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dennis100
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« Reply #30 on: July 28, 2017, 07:02:42 AM »

Model Number 302-30
Event Date 03/01/2011
Event Type  Malfunction   
Event Description
A physician reported that a patient had received high impedance on a normal mode diagnostic test "the other day. " the last acceptable diagnostics were performed in (b)(6) 2010 with a dcdc code on 2 on normal mode diagnostics. The patient's current settings were 0. 75 ma/20 hz/250 microsec/30 sec/5 min and 1 ma/60 sec/500 microsec. There was no reported trauma or manipulation preceding the event, and no adverse events were reported. X-rays were going to be taken of the patient to identify any observable issues. X-rays were received by the manufacturer and no obvious discontinuities or anomalies were noted; however, there did appear to be an acute angle in the lead body on one of the received x-rays, although the remaining three views did not show it. It was decided by the treating physicians that a revision surgery would be postponed in the short term - the patient was present at an appointment and stated he was not sure if the vns "ever worked. " the physicians agreed to disable the patient's device and re-evaluate his status later. Follow-up with the local company representative, through, indicated that the neurologist felt that the device had been helpful for the patient. Based off the information received to date, a revision surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinues visualized. 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=2050195
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dennis100
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« Reply #31 on: July 29, 2017, 09:22:23 AM »

Model Number 103
Event Date 05/06/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, it was reported by a vns treating neurologist's registered nurse, that the vns pt presented with high impedance that day with lead impedance greater than 10000 ohms. The pt had their battery replaced in (b)(6) 2010, and on (b)(6) 2011, the pt came in and system diagnostics were run, with output status = ok, lead impedance = ok of 2406 ohms, and ifi = no. The device was disabled on (b)(6) 2011, and x-rays were taken. The nurse reported that no obvious lead breaks were observed, but they did see "kinks" in the lead wire in a couple of different spots. They referred the pt for surgery to replace the whole system. The pt is also having an increase in seizures, but it is unk if they are above or below pre-vns baseline levels. The pt's mom denies any trauma to the pt's device, but the nurse said that the pt is very active. Ap and lateral x-ray views of the chest and neck were received for review on (b)(6) 2011. Based on the views received, it appeared that a possible incomplete pin insertion could be contributing to the observed high impedance. However, an unpronounced lead fracture or discontinuity cannot be ruled out. Clinic notes were received from the physician and review of the clinic notes dated (b)(6) 2011, state that the vns pt was hospitalized in (b)(6) 2011, for seizure activity and a prolonged postictal state. A workup done at the time was unremarkable. A month ago, the pt had mononucleosis and with it, had a marked increase in her seizure activity. The pt was also seen for an upper respiratory infection and ear infection at that time. The physician states that he wonders if the increase in seizure activity is secondary to the vns being disconnected. On (b)(6) 2011, the pt went for surgery. During pre-op interrogation, diagnostics were within normal limits of 3000ohms but surgery continued. The hospital reported that during surgery, only the pt's generator was replaced. Explanted product return has been requested from the hospital, but it has not yet been received by the manufacturer. When additional info is received, it will be reported.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2101953
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dennis100
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« Reply #32 on: July 29, 2017, 09:23:00 AM »

Model Number 102
Event Date 04/19/2011
Event Type  Malfunction   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, lead pin not fully inserted past the connector block of generator.
 
Event Description
On (b)(6), 2011, a vns treating physician reported that the vns pt presented with high impedance during their last visit on (b)(6), 2011. System diagnostics were run on (b)(6) 2011, which showed output = limit/lead impedance = high/ dcdc = 7; normal mode diagnostics showed the same results. The pt is doing well with no increase in seizures or pain. The pt's settings were 1. 75/30/500/30/3 but the pt was programmed to 0ma prior to leaving. The pt went for x-rays and they were reviewed by the mfr on (b)(6) 2011. Using the curvature of the generator can, the connector pin did not appear to be fully inserted into the connector block. Furthermore, the end of the connector pin could not be visualized past the connector block. There did not appear to be any gross fractures or discontinuities in the lead body; however, there did appear to be two sharp angles in the lead body, one near the anchor tether and the other prior to the first tie-down. There was a portion of the lead body coiled behind the generator that was unable to be assessed. Based on the x-ray review, the connector pin appearing to not be fully inserted into the generator connector block and the sharp angles could be the cause of the pt's high impedance. No obvious discontinuities were noted in the visualized portion of the lead; however, an unpronounced lead fracture cannot be ruled out. The nurse practitioner reported that she was not aware of any pt manipulation or trauma that occurred that could have caused or contributed to the pt's high impedance. She said that the last time the pt was seen before the high impedance was detected, was on (b)(6) 2010, and the clinic notes state that the vns was interrogated and everything was found as expected but that specifics were not listed. Surgery is likely but has not yet been scheduled. If add'l info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102366
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dennis100
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« Reply #33 on: August 01, 2017, 12:14:26 AM »

Model Number 302-20
Event Date 05/19/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a company representative that a vns patient was in a follow-up appoint and high lead impedance (>10,000 ohms) was read during diagnostics. The patient's generator was programmed off due to the high lead impedance and was referred for x-rays. Further information was received from the patient's treating neurologist indicating the high lead impedance was found on (b)(6), 2011. Furthermore, the treating neurologist had no additional diagnostics for the patient to pin point good results as the patient was a new referral. There was no medical history of any severe trauma. Manipulation was as in daily care of a severe motor and mental handicapped youth in accordance to the treating neurologist. X-rays were taken and received by the manufacturer. Review of x-rays revealed that the generator placement appeared to be normal and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. A portion of the lead was behind the generator. Acute angle observed in the neck area. No lead breaks were observed in the portions of the lead that could be assessed. At the moment no interventions have been planned yet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2189258
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dennis100
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« Reply #34 on: August 03, 2017, 07:23:49 AM »

Model Number 302-20
Event Date 06/16/2011
Event Type  Malfunction   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a physician that the pt came into the office "not feeling the vns". The pt was said to be very depressed, so diagnostic testing was performed, which resulted in high impedance. The device was disabled and x-rays were taken. There was no known trauma or manipulation to the pt or device. The x-rays were reviewed by the mfr. The connector pin appeared to be fully inserted, the filter feed thru wires appeared intact, and the lead wires appeared intact at the connector pin. No obvious discontinuities were observed. However, an acute angle in the lead body was noted where the lead exits the final tie-down before heading caudally toward the generator can. The pt's last known settings were from (b)(6) 2010 and last known diagnostics on (b)(6) 2009 showed the device to be properly functioning. A revision surgery in the future is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2182411
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dennis100
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« Reply #35 on: August 10, 2017, 07:23:14 AM »

Model Number 303-20
Event Date 08/18/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The generator and lead were returned to the manufacturer on (b)(4) 2011. Additional information received from the return product form indicated that the ''generator screw would not release lead after one trial tightening. '' product analysis on the generator has been completed. No mechanical anomalies were observed with the returned torque wrench or generator. The torque wrench functioned properly when tightening the setscrew on the generator. Visual inspection results revealed that the septum was damaged on the inside by the setscrew; small pieces of the septum were in the hex head socket of the setscrew. No anomalies were noted on the hex head socket of the setscrew. A test resistor was inserted into the lead cavity and the setscrew tightened and secured the test resistor with the returned torque wrench. No anomalies were noted on the hex head of the torque wrench. No surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. Results of diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that during the patient's initial implant procedure, a lead and generator were opened and not used because the set screw broke intraoperatively. Attempts for additional information and product return have been unsuccessful to date.
 
Event Description
Additional information was received from the product analysis. When returned, the lead pin was still attached to the generator. Also, during the decontamination process, the pieces of septum which were observed inside the hex head socket of the setscrew may have been removed, so it is unknown if the pieces could have contributed to the inability for the setscrew to be loosened. Also, the damage to the septum was observed on both the slit side, most likely caused by the torque wrench, and the underside most likely caused by backing out the setscrew to make sure it wasn't binding on the lead tip - to allow removal. Product analysis on the lead was completed on (b)(4) 2011. During product analysis the connector pin was found to be bent. Identification of the reported bent pin may confirm this to be a contributing factor for the reported event; however, the exact point in time of when this occurred is unknown. The lead connector boot appears to have been torn and the lead coils appear to have been torn at this location as well. Also, the connector ring has noticeable scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is also unknown. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified within the returned lead portions. Follow up was performed with the implanting surgeon regarding the bent pin. The surgeon indicated that the pin did not appear bent or misshapen prior to implant. He indicated that the setscrew would not reverse initially, however when it did, he then could not remove the pin. The device history record for the lead was also reviewed. It was confirmed that the lead passed all functional and visual inspections prior to shipment.
 
Manufacturer Narrative
While no device failure was identified during product analysis of the device, it is likely that user interface caused the damage to the septum.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2279016
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dennis100
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« Reply #36 on: August 19, 2017, 02:39:05 AM »

Model Number 302-20
Event Date 09/12/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a company representative that high lead impedance (7/limit/high) was received at a follow-up appointment with the treating neurologist. The patient was referred for x-rays. X-rays were received and evaluated by the manufacturer. Review of x-rays indicated that the generator was visualized in a normal placement in the left upper chest. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The positive electrode appeared to be placed in normal arrangement. The negative electrode could not be assessed due to lack of neck x-rays. The lead wires at the connector pin appeared to be intact. No lead breaks were observed in the assessed portions of the lead. However, an acute angle appeared to be present slightly below the lead bifurcation. Further information from a company representative indicated that there was a possibility of trauma as the patient suffers from many tonic seizures with several drops from a wheelchair. At the moment no interventions have been planned however replacement surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2314931
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dennis100
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« Reply #37 on: September 01, 2017, 01:31:00 AM »

Model Number 104
Event Date 11/14/2011
Event Type  Malfunction   
Event Description
X-rays of the patient's device were received and reviewed by the manufacturer. A sharp bend appeared to be present in the x-ray dated (b)(6) 2011, in a portion of the lead above the generator. Based on the x-ray images provided, the cause of the high impedance was not determined, however the sharp bend may be a potential reason. The presence of a micro-fracture cannot be ruled out. Also, since a portion of the lead was located behind both generators, the entire lead could not be assessed.
 
Event Description
It was reported that the pt's device was showing high impedance with his new generator (implanted about a month prior). It was verified that diagnostics were indeed run on the date of implant and everything came back fine at that time. X-rays were taken, but have not been sent to the mfr for review. Revision surgery is likely, but has not occurred to date.
 
Event Description
It was reported that surgery is likely; however, the surgery is not related to these events or this report. Clinic notes dated (b)(6) 2016 reported that device diagnostics were still within normal limits with lead impedance of 1278 ohms. Review of the in-house programming history database did not reveal any evidence of high impedance on this patient's device. There was no history from around time of implant in (b)(6) 2011. Review of the internal data of the generator shows that high impedance >10,000 ohms was present until system diagnostics was performed on (b)(6) 2012. This is related to high impedance message seen upon interrogation of demi-pulse generators but resolves after completion of a system diagnostics test. No lead issue suspected. Issue related to the generator being programmed on following implant surgery without first performing a system diagnostics test to clear the stored impedance value from manufacturing. Based on the evidence, no device issue occurred.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Further information from physician reveals that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No surgery or other interventions have occurred to date.
 
Event Description
The high impedance previously observed was due to a stored impedance value from manufacturing. This is not a device failure. No additional relevant information has been received.
 
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #3 inadvertently mis-assessed the diagnostics in relation to the model generator which does not have dcdc values or limit output status; rather, the model generator has specific impedance values.
 
Event Description
Upon further review of the information provided by the physician on (b)(6) 2012, it was indicated that high lead impedance was detected on a systems diagnostic test. However, the physician did not provide the dcdc code or the output status. Therefore, it is unknown if the dcdc was 7. Although the physician reported that the high lead impedance was detected on a systems diagnostic test, the company representative reported on (b)(6) 2012, that the physician reported to him that the output status was not at limit, so the physician deduced that the patient is still receiving therapy. The physician plans on continuing to monitor the patient, but the patient is not being referred for surgery at this time. The company representative suspects that the physician saw high impedance during a normal mode test rather than a systems test as initially reported.
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: the initial report inadvertently reported that during a systems diagnostic test the output status = limit and dcdc=7, but the physician did not report this information. The physician only reported that lead impedance = high and eri=no during the systems diagnostic test.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2432841
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dennis100
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« Reply #38 on: September 03, 2017, 01:07:00 AM »

Model Number 302-20
Event Date 01/30/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a nurse that high impedance was found at a follow-up appointment. X-rays were taken, electrode placement seemed ok as does the lead and pin insertion in accordance to the nurse. The device was switched off due to the high impedance. The nurse also reported that the patient is a known twiddler and fiddles with the device; however it is unknown if the patient contributed to the high impedance reported. X-rays were received by the manufacturer and reviewed. Review of x-rays indicated the generator was visualized in the left upper chest. The filter feed-through wires appeared to be intact, and the lead connector pin appeared to be fully inserted into the generator connector block. Part of the lead was visible, apart from a section of the lead that is placed behind the generator and could therefore not be assessed. Electrodes seem correctly aligned on the vagus nerve. One acute angle was observed in the assessed portions of the lead, distal to the positive electrode; however no obvious lead break could be identified in the visible portion of the lead. At the moment lead revision surgery is planned but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465799
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dennis100
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« Reply #39 on: September 06, 2017, 01:10:51 AM »

Model Number 302-20
Event Date 01/11/2012
Event Type  Malfunction   
Event Description
Product analysis was completed on the returned vns generator and lead. The generator was found to be at normal end of service. The depletion was an expected event as determined by a battery life calculation (-0. 67 years) and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The abraded opening found on the lead outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Note that since 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
Reporter indicated that during a prophylactic vns generator replacement, the vns lead was noted to be kinked and fractured in the generator pocket. A new vns generator and lead was implanted. No x-rays were done prior to the surgery, and no recent vns diagnostics results were available. It is unknown if the patient had any trauma or manipulated the vns. The explanted vns generator and lead have been returned and are pending product analysis.
 
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.
 
Manufacturer Narrative
Device failure occurred, 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=2442524
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« Reply #40 on: September 07, 2017, 02:55:00 AM »

Model Number MODEL 250
Event Date 11/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician¿s handheld device was not functioning. The battery latch would not close and therefore the device could not be used. The wand was confirmed to not be causing or contributing to the issues. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and flashcard were completed where no issues were found with the flashcard or associated software. During analysis of the handheld it was observed that the battery latch was functioning properly however the handheld device would still not power on. The cause for the inability to power on was due to a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld device from powering on (this condition can also cause the handheld device to power off intermittently). Additionally it was identified that the main battery was unable to fully charge and power the handheld device for over 30 minutes. The cause for the anomaly is associated with a defective main battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347788
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dennis100
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« Reply #41 on: September 08, 2017, 01:32:35 AM »

Model Number MODEL 250
Event Date 02/29/2012
Event Type  Malfunction   
Event Description
It was reported that the company representative was able to pick up the suspect serial cable for return to the manufacturer. The cable was received on (b)(4) 2012. However, product analysis has not been completed to date. The company representative reported that the serial cable adapter connector appeared bent.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that a physician's handheld computer was not charging properly. The company representative followed up with the site and confirmed that the computer was not properly charging. When the serial cable adapter connector was pushed upward, it would charge. However when the adapter connector was released, the battery icon would stop showing that the computer was being charged. Attempts for product return have been unsuccessful to date.
 
Event Description
Product analysis for the dell x50 handheld computer serial data/power cable was completed on (b)(6) 2012. It confirmed an open conductor in the cable which resulted in unreliable operation (power). The cause is associated with a broken wire connection in the serial cable plug assembly. Once the wire connection was restored using a jumper wire, no further anomalies were identified and full product functionality was restored.
 
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=2502396
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« Reply #42 on: September 08, 2017, 01:33:10 AM »

Model Number 302-20
Event Date 09/01/2006
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description 
It was reported that the vns patient's lead and generator were explanted, as the device was no longer needed. The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the generator revealed no anomalies, and the device performed according to specifications. Analysis of the lead revealed a lead fracture with pitting, which was identified on the positive coil in the body region of the lead near the connector boot. Sem performed on the positive coil break, showed that pitting or electro-etching conditions had occurred at the break locations. Also, sem showed what appears to be abrasive wear on the coil wires at the break location. Due to mechanical distortion and/or metal dissolution, the fracture mechanism cannot be determined. An abraded opening in the inner and outer tubing was observed in the lead body below the electrode bifurcation. The abraded opening was found in the product analysis laboratory to be wear-related. Further follow up was performed with the treating neurologists office based on the pa results. It was communicated that in sept. 2006, the patient began "clawing at the neck incision site", and the patient was experiencing irritation at the site, which was clarified as constant left neck pain. The patient was referred for x-rays to assess the integrity of the vns system. The surgeon, who received the x-rays, observed an acute angle in the lead body in the sternocleidomastoid. The surgeon further explained that this may be putting tension on the lead and causing the pain. There were no discontinuities observed, and that the observations did not lead him to believe that the lead was in imminent risk of causing a lead malfunction. It was also noted that the generator may have moved. Further follow up revealed that the presence of the acute angle, tension in the lead, and the generator migration were a direct result of the patient's manipulation of the device in the neck region. The last diagnostic testing was done on (b) (6) 2006, where system diagnostic test revealed normal device function. There was no additional diagnostic testing performed on the device, even when the pain began in (b) (6) 2006. The site could not state conclusively that the patient manipulation is what actually caused the fracture, due to lack of diagnostic testing from (b) (6) 2006 and (b) (6) 2006.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1494610
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« Reply #43 on: September 08, 2017, 01:34:00 AM »

Model Number 300-20
Event Date 03/05/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The generator was confirmed to be at end of service; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications and no abnormal performance or any other type of adverse condition was found with the generator.
 
Event Description
On (b)(6) 2012, the manufacturer's consultant reported that during the patient battery replacement surgery that day due to end of service (eos), high impedance was seen during the pre-operation diagnostics. A system diagnostics showed output=limit/lead impedance=high/dcdc=7/eos=yes and a normal mode diagnostics showed dcdc=2/eos=yes. The patient's settings were output=0. 75ma/frequency=30hz/pulse width=750usec/on time=60sec/off time=10min. The consultant then decreased the patient's settings to output=0. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min and then the system diagnostics test showed results within normal limits of dcdc=2/eos=yes. The consultant stated that she believes the patient's head was straight in the first system diagnostics test and turned to the left for the second diagnostics test. During surgery the surgeon stated that the lead was a little kinked close to the generator, but no sign of a lead fracture. The surgeon un-kinked the lead when he implanted the new generator. After the surgeon replaced the generator he performed system diagnostics inside and outside the generator pocket and results were within normal limits of dcdc=2. The leads were not replaced. The consultant performed normal mode diagnostics tests with the patient's head turned to the left, right, and straight and the results were all within normal limits with a dcdc=0/eos=no. The consultant also performed system diagnostics tests with the patient's head turned to the left and straight and results were within normal limits of dcdc=2/eos. The patient was then programmed to output=0. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min. The consultant reported that during surgery was the first time that the high impedance was seen. No patient manipulation or trauma occurred that could have caused or contributed to the patient's high impedance. The explanted generator was returned to the manufacturer on (b)(4) 2011 for product analysis that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2500478
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« Reply #44 on: September 09, 2017, 12:02:44 AM »

Model Number 302-20
Event Date 02/20/2012
Event Type  Malfunction   
Event Description
Additional information was received from the area representative indicating revision surgery is likely, but no date has been confirmed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a nurse that high impedance was received at a follow-up appointment on both normal and system diagnostics. The patient's generator was set to 0 ma and was referred for x-rays. Additional information was received from the treating nurse indicating trauma was not reported and it was unknown if it contributed to the reported high impedance. X-rays were received by the manufacturer and reviewed. The generator was visualized in the left upper chest. The filter feed-through wires appeared to be intact. It cannot be determined from the images if the lead connector pin is fully inserted into the generator connector block. Electrodes appeared correctly aligned on the vagus nerve. Two acute angles were observed in the portion of the lead close to the electrodes, distal to the positive electrode. No obvious lead break could be identified in the visible portion of the lead. At the moment good faith attempts to obtain further information have been unsuccessful to date.

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« Reply #45 on: September 10, 2017, 12:43:16 AM »

Model Number 302-20
Event Date 01/27/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient will have revision surgery either (b)(6) 2013. The site reported that their x-rays showed a lead break. Our review did not show a lead break. It is unknown if another x-ray was attained at the site.
 
Event Description
It was reported by a physician that patient complained of not being able to perceive magnet stimulation when swiping the magnet. The patient was seen at a follow-up appointment and high impedance was found when running system diagnostics. The patient's device was programmed off and the patient was referred for x-rays. Additional information from the treating physician indicated there was no patient manipulation or trauma that contributed to the event. X-rays were to be sent for manufacturer review. Attempts for further information have been unsuccessful to date.
 
Event Description
Surgery is likely but has not taken place.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
X-rays were received and reviewed by the manufacturer. Review of x-rays indicated the generator appeared in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The arrangement of the electrodes on the vagus nerve could not be fully assessed due to lack of a full neck view. However, the visible parts of this portion appeared to be coiled and presented sharp angles. Part of the lead was behind the generator. No clear lead breaks were observed in the assessed portions of the lead, but two sharp angles were observed on at the lowest portion of the lead, next to the generator. Additional information from the treating physician indicated the patient had gone to a different country for a surgical procedure and further interventions will be discussed with the patient when return is planned.

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« Reply #46 on: September 12, 2017, 12:06:09 AM »

Model Number 103
Event Date 02/07/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The site feels the patient not feeling their stimulation is related to their high impedance and seizures are possibly related, but still under investigation at the site. X-rays were received for review. The generator is present in the left chest. The lead wires appear intact at the connector pin. However, the connector pins do not appear to be fully inserted in the x-ray images provided. It appears that one feedthru wire may be bent, but since there is only one angle of the x-rays with the feedthru wires visible, it is unable to be assessed whether the wires are intact. The electrodes appear to be in the correct orientation, but the strain relief is not placed per labeling. A strain relief bend is present, however no strain relief loop is present. The first tie-down is placed lateral to the anchor tether, and the second tie-down is placed lateral to the strain relief bend. However, there is no tie-down securing a strain relief loop. There is a portion of the lead not visible upon the superior portion of the generator, so continuity in that portion of the lead cannot be assessed. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is possibly attributed to the connector pin not being fully inserted into the connector block but unable ot be confirmed as only one view reviewed. In addition, it cannot be assessed whether the feedthru wires are intact. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out. Surgery has not been scheduled at this time.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. A lead pin not being fully inserted into the header of the generator cannot be confirmed. Additionally filter feedthrough wires could not be assessed fully.
 
Event Description
Device history review was performed and all items signed off on prior to distribution.
 
Event Description
The patient had full revision surgery performed on (b)(6) 2013. Their explanted products have not at this time been returned for analysis.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that since the patient's vns has been disabled the patient has been having an increase in seizures. The patient will have surgery scheduled to check the lead pin and possibly a full revision. Unknown at this time if the battery will be replaced. At this time no surgery date is set.
 
Event Description
An update was received in regards to the patient. Their device has been disabled for about a month, and is going to be left off for now. The family feels the vns may not be beneficial for the patient's seizures; however, their treating physician feels it is beneficial since their medication has been increased since the high impedance/device disablement occurred. Since the family feels it has not been beneficial, they have elected not to have the patient's device replaced at this point. In three months, the patient will have an eeg to evaluate if anything has changed. At that point, it will be decided if a replacement will occur.
 
Event Description
The generator was returned for analysis. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 951 volts, (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 41. 803% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 88mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Visual analysis was performed and identified evidence of pitting and deposits on the surface of the connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The condition of the remaining portions of the returned lead is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. 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 in the returned portions of the device. Note that since the electrodes array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
A vns treating physician reported that their was a vns patient showing high lead impedance on his generator. When system diagnostics were performed (high lead impedance >10000 ohms) was noted. The patient's device was disabled at that time and they were referred for x-rays. The physician reviewed the x-rays and didn't notice anything. At this time they have not been sent to the manufacture for review. The patient is a wrestler at school and specifically noted that on (b)(6), he got a really strong jolt twice in the neck while wrestling. The patient now reported that he could no longer feel the stimulation during normal mode and magnet mode, but when did a magnet swipe in the appointment, he had some voice alteration, which is normal for him. The physician initially believed that the patient wasn't getting any efficacy from the therapy since there wasn't a change in the seizures, but since (b)(6), the patient has had an increase in his grand mal and petit mal seizures (baseline above). The parents feel that the patient was receiving efficacy from the therapy. No surgery is planned at this time.
 
Manufacturer Narrative
Suspected medical device: 1, 2, 4 corrected data: updated to generator information. Device manufacture date (mo/day/yr) corrected data to generator information.
 
Event Description
The patient's explanted lead was returned for analysis and is pending completion. It was noted that it was reported that their lead was broken and the patient was having a shock sensation in their neck on the return product form.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.

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« Reply #47 on: September 16, 2017, 12:12:28 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem, corrected data: information regarding the lead pin issue being ruled out and a lead fracture is more likely was inadvertently omitted from follow-up mdr #1.
 
Event Description
Reporter indicated the patient had vns lead replacement surgery performed on (b)(6) 2012. The explanted lead portion will not be returned. Some of the lead body was retained in the patient.
 
Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Suspect medical device, corrected data: the incorrect lot number and expiration date were inadvertently reported on the initial mdr report. The correct lot and expiration dates are provided. Device manufacturing date, corrected data: the incorrect manufacturing date was inadvertently reported on the initial mdr report. The correct manufacturing date is provided.
 
Event Description
X-rays were reviewed by the manufacturer. The lead pin appeared fully inserted into the connector block. No acute angles were observed, and no obvious lead break could be identified in the visible portion of the lead. A portion of the lead was behind the generator and could not be assessed. Surgery to replace the lead is planned, but has not occurred to date.
 
Event Description
It was reported by a physician that high impedance was found during a follow-up appointment. The patient was referred for x-rays in which the physician assessed a kinked electrode. At the moment good faith attempts to obtain further information have been unsuccessful to date although surgical intervention has been agreed upon the receipt of high impedance.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
As the x-rays indicated the vns lead pin was fully inserted into the generator header, a lead pin issue has been ruled out and a lead fracture is the most likely cause of the high lead impedance.

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« Reply #48 on: September 16, 2017, 12:13:13 AM »

Model Number 103
Event Date 04/03/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns was now indicating high impedance a few months after having the generator replaced. Clinic notes received indicated that the patient was experiencing pain at the generator site that recently stopped and the patient feels that the vns "fell into the right spot. " the cause of the pain is unknown per the site. No trauma or manipulation is noted. X-rays were taken and forwarded to the manufacturer for review. No gross lead discontinuities were observed however it was noted that the lead pin did not appear to be fully inserted. The implant card for the recent generator replacement indicates lead impedance was normal following replacement. Based on the x-rays, the high impedance is suspected to be due to improper lead pin insertion. Surgery to correct the high impedance is likely. No adverse events have been reported.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day" for report type.
 
Event Description
Additional information was received indicating that surgery to correct the high impedance has occurred. Neither the lead nor the generator was replaced. An op report was received that indicated that the high impedance resolved after the lead pin was removed and re-inserted. The surgeon indicated that there was some kinking and scar tissue noted however based on the resolution following lead pin reinsertion and the x-rays, it is likely that the lead pin was not inserted.

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« Reply #49 on: September 17, 2017, 01:49:41 AM »

Model Number 302-20
Event Date 05/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Evaluation, method: analysis of programming history. Conclusions: device failure is suspected but did not cause or contribute to patient death.
 
Event Description
On (b)(6) 2012, it was reported that a physician had a patient with a dead battery as he was unable to communicate with the patient's generator. Clinic notes were received on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that the patient had been experiencing a mild increase in seizures over the past few months. The patient had a grand mal on the eight (the month is unknown) and some partial complex seizures. The patient was unsure why. The physician wrote "i was unable to get a reading after several attempts - will recheck with rep. " notes dated (b)(6) 2012 stated that the patient was seen on this date due to his vns not being read last week. A company representative was present, and it was determined that the battery was dead. The patient would be referred for replacement. A battery life calculation was performed on (b)(6) 2012. The battery life calculation results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the patient was scheduled for surgery on (b)(6) 2012. On (b)(6) 2012, the patient's surgery was confirmed to have occurred on (b)(6) 2012. The patient underwent total revision. On (b)(6) 2012, the patient told the physician that the surgeon stated that "the surgeon replaced the lead because of a "crimp or kink" in the lead along with lots of scar tissues". The generator was programmed on at the settings from the previous generator; however, the patient said that it was uncomfortable, and went to see the physician the following day. The stimulation was reduced by half, and the patient was fine. (it is unclear what parameters were adjusted to reduce stimulation. ) the physician reported that the patient was fine after the adjustments. On (b)(6) 2012, the explanting facility reported that the generator would be returned to the manufacturer; however, the lead would not be returned to the manufacturer. On (b)(6) 2012, the patient's generator was received and is currently undergoing product analysis. On (b)(4) 2012, design history files for the explanted lead were reviewed. The lead passed all inspections prior to distribution.
 
Event Description
Product analysis for the explanted generator was approved on (b)(6), 2012. The failure to program allegation was duplicated in the product analysis laboratory and determined to be the result of normal expected battery depletion. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Follow up on (b)(6), 2012 revealed that the physician initially believed that the electrode had not been attached to the vagus nerve. The physician spoke with a consultant and reported that the surgeon indicated that there was a lot of scar tissue. The consultant suggested that this may be the reason for the patient's different tolerance for the same settings after the revision. The physician agreed with this assessment.

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« Reply #50 on: September 18, 2017, 12:03:10 AM »

Model Number 105
Event Date 05/21/2012
Event Type  Malfunction   
Manufacturer Narrative
Suspect medical device, corrected data: with the new information available, the suspect medical device is the generator as the high impedance resolved with generator replacement so the product information was initially reported incorrectly. Device manufacture date, corrected data: with the new information available, the suspect medical device is the generator as the high impedance resolved with generator replacement so the manufacturer date was initially reported incorrectly. Review of manufacturing history records performed. Review of the generator manufacturing history records confirmed all quality tests were passed prior to distribution.
 
Event Description
In the product analysis lab, the in-line cavity go gage or bench test leads would insert into the negative connector block. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Per the device¿s internal data, a change in impedance on (b)(6) 2012 was from 7741 ohms (high impedance) to >10,000 ohms. As a result, the event date was updated to (b)(6) 2012.
 
Event Description
It was reported by the hospital facility that the patient had generator replacement on (b)(6) 2013 because the ¿device had stopped working. ¿ the reported indicated that it was initially thought that the patient had high impedance but when the replacement generator was connected to the existing lead, the impedance value was okay. The explanted generator has not been received by the manufacturer to date. Subsequent good faith attempts for product return have been unsuccessful to date. A lead pin insertion issue cannot be ruled out as a causal factor of the high impedance, as the x-ray review previously performed could not be confirm if that the lead pin was fully inserted as it could not be seen past the second connector block.
 
Manufacturer Narrative
The supplemental report #3 inadvertently did not report this data.
 
Event Description
It was reported on (b)(6) 2012, that a vns patient was showing high lead impedance a few days after the generator was replaced due to end of service that occurred on (b)(6) 2012. The impedance value was >10,000 ohms. The device had been programmed on during surgery and it is unknown if it was programmed off when the high lead impedance was obtained. The patient cannot feel stimulation (normal mode or magnet mode). There were no reports of trauma or falls. Follow up with the surgeon revealed that the first time the diagnostics were performed in the or, high lead impedance was obtained, but when repeated, the diagnostics were within normal limits. X-rays were sent to the manufacturer for review and two possible causes for the high lead impedance were observed. The lead pin could not be seen past the connector block in the generator header indicating that it may not be fully inserted. Additionally, a portion of the lead body appeared abnormally wavy and kinked suggesting a possible lead issue however a full lead break was not seen. The patient has been referred back to the surgeon however there is no report that any interventions are being taken at this time.
 
Event Description
It was reported that the patient was moving forward with surgery. The surgeon's office reported that they are not sure yet if the procedure will entail replacement or checking to see if the electrodes are connected properly. The vns has reportedly not worked the same since generator replacement on (b)(6) 2012. The patient's neurologist has not evaluated the patient since (b)(6) 2012. There is no mention of trauma, increased seizures or any adverse events at that time. Although surgery is likely, it has not occurred to date. Notes from the surgeon's office dated (b)(6) 2013 reported that the vns has "not actively worked" for the patient since generator replacement in (b)(6) 2012. "there was a question that perhaps the pin of the leads may not be all the way into the generator device. " the neurologist would like the surgeon to "reattempt to reimplant it. " if the lead pin insertion does not work, the surgeon noted that he may replace the leads. Previously on (b)(6) 2012, the surgeon noted in the clinic notes that the vns device was working intraoperatively after reconnecting the generator to the leads. He was not sure why the high impedance was detected, but indicated that he will check the lead pin placement in the generator in surgery.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Lead pin may not be fully inserted and a suspect area was identified in the lead body where the lead had a wavy/kinked appearance.
 
Manufacturer Narrative
Review of manufacturing records. Review of the lead manufacturing history record confirmed that all quality tests were passed prior to distribution.
 
Manufacturer Narrative

Event Description
The explanted generator was received by the manufacturer on (b)(4) 2013. The return product form indicated that the reason for the generator replacement on (b)(6) 2013 was that the surgeon stated that the "device stopped working; stated possible lead impedance issue. " product analysis has not been completed to date.

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« Reply #51 on: September 19, 2017, 02:21:57 AM »

Model Number 105
Event Date 04/27/2012
Event Type  Malfunction   
Event Description
It was reported that the patient complained of not feeling normal and magnet mode stimulation since generator replacement on (b)(6) 2012. Diagnostics were reportedly within normal limits following generator replacement. She was referred to her surgeon for the case. The surgeon and the neurologist both interrogated the device and performed diagnostics which revealed high impedance with 10,000 ohms multiple times. The neurologist had one interrogation come back okay with all of the other tests resulting in high impedance. X-rays were performed and were reviewed by the neurologist. No lead or electrode issue was present to the physicians, so it was planned to have the patient's generator checked in the operating room by reinserting lead and checking device again. The lead pin did not appear fully inserted. The patient was taken to the operating room for exploratory surgery on (b)(6) 2012. The first pre-operative diagnostic test revealed high lead impedance. After reposition of the lead in the generator, there was still high impedance. Generator diagnostics were unremarkable. The lead was repositioned in the generator again, and six additional system diagnostic tests were performed at varying positions during surgery and no high lead impedance was detected. The company representative reported that the lead had a slight kink at the connector book. If it was manipulated either way, system diagnostics were still within normal limits. The patient's incision was closed, and the patient was referred to follow up with the neurologist closely. It was therefore confirmed that the lead pin was not making proper connection in the connector block which resulted in the high impedance.

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« Reply #52 on: September 22, 2017, 01:02:25 AM »

Model Number 302-20
Event Date 06/28/2012
Event Type  Injury   
Event Description
The explanting facility reported that the generator was available for return. The generator was received for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
The company representative followed up with the replacement facility, however the patient's explanted generator and lead were not available for return to the manufacturer.
 
Event Description
It was reported by the neurosurgeon's office that the patient came into the clinic on (b)(6) 2012 complaining of sharp pains in the chest and neck that occur about three to four times per week. The surgeon thought it may be related to the vns lead at the time. The patient was scheduled for generator replacement with possible lead replacement at that time. X-rays were taken of the patient's vns system for review by the manufacturer. Film a/p and lateral views of the neck and chest were received and reviewed on (b)(6) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact and the connector pin appeared past the connector block. The lead was routed upwards to the left side of the neck. The lead wires appeared to be twisted and kinked in the chest area which formed sharp angles in the lead wire. No lead discontinuities were seen in the visible portions of the lead. Based on the x-ray images provided, there is no clear cause for the patient's pain in the chest and neck. However, it may be likely that the twisted and kinked lead wires in the chest are a result of patient manipulation which may be causing the pain. A micro-fracture that cannot be seen in the images provided or a break in the portion of the lead which could not be assessed cannot be ruled out as a casual factor. Attempts for additional information from the treating ent and neurosurgeon have been unsuccessful to date. The patient had surgery on (b)(6) 2012, however attempts for return of the generator and lead have been unsuccessful to date.
 
Event Description
Analysis of the generator was completed on (b)(4) 2013. 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.

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« Reply #53 on: October 03, 2017, 12:23:25 AM »

Model Number MODEL 250
Event Date 10/27/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's programming system was giving a "retry" message when trying to interrogate patient's devices. The wand battery was changed and the issue did not resolve. The wand was changed and interrogation was possible. It was later reported that the wand was working fine and that the issue was narrowed down to the usb connector. A new usb connector was used and there were no issues interrogating the generator. The usb was found to be kinked. The usb cable was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Analysis of the returned usb adaptor was completed. The cause for the reported allegation is associated with two disconnected wire connections in the returned serial cable. Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.
 
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=4277704
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« Reply #54 on: October 06, 2017, 01:32:12 AM »

Model Number 302-20
Event Date 11/08/2011
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.

Manufacturer Narrative
An incomplete device manufacture date was inadvertently reported on the initial mdr report. The complete manufacturing date is provided.

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

Event Description
Further information was received from the treating nurse indicating the parents of the patient have decided not to re-implant for the time being. X-rays were received and reviewed by the manufacturer. Review of x-rays indicated the generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appeared to be intact, and the lead connector pin appears to be fully inserted into the generator connector block. Part of the lead was visible, apart from a section of the lead that is behind the generator and could therefore not be assessed. Not enough of the neck area was visible in order to assess the electrodes. No acute angles or breaks were observed in the assessed portions of the lead.

Event Description
It was reported by a nurse that a vns patient did not feel her magnet activate the vns generator. Diagnostics were performed at the office visit and it was indicated that high lead impedance was received. The patient manifested an increase in seizures corresponding with the high lead impedance that was received. The patient was referred for x-rays and the device was disabled due to the reported high lead impedance. Additional information was received from the nurse who indicated the patient's generator moves when the patient lifts her left arm. The nurse contacted the implanting surgeon who indicated that the generator was placed in the pocket of the muscle and did not see a problem with it as a lead break could be suspected. At the moment, good faith attempts to obtain further information have been unsuccessful to date.

Event Description
Product analysis was completed on the returned vns generator and lead. The generator analysis did not reveal any anomalies, and the generator performed per specifications. The abraded opening found on the outer silicone tubing during the lead analysis most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. 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 portions were performed, during the visual analysis, with no discontinuities identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. As the lead pin was fully inserted, a lead pin issue has been ruled out and a lead fracture is more likely to have occurred in the lead portion not returned.

Event Description
Reporter indicated the patient had vns lead and generator explant surgery performed on (b)(6) 2012. No new devices were implanted. Immediately prior to the surgery, systems diagnostics testing was performed which resulted in high lead impedance, with eos = no. During the explant surgery, the lead pin was reinserted into the generator several times and high lead impedance continued to occur, ruling out a lead pin issue and making a lead fracture more likely. In addition, inspection of the lead showed a sharp angle close to the pin. Generator diagnostics performed during the surgery indicated normal generator function. The explanted generator and lead have been returned and are pending analysis.

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« Reply #55 on: October 06, 2017, 01:33:10 AM »

Model Number 102R
Device Problem Mechanical issue
Event Date 09/01/2017
Event Type  Malfunction   
Event Description
Report received that while a generator was prophylactically replaced, it was found that the explanted generator header was bent. The header was reportedly bent prior to the explant procedure. The surgeon indicated he did not do anything during the surgery that bent the header and that it was bent while implanted. A review of the device history record showed the generator had passed all quality inspections prior to release for distribution. The generator has been received by the manufacturer and is pending analysis. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6890683
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dennis100
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« Reply #56 on: October 06, 2017, 09:33:16 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 08/18/2017
Event Type  Malfunction   
Event Description
A patient was scheduled for prophylactic generator replacement. Before surgery, the lead impedance was within normal limits. After the generator was replaced, the lead impedance value was high. The lead pin was removed and placed again with the same results. The company representative stated there was possible separation of silicone from connector tip and kink in lead about 6 centimeters from the lead tip. The old lead was removed and a new lead was placed, and was reported to be fine. Additional relevant information has not been received to-date. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6860203

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dennis100
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« Reply #57 on: October 10, 2017, 02:43:34 AM »

Model Number 103
Event Date 02/01/2013
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.

Manufacturer Narrative
Review of programming history. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized, complete pin insertion could not be verified.

Event Description
It was reported that the patient was scheduled for lead replacement surgery. The lead was replaced on (b)(6) 2013. The lead was received for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.

Event Description
Generator analysis generator pa approved: (b)(4) 2013. In the pa lab, the device output signal was monitored for more than (b)(4), 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. Attempts for additional information have been unsuccessful.

Event Description
On (b)(6) 2013, it was reported that diagnostics on this date indicated high impedance. It was reported that the patient fell in february and that was believed to be the cause. It was also stated that beginning in march, the patient began having an increase in seizure frequency and intensity. There have not been any other changes that could have been a cause to the seizure changes. The patient was last seen on (b)(6) 2012 at which time diagnostics were within normal limits. The patient's device was disabled, and the patient was referred for revision and x-rays. X-rays were reviewed: the generator and lead are visible with almost uniform brightness/contrast across the images. Placement of the generator is normal in the left chest pocket, and the feedthru wires appear intact. It cannot be confirmed that the connect pin is fully inserted inside the connector block. A strain relief bend is present and is placed per labeling. A strain relief loop is not present. Two tie-downs are also present, one of which is securing a strain relief bend as specified per labeling. Lead is present behind the generator. There are not any gross fractures or discontinuities in the lead. There appears to be a sharp angle near the header of the generator in a portion of the lead. The lead wires appear intact at the connector pins. On (b)(6) 2013, it was reported that this patient underwent generator revision on (b)(6) 2013. The lead was not replaced. The explanted generator was returned on (b)(6) 2013 and is pending product analysis.

Event Description
The lead analysis was completed on (b)(4) 2013. 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. 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 calcium, sodium, magnesium, zirconium, silicone and phosphorus. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081227
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dennis100
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« Reply #58 on: October 13, 2017, 12:16:37 AM »

Model Number 302-20
Event Date 05/10/2012
Event Type  Malfunction   
Event Description
It was reported by a physician that high impedance was read at a follow-up appointment upon performing system diagnostics. The patient was referred for x-rays and the generator was programmed off. The last known good system diagnostics were noted to be from (b)(6) 2011. X-rays were received and evaluated by the manufacturer. The generator was placed in the lower left chest, in the left side of it, a few centimeters below the axilla. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The lead wires at the connector pin appeared to be intact. The negative and positive electrode appeared not be aligned, and the negative electrode seems to be detached from the vagal nerve. Portions of the lead appeared to be behind the generator and could not be fully assessed. An acute angle appears to be present right below the positive electrode. At the moment, good faith attempts to obtain further information have been unsuccessful to date.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate type of report. Report should have read 30-day.
 
Event Description
Additional information was received that the patient did not have any trauma or manipulation of their device reported prior to the event. At this time no surgery is scheduled. The patient may in the future have either replacement or explant of their lead. The patient is reported to be doing well and a decision will be made in (b)(6) when they see a surgeon.
 
Event Description
Additional information was received from the area representative indicating there was no manipulation or trauma involved that could have had contributed to the report of high lead impedance. At the moment no interventions have been planned for the patient.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592703
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dennis100
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« Reply #59 on: October 30, 2017, 01:34:00 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type Malfunction
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.

Event Description
It was reported that the patient underwent generator and lead replacement surgery. Pre-operative diagnostics showed high impedance (dc dc code - 7). During the surgery, a new generator was placed on the existing lead at which time device diagnostics were within normal limits. The patient's head was placed in four different positions with subsequent device diagnostics being within normal limits. The generator was moved and device diagnostics then resulted in high impedance (>10,000 ohms). The lead was dissected off of the patient's nerve and a new lead was placed. The surgeon reported that the lead appeared to be kinked when the generator pocket was opened. Device diagnostics with the new vns system was within normal limits. The generator and lead were received for analysis. Analysis of the lead was completed on 05/22/2014. Note the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. One of the quadfiler coils was kinked. 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 portions were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator is underway, but has not been completed to date.

Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient has been experiencing neck pain over the last two months and that device diagnostics approximately six months prior were within normal limits. Attempts to obtain additional information have been unsuccessful to date. It was reported that the patient was scheduled for system replacement, but surgery has not yet occurred.

Event Description
No anomalies were identified during the analysis of the patient's explanted generator.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3724366
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