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient experienced constant hoarseness since her vns implant surgery. The patient was referred for vocal medialization surgery, and it was believed that the patient's vocal cord was possibly nicked during the implant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7282410
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dennis100
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« Reply #579 on: March 11, 2018, 01:17:05 AM »

Model Number 302-30
Event Date 06/18/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
Clinic notes dated (b)(6) 2011 and (b)(6) 2012, were reviewed on (b)(6) 2012 and indicated that the device was "working well. " on (b)(6) 2012, it was reported that the patient's explanted devices had been discarded and were unavailable for product return. Additional information was received on (b)(6) 2012, indicating that high impedance was not seen until the generator was replaced. Pre-operative diagnostics were not performed. A battery life calculation on (b)(6) 2012, indicated negative results at the time of revision surgery.

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

Event Description
An implant card from this vns patient's implant surgery on (b)(6) 2012 was received on (b)(6)2012 indicating lead impedance was seen after the new generator was implanted; therefore, the lead was also replaced. Operative notes were received on (b)(6) 2012. The generator was explanted and a new model 103 generator was attached to the existing leads. Interrogation showed lead impedance to be high. Repeat interrogation showed the same thing. The generator was disconnected and then reconnected and still showed high impedance. During dissection for lead replacement, a large amount of fibrous adhesions were noted where the lead was attached to the nerve. The uppermost portion of the old lead was dissected away from the nerve allowing for a longer exposed nerve for attachment. Interrogation was performed and lead impedance was okay. A strain loop was created with two pledgets and then another strain loop was created. The old lead was bluntly removed. The generator was disconnected, the lead was tunneled to the generator site, the generator was connected to the lead, and interrogation showed normal lead impedance and full battery life. The generator was placed in the pocket, and another interrogation showed normal lead impedance. Notes from the patient's appointment on (b)(6) 2012 were also received in (b)(6) 2012. The notes indicated that the patient experienced a hoarse voice for a little while; however, it appeared to be better on this date. The patient's incisions were reported to be healing well without evidence of infection. No hoarseness was detected. It was noted that injury or irritation of the vagus nerve or recurrent laryngeal nerve was a concern; however, it was believed that if the nerve was actually damaged, the effect on voice would be more dramatic. It was suspected that some vocal cord irritation form endotracheal intubation was the culprit, hence the improvement with time. If the issue was of concern in a few weeks, the patient would be referred to an ent for visualization of the cords. Attempts for product return and additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2669499
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dennis100
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« Reply #580 on: March 12, 2018, 01:41:32 AM »

Model Number 302-30
Device Problems High impedance; Improper or incorrect procedure or method
Event Date 06/13/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, a vns treating physician reported that the vns patient was at settings of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=3min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed output=ok/lead impedance=ok/dcdc=3/eri=no. The patient was at these settings until (b)(6) 2011, when he was changed to a more rapid cycling of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics were still output=ok/lead impedance=ok/dcdc=3/eri=no. The physician commented that this patient has only been seen by him since (b)(6) 2010. The physician further stated that despite instructing the patient to return sooner, the patient was not seen again until (b)(6) 2012. The patient was reported to be doing much better, with seizures reduced from 2 per week to 2-3 per month. The patient is mentally handicapped so the physician believes that reporting is not great, but the patient does report continuing to feel the device in his throat during stimulation and there is a subtle change in his voice. The patient's parameters continue to be the same, however, his normal mode diagnostics show, output status=limit/output=2. 5ma/lead impedance=high/dcdc=7/eri=no. The physician reported that he feels the high impedance is due to a battery failure and not lead failure as there has not been any reported trauma or issue that would be expected to have damaged the lead. The patient still feels stimulation. Clinic notes were also received. Clinic notes dated (b)6) 2012, revealed that the patient has clearly improved with about 2-3 seizures per month, down from 6 per month last visit. The intensity and duration are about the same. The patient's mother called in the fall stating that the patient has some swelling at the vns site, but it resolved spontaneously. The patient's mother reported a significant decrease in the frequency of his seizures that is likely related to the rapid cycling of his vns, as no other medication changes were made. The physician stated that vns interrogation indicated, high lead impedance, which the physician attributes to battery failure, as the patient continues to report feeling stimulation intermittently. The physician commented that he had to re-program the patient to 30seconds on time, in order to run the diagnostics, and then he switched the patient back. The physician later reported on (b)(6) 2012, that he saw the patient again and system diagnostics were performed which also showed high impedance; output=limit/lead impedance=high/dcdc=7. The physician disabled the device due to high impedance and the patient was referred to a surgeon for replacement. The physician stated that he did not order any x-rays. The physician stated that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. He also stated that the patient normally has voice alteration and is nothing atypical for the patient. The swelling was reported in (b)(6) and resolved spontaneously. He believed the swelling was at the generator location, but was unsure. It was also unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the swelling. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient underwent a full revision surgery that day. The leads were replaced due to high impedance and the generator was replaced for prophylactic reasons. The hospital reported that the products were discarded in surgery as the surgeon routinely asks the staff to discard the explanted devices.

Event Description
The physician reported that the revision surgery done on (b)(6) 2012 was very lengthy and difficult and that he had a long time recovering from it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2645547
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dennis100
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« Reply #581 on: March 12, 2018, 01:42:34 AM »

Model Number 103
Event Date 05/17/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. Review of the clinic notes dated (b)(6) 2012, revealed that the patient's seizures seem to be more severe. The patient was reported to have been in a "slump" since last visit and not doing as well. The patient's nightly events are slightly worse and the patient is not improving as much. The physician increased the patient's settings but still no better. The patient was reported to not have any daytime seizures but has nightly nocturnal seizures, not as severe at times. Clinic notes dated (b)(6) 2012, were also received which indicate that the patient's seizures are less severe and no change in frequency. The patient's seizures were reported to have improved with vns changes. The patient stated that nocturnal events occur nightly but not as severe. The patient's vns was adjusted to output=2. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=0. 8min/magnet output=2. 5ma/magnet on time=60sec/magnet pulse width=500usec. Attempts for additional information have been made but no further information has been received from the physician. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2012, when the physician reported that the change in seizure pattern, increase in seizures, and voice alteration were "not an issue". As an intervention the physician adjusted the vns settings and vimpat dosing. The increase in seizures was below pre-vns levels. The voice alteration was associated with stimulation but was not a continual issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2646007
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dennis100
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« Reply #582 on: March 12, 2018, 01:44:03 AM »

Model Number 302-20
Event Date 02/29/2012
Event Type Malfunction
Event Description
On (b)(6) 2012 a vns treating nurse reported that the vns patient has high impedance with a dcdc of 7. The care giver noticed that the patient's hoarseness was gone. It was reported that x-rays were taken with a potential lead breakage and that they would be sent to the manufacturer for review. The battery was stated to be ok and the patient's settings are output=1. 75ma/pulse width=500usec/frequency=30hz/on time=30sec/off time=3min/magnet output=3ma/magnet on time=30sec. X-rays were received and reviewed by the manufacturer. The lead connector pin appeared to be fully inserted into the generator connector block. Part of lead is placed behind the generator and could not be assessed. No obvious lead discontinuity found on part of the lead that could be assessed. Due to the quality of the images, part of the lead close to the electrodes cannot be fully assessed. Based on the x-ray images, the cause of the reported high impedance cannot be identified.

Manufacturer Narrative
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) 2012, the programming history was reviewed. A battery life calculation was performed which showed 1. 03 years remaining until neos=yes.

Event Description
On (b)(6) 2013, the manufacturing records for the lead were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

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

Event Description
Additional information was received on (b)(6) 2012, when the nurse reported that the patient doesn't speak, but communicates by pointing at pictures; sometimes when the vns stimulates the patient will make a sound that sounds like "hoarseness". This has not occurred since (b)(6) 2011. The nurse stated that she does not know the relationship of the hoarseness to vns. System diagnostics were performed on (b)(6) 2011, which showed dcdc of 2 and then on (b)(6) 2012, system diagnostics showed high impedance with dcdc=7. Therefore x-rays were ordered. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator has been disabled due to the high impedance. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666564
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dennis100
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« Reply #583 on: March 19, 2018, 01:52:19 AM »

Model Number 102
Event Date 06/18/2012
Event Type Injury
Event Description
A registered nurse at the treating physician's office reported on (b)(6) 2012 to the company representative that the patient complained of left mid axillary pain and thought it was due to the vns having moved. A chest x-ray was ordered, and the nurse reported that it appears to have shifted slightly inferomedially. The electrode reportedly has moved as well. Previously, it was reported on (b)(6) 2012 from the surgeon's office that they were planning on seeing the patient for evaluation of the patient's reported complaint of pain at the generator site. The neurologist's office referred the patient to the ent to see if the complaint she had was related to another reason other than vns. An ent evaluated the patient and concluded that there may be generator migration which may be causing the discomfort at the generator site. Clinic notes dated (b)(6) 2012 reported that the patient still remains with difficulty tolerating the device. She has intermittent dysphonia, pain in the neck radiating to the ear and the mandible and sometimes problems swallowing. The previous visit they discussed referral to ent for evaluation, and the patient requested for the referral. The referral requested for evaluation of the neck, ear and mandible pain related to vns to see if there is a need to revise the area where the device is placed. On the previous visit on (b)(6) 2012, the patient presented with no side effects. Follow up with the referring neurologist revealed that the pain was first observed on (b)(6) 2010. The dysphonia and trouble swallowing are reportedly recurring problems noticed in (b)(6) 2010. The patient was advised to have x-rays taken and to be evaluated by a neurosurgeon. No patient manipulation or trauma occurred that is believed to have caused/contributed to the events, and no causal or contributory changes preceded the onset of the events either. The neurologist reported that the pain, trouble swallowing, and dysphonia are associated with stimulation. The patient does not have a pre-existing medical history of having difficulty swallowing prior to vns. Although surgery was still being considered in (b)(6) 2012, it had not been scheduled to date due to the physician wanting the patient undergo imaging studies. Attempts for additional information from the surgeon and treating physician's office have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the treating neurologist which revealed that medical/surgical intervention was planned with regards to the migration and discomfort at the generator site due to patient comfort and not to preclude a serious injury. The outcome of the repositioning surgery was "good", per the physician. The lead migrated due to "body habitus" (patient physique), however details were not provided. No causal or contributory programming or medication changes precede the onset of the lead migration. X-rays of the patient's vns were taken but have not been received by the manufacturer to date. The x-ray report was provided by the physician which indicated that the patient "complained of pain in the region of the vns device. Also states that she feels the device has shifted. Exam was done for vns placement. " chest x-ray of (b)(6) 2012 and also compared to soft tissues of the neck x-ray of (b)(6) 2010. The vns generator reportedly appeared to have shifted slightly inferomedically relative to its position previously. The electrode coursing into the base of the left neck appears intact; however, it also appeared to have shifted slightly, per the report. Previously, it was overlying the 2nd rib and on (b)(6) 2012 appeared to have shifted interomedially and was overlying the left apex. It coursed into the base of the neck as previously.

Manufacturer Narrative

Event Description
The patient had vns repositioning surgery on (b)(6) 2012. Further details were not available. Attempts for additional information have been unsuccessful to date. The clinic notes dated (b)(6) 2012, reported that the generator appeared to have shifted slightly inferomedially which was believed to have caused pain to the neck and left face area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2792685
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dennis100
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« Reply #584 on: March 20, 2018, 01:25:42 AM »

Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912
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« Reply #585 on: March 21, 2018, 03:16:07 AM »

Model Number 102
Event Date 09/02/2012
Event Type Injury
Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.

Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769409
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« Reply #586 on: March 21, 2018, 03:18:26 AM »

Model Number 102
Event Date 08/26/2011
Event Type Injury
Event Description
(b)(4). Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the patient's settings were changed. The patient's neurologist felt that the patient had pseudoseizures and anxiety. The patient was requesting explant. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, this patient's settings were adjusted to reach more efficacious levels. Diagnostics on this day were within normal limits. On (b)(6) 2012, the patient was reportedly having an increase in seizures, lack of efficacy, voice alteration, and an increase in depression. The patient reported potentially having the explanted due to the adverse events.

Event Description
Clinic notes regarding this vns patient were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient presented with a major complaint of frequent migraines. These were occurring so often that the patient became dehydrated and was hospitalized numerous times in the past year. The patient had to have iv fluids and narcotics in order to control them. The patient and her husband both felt that the patient was having more migraines since vns implant. The patient came in to request that the device was turned down or off to see if this may have some effect on her migraine frequency. The patient's headaches were now almost daily and severe two or three times a week. The patient was largely in the right side of her head and was associated with an inability to stand noise, light, movement, nausea, and vomiting. The patient was seeing a physician for the migraine treatment at least one per month (or every other month). It was also noted that the vns had not seemed to help the patient's seizures. The exact seizure frequency was not known but that patient averaged, at least, anywhere from two to five generalized tonic-clonic seizures per month and six complex partial seizures per month. The patient believed these were less now than before although the previous frequency estimate was somewhere between four and five per month. The patient's settings were altered at this appointment. The physician noted that the changes would be turning the device to less than therapeutic levels. The physician also seriously doubted that it would cause any migraines. It was noted that the patient's medications were all associated with increase seizures in patients predisposed; however, the patient had more of a problem with the pain from migraines. The patient's settings from (b)(6) 2011 were provided. It was also noted that patient wanted her vns turned down or off. The patient's migraines seemed worse with vns. Notes dated (b)(6) 2011 indicated that the patient's severe migraines were worse and more frequent and that the patient had been hospitalized with migraines with dehydration. The patient's seizure and headache frequencies were also noted. Notes dated (b)(6) 2010 also provided seizure and headache frequencies and stated that the migraines may last up to four days. The patient felt that the partial seizure frequency had decreased. Notes dated (b)(6) 2010 indicated the patient's seizure frequency, but the text was illegible. It was written that the patient felt that the partial seizure frequency decreased. The patient's migraines may last up to four days.

Event Description
Per the return product form, the device was explanted because the patient did not want it. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿pain with stimulation¿). 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. 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. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. Based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Since a portion of the lead assembly (body) including the electrodes array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.

Event Description
Clinic notes dated (b)(6) 2013 were received indicating that the patient was referred for removal of her vns. The patient had three grand mal seizures per month on average. The device was disabled in (b)(6) 2012. The patient was currently having one grand mal seizure and one partial complex seizure per week. The patient had significant a significant medical condition of depression. The patient also presented with headaches. The headaches occurred daily. Associated signs and symptoms included phonophobia, photophobia, and scalp soreness. The headaches were incapacitating. Stress, phonophobia, and photophobia were possible exacerbating factors. The patient is continues to have migraines which she takes morphine for. The physician would like to find a different non-opioid medication to control the patient¿s headaches. Per the physician morphine had the tendency to lower seizure threshold in some patient and can cause rebound headaches.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773585
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« Reply #587 on: March 22, 2018, 12:41:02 AM »

Model Number 304-20
Event Date 08/01/2012
Event Type Injury
Event Description
It was reported that the patient was experiencing extreme fatigue after having his vns generator replaced on (b)(6) 2012. Per the patient's wife, since vns stimulation was resumed, the patient has been more tired and sleeping longer. Information was later received indicating the patient has had shortness of breath since the replacement and a physician indicated that the patient's o2 levels are lower than normal and have yet to increase to the proper levels. Reportedly there was difficulty intubating the patient during the replacement surgery which may have caused problems with the vocal cords. The patient;s voice was noted as "hoarse and raspy" and there are concerns for the patient's air capacity. It was also noted that around (b)(6) 2012, "some sort of internal stitching began to pop nearly out of the skin. " attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766128
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« Reply #588 on: March 23, 2018, 01:33:25 AM »

Model Number 102
Event Date 09/01/2012
Event Type Injury
Event Description
Information was received that a vns patient had their generator replaced. Per the patient's mother about a month ago the patient experienced painful stimulation in the left neck which the mother described as the vns device "misfiring. " the patient presented to (b)(6) hospital where er physicians were unable to stop stimulation when the magnet was placed over the device. The mother states the device was located in a difficult to access place and was approximately six years old. Per mom, the er physicians did not understand why they could not stop stimulation with magnet placement, and had to get a programmer to turn off the device. Per mom, after the vns was turned off, the family flew to (b)(6) where established physicians reimplanted the vns on (b)(6) 2012. Their mother reported that their voice was hoarse for 2 ½ weeks after the painful stimulation episode , but is resolved now. The surgeon's office reported that the patient reported painful stimulation in the throat area that resolved with the vns being programmed off and felt surgery needed to investigate the pain event. Their device was not at eos and diagnostics were reported in the or to be within normal limits. Product analysis was completed on the returned generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No eri flags were identified during the analysis. Although the reported allegation of "painful stimulation" cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. The septum was cored. However, no evidence of bodily fluid remnants were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation"). Magnet activations performed at the bench (at a distance of one-inch, spacer block, from generator); demonstrate the appropriate magnet output for the programmed settings. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator output was disabled using a magnet at a distance of one inch using a spacer block with no observed anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2846784
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« Reply #589 on: March 23, 2018, 01:34:34 AM »

Model Number 103
Event Date 09/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the device had been discarded. Attempts for additional information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The patient presented for low battery. The patient had excellent prior response to stimulation with reduction of seizures and earlier abortion of her seizure episodes with use of the magnet. May weeks ago, the patient began having sporadic discharges from her vns which results in throat discomfort, coughing, breathing difficulties, and speech hoarseness. The patient was also concerned that the increase in seizures could make it difficult to work. The notes stated that the patient needed urgent replacement of her device due to the severe symptoms attributable to low battery resulting in sporadic discharges. An implant card dated (b)(6) 2012 indicated that the patient underwent generator revision on (b)(6) 2012 due to battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2847361
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« Reply #590 on: March 25, 2018, 02:05:32 AM »

Model Number 103
Event Date 08/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was making new "breathy or wheezy" noises that were different than normal. The patient was noted as having to go to the hospital in august due to increased seizures. The patient was noted as no longer experiencing seizures in the daytime. The patient used to experience 1-2 seizures per week in the daytime that are approximately 30 seconds in duration however now the patient experiences 5 seizures per night that are approximately 10 seconds in duration. Vns magnet activations are usually effective at stopping the patient's seizures. The patient was also noted as experiencing a change in vocalizations. The patient's vns was noted as now being near end of service. The patient has been referred for vns generator replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2832892
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« Reply #591 on: March 26, 2018, 12:51:32 AM »

Model Number 302-20
Event Date 05/01/2012
Event Type Malfunction
Event Description
On (b)(6) 2013 the physician¿s nurse stated that per the operative note from surgery, the old generator was removed from the pocket, and a replacement device was connected to a lead and the lead was found to be functioning normally. The battery was put back into the pocket and tested again with normal impedance and proper lead function found. She said that it does not appear from the notes that any other actions were taken except replacing the generator which reportedly resolved the high impedance. However, per the implant card, the patient's lead was indeed replaced. They have not heard from the patient since the surgery so assume everything is okay. It was not dictated in the notes if the electrode was off of the nerve. No additional information or clarification could be provided.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. Describe event or problem: corrected data: follow-up report #1 inadvertently did not include the information that the lead and generator were replaced and that the generator was returned to the manufacturer for evaluation. If explanted, give date (mo/day/yr): corrected data: follow-up report #1 inadvertently did not include the explant date of the lead.

Event Description
Additional information was received that the patient had a generator and lead replacement. Only the generator was returned to the manufacturer for evaluation. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description
It was reported that the patient's vns was now indicating high lead impedance. Follow-up with the site found the high impedance is believed to be related to the electrode no longer being on the nerve based on ct scans taken in may of 2012. No trauma or manipulation is believed to have caused or contributed to the high lead impedance. The patient was noted as having an "exponential" decrease in seizures with vns however they suspected an issue when the seizures began to return. The increased seizures are back at the pre-vns baseline. The patient was noted as now "playing" with the lead in his neck which is in a ball that can be felt by the patient. The magnet has been used to temporarily disable the patient's vns however the site has not had a chance to turn off the patient's vns. The patient was noted as experiencing voice alteration following vns implant which went away but has now returned with the high impedance. Last known diagnostics were not available upon request. Surgery to replace the lead and generator is likely.

Event Description
Review of decoder data shows that the device impedance went from 4137 ohms to 3039 ohms on (b)(6) 2011. The as-received decoder does not indicate that high impedance was ever seen. Of note, the generator was returned programmed to 1 hz. It is unknown when this was programmed.

Manufacturer Narrative
Device failure is suspected.

Event Description
Additional information was received that product analysis was completed on the generator. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2825195
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« Reply #592 on: March 28, 2018, 01:59:20 AM »

Model Number 303-20
Event Date 11/18/2009
Event Type Malfunction
Manufacturer Narrative
If explanted, give date (mo/day/yr), corrected data: the initial mdr inadvertantly listed an explant date for the lead; however the lead has not been explanted.

Event Description
An implant card was received which confirmed that the generator replacement was prophylactic. The implant card also indicated that the lead impedance was ok and the lead was not replaced. Attempts for additional information have been unsuccessful. No additional information has been provided. The explanted generator has not been returned.

Manufacturer Narrative
Device failure suspected, but did not lead to a death.

Event Description
Clinic notes dated november 13, 2012 note that the patient has high lead impedance. This was found through diagnostic results that showed a dcdc code of 4. In addition, it was noted that the patient experienced voice hoarseness with stimulation, pain on the left side of the face and jaw, pain in the throat and teeth, and coughing with stimulation. The patient was scheduled for surgery on (b)(6) 2012. Good faith attempts are underway for further details about the reported events.

Event Description
A programming history review was performed which found no anomalies.

Event Description
On (b)(6) 2012 it was confirmed that the generator replacement surgery took place that day. It was stated that the surgery was a prophylactic replacement. The product is pending return for product analysis.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880622
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« Reply #593 on: March 29, 2018, 01:23:31 AM »

Model Number 302-20
Event Date 11/07/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause a death or serious injury.

Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated the incorrect event date: additional information was received showing that event date is (b)(6) 2012. This report is being submitted to correct this information.

Event Description
X-rays were received and reviewed by the manufacturer. No acute angles were observed in the assessed portions of the lead, but one break was found next to the second tie-down. Based on the x-ray images, the reason for the reported high lead impedance is likely the lead break identified.

Event Description
On (b)(6) 2013 additional information was received indicating that the event began (b)(6) 2012. The patient has problematic behavior with hyperkinetic and aggressive way of acting, so trauma cannot be excluded. Surgery is likely but has not taken place.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devicereview of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated high lead impedance was noted for a patient with vns diagnostics testing at an office visit. The generator was disabled. X-rays were ordered. The patient no longer has voice alteration with stimulation since approximately two weeks before the high lead impedance was noted. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2879594
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« Reply #594 on: March 30, 2018, 02:45:27 AM »

Model Number 102
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a patient has not experienced efficacy from vns therapy. It is unknown if the settings have been changed in effort to increase efficacy, and the patient stated that vns settings have not been increased due to patient's coughing, voice alteration, and pain during stimulation. The patient reported that she may have the vns devices explanted due to the lack of efficacy. The patient also reported that she has experienced depression for 40 years and no treatment has been effective.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=969151
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« Reply #595 on: April 04, 2018, 01:28:33 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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« Reply #596 on: April 07, 2018, 12:53:47 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 12/30/2005
Event Type  Injury   
Event Description
It was reported that the patient had complained of hoarseness uncorrelated with generator ¿on¿. The patient said that it had been worse the ¿last several years¿. This hoarseness had been present since the patient was first implanted. The surgeon believed it was likely due to the low placement of the first lead implanted because it was close to the vocal cords. The surgeon thought that the patient may have vocal cord paralysis. It was also possible that the patient was just old. No known surgical interventions have occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary as the event has been attributed to the placement/surgery for the vns and is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7376026
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« Reply #597 on: April 08, 2018, 12:59:20 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/31/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that a patient was seen in the clinic and reported experiencing a lack of perception of vns stimulation, an increase in depression symptoms, and a deepening of her voice during stimulation. The vns was interrogated and high impedance was observed. The clinic notes from this visit were also reviewed and indicated that the patient had a worsening of depression symptoms especially over the few weeks prior to this appointment. The patient's husband was reportedly concerned that the vns was not working properly. No surgical intervention has occurred to date. No additional relevant information has been obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7341801
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« Reply #598 on: April 14, 2018, 12:44:17 AM »

Event Type  Injury   
Event Description
Additional information was attained that this patient's treating physician seemed to attribute the patient's lessened adverse events to improvements in our batteries in the last few years. The patient does well with their depression with the vns.
 
Manufacturer Narrative

Event Description
It was reported that a vns patient had often complained about hoarseness and discomfort when he would receive stimulation. Recently the patient was hospitalized and the battery in his device was replaced. He now states that he doesn't feel the discomfort/effects from the treatment nearly as much. No information has been received to indicate whether their surgery was to preclude a serious injury or not. Information provided from investigation with the reporter did not indicate answers to the questions asked. No patient information has been provided. Only information provided is as follows. "the effects before the change of device were not at all unbearable for the patient and all is resolved now. ".
 
Manufacturer Narrative
Patient implanted for depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993139
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dennis100
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« Reply #599 on: April 19, 2018, 12:44:56 AM »

Model Number 303-20
Event Date 12/28/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that voice change and cough were found on (b)(6) 2010 by a physician. The physician believed the cause of the events was left recurrent laryngeal nerve paralysis due to surgery. The event was resolved as of (b)(6) 2011. The patient also experienced voice alteration and coughing during stimulation at exams on (b)(6) 2011. The events resolved on the same day. No additional information have been received.
 
Event Description
Additional information was received on (b)(6) 2013. The event was related to vns surgery. No interventions were planned or taken. Recent diagnostic results were provided.
 
Event Description
The abstract of the article, "technical points in vns implantation and its complications" was received and reviewed by the manufacturer. It was confirmed that one of the patients that experienced vocal cord paralysis. In the abstract was the patient who was previously reported on in this report. Abstract: rationale: vagus nerve stimulation (vns) was approved by the japan ministry of health, labor and welfare in 2010. The japan neurosurgical society, the japan epilepsy society, and the japanese society for epilepsy surgery created the vns committee in order to verify and approve neurosurgeons and epileptologists to perform vns for patients with medically refractory epilepsy. There is a strict regulation in our country in terms of privileges and a guideline to perform vns. As an example, neurosurgeons who are responsible to perform vns implantation, they must have the dual certificate by the japan neurosurgical society and the japan epilepsy society. Then the vns committee requests neurosurgeons to attend the training session before they perform vns implantation in practice. Although some neurosurgeons are very familiar with anatomy of the cervical region, others do not have enough experience to expose the neck even if they take the training session. Ent surgeons know anatomy of the neck very well. However, ent surgeons are not allowed to carry out those implantations in japan. Therefore it is essential to demonstrate and share the technique and pitfalls in vns implantation. Methods: the most important thing in the beginning is positioning of patients. The neck should be well extended to make the vagus nerve exposed more easily. We normally introduce a microscope from the skin incision instead of surgical loupes. Then we dissect along the inner surface of the sternocleidomastoid muscle. The vagus nerve is usually found between the carotid artery and the internal jugular vein surrounded by the carotid sheath, sometimes deep in the sheath. That causes exposure of the vagus nerve more complicated. However, exposure by a microscope makes the operative field bloodless and clean, because a microscope shows small and tiny vessels more clearly for preservation. After the vagus nerve is well dissected from the carotid sheath, helical electrodes are placed around the vagus nerve under the microscopic magnification. Skin incision for a generator is normally placed anteriorly to the axilla. Insertion of a generator is occasionally under the major pectoralis muscle especially in small children for cosmetic reasons. Results: we have carried out 65 cases of vns implantations since we started the treatment in december 2010. A procedure usually takes an hour and a half from skin incision through closing. Sixty-one out of 65 cases did not show any perioperative complications. We had two cases of vocal cord paralysis (3%) and two cases of cough and hoarseness (3%) that gave some influences in qol. These complications were temporary and there was no permanent morbidity. Surgical site infection did not happen in these consecutive cases. Conclusions: vns implantation is safe and does not make any serious or permanent morbidities even for children as well as chronic treatment by vns itself. Then vns should be recommended when cranial surgery is not indicated after full evaluation including video-eeg monitoring and imaging studies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3033871
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