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dennis100
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« Reply #90 on: January 14, 2019, 04:33:12 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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dennis100
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« Reply #91 on: January 14, 2019, 04:34:30 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
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dennis100
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« Reply #92 on: January 20, 2019, 03:20:39 AM »

Model Number 302-20
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head. The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression. It was later determined that the patient did not have depression but was suffering from an anxiety disorder. The patient¿s generator and lead were explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury. The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced. Analysis of the returned generator and lead was completed. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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. The connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, 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. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854239
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dennis100
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« Reply #93 on: January 20, 2019, 03:21:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
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.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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dennis100
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« Reply #94 on: February 12, 2019, 03:23:25 AM »

Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532847
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dennis100
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« Reply #95 on: February 13, 2019, 03:02:24 AM »

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

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dennis100
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« Reply #96 on: February 17, 2019, 06:22:08 AM »

Model Number 302-30
Event Date 01/01/2015
Event Type  Injury   
Event Description
Analysis of the generator was completed on 03/05/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative

Event Description
Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason. It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown. The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery. The reason for the protrusion is unknown. Device diagnostics were within normal limits. It was reported that the lead was replaced to preclude a serious injury and for patient comfort. The pain and protrusion resolved following generator and lead replacement surgery. The explanted lead was discarded during surgery. The explanted generator was returned for analysis on 02/10/2015. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570551
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dennis100
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« Reply #97 on: February 21, 2019, 02:01:13 PM »

Model Number 300-20
Event Date 03/20/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). X-rays were taken and device settings were increased. It was reported that the patient would be referred for surgery and x-rays would be sent to manufacturer for review. It was later reported that the increased settings caused the patient to have a "chewing on foil" sensation when turning his head. The device was later disabled. X-rays were received by manufacturer to review. Review of x-rays did not identify any obvious discontinuities with the vns system; however, a micro-fracture could not be ruled out. It was reported that the patient plans on undergoing oral surgery prior to vns system replacement. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. Pre-operative diagnostic results showed a high impedance condition (impedance value >= 10,000 ohms). The explanted devices have not been returned to date.
 
Event Description
The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698547
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dennis100
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« Reply #98 on: February 21, 2019, 02:01:51 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4697733
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dennis100
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« Reply #99 on: March 05, 2019, 06:49:40 AM »

Model Number 102
Device Problem Use of Incorrect Control Settings
Event Date 06/27/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's mother reported on (b)(6) 2015 that the pain has gotten to the point where she can no longer eat. She wants the vns removed. It was reported on (b)(6) 2015 that the patient had a mass on her neck and pain when turning her head due to the mass. The patient was referred for x-rays. Follow up with the patient's caretaker on (b)(6) 2015 indicated that the mass on the patient's neck was determined to be the tie-down. The patient was losing weight due to an increased dosage of topamax, so the tie-down has become visible and likely also caused the neck discomfort from the lead occurring for about 18 months. The patient also experienced constant difficulty swallowing which the caretaker believed is related to the position of the lead. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
Additional information was received that the patient is not eating due to discomfort form vns. X-rays were taken which revealed no issues.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the information about the x-ray review and continued discomfort and weight loss issues.
 
Event Description
It was reported that the patient experiences a difficult time tolerating device settings increases and then collapses. It was reported that it takes the patient 2-3 days to no longer feel pain following the increase in settings and that the patient becomes accustomed to the device stimulation after about 3 days. The patient is trying to find a new vns physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5009038
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dennis100
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« Reply #100 on: March 07, 2019, 02:11:54 AM »

Model Number 300-20
Event Date 07/15/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4959601
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dennis100
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« Reply #101 on: March 22, 2019, 02:18:50 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
It was reported that the patient was referred for an explant surgery, which at that time was for an unknown reason. Follow up with the treating physician regarding the reason for explant showed that the patient was experiencing pain on the left chest, jaw, and head. The pain did not start immediately, but had progressively gotten worse and required narcotic medications to control. The chest pain was reported to have occurred prior to the referral for explant. The pain was described as a burning sensation was over the generator site. The office of the treating physician did not find anything wrong with the system at that time and observed no warning messages. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Follow up with the patient¿s treating surgeon showed that the vns explant surgery was completed. The physician assessed that the pain was likely caused by the presence of the device since no other cause was found. The surgery was not to preclude a serious injury. The explanting facility reportedly discards of explanted devices. Therefore, product return is not expected. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434705
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dennis100
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« Reply #102 on: April 02, 2019, 01:35:35 AM »

Model Number 102
Event Date 07/14/2015
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the patient's vns device was testing during an office visit on (b)(6) 2015 and system diagnostics revealed high impedance (dc dc - 6). The device was evaluated again on (b)(6) 2015 and system diagnostics revealed high impedance again on that date (dc dc - 6). No patient adverse events have been reported and no known surgical interventions have occurred to date. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Information received on 06/09/2016 states that the patient was last seen (b)(6) 2016 and lead impedance was ok. The patient has had no adverse events that may be associated with the high impedance. X-rays have not been taken and patient manipulation or trauma is not expected to be related. The physician's office is aware that there may be a fluctuating high impedance issue so the patient was referred to neurosurgery. No further relevant information has been received to date.
 
Event Description
It was reported by the patient's mother that the patient's head had been shaking and that the patient was acting differently. The neurologist indicated that the patient had not been acting the same on her current generator as she had on her previous generator, so she was referred for surgery consult for symptom assessment and a lead check. After the consult, the patient was scheduled for surgery. Per the manufacturer's programming database, high impedance was detected again on this patient's device within the last year. No further relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
It was reported through implant card that the patient underwent planned lead and generator replacement surgery due to high impedance and prophylactic replacement. However, during surgery, it was determined that replacing the generator solved the issue. The lead pin was not re-inserted into the old, explanted generator to ensure that the pin was past the connector block with a good electrical connection. No further relevant information had been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5672077
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dennis100
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« Reply #103 on: April 07, 2019, 02:48:08 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2000
Event Type  Injury   
Event Description
The patient's generator was disabled after 6 months of use reportedly due to lack of benefit. It was reported that the patient's generator was explanted due to considerable irritation on the left site of their neck where the electrodes were located, which worsened when they turned their head. It was reported that prior to explant the patient's skin was puckered and that an anchor tether, part of the lead body, had poked through their skin. Another reason for explant was indicated as scar tissue, likely at the electrode site caused by chronic irritation. While the patient's generator was implanted they reported having tightened neck muscles due to vns stimulation, likely related to the lead extrusion and scar tissue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425064
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« Reply #104 on: April 12, 2019, 01:24:55 AM »

Model Number 302-20
Event Date 11/01/2015
Event Type  Injury   
Event Description
It was reported that the patient was referred for generator replacement surgery. Information received at the time of the referral showed that the patient experienced tugging sensations from the lead when he turned his head to the right. Follow up with the referring physician's office determined that the patient was still experiencing these sensations, and the patient noticed it was exacerbated by wearing a seatbelt. Device diagnostics were confirmed to be within normal limits in the most recent appointment on (b)(6) 2016. The physician's office could not offer an assessment and deferred to the potential surgeon as a source of information. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
The office of the intended surgeon reported that the patient did not indicate whether or not there were pulling sensations when he was seen in (b)(6) of 2015. No interventions were planned for the lead at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5771226
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« Reply #105 on: April 15, 2019, 01:33:09 AM »

Model Number 302-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported that in (b)(6) 2016 the patient reported erratic stimulation. It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation. The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician. Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery. After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation. The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off. The painful stimulation was reported as occurring in the neck and the head. Impedance was reported to be normal at 1171 ohms. A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator. The treating physician also believed that there was a lead fracture. There was no known trauma or manipulation at the site of the fracture. The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Further programming/diagnostic history from the physician's tablet was reviewed. All reported impedance values were within normal limits. Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980471
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« Reply #106 on: April 15, 2019, 01:33:56 AM »

Model Number 103
Event Date 08/29/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received for a patient providing that she was experiencing sudden pain with swallowing and with turning of the head. Reducing the output and also lowering the pulse width did not improve the pain. Diagnostics were within normal limits. The patient is in referral for surgery, however no known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating physician provided the pain was located in the patient's neck area around the lead. Diagnostics were reported to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5978720
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« Reply #107 on: April 22, 2019, 01:44:34 AM »

Model Number 304-20
Event Date 05/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having chronic vomiting, nausea, dizziness and orthostatic hypotension that is possibly related to the vns. During these episodes the patient feels like his brain is "banging around" in his head and he holds his head with his hands. The patient then vomits 20 times. The patient vomits when he moves his head. These episodes started with a frequency of once or twice a month and has increased to a couple of times a week. They started one month after implant and the relationship to vns stimulation was not known. These episodes are still occurring even though the patient is only implanted with the lead. The patient's generator was previously explanted as reported in mfg report #:1644487-2016-02184. The patient was hospitalized for the episodes. No root cause was found, but the patient's physician thought that it may be related to the vns lead. The patient was also referred to an infectious disease specialist to see if the symptoms are related to the infection reported to mfg report #:1644487-2016-02184. The patient was referred for lead explant. The patient's implant surgeon does not believe it is related to the vns lead. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's neurologist strongly believed that the patient's symptoms were not related to vns or the implanted lead. The patient had a strong tilt-table test and had postural orthostatic tachycardia syndrome (pots) and the physician attributed his symptoms to this. The neurologist reported that the patient had a lot of issues. No additional relevant information has been received to date. No known intervention has occurred to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient is no longer planned to undergo lead explant surgery due to the symptoms initially reported. Clinic notes dated (b)(6) 2016 reported that the patient was prescribed fludrocortisone for his dizziness. No additional relevant information has been received to date.

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« Reply #108 on: April 24, 2019, 02:40:07 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported by a medical professional that a vns patient presented in clinic with hoarseness which has come on with stimulation recently. He also has high impedance upon system diagnostics. The patient reports he has had no falls and no impacts. The only physical activity he has performed lately has been lifting boxes at work. He does not attribute the current lead issues to any particular event. It was provided that when the patient moves his head to the left the lead impedance value was normal and the lead impedance value is high when his head is turned to the right. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred on (b)(6) 2017. Follow-up to the company representative who attended the surgery provided that pre-operative diagnostics were within normal limits when the patient¿s head was facing forward, however when diagnostics were performed with the patient¿s head turned to the right, the impedance was high at 7,500 ohms. She stated that after the lead had been removed upon visual examination, it was apparent that the lead coil was broken and ¿bent¿ and the outer tubing was split open. The explanted generator was received by the manufacturer and analysis is underway, but has not been completed to-date. The explanted lead was not returned to the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were tested and results demonstrated accurate resistance measurements were obtained in all instances. Proper functionality of to provide appropriate output currents was successfully verified and the septum was not cored eliminating the possibility of an unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator¿s output signal and the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed the generator performed according to functional specifications. The battery measured 3. 075 volts and did not show an end-of-service indicator. The downloaded data revealed that 22. 513% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6188111
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« Reply #109 on: April 24, 2019, 02:41:40 AM »

Model Number 106
Event Date 06/24/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the nurse practitioner that the patient received a full vns revision a few months ago and now has partial vocal cord paralysis, but is seeing an ent for treatment and improving. The physician decided to leave the vns programmed on. It was also noted when the patient turns her head to one side, her voice goes high and faint. The surgeon had later noted that this most recent surgery had been the third time someone was in the patient's neck accessing the nerve and he was not surprised the patient would have some vocal cord paralysis and voice alteration. Attempts for additional relevant information have been unsuccessful to date.

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« Reply #110 on: May 03, 2019, 02:05:00 AM »

Model Number 304-20
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was having lead problems related to her clotting disorder. The patient believed that her physician told her that this was the case and stated that she needed to undergo full revision surgery to resolve the issue. No further relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The lead was not replaced as the surgeon reportedly did not feel it necessary to replace the lead. No additional relevant information has been provided to date.
 
Event Description
It was reported that the patient was actually experiencing a tethering sensation accompanied by pain and discomfort when she turned her head. The lead was only repositioned during generator replacement surgery. The lead repositioning was for patient comfort. The surgeon believed that scar tissue formation, and not a clotting disorder, was the cause of the patient's lead issues. No additional relevant information has been provided to date.

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« Reply #111 on: May 06, 2019, 03:35:11 AM »

Model Number 300-30
Device Problem Low impedance
Event Date 12/13/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that the patient was not feeling stimulation like she did before. She was now feeling pain in her ear and jaw when stimulation was delivered along with an increase in gagging and choking sensations. The patient also reported that she was experiencing a shocking sensation when she turned her head to the right occasionally which resulted itching at the electrode site. The patient also reported that the muscles in her neck would tense up for 30 seconds and then relax. The patient's generator was disabled and the tension resolved. Diagnostics showed that the impedance on the patient's generator was at dcdc 0, which could be indicative of a short circuit issue under certain circumstances. The patient then had her device prophylactically replaced in (b)(6) 2017. No additional relevant information has been received to date. The explanted generator and lead have not been received to date.
 
Manufacturer Narrative
Device information, corrected data: the initial report inadvertently reported the incorrect device information. Implant date, corrected data: the initial report inadvertently reported the incorrect implant date. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect manufacture date.
 
Event Description
The generator and lead were received. Analysis on the generator was approved. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that 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 portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed with no discontinuities identified.
 
Manufacturer Narrative
Follow-up report #2 inadvertently listed the incorrect results and conclusion codes.

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« Reply #112 on: May 09, 2019, 07:30:44 AM »

Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. 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. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and 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 set screw 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.

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« Reply #113 on: May 27, 2019, 11:21:10 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/10/2017
Event Type  Injury   
Event Description
A patient reported that he had been experiencing pressure in the back of his head since his vns was initially implanted. The patient stated that the pressure was constant and did not occur with stimulation. The patient's device was programmed off for one week, but that did not relieve the pressure, nor did pain medication. The patient was later hospitalized for two weeks due to the pressure and a bout of non-epileptic seizures. The patient's treating neurologist reported that the patient had previously complained of this head pressure at his previous appointment prior to the report. The patient's vns output currents had been programmed down in response at that appointment. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The surgeon's office reported that the patient was referred for surgery to have the anchor tether of his lead removed due to it poking him. A company representative believed that the surgery had already occurred, but the surgical intervention has not been confirmed to date. No additional relevant information has been received to date.
 
Event Description
The anchor tether removal surgery was performed as intervention for the patient's pain and dysphagia. The surgery was for patient comfort and was not required to preclude a serious injury. Per the surgeon, the dysphagia improved some after surgery, and the pain fully resolved after surgery. No additional relevant information has been received to date.

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« Reply #114 on: June 03, 2019, 04:56:59 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient has had a recent increase in seizure frequency and duration. It was reported that the patient normally has mostly simple partial seizures with occasional grand mal seizures, but the patient stated that she was having grand mal seizures that lasted over 30 min each in a few days and the partial seizures are also more frequent. The patient's device was tested at the doctor's office and was determined to be providing magnet activation as normal, but the patient cannot feel the magnet activation when her head is tilted to the left. Diagnostics and lead impedance were both tested, and both were found to be ok. No additional relevant information has been received to date.

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« Reply #115 on: June 18, 2019, 12:53:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient's mother reported that a patient received stronger stimulation with a magnet swipe. The magnet stimulation reportedly made the patient's seizure worse. No additional relevant information has been received to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not include known medical intervention describe event or problem, corrected data: initial report inadvertently did not include known medical intervention and full list of patient events event problem codes, corrected data: initial report inadvertently did not include full list of patient events. Report source, corrected data: initial report inadvertently did not include consumer. (b)(4).
 
Event Description
It was reported that the patient swiped her magnet again after a dosing appointment where her settings were increased, and she experienced a head tilt to the left, a cold sensation, shaking, painful stimulation, nausea, and pallor with magnet stimulation. This reportedly occurred a few more times, but each time was less intense; however, these events made the patient afraid to use her vns magnet. A company representative and the physician met with the patient and her mother. During the clinic visit, the patient's magnet pulse width setting was reduced from 500 to 250 microseconds. The patient was then able to tolerate stimulation, and the events resolved. Diagnostics were within the normal limits. Use of the magnet had made the patient anxious since she reportedly did not expect to feel stimulation as strongly as she did following the initial settings increase. The physician believed that the reported events the patient's anxiety contributed to the adverse events she experienced with magnet stimulation. Stress was also a trigger for the patient, so the physician believed that the combination of original settings and the patient's anxiety also contributed to the change in seizure intensity. No additional relevant information has been received to date.

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« Reply #116 on: June 26, 2019, 07:23:24 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that this patient is being referred for generator replacement. The patient has had the vns implanted 10 years ago, and it is now off, and the neurologist wants to restart vns therapy for the patient. The patient later reported that they need an mri of their head, and has been having pain in his head. The patient reported that they would like the device out.
 
Event Description
Additional information was received from the neurologist¿s office stating that the patient's head pains were related to vns therapy per the patient, and the doctor was not sure of the relationship between the two as he did not interrogate the device. The patient's head pains were a contributing factor for surgery referral, but surgery is for patient comfort reasons. The doctor stated that the patient¿s device will be explanted, not replaced. No known surgical intervention has occurred to date. No other relevant information has been received to date.

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« Reply #117 on: July 01, 2019, 10:30:30 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
Physician reported that patient developed torticollis (a rare condition in which the neck muscles contract, causing the head to twist to one side). Patient does not have an history of torticollis prior to vns implant or any risk factors that makes patient susceptible to torticollis. The physician thought there was a high likelihood that the torticollis is related to vns stimulation. The torticollis initially gradually got better when the device was disabled for torticollis correction surgery. After surgery, when vns was turned on, the torticollis gradually returned. The vns was again disabled and the patient's condition with torticollis was better.

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« Reply #118 on: July 02, 2019, 01:18:41 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating that the patient was having an increase in seizure-like symptoms, such as head drops. It was further noted that the caregiver would attempt magnet swipes, but the magnet did not help the patient¿s seizure activities. The physician checked and reprogrammed vns, but it was stated ¿will make arrangement for vns to be checked to see if battery needed to be replaced again or the whole unit to be replaced with a newer model¿, indicating that the increase was suspected to potentially be due to vns. It is known that an error message will display upon interrogation if there is a device malfunction or impedance issue. As the device was reprogrammed during this office visit and no anomalies were noted, it was likely the device was functioning as intended. No additional relevant information was received to date.
 
Event Description
An implant card was received for the patient's prophylactic generator replacement. Diagnostics performed with the new generator indicated ok impedance. It was stated that the device was discarded after surgery and would not be available for return for analysis. No additional relevant information has been received to date.

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« Reply #119 on: July 05, 2019, 11:15:12 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/16/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient suffered from cervical dystonia, which the physician attributed to the placement of the vns. It was reported that the patient had two vns generators implanted, one in the upper left chest and one further down in the patient's breast tissue. The patient was referred for vns explant. Multiple attempts were made for additional information; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

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