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Author Topic: Painful Stimulation  (Read 14374 times)
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dennis100
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« Reply #330 on: December 07, 2018, 10:24:35 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had high impedance. The patient was experiencing pain around the site of the generator with stimulation. The patient was sent for an x-ray and consult. The physician thought that the patient¿s high impedance may be related to something to do with a chainsaw that he used last week. The x-ray summary was received, and indicated that a break in the wire was seen on the level of c7. The note also indicated that the patient has been experiencing an increase in seizures. The patient's lead and generator were replaced. They have not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8112599
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dennis100
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« Reply #331 on: December 07, 2018, 10:25:15 AM »

Model Number 304-20
Device Problem Fracture
Event Date 10/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads. X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working. Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018. Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects. Diagnostics from this visit were indicated to be abnormal because the lead impedance is high. The doctor decreased the pulse width, and it was stated that this was much better tolerated. The physician stated that the cause of the burning paint the patient is experiencing is unknown. Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time. Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time. X-rays were provided and reviewed by the manufacturer. Chest x-rays were not provided and therefore the generator was unable to be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. No sharp angles or gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s painful stimulation could not be determined based on the images provided. Note that incomplete pin insertion and the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8088687
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dennis100
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« Reply #332 on: December 07, 2018, 10:26:44 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8071032
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dennis100
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« Reply #333 on: December 08, 2018, 02:10:25 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient's sister that the patient had a seizure and experienced painful stimulation with magnet activation following the seizure. The patient's sister wondered if this was the result of a low battery. It was stated the patient's physician was on vacation and unable to check the patient's vns. It was later reported that it was thought that the generator battery was dead. The patient was referred for replacement surgery. The patient underwent replacement surgery, which was reported via implant card as for prophylactic reasons. During attempts at product return, it was revealed that the facility, historically, discards explanted products. It was later reported that the reason for the replacement surgery was due to an increase in seizures and low battery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8048249
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dennis100
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« Reply #334 on: December 12, 2018, 02:35:21 AM »

Model Number 102R
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
An implant card was received which indicated that the patient underwent generator replacement surgery due to "inactive painful stimulation. " the lead impedance was marked as "ok". Attempts for additional information will be performed. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3365901
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dennis100
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« Reply #335 on: December 12, 2018, 02:36:04 AM »

Model Number 304-20
Event Date 08/26/2013
Event Type  Malfunction   
Event Description
An emergency room physician reported that the vns patient presented to the er with complaints of seizures, swelling in her throat and painful stimulation. The emergency room physician indicated that he was unsure if there was a lead malfunction, but wanted information on how to disable the device without the patient's magnet. The physician was informed that he could obtain magnets from the neurologist or obtain a cow magnet or if the hospital had a programming system he could disable the device with it. The physician stated that he would consider the options. No other information was provided at the time of the initial report. Attempts to obtain additional information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3362443
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dennis100
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« Reply #336 on: December 13, 2018, 04:51:25 AM »

Model Number 100
Event Date 08/19/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator and lead confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that the patient was experiencing painful stimulation and that the device needed to be programmed off. The physician reported that the patient's device was programmed off in 2001 and that she was not aware of it being programmed back on since that time. However, upon device interrogation by a company representative, the output current was at 5. 75ma which is outside of the range for output current (0-3. 5ma). Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3351087
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dennis100
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« Reply #337 on: December 15, 2018, 02:52:06 AM »

Model Number 102
Event Date 09/23/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient experienced painful stimulation at low settings. System diagnostic results were reported to be ok. Follow up with the patient's physician for additional information resulted in unclear information. Physician reported that the patient has a girdle, "viral incerfrolitis" (probably viral encephalitis), and has sustained a lot of injuries. The patient had problems with vocal cord paralysis, spells of breathlessness, and choking.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5191161
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dennis100
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« Reply #338 on: December 16, 2018, 05:01:40 AM »

Model Number 102
Event Date 01/14/2009
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. X-rays reviewed by the manufacturer, migration of the generator was not able to be confirmed on the x-ray views received.

Event Description
It was reported to manufacturer that the treating vns physician saw the vns pt due to swelling in the left armpit and possible generator migration. X-rays were sent to manufacturer to review, and the migration event could not be confirmed as there were no baseline x-rays to compare them to. Diagnostic tests were performed following the onset of the reported event and revealed normal device function. Approximately a week later, the swelling appeared to be improving. Further info received revealed that the treating physician saw the pt again at a later date due to the continuation of the migration of the generator, which the pt believed was causing painful stimulation. Additionally, it was reported that the pt was experiencing an increase in seizure activity. The physician discussed with the pt, the possibility of surgical intervention. The pt then reported that she was seen by the primary care physician and stated that an infection was present, and that the swelling has gotten worse had moved down the left arm. The pt reported that antibiotics were prescribed. Additional info received from the treating vns physician's office revealed that the pt went to an emergency room and was treated with antibiotics and was subsequently released. The fever had resolved, and the swelling was improving. The vns device was disabled and they are continuing to monitor the pt. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341924
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dennis100
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« Reply #339 on: December 18, 2018, 01:07:11 PM »

Model Number 103
Event Date 07/19/2012
Event Type  Injury   
Event Description
The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

Event Description
On (b)(6) 2015 it was reported that the patient¿s generator and a lead portion were explanted on (b)(6) 2013. The hospital reported that they do not return explanted devices, therefore the explanted products could not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406219
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dennis100
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« Reply #340 on: December 20, 2018, 01:52:00 AM »

Model Number 303-20
Event Date 04/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient did not feel stimulation as much as before. It was also reported that the patient experiences burning at the generator site with magnet stimulation. It was reported that the patient only felt stimulation a few times a day and that at times had sharp pain in the neck area with stimulation. It was reported that the patient's device was programmed off on (b)(6) 2013 due to the shocking sensation feeling after reducing the settings did not alleviate the pain. It was reported that the patient has not reported any further problems since programming the device off. It was reported that the physician was curious if there was something wrong with the device despite diagnostics being within normal limits. It was reported that chest and neck x-rays reviewed by the physician appeared that the lead was intact, but that they don't always show "something is going on". It was reported that the plan is to keep the patient's generator off unless the patient calls back.

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

Event Description
On (b)(6) 2014, it was reported that the patient was pursuing explant surgery. No explicit reason was provided; however, the patient was previously experiencing adverse events related to stimulation and the presence of the device. The device had been disabled; therefore, the explant is likely related to these adverse events. Explant surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3475356
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dennis100
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« Reply #341 on: December 20, 2018, 01:52:59 AM »

Model Number 304-20
Event Date 10/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
The mdr with manufacturing number 1644487-2016-02598houses the reports of chest pain and device repositioning. The patient reported experiencing neck pain associated with stimulation. The device was then disabled. The patient's surgeon elected to perform an exploratory surgery. During a pre-operative system diagnostics test the patient had severe pain at their neck and it was decided that the exploratory surgery would open the neck incision. The surgeon opened the neck incision and found scarring and inflammation present. The surgeon then dissected the lead and discovered that the electrodes were placed on the wrong nerve. A tension lead fracture was also observed. The lead was then removed and a new lead was inserted. A significant drop in lead impedance was observed from 3944 ohms to 1208 ohms once the new lead was placed on the nerve and connected to the generator the explanting facility disposed of the explanted lead and thus no product return is expected. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6122152
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dennis100
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« Reply #342 on: December 21, 2018, 09:53:18 AM »

Model Number 304-20
Event Date 07/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, an image of a patient¿s neck/chest area was provided where it appeared that the generator was sideways and protruding. Follow-up showed that the patient was implanted on (b)(6) 2013. The patient was seen on (b)(6) 2013 and reported that the device had been the way it was for a couple of weeks. Thee surgeon manipulated the device with some improvement of the protrusion. The patient was advised to continue to observe, but no intervention was recommended. There was no reported patient manipulation, trauma, or physiological changes that may have caused/contributed to the event. Follow-up with the surgeon showed that there was slight protrusion/flipping of the patient¿s generator. Clinic notes dated (b)(6) 2103 indicated that the patient had pain at the generator site when lying prone and on her side. The generator was mildly painful to palpitation. The device appeared rotated within the surgical pocket and was protruding beneath the skin. The device had not been programmed on. Clinic noted dated (b)(6) 2013 indicated that the patient returned for titration. The patient had continued pain at the generator site when lying prone or on her side. The device was interrogated: 0. 50/30/500/30/5/0. 75/60/500. The patient¿s pain would continue to be observed. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have discomfort intermittently with stimulation, particularly when lying down at night. A system diagnostic was performed with results of 3282 ohms. The patient was unable to tolerate an increase in output current, so stimulation was returned to the previous settings. Device settings were provided: 0. 50/30/500/30/5/0. 75/60/500. A revision referral indicated that the patient was to be revised due to discomfort and slightly elevated lead impedance. Follow-up showed that the referral was for patient comfort. On (b)(6) 2013, the patient underwent lead revision. At the time of surgery, fluid was seen in the outer tubing. The generator was briefly soaking in betadine. It was also noted that the lead was placed on the wrong nerve (anysa) by the previous surgeon. The new surgeon fixed the issue and notified the neurologist. The implant card indicated that the replacement was due to an "adverse event" and "malfunction". No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444285
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dennis100
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« Reply #343 on: December 22, 2018, 11:18:40 AM »

Model Number 102
Event Date 11/27/2013
Event Type  Injury   
Event Description
Although the reported allegation of chest pain at the generator site and pain with stimulation cannot be evaluated in the product analysis laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. However, the cored septum may have been a contributing factor. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the septum anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. Attempts were made for additional information; however, they were unsuccessful. No additional information has been received.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent generator explant due to pain and the patient no longer wanting the device. The lead was not removed. The generator was returned on (b)(6) 2013 and is pending analysis. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531374
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dennis100
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« Reply #344 on: December 22, 2018, 11:19:28 AM »

Model Number 300-20
Event Date 09/01/2013
Event Type  Injury   
Event Description
The explanting facility does not return product; therefore, the explanted devices are not expected for return.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the patient underwent full vns revision surgery. Per the implant card, the device was explanted due to the patient experiencing. Previously, it had been reported that the patient felt as though the vns lead body was pressing up against her skin and she could feel and see it. The patient also reported a painful shocking sensation that was believed to be associated with stimulation; however, it was not felt every time. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443137
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« Reply #345 on: December 22, 2018, 11:21:50 AM »

Event Date 11/16/2009
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient was referred for breast implant surgery as she has no breast tissue to attach the device to. Surgery is likely but has not taken place.

Event Description
Analysis of the generator was completed on 07/10/2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes dated (b)(6) 2013 stated that this vns patient recently relapsed and began to have spells of confusion several times each day. The patient was seen on (b)(6) 2013. When the patient was seen on (b)(6) 2013, she had return to her baseline neurological status. Apart from the complex partial seizure with awareness and confusion impairments, there were no other positives in the patent¿s review of systems. The patient complained of pain at the generator site due to the sagging nature of the device related to the site of implant. The patient wanted breast augmentation and evaluation of the implant site. The device was interrogated, and the settings had been recently adjusted on (b)(6) 2013 to abort seizures. The patient was now doing well. The patient¿s condition was stable. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2014 note that device diagnostics were within normal limits. Clinic notes dated (b)(6) 2014 note that the patient has experienced issues with the position of the device over the last several months and now complained of pain related to stimulation of the device. At times the patient states the pain is not tolerable. The notes indicate that the patient's seizure frequency is much improved due to the device itself. The patient complains about pain in the neck at the site of the device. The patient also complains that pain in the left side of the chest is close to the device. It was noted that the generator seems to be hanging and it makes her more uncomfortable. The patient has tenderness at the site of the generator and also in the neck where the lead is placed. The notes indicate that the pain is intensified with magnet use. It was noted that the problem appears to be due to the suspension of the device. Device settings were adjusted and the patient was referred for an appointment with a neurosurgeon. The patient underwent generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Additional information was received stating that the vns patient¿s lead was not replaced during the procedure on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostic results showed lead impedance within normal limits (impedance value - 3459 ohms). The patient¿s replacement device was programmed back on previous device settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3537553
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« Reply #346 on: December 23, 2018, 10:42:09 AM »

Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/01/2014. The puncture mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities 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.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3527747
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« Reply #347 on: December 23, 2018, 10:43:05 AM »

Event Date 11/01/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was also reported that x-rays did not show a lead fracture. It was reported that the patient experienced discomfort in her jaw during device stimulation. The patient has been referred for surgery. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance. It is unknown if the physician programmed the device off after observing the high impedance. Attempts to obtain additional information will be made, but no additional information has been received to date. Surgery is likely, but has not 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=3530331
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« Reply #348 on: December 24, 2018, 08:49:40 AM »

Model Number 302-20
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient was experiencing chest pain associated with magnet stimulation. It was reported that the physician did not program the device off after observing the high impedance because the patient has good seizure control and the patient's mother did not want the device disabled. The magnet output current was reduced and the magnet mode stimulation did not cause the patient pain. X-rays were ordered and a lead revision was discussed. It was reported that the patient's family did not recall a fall, accident or manipulation that could have caused or contributed to the high impedance. It as later reported that x-rays were performed and surgery was scheduled. It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. It was noted that pre-operative diagnostics resulted in high impedance (>=10,000 ohms) and that device diagnostics with the new lead and existing generator were within normal limits (1259 ohms). The lead has not been received for analysis to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement; however, only a small portion of the generator is visible. The filter feed-through wires and the lead pin cannot be assessed with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3523405
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dennis100
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« Reply #349 on: December 24, 2018, 08:50:17 AM »

Event Date 10/22/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 note that the vns is hurting the patient. The notes indicate that the patient is experiencing too much pain from the lead and in her neck and she wants the device programmed off and removed. The notes indicate that the patient complains of constant pain at the site of the vns. The notes indicate that the device was programmed off at that visit per the patient's request. Clinic notes from the patient's implant surgery note that the device was tested and found to be properly functioning. Then physician indicated that the patient complained of neck pain on (b)(6) 2013. The physician reported that the patient indicated that the neck pain occurred with device stimulation. The physician reported that the neck pain occurred prior to check the device, but that causal or contributory programming changes preceded the onset of the neck pain. The physician reported that the patient will be referred to surgeon for explant per patient's request. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3523135
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dennis100
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« Reply #350 on: December 24, 2018, 08:51:22 AM »

Model Number 103
Event Date 07/19/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the patient had two bad seizures that friday. The office was pending approval from insurance to have the vns generator replaced at the time. The generator was replaced on (b)(6) 2013, due to an "adverse event". Previously it had been reported that the patient was experiencing pain with vns stimulation and was considering having the vns explanted for this reason. Clinic notes dated (b)(6) 2013 indicate the patient experienced continued pain at the generator site every five minutes. The vns device was turned off to 0ma and the pain completely went away. Pain during stimulation is rated as a 7-8 on a scale of 10. Device diagnostics indicate the lead impedance was 3100 ohms. The chest x-ray was normal. Clinic notes dated (b)(6) 2013 indicate the patient was still complaining of pain. Clinic notes dated (b)(6) 2013 indicate the patient returned for vns titration and was last seen about a month ago. The patient had continued pain at the generator site when the device is stimulating. The patient rates it about four to five on the pain scale. The physician tried to increase the normal output current and magnet output current to 1. 25 ma and 1. 5 ma respectively; however, this was uncomfortable to the patient and she did not feel as though she could tolerate it. The settings were decreased to be more comfortable and device diagnostics indicated the device was functioning.

Manufacturer Narrative

Event Description
The generator and lead were returned for analysis on 03/07/2014. Analysis of the lead was completed on 03/26/2014. Note that since the furthest electrode to the bifurcation was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on 03/27/2014. 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 patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. The physician assistant reported that the painful stimulation resolved with vns system replacement. The physician assistant reported that they were not aware of a change in seizure pattern with the patient. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3521100
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dennis100
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« Reply #351 on: December 29, 2018, 04:33:31 AM »

Model Number 300-20
Event Date 11/04/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery due to a lead break with high impedance greater than 10,000ohms. The patient had a lot of pain at the generator site. It was stated that the x-ray did not show a lead fracture but when explanting the lead, investigation showed some silicone of the lead body had disappeared. It was stated that since there was conductor material in contact with soft tissue, which caused pain during stimulation. It was later reported that the device was programmed off following the high impedance observation. It was stated that the patient did hard work while moving houses which might have caused or contributed to the high impedance. The patient felt painful stimulation some days prior to (b)(6) 2013. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3495296
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dennis100
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« Reply #352 on: December 30, 2018, 06:20:28 AM »

Model Number 102R
Event Date 06/01/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2014, it was reported that this vns patient experienced an increase in seizure frequency during (b)(6) 2012 for an unknown reason. The physician reported that the patient's seizures were cyclic in nature and increased despite vns therapy and without any triggering factor. The seizures resolved to a normal baseline; however, no other information regarding interventions or device functionality at the time was available. It was also reported that the patient experienced pain in the left neck at the electrode site that was reported to the physician on (b)(6) 2012. The pain was occurring with stimulation on times and corresponding with voice alterations. The physician told the patient to tape the magnet over the device; however, this did not cause the pain to stop. X-rays were taken at the patient's appointment on (b)(6) 2012; however, there was nothing remarkable, per the x-ray report. The pain spontaneously resolved at an unknown date. Based on the information available, the physician did not believe the event was related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3575810
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« Reply #353 on: January 01, 2019, 04:47:56 AM »

Model Number 302-20
Event Date 12/11/2013
Event Type  Injury   
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
It was reported that the patient experienced erratic device stimulation and that it "felt like the magnet was going off by itself all the time". The device was programmed to lower settings and the issues resolved, but then after five minutes, the patient reported that it was painful like prior to reducing the settings. The generator was programmed off and the patient was referred for x-rays. It was reported that device diagnostics showed dc dc code - 0 and that the patient would be referred to surgeon. There was no causal or contributory programming or medication changes that preceded the onset of the painful and erratic device stimulation. No patient manipulation or trauma occurred that could have caused or contributed to the painful and erratic device stimulation. It was reported that the pain is located at the patient's neck. The patient later reported that her seizures have worsened and that she was hospitalized for that as well as injuries sustained during falls due to seizures. It was confirmed that the device was still off. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative

Event Description
An implant card was received which indicated that the lead impedance with the new generator and existing lead was within normal limits (2117 ohms).
 
Event Description
Additional information was received that the patient had a generator replacement on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3556121
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dennis100
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« Reply #354 on: January 03, 2019, 08:56:41 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. During the surgery, the surgeon saw fluid in the lead so completed a lead revision during the prophylactic generator replacement surgery. Attempts for product return have been unsuccessful to date. The products have not been received by the manufacturer. Previously, it was reported in (b)(6) 2013 that the patient was experiencing painful stimulation in the chest and neck areas. The painful stimulation resolved when the vns was disabled with the vns magnet. X-rays dated (b)(6) 2013 were later received and reviewed by the manufacturer. There was no evidence of lead twisting, or sharp angles suggestive of a lead break. It is noted the lead appears to be ¿stretched¿ across the chest, as if it may be pulled if the head was turned to the right. No obvious lead anomalies were seen. There was no known trauma or manipulation. The painful stimulation was reported to be positional and was thought to have resolved prior to referral for surgery, and the cause of the painful stimulation was unclear to the physician.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639409
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dennis100
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« Reply #355 on: January 03, 2019, 08:57:20 AM »

Model Number 103
Event Date 01/23/2014
Event Type  Injury   
Event Description
It was initially reported that the patient was in the emergency room due to painful stimulation in her neck due to her vns. The patient felt her vns was stimulating more than it should and seems more painful. The pain was causing her seizures to be worse. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639394
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dennis100
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« Reply #356 on: January 04, 2019, 11:10:56 AM »

Model Number 1000
Device Problem High impedance
Event Date 11/13/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's device showed high impedance. X-rays had been performed and there were no observed issues with the lead or pin insertion. Per x-ray review by medical professional, there were no obvious break or crack. The patient also reported some neck pain with stimulation and the vns device was programmed off due to the high impedance. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8140647
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dennis100
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« Reply #357 on: January 04, 2019, 11:11:31 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 09/28/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was prematurely depleting, as there was a unexpected decrease in the past four months. It was also reported that the patient had high impedance, low output current, and pain with stimulation, which is reported in mfr report #1644487-2018-02285. The patient's device was disabled. The patient's lead and generator were replaced. The devices have not been received into livanova to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180507
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dennis100
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« Reply #358 on: January 04, 2019, 11:12:32 AM »

Model Number 302-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 11/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's neurologist reported that they interrogated the device because the patient was having some discomfort. Upon interrogation, high impedance was observed and the neurologist thought there could be a disconnection along the electrode and stated that ¿the device cannot transmit the proper stimulation to the patient¿s vagal nerve. " additional information was received that the patient has been referred for a revision. It was stated that the patient's discomfort is occurring in the neck area and is associated with stimulation. There was no trauma reported to that area, and the physician does not have an assessment of the cause of the patient's discomfort. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8146223
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dennis100
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« Reply #359 on: January 04, 2019, 11:13:25 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant 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=8127177
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