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dennis100
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« Reply #420 on: February 11, 2019, 01:58:26 AM »

Model Number 300-20
Event Date 12/31/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Hospital procedure notes dated (b)(6) 2014 note that during generator and lead replacement surgery (mfr. Report # 1644487-2014-03136), during dissection of the electrodes from the patient's vagus nerve the surgeon experienced brisk venous bleeding from the jugular vein. The surgeon identified a small hole in the vein and controlled the bleeding with direct pressure and then closed the hole with a 5-0 prolen interrupted suture. The surgeon then placed surgicel over this. It was noted that the patient tolerated the procedure well and was transferred to pacu in stable condition. The physician assistant indicated that the bleeding is a known complication when removing old lead and that the risk was discussed prior to surgery. It was reported that the vns caused this in the fact of it's presence and the leads scared down to the surrounding anatomy.

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dennis100
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« Reply #421 on: February 13, 2019, 02:48:41 AM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis was completed on the explanted generator and lead. The lead fracture was not confirmed in the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut/torn end of the coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred on the coil surface. Although not conclusive, the most likely cause for the observed pitting conditions is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the generator revealed that the elective replacement indicator (eri) was set. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion no returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date. The reason for product return was documented by the explant hospital as "non-functioning battery and leads. ".
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that high lead impedance was detected with report of ¿battery failing. ¿ there was mention of ¿scar under electrode¿ and jump in impedance to dcdc ¿ 7. Follow-up with the physician¿s office was performed. It was reported that high impedance was detected on system diagnostic testing. Although surgery is likely, it has not occurred to date.

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dennis100
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« Reply #422 on: February 14, 2019, 02:04:41 AM »

Model Number 300-20
Event Date 03/04/2015
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. Date of event, corrected data: the initial report inadvertently reported the incorrect date.
 
Event Description
It was reported that during generator replacement surgery for infection (mfr. Report # 1644487-2015-04272), a lead fracture was identified. It was reported that the initial plan was to replace the generator and create a new pocket away from the infected implant site, but that when the lead was identified as fractured the lead and generator were both explanted and not replaced. Reimplant will occur when the infection is cleared and will be captured in mfr. Report # 1644487-2015-04272. It was reported that there was resistance when explanting the lead believed to be due to scar tissue. The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the patient was referred to have the remaining portion of the lead explanted and surgery to remove the remaining portion of the lead was performed on (b)(6) 2015. The device was discarded and is not available to be returned for analysis.
 
Event Description
Product analysis has been completed for the lead. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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dennis100
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« Reply #423 on: February 14, 2019, 02:05:33 AM »

Model Number 302-20
Device Problem High impedance
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed for the patient¿s device during a clinic visit. X-rays were ordered for the patient. The physician chose to leave the device on despite cyberonics¿ recommendation to disable the vns. There were no known patient adverse events present. Additional relevant information have not been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: information regarding device disablement was inadvertently left out of the supplemental #1 report.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
The explanted lead has been returned to the manufacturer. Product analysis was completed for the lead. No obvious anomalies were noted. No discontinuities were identified. There is no evidence to suggest discontinuities in the returned portion of the device. 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.
 
Event Description
X-ray images of the neck and chest were dated (b)(6) 2015 were received and reviewed. The lead connector pin inside the connector block appeared to be completely inserted. There did not appear to be any gross fractures or discontinuities that might explain the high impedance. No known surgical interventions have been performed to date.
 
Event Description
Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures prior to the high impedance observation. X-rays were taken and were reported by the physician to be unremarkable. The patient underwent lead replacement surgery on (b)(6) 2015. Pre-operative system diagnostic results showed high impedance (impedance value >= 10,000 ohms). The patient's neck incision site was opened and the surgeon observed connective and scar tissue surround the nerve. The surgeon replaced the lead and system diagnostic results showed lead impedance within normal limits (impedance value - 1454 ohms). The explanted lead has not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury. Review of the available programming and diagnostic history.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the patient's generator was disabled.

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dennis100
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« Reply #424 on: February 23, 2019, 02:31:29 AM »

Model Number 300-20
Event Date 06/01/2006
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing shocking sensation with stimulation that the patient had been having for over a year. Additionally it was reported that the patient was having prolonged seizures lasting up to two hours long. Previously their seizures were one hour long. The patient, it was reported, had a large amount of scar tissue around their nerve. The patient had not had any falls or injuries preceding their shocking sensation. Full revision surgery was performed. The explanted products will not be returned for analysis. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death.

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dennis100
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« Reply #425 on: February 25, 2019, 02:25:41 AM »

Model Number 302-30
Device Problem High impedance
Event Date 04/14/2015
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the report of fluids and wear on the lead observed during surgery was inadvertently not provided on follow-up report #01.
 
Event Description
It was reported that the lead showed wear and moisture inside the casing observed during the revision surgery.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2015 note that high impedance was observed. The device was programmed off after observing the high impedance. The patient was referred for surgery. No known surgical interventions have been performed to date.
 
Event Description
Operative notes were later received indicating that the generator was not replaced during the lead replacement surgery. During surgery, the generator was removed from the pocket and disconnected from the lead. The lead was cleaned and reconnected to the generator and the device was re-interrogated. The lead was found to still have high impedance. While dissecting towards the lead while using electrocautery brisk bleeding occurred from the jugular vein, which was controlled with a suture. The surgeon decided not to pursue the lead further superiorly because of the scarring. As the surgeon dissected inferiorly, the vein began to bleed again from that point and another suture was placed which stopped the bleeding. The new lead was placed and the generator was re-attached and interrogation revealed the parameters were normal. No additional relevant information has been received to-date.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The generator was replaced prophylactically. The generator and lead were discarded by the explanting facility; therefore, product analysis cannot be performed.
 
Event Description
A review of the manufacturer's in-house programming history database provided more specific data from regarding the high impedance, and that the device was programmed off on (b)(6) 2015.

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dennis100
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« Reply #426 on: March 07, 2019, 01:56:19 AM »

Model Number 300-20
Device Problems Low Battery; Device Displays Incorrect Message
Event Date 09/04/2015
Event Type  Malfunction   
Event Description
A copy of the operative notes from the (b)(6) 2015 surgery were received for review. It was noted that a new lead could not be placed on the nerve as there was no free portion. The surgeon tried to dissect the area but to no avail.
 
Event Description
On (b)(6) 2015 it was reported that the patient was scheduled for a full revision surgery. The patient underwent the full revision surgery on (b)(6) 2015. The new lead was placed above the old set of electrodes and the old lead was cut near the generator down in the chest pocket. The explanted generator and lead were discarded and therefore cannot be returned for product analysis.
 
Manufacturer Narrative

Event Description
The patient reported on (b)(6) 2015 that during interrogation, the physician reported that he believes that the battery has died or is going dead. The physician stated that a low battery message appeared but another unspecified message was displayed as well and that there is a "problem" with the vns and it is not generating enough power. The patient was referred for a full revision. The patient reports no adverse events associated with this latest development and states that he does still have seizures but the vns is efficacious and does not want to regress to "how it used to be" (pre-vns baseline disease state). Clinic notes dated (b)(6) 2015 were received which indicated that the patient has high impedance with a dcdc of 7 on a system diagnostics test. The patient underwent surgery on (b)(6) 2015 but the surgeon was only able to remove some of the scar tissue and was unable to remove the lead. The surgeon said that there was not enough space on the vagus nerve to attach a new lead. The patient noted that his seizures have gotten worse and he would like the revision to take place as soon as possible. Although surgery is likely, it has not occurred to date. The physician noted that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No x-rays were taken.

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dennis100
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« Reply #427 on: March 09, 2019, 02:18:32 AM »

Model Number 300-20
Device Problem Fracture
Event Date 05/18/2018
Event Type  Malfunction   
Event Description
Initial report was an implant card received indicating that a patient underwent generator replacement due to high impedance. It was noted on the implant card that the lead had an "electrode defect. " further information was received that the generator was replaced due to eos. It was stated that "the battery was so empty that the physicians could not do an interrogation. " after generator replacement high impedance was observed. It was stated that the surgeon spent 5 hours trying to explant the lead and the "gave up and decided to speak with the treated doctor how to proceed. " further information was received that there was "many fibrosis that the physician did not get through the vaugs. " the lead was not replaced. It was also stated that a dual pin lead was not available during the surgery for replacement. The operation was stopped to further consult the patient's treating physician. The explanted generator was reported to be given to the patient's parents. It was stated that due to the surgery circumstances and the lack of x-ray availability during the surgery, the surgeon speculated that the electrode may be broken. Further information was received indicating that patient physiology was the cause of the fibrosis and that no intervention was taken for the fibrosis. The only noted reason that the surgery took several hours was that the surgeon was attempting to clear the fibrosis for several hours before deciding to end the surgery and consult the referring physician. No known surgical intervention has occurred to date. No other relevant information has been received to date.

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dennis100
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« Reply #428 on: March 18, 2019, 02:09:23 AM »

Model Number 300-20
Device Problem High impedance
Event Date 09/08/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient铠system was tested and high impedance was observed (impedance value > 6520 ohms). The physician was advised to turn off the device. X-rays were taken and provided to the manufacturer for review. The generator appears in the upper left chest in a normal arrangement. The filter feed-through wires appeared to be intact. The lead-pin was fully inserted into the generator's connector block. The electrodes appeared to be placed on the vagus nerve in a normal arrangement. A strain-relief bend and loop were visible. Only one tie-down was found holding the lead. Part of the lead was behind the generator. No lead break or sharp bend was found on the visible parts of the lead. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Event Description
Further information was received indicating that the patient was seen in clinic for a surgical intervention on (b)(6) 2015. The vns patient's device was tested and system mode diagnostic returned again high impedance (5790 ohms). The device communication, output status and current delivered were all ok. The generator battery showed 100% (ifi = no). It was reported that the patient is seizure free and did not report any side effects. The surgeon team decided to not perform the lead replacement surgery as it appears to be not necessary. The surgeon team believed that high impedance could be a result of scar tissues. It was reported that the physician will continue to follow-up the patient, in a regular way.

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dennis100
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« Reply #429 on: March 19, 2019, 01:17:36 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/28/2015
Event Type  Malfunction   
Event Description
A report was received indicating that a patient's device was exhibiting high lead impedance. X-rays were ordered and there was indication that the patient may undergo full system revision. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
X-rays were submitted to the manufacturer for evaluation. The x-rays did not reveal any gross fractures, discontinuities, or sharp angles in the portion of the lead that could be assessed. A portion of the lead was not visible on the x-rays and therefore could not be evaluated. A definitive cause for the high impedance could not be determined from the images provided and the presence of a microfracture could not be excluded. The patient's treating neurologist indicated that the high impedance was measured via system diagnostics from the device on (b)(6) 2015 and that the device output was disabled on that date. The patient was referred for surgical consult and the surgeon indicated he planned to evaluate the generator pin connection first and then perform a full system revision if necessary. Surgery is likely but has not occurred to date.
 
Event Description
The patient underwent successful generator lead explant and replacement on (b)(6) 2016. No visual anomalies were reported regarding the generator pin connection or the lead body. An implant card received indicated the reason for replacement to be lead discontinuity. The physician noted scar tissue on the nerve in the location of the former lead electrodes but was able to successfully remove the former electrodes and place the new electrodes in the same area. Impedance measurements were normal. The explanted generator and lead were discarded by the explanting hospital.

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« Reply #430 on: March 21, 2019, 01:09:06 AM »

Model Number 103
Event Date 09/25/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was complaining of swelling and tenderness around the generator site. The swelling and pain was believed to be due to some scar tissue that had developed since implant that caused severe pain and irritation when the patient moved her arm. The patient underwent a generator pocket revision surgery on (b)(6) 2015 and a hematoma was identified at the generator site. It was reported that this was caused by the patient doing some lifting too soon after vns implant surgery. No migration had occurred. The hematoma was drained and the generator was re-sutured in place. Diagnostics following the revision were within normal limits. No additional relevant information has been received to date.
 
Event Description
The patient was seen in follow-up with the surgeon and it was noted that there was still swelling in the neck area. The surgeon ordered a laser treatment, but is certain he will need to proceed with another surgery. No additional surgical interventions have been performed to date.
 
Event Description
It was reported that the patient was seen by an ent who performed a laser procedure. It was found that there is a gland that is leaking and a procedure will need to be performed. No additional relevant information has been received to date.

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« Reply #431 on: March 23, 2019, 01:12:35 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On 11/18/2015 it was reported that a patient was implanted in (b)(6) 2015 and did receive benefit from the vns. However, there was an ongoing latent infection that persisted. They thought the patient was allergic to the system but upon explanation today they were able to see there was an infection behind the generator. Also, previously the wound in the neck had some secretions and issues; therefore they believe that where it stemmed from. It was also reported that the nerve appeared scarred and not viable for another implantation. The patient's identity was not provided. Additional information has been requested from the physician but no further information has been received to date.
 
Event Description
This report is a duplicate of mfr. Report # 1644487-2015-06659. All further information will be reported under mfr. Report # 1644487-2015-06659.

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dennis100
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« Reply #432 on: March 23, 2019, 01:13:20 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the physician ran a system diagnostic test and received high impedance. The patient was referred to the surgeon. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2016 the patient underwent a full revision. The surgeon first just replaced the generator but high impedance was still observed. The surgeon decided the left side was too scarred so he proceeded with right sided implant of the lead and generator. The old leads were cut with less than 2 cm of lead with electrodes left on the nerve. The explanted devices were requested for return but they have not been received to date.
 
Event Description
On (b)(6) 2016 it was reported that the explanted device cannot be returned for product analysis as the hospital requires a patient signed release.

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« Reply #433 on: March 31, 2019, 07:20:10 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/30/2015
Event Type  Malfunction   
Event Description
It was reported through clinic notes dated (b)(6) 2015 that the patient's vns system indicated a high lead impedance. Surgery to explant the lead has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient's generator and lead were explanted. The explanting facility discards products per their protocols, so return and analysis of the explanted devices could not be performed. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient¿s nerve remained irritated due to the presence of fibrotic scar tissue. No medical intervention was noted for the fibrosis, but its relation to the high impedance has not been clarified to date. No additional pertinent information has been received to date.
 
Event Description
Communication with the explanting surgeon showed that fibrosis was observed around the lead coils at the time of explant. No assessment was given that described any potential contribution to the reported high impedance. No additional pertinent information has been received to date.

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« Reply #434 on: April 01, 2019, 12:47:47 AM »

Event Date 02/09/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient's device had high lead impedance and was in referral for surgical revision. No known surgery has occurred to-date. No additional information has been received to-date.
 
Event Description
Clinic notes dated (b)(6) 2016 were received for the office visit where high impedance was found. The high impedance was detected on (b)(6) 2016 and the battery status was observed as intensified follow-up indicator = yes. Generator and lead revision surgery occurred (b)(6) 2016. The explanted products have not been received to-date. Additional relevant information has not been received to-date.
 
Event Description
It was reported that the hospital has likely discarded the explanted products.
 
Event Description
Operative notes were received, which reported that the patient had also experienced an increase in seizure frequency and intensity. During the revision surgery, scarring on the nerve was observed which was dissected free, as well as mineralization of the electrodes at the nerve site.

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« Reply #435 on: April 05, 2019, 01:38:40 AM »

Model Number 302-20
Event Date 07/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On 5/16/2016 the patient¿s mother reported that her daughter¿s generator was unable to be interrogated by the new physician and that her previous physician noted an ¿impedance issue¿ at the last appointment on (b)(6) 2015. The mother noted that it was very difficult to get her daughter's device managed because she was never able to consistently see a physician or at the same facility. The patient¿s mother then stated that over the last several months ((b)(6) 2015), her daughter has been having an increase in grand mal seizures and the mother was concerned that it would get worse. The mother confirmed that the patient is not as bad as she used to be prior to the vns therapy. The patient¿s mother later reported that high impedance had been seen during the clinic visit on (b)(6) 2015. At that time, no therapy level adjustment was made to discontinue therapy. The doctors had told the patient the high impedance was possibly due to scar tissue but therapy was allowed to continue. The patient¿s new doctor is unable to communicate with the patient's vns therapy system and the patient reports an increase in seizures as well as a failure of the magnet to abort the seizures. The patient¿s settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min. A review of the patient¿s programming history revealed that system diagnostics performed on (b)(6) 2015 showed results within normal limits and no high impedance.
 
Event Description
Generator and lead replacement surgery occurred on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date.
 
Manufacturer Narrative
Relevant test data, corrected data: the date of systems diagnostics was inadvertently reported as (b)(6) 2015, when the date was intended to be reported as (b)(6) 2013.
 
Event Description
Additional information was received that the patient was referred for revision surgery. It was reported that the device had been turned off for a while. The generator and lead were explanted on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted lead and generator were received. Analysis was completed for the returned lead portions. The lead coil appeared to be broken approximately 1mm and 2mm from the end of the electrode bifurcation. A short section of coil was observed between the two coil breaks. Scanning electron microscopy was performed on the coil break found at 1mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Scanning electron microscopy was performed on the short section of the coil break found between 1mm and 2mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the coil break found at 2mm and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Abraded openings were found on the outer silicone tubing, and most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the connector boot. During the visual analysis electrode ribbons appeared to be partially embedded in what appeared to be remnants of dried body tissue. With the exception of the observed discontinuities, abraded openings and tissue covered electrode ribbons the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. No other anomalies were noted. Analysis was completed for the returned generator. Review of the downloaded data from the pulse generator shows high impedance on the date of explant, (b)(6) 2016. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The pulse generator was interrogated at multiple orientations adjacent to the programming wand. The pulse generator interrogated at all orientations. The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment. Results showed that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring, demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, voltage measured 2. 938 volts and shows the intensified follow-up indicator was not set. The downloaded data revealed that 26. 496% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #436 on: April 05, 2019, 01:39:57 AM »

Model Number 302-20
Event Date 08/03/2015
Event Type  Malfunction   
Event Description
A report was received indicating that a patient's vns system had been replaced on (b)(6) 2015. The stated reason for generator replacement was prophylactic due to ifi (low battery) and the reason for lead replacement was high impedance found during the generator replacement surgery. Review of available programming and diagnostic data revealed no anomalies. The lead impedance value on the reported date of explant ((b)(6) 2015) was normal at 1603 ohms. A battery life calculation performed with available data indicated the device had 1. 5 years remaining until neos = yes as of the reported date of explant of (b)(6) 2015. Operative notes were obtained and indicated a pre-operative and post-operative diagnosis of "vagal nerve stimulator malfunction. " the notes indicate that the patient presented for pulse generator replacement. After removal of the prior generator and attachment of the new generator high impedance was observed. After further inspection the lead was noted to be broken necessitating a full system revision. The physician felt the root cause was the fact that the battery (generator) was right over the bone and held down tight with the pectoralis muscle. A new lead was implanted and connected to the new generator and normal impedance was observed. The notes indicate that the procedure was complicated due to severe scarring of the carotid sheath due to previous revision of the lead (see mfg. Rpt. # 1644487-2010-01436). The explanted pulse generator and lead were returned to the manufacturer and are now undergoing product analysis.
 
Event Description
Follow-up revealed that no pre-explant malfunction was suspected and that only the low battery ifi condition led them to indicate "vagal nerve stimulator malfunction" in the operative notes. There was no indication of any pre-surgical anomaly other than the low battery condition. Analysis of the returned lead portions confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Stress induced fractures were noted at some of the fracture points. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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 found inside the outer and inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Analysis of the pulse generator revealed an end-of-service warning message which was found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant. The pulsedisabled byte would not reset. With the pulse generator case removed and the battery still attached to the printed circuit board, the battery measured 1. 988 volts, confirming an eos condition. Data in device memory revealed that 91. 424% of the battery had been consumed. The electrical performance of the generator as measured in the product analysis lab indicates that no anomalies exist and the end-of-service (eos) condition is an expected event.

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« Reply #437 on: April 06, 2019, 01:34:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

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« Reply #438 on: April 07, 2019, 02:31:25 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 #439 on: April 09, 2019, 12:39:01 AM »

Event Type  Malfunction   
Event Description
An article titled "complications and safety of vagus nerve stimulation ¿ 25 years¿ experience at a single center¿ was published and the abstract was reviewed, which included adverse events involving vns patients. In many procedures performed between 1990 and 2014, patients suffered from complications related to vns surgery. The article reports of thirteen lead malfunctions in 12 patients (no children). Lead exploration to try to salvage the lead was required in 5 cases, 1 was successful and the remaining resulted in replacements. In 2 adult patients, an immediate postoperative lead disconnection was suspected, resulting in an early surgical reconnection. This was probably due to unsuccessful connection between the lead and stimulator during primary surgery. It is unclear if the surgeon performed a proper lead test in these cases. Not all lead fractures were visible on radiography, and the lead failures were mainly detected by diminished function, e. G. , increased seizure frequency and increased impedance measurement leading to revision or replacement of the lead. Only a few were detected on radiography, and the etiology of high impedance is not entirely clear. Some have described lead failure in the absence of visible fractures as ¿microlesions¿ within the lead cable others have presented significant scar tissue around the as a possible cause of high impedance. We report 13 cases (3. 0%) of lead malfunction, of which no children were involved. Previous studies report 0. 5% to 20. 8%. The present reports of patient ((b)(6) at first implant) had a high lead impedance (lead failure or significant scar tissue) which was detected by diminished function (increased seizure frequency/increased impedance measurement). The patient had a full revision surgery in 1 session after 3. 4 years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5694084
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« Reply #440 on: April 10, 2019, 01:36:36 AM »

Model Number 302-20
Event Date 01/10/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient underwent full replacement surgery on (b)(6) 2016. The generator was replaced due to battery depletion. It was reported that the lead was replaced due to severe fibrosis which caused high impedance. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with 1285 ohms. It was reported that high impedance was discovered on (b)(6) 2016 during a routine follow-up visit. As reported, it was first thought to be caused by a lead break but it appeared, during the surgery, to be due to fibrosis. It was reported that the explanted devices could not be returned to the manufacturer. Therefore, no analysis results could be provided. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5808146
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« Reply #441 on: April 11, 2019, 02:32:15 AM »

Model Number 304-20
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had a lump under her jaw. She was experiencing pain and flushing with and without device stimulation. The physician evaluated the lump and assessed that it was related to the vns lead but was unsure how. The patient was referred to a surgeon for evaluation and after the evaluation she was referred for lead revision surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent exploratory surgery on her neck at the vns electrode site. During the surgery the surgeon removed an existing tie down because he believed it was too superficial and along with scar tissue it was causing the mass and pain in the patient's neck. The surgeon left a second tie in place since it was deeper and he did not believe it was contributing to the mass or pain. The vns lead and generator were left implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780196
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« Reply #442 on: April 15, 2019, 12:46:24 AM »

Model Number 304-20
Event Date 09/06/2016
Event Type  Injury   
Event Description
It was reported through an implant card that patient underwent a full revision due to strong fibrosis and stimulation of the muscle. Company representative was present in the or. The plan was a lead replacement but after the connection of the new lead to the generator a "near end of service" flag was observed. They decided to replace the generator as well. Company representative indicated that the follow up physician has the patient in visit in (b)(6) 2016 for the last visit before the intervention took place. No product failure was reported or suspected. It was reported that no explanted devices are available for the return.
 
Event Description
Further follow up indicated that the surgeons saw the fibrosis on the mri, and so they decided to perform new lead implantation. It was reported that sometimes the patient felts the stimulation because the muscle twitched. This is more a physiological process by the patient. The available programming history data was reviewed, this review showed that the diagnostic test was recorded only on two dates: on (b)(6) 2012 the impedance value was 1864 ohms and on (b)(6) 2012, the lead impedance was 3473 ohms. Those values support the reported fibrosis. Further attempts, to obtain more information about this incident, were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5989722
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« Reply #443 on: April 15, 2019, 12:47:07 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported the patient needed to be scheduled for a full vns revision due to high impedance. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient underwent full revision surgery on (b)(6) 2016. It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant. It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed. After the new generator and lead were replaced, the diagnostics were confirmed as ok. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received noting the devices were discarded after surgery. Therefore, the devices are not expected for return and no analysis will be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857766
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« Reply #444 on: April 15, 2019, 12:48:49 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.
 
Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
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« Reply #445 on: April 29, 2019, 05:45:37 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/08/2017
Event Type  Malfunction   
Event Description
A call was received from a physician indicating that high impedance was seen with the patient's device. The patient's device was then programmed off. There was no reported trauma or manipulation that is believed to have caused the high impedance. No x-rays were taken at this time and no surgical intervention has occurred to date. A decoder revealed that no high impedance had been seen as of (b)(6) 2016. No other relevant information has been received to date.
 
Event Description
It was reported that the patient was underwent lead and generator replacement surgery. The surgeon found that the lead appeared intact and the old electrodes appeared to be in full contact with the nerve however it was the surgeon's opinion that the strain relief of the previous lead was not adequate. However the placement of the previous lead has not been evaluated by the manufacturer therefore its unclear if the strain relief was placed per labeling. The surgeon also noted that there was fibrosis adhering the lead electrodes to the vagus nerve and the jugular vein. The surgeon did not want to disturb the scar tissue so the lead was clipped at the electrodes and the new electrodes were implanted above the old electrodes. The explanted lead and generator have not been received to date.
 
Manufacturer Narrative
"the explanted lead and generator were received. " this information was inadvertently left off on mfg. Report #1. Corrected data: device available for evaluation; this information was inadvertently left off on mfg. Report #2. Corrected data. Device evaluated by mfr; this information was inadvertently left off on mfg. Report #1. Corrected data: (b)(4).
 
Event Description
The explanted lead and generator were received. Analysis was completed for the generator and found that the device met functional specification. During test various electrical loads were attached to the generator and the results of subsequent diagnostic tests were as expected.
 
Event Description
Analysis was completed on the lead. It was noted that the lead was received in one portion however the segment containing the electrodes and tie downs was not returned. Setscrew marks were observed on the lead¿s connector pin; indicating that there was proper contact between the lead and generator at one point in time. Fractures were identified in the quadfilar coil in two parts of the lead. Scanning electron microscopy was used to evaluate the lead fracture and observed signs of pitting which indicates that stimulation was being provided after the fracture occurred. Abrading openings were also identified in the outer tubing and bodily fluid was found inside the outer tubing in various locations.

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« Reply #446 on: May 03, 2019, 01:45:16 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6449279
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« Reply #447 on: May 05, 2019, 12:55:56 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
Clinic notes were received for a replacement referral from a visit dated (b)(6) 2017. Within the notes it was provided that after interrogation the device was non-functional. The patient was reported to have done very well with vns. It was stated she developed seizures over the past weeks. Follow-up from the company representative provided that the patient had seen the neurologist and a message indicating high lead impedance displayed. The neurologist had lowered the patient¿s output current. At surgical consult, the surgeon interrogated the device and the same message appeared. Systems diagnostics were then performed and were within normal limits. Four days later at surgery on (b)(6) 2017, the previous generator was removed and the new generator was placed. Systems diagnostics performed while the lead was connected to the new generator were within normal limits. The surgeon asked the company representative to interrogate the previous generator after it was removed (no lead attached). The high lead impedance message again appeared after doing so. The company representative asked the surgeon about the lead pin insertion with the previous generator, and he stated he had visually inspected the lead pin and found it to have been fully inserted. The lead in the generator pocket area was heavily coiled and appeared to have a kink in a portion with evidence of scar tissue. He stated he did not visually observe a fracture or breaks in the lead. Additional relevant information has not been received to-date. No known surgery has occurred to-date to replace the lead.
 
Manufacturer Narrative
Event description, corrected data, it was inadvertently not provided on the initial report that the explanted generator was discarded by the explant facility.
 
Event Description
The explanted generator was reported to have been discarded.
 
Event Description
The explanted generator was first reported to have been discarded, however was later available for return. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted generator was received and analysis was completed. The pulse generator was interrogated successfully at multiple orientations adjacent to the programming wand. Various electrical loads were attached to the generator diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24 hours, in a simulated body temperature environment. Results showed no signs of variation in the output signal and the device provided the expected level of output current for the entire monitoring period. Diagnostics were as expected for the programmed parameters. Electrical evaluation showed the generator performed according to specifications. The battery, was not at an end-of-service condition. The downloaded data revealed that (b)(4)% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #448 on: May 20, 2019, 09:37:15 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2008
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by a surgeon that in the past the patient had a severe infection and had to be explanted. The site of the infection was at the neck and around the vagus nerve. The infection had left scarring that made it impossible to re-implant on the left vagus nerve. The manufacturer's device history records were reviewed and verified sterilization prior to final release. No further relevant information has been received to date.
 
Manufacturer Narrative
The original report did not indicate that intervention was required.
 
Event Description
Operative notes were received describing the patient's explant surgery due to her infection. This operation was planned as an exploratory surgery due to exuberant granulation tissue and believed wound breakdown at her neck incision. The generator pocket was palpated, and upon compression, there was visible cloudy fluid extravasating from the cervical wound consistent with a continuous infected fluid pocket. For this reason, both the lead and generator were explanted. The scarring was noted to be extensive during lead explant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566676
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