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dennis100
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« Reply #30 on: October 06, 2015, 02:55:01 AM »

Model Number 102
Event Date 05/17/2013
Event Type Malfunction
Manufacturer Narrative
Brand type, corrected data: the initial report reported that the suspect product was the lead it is now known the issue is with the generator. Brand type was changed to the generator. Type of device , corrected data: the initial report reported that the suspect product was the lead it is now known the issue is with the generator. Type of device was changed to the generator model # , corrected data: the initial report reported that the suspect product was the lead it is now known the issue is with the generator. Model # was changed to the generator (b)(4). Lot # , corrected data: the initial report reported that the suspect product was the lead it is now known the issue is with the generator. Lot # was changed to the generatordevice manufacture date (mo/day/yr), corrected data: the initial report reported that the suspect product was the lead it is now known the issue is with the generator. Device manufacture date (mo/day/yr) was changed to the generator.

Event Description
Additional information was received that the patient had surgery to re-insert the lead pin. The re-insertion of the lead pin resolved the high impedance.

Event Description
It was initially reported that he patient had high impedance at a recent appointment. The patient was to have surgery but the surgeon decided that he did not what to do the surgery. The office decided not to disable the patient at this time. X-rays will not be taken and there was no reported manipulation or trauma. Good faith attempts for additional information been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3174753
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dennis100
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« Reply #31 on: October 06, 2015, 02:56:18 AM »

Model Number 103
Event Date 05/03/2013
Event Type Malfunction
Event Description
It was reported that the patient had a battery replacement due to end of service on (b)(6) 2013. While in the operating room, the surgeon interrogated the patient's device three times and found that everything "looked great"; and all testing was within normal limits. The surgery was completed without any problems and the patient was discharged to the recovery room to recover. When an attempt was made in the recovery room to program the patient"s device to his previous pre-surgery settings, the following warning was seen: "programmed current was not being delivered to the programmed level. " the patient then began getting sick and was vomiting and coughing due to the stimulation being turned on. The patient was sent home and came back on (b)(6) 2013 to get the device programmed. It was unknown if the patient left the hospital after surgery with the device turned on or turned off. During the office visit on (b)(6) 2013, the same warning message was observed. Diagnostic testing showed high impedance and the patient was sent for x-rays. The physician's assistant stated that the lead appeared fine on the x-ray; however, the images were sent to the manufacturer for review. It was unknown if the explanted generator had been tested prior to surgery to confirm if the lead was ok. The patient's mother reported that the patient did not tolerate the settings very well when the physician tried to program the device to the pre-surgery settings in the recovery room. The patient "wretched; and vomited" several times while the nurse was trying to adjust the settings. Per the mother, the device was left turned on when the patient was discharged home. The patient's mother stated that she reported to the physician on (b)(6) 2013 that the patient was having an increase in seizures since the replacement. The physician checked the device and found high impedance, then disabled (programmed to 0ma) the device. On (b)(6) the patient received a call from the physician's office saying that the x-rays needed to be repeated as they were not acceptable. X-rays were taken again on (b)(6) 2013, and the mother admitted that the patient had a difficult time lying still for the x-rays the previous time and it was possible they were not clear. The manufacturer's records for the lead were reviewed and it was confirmed that the lead met all final testing specifications prior to distribution. Ap and lateral views of the neck and chest were received and reviewed. The generator is seen in normal orientation in the left chest area. The filter feedthru wires appear intact. Due to the image quality, it cannot be assessed if the lead is intact at the connector pin. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. The electrodes were observed in the neck and appear to be in proper alignment. There appears to be a sharp bend beyond the last electrode. The lead is seen routed down toward the generator. A portion of the lead appears to be present behind the generator and could therefore not be assessed. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend is present; however, it is not per labeling as it begins at a sharp bend right where the anchor tether should be. The strain relief loop appeared to be per labeling. Two tie-downs were present. The first tie-down was within the strain relief loop, while the second tie-down was beyond the strain relief loop. There was no tie-down placed lateral to the anchor tether as labeling suggests. Surgery was scheduled for (b)(6) 2013. A visual inspection of the lead found no obvious lead breaks or fractures. The lead pin was removed and re-inserted. Diagnostics were performed five or six times during surgery and showed ok results. It is unknown what caused the high impedance, but the high impedance was resolved. The patient's device was not replaced. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. 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=3170988
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dennis100
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« Reply #32 on: October 06, 2015, 02:57:10 AM »

Model Number 102
Event Date 01/24/2006
Event Type Malfunction
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.

Event Description
During programming history review it was discovered that high impedance (dc dc code 5) was obtained approximately two months after the patient underwent generator replacement surgery. Previously it was reported that the high impedance was first obtained on (b)(6) /2006; however, the programming history confirms that the high impedance was first observed on (b)(6) 2006. X-rays reviewed by manufacturer revealed that the lead connector pin was not fully inserted into the generator connector block. The patient underwent revision surgery on (b)(6) 2006. It was noted that the lead was reinserted into the generator header and diagnostic testing was then within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3180795
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dennis100
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« Reply #33 on: October 07, 2015, 05:53:40 AM »

Model Number 104
Event Date 04/25/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, the hospital called to get information on returning the explanted device. It was found that the generator was explanted on (b)(6) 2013. The reason for explant was not provided; however, the implant card indicates that the generator was replaced due to battery depletion nearing end of service. The card stated that the lead impedance was ok, with a dcdc code of 2. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided. The explanted generator was returned on (b)(4) 2013 and is pending product analysis.

Event Description
On (b)(6) 2013, the physician stated that during the interrogation of the patient's device, an error message kept appearing. He stated that he could not remember what the error message was, but he had spoken to the manufacturer's sales representative about it and interpreted the message as the patient's vns battery failing. Follow up with the manufacturer's sales representative found that the physician had indicated that he saw an ifi warning message. It was stated that the physician referred the patient for consult surgery and that surgery was planned. During surgery on (b)(6) 2013, the surgeon reported that he performed system diagnostics on the implanted device and got a >10,000 ohms message. The surgeon did not have an accessory pack to test the generator, but stated that he would remove the pin, and re-insert it to confirm that the issue was not the generator. The surgeon stated that he would attempt to resolve the impedance with a pin insertion, but would plan for a full revision if it did not resolve. It was confirmed that the surgery occurred; however, it is unknown if both the lead and generator were replaced or if it was just the generator. An attempt has been made to get additional information from the surgeon; however, it was unsuccessful. No additional information has been provided.

Event Description
Further follow-up revealed that the high lead impedance was resolved when the lead was reinserted into the generator header and the setscrew was retightened. Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative
Information was received which changes the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3148057
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dennis100
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« Reply #34 on: October 07, 2015, 05:54:40 AM »

Model Number 103
Event Date 04/15/2013
Event Type Malfunction
Manufacturer Narrative
Observed during surgery, lead pin not fully inserted past the connector block of generator. Additional information was received which changes the product the report is reported on.

Event Description
On (b)(6) 2013 it was reported that a lead break was observed for the vns patient. It was stated that high lead impedance was observed on (b)(6) 2013. The patient¿s device was turned off at that time and x-rays were performed. It was stated that the hospital will not release the x-rays for review. The patient falls during seizures but there has been no obvious trauma that may have resulted in a lead break. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2013 it was reported that the patient had undergone surgery on (b)(6) 2013 and it was found that the cause of the high impedance was that the lead pin was not fully inserted into the header of the generator.

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=3149567
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dennis100
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« Reply #35 on: October 07, 2015, 05:55:34 AM »

Model Number 103
Event Date 05/08/2013
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Manufacturer Narrative

Event Description
Additional information was received that the patient had an impedance of 5500 ohms at a recent appointment. The patient had exploratory surgery and the lead pin was found to not be fully inserted into the generator cavity. Once the pin was fully inserted diagnostics were within normal limits (3856 ohms).

Event Description
It was initially reported that the patient had high impedance at a recent diagnostics. The generator was disabled that day and x-rays were ordered. The patient was implanted a couple weeks prior and the high impedance was found the day the patient came in for an appointment to be turned on. There was no reported manipulation or trauma. No further information was provided. X-rays were received by the manufacturer for review. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. The lead connector pin cannot be confirmed as completely inserted into the generator connector block. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3145038
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dennis100
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« Reply #36 on: October 07, 2015, 05:56:21 AM »

Event Date 05/10/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the vns patient was interrogated and high impedance was found with an impedance value of greater than 10,000ohms. X-rays were requested and the device was turned off. It was stated that the lead appears intact but the pin may not be fully inserted and that the patient does not wish to have a further procedure to correct the problem at this time. Although surgery is likely, it has not occurred to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144353
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dennis100
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« Reply #37 on: October 08, 2015, 12:35:13 AM »

Model Number 102
Event Date 01/30/2013
Event Type Malfunction
Manufacturer Narrative
Event description, corrected data: device manufacturing records were reviewed, but not reported on the previous mdr. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

Manufacturer Narrative

Event Description
Device manufacturing records were reviewed which indicate that the device passed all specifications prior to distribution.

Event Description
Products were returned for analysis after a full revision surgery was performed in medwatch report number: 1644487-2013-00547. It was noted that the patient's lead pin was not fully inserted into the generator header. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. 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. An analysis was performed on the returned lead portions and the reported ¿mechanical problem / punctured insulation¿ allegation was verified. A lead break was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The report indicated that during revision surgery there was an opening in the tubing with body tissue going into the lead body close to the generator can. It appears this portion was not returned, since body tissue was not observed on the returned lead portions. During the visual analysis an incision mark was observed on the body of the returned lead assembly. The incision mark penetrated one side of the outer silicone tubing. The incision mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the 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. The connector pin was inserted into the original generator 102-62570 to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. 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. 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 a discontinuity in the returned portions of the device which may have contributed to the stated allegations. Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition during the implant of this lead. Since a portion of the lead was not returned that was reported to have body tissue in it is unknown if this was also a contributing factor to their high impedance. The patient's reported high impedance related to a lead issue addressed in medwatch report number: 1644487-2013-00547.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3134918
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dennis100
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« Reply #38 on: October 09, 2015, 01:24:47 AM »

Model Number 105
Event Date 06/20/2014
Event Type Malfunction
Event Description
An explanted generator and lead were returned to the manufacturer for analysis in mfr. Report # 1644487-2015-05052. Product analysis was completed for the lead. No obvious anomalies were noted except for the set of setscrew marks found 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. It appears that the incomplete pin insertion condition existed during the time of implant, as no other sets of setscrew marks were observed on the connector pin surface. There was no evidence to suggest an anomaly with 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. Product analysis was completed for the generator. There were no performance or any other type of adverse conditions found with the pulse generator. It was found that impedance increased from 2268 ohms to 5717 ohms on approximately (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5102882
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dennis100
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« Reply #39 on: October 09, 2015, 01:25:53 AM »

Model Number 106
Device Problem Impedance issue
Event Date 09/02/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that during implant surgery system diagnostics returned high impedance. A system diagnostic test was performed with the resistor connected to the generator with lead impedance value within normal limits. The patient was left with generator and lead connected to the vagus, but generator turned off. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears not to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received that patient was readmitted for surgery and upon pin reinsertion into the generator block, the value of the lead impedance measured was within the acceptable range.

Manufacturer Narrative
Udi# (b)(4). The previously submitted mdr inadvertently lacked the udi number of the suspect device for the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5100863
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dennis100
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« Reply #40 on: October 09, 2015, 03:26:46 AM »

Model Number 300-20
Device Problem High impedance
Event Date 08/24/2015
Event Type Malfunction
Event Description
Analysis was completed on the generator explanted on (b)(6) 2015. The pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The suspect lead and generator explanted on (b)(6) 2015 were received on (b)(4) 2015 but analysis has not been completed to date.

Event Description
During a generator replacement surgery on (b)(6) 2015, high impedance was observed with the newly implanted generator. When connected to the old lead with > 10. 000 ohms. The lead pin was removed and re-inserted and the impedance was ok with 2614 ohms. When the generator was placed in the generator pocked, high impedance was again seen with impedance > 10. 000 ohms. The surgeon then repositioned the generator in pocket and checked again with results showing impedance of 6013 ohms. The surgeon then made a more superficial pocket and placed generator inside. Diagnostics showed normal impedance of 2339 ohms, 3254 ohms and 2483 ohms for subsequent diagnostics. The lead was not replaced at this time. Patient's vns was later programmed on in the recovery room. The explanted generator was received on (b)(6) 2015 but analysis has not been completed to date. During the post-op follow up appointment at the surgeon's office, patient's device was interrogated and high impedance was observed again. Multiple diagnostics done in different positions all resulting in impedance of greater than 10,000 ohms. Vns output current and magnet current were programmed to 0 ma. Patient underwent full revision surgery of the generator and lead on (b)(6) 2015. Product return of the suspected lead is expected but has not been received to date.

Manufacturer Narrative

Event Description
Analysis was completed on the generator and lead. The battery voltage for the generator was 2. 729 volts (at ifi) the battery is partially depleted. 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. A coil break was identified and it was determined to be a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Pitting on the coil and fluid leak on the outer silicone tubing was also observed during analysis. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5085207
« Last Edit: November 22, 2015, 01:34:35 PM by dennis100 » Logged
dennis100
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« Reply #41 on: November 06, 2015, 12:24:49 AM »

Model Number 105
Device Problems Break; High impedance
Event Date 09/24/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 from the patient's mother that the patient was seen on (b)(6) 2015 and the physician indicated that the device wires are either disconnected or broken. The sales representative was able to see the patient on (b)(6) 2015 right after the report and interrogated the device and found that she did have high impedance >10,000 ohms. Upon examination of the x-rays it appeared that the pin was not past the connector block. She noted that the x-rays were very large and the only copy and she was not allowed to obtain a copy. The physician plans to revise as soon as possible. Although surgery is likely it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5162668
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« Reply #42 on: November 06, 2015, 12:25:22 AM »

Event Type Malfunction
Event Description
An article titled;vagus nerve stimulation for pediatric and adult patients with pharmaco-resistant epilepsy; was published in 2015 which included an incomplete lead-pin insertion into the generator; connector block, involving 1 vns patient. The patient underwent surgical revision for insertion of the lead pin. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5177129
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« Reply #43 on: November 06, 2015, 12:26:05 AM »

Model Number 105
Event Date 09/25/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported by the physician the patient had high impedance. It was later reported that patient had surgery on (b)(6) 2015 due to the high impedance observed. During surgery, the physician removed the vns generator from the pocket, removed the lead pin from the vns generator, wiped the lead pin off, re-inserted the lead pin into the vns generator, and tightened. After the lead pin was re-inserted into the vns generator, multiple diagnostics tests were run, both outside and inside the pocket, which showed the impedance was within the acceptable range.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5166718
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« Reply #44 on: November 06, 2015, 04:59:22 AM »

Event Date 09/14/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that system diagnostics run on the patient's vns device returned high impedance immediately after suturing the incisions of the implant surgery. X-rays were taken and review by the healthcare professionals determined that the lead-pin was not fully inserted into the generator's connector block. X-rays review by the manufacturer found that the generator was in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector-pin was not fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. There was lead behind the generator. No lead breaks or sharp bends were found in the visible parts. The lead wires appeared to be intact at the connector pin. It was reported that the patient underwent surgical intervention one day after the implant for lead-pin re-insertion. Once completed, the impedance of the vns system was found to be normal. No device was explanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5136335
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« Reply #45 on: November 12, 2015, 03:12:07 AM »

Model Number 102R
Event Date 05/06/2008
Event Type Injury
Event Description
Reporter indicated that a vns pt underwent generator replacement surgery due to normal end of service. During surgery, it was discovered the pt's lead pins were inverted in the generator. The pt's lead was connected correctly to a new generator and the pt experienced tachycardia during diagnostics testing and asystole when the device was programmed on later in the surgery. The device was then programmed off and the pt became stable. X-rays reviewed by the mfr revealed no anomalies. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1057231
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« Reply #46 on: November 12, 2015, 05:30:52 AM »

Model Number 302-20
Event Date 02/07/2008
Event Type Malfunction
Event Description
The reporter indicated the device diagnostics during an office visit, resulted in high impedance. This result indicates a possible lead break or pin insertion issue. The pt has experienced an increase in seizures. The reporter scheduled x-rays and revision surgery. The mfg rep attended the surgery. The x-rays were reviewed by the mfr. The rep stated "no gross lead break". " the pin area was not visible on the x-rays. " during surgery, the rep performed the pre-operative diagnostics on the generator, resulting with high lead impedance. The reporter removed the pin and ran a generator test. The generator test resulted with ok. Then, the lead pin was re-inserted into the generator. The mfg rep performed three system diagnostics tests with lead impedance-ok. The reporter did not replace the generator. Since, the pin insertion resolved the high lead impedance issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009253
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« Reply #47 on: November 12, 2015, 06:30:48 AM »

Model Number 101
Event Date 02/07/2008
Event Type Malfunction
Event Description
Reporter indicated that, "connector pin has separated from the generator. " it was reported that connector pin separation has been determined by looking at the diagnostic testing. Additionally, the pt has also been experiencing an increase in seizures. The pt experienced no trauma or manipulation of the device that could have contributed to the reported event. Further follow up with the physician revealed that the pt will be seen by a neurosurgeon to get an assessment of the reported events. There is no reported trauma or manipulation of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009802
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« Reply #48 on: November 13, 2015, 01:17:08 PM »

Model Number 302-20
Event Date 09/24/2007
Event Type Malfunction
Event Description
Reporter indicated that a pt underwent surgery to replace the vns generator due to end-of-service. It was reported that when the lead pin was removed from the generator during surgery, the surgeon identified that a portion of the silicone near the tip of the lead pin had become detached. The surgeon elected to leave the lead implanted as device diagnostics were within normal limits and the portion of the affected lead was fully enclosed within the generator header.

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=930363
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« Reply #49 on: November 14, 2015, 03:10:01 AM »

Model Number 302-20
Event Date 08/21/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that at an office visit following vns revision surgery, high lead impedance was indicated on diagnostic tests. Reporter said that the surgeon had stated that intraoperative diagnostic were within normal limits with the new lead and generator. It was reported that x-rays had been reviewed by the doctor, and the cause of the impedance could not be identified. The patient underwent exploratory surgery to identify the cause of the high lead impedance. The surgeon removed and reinserted the lead pin, and the high lead impedance resolved. The surgeon stated that the believed air must have entered the header of the generator, forcing the lead pin out when he tightened the set screw.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=922935
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dennis100
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« Reply #50 on: November 14, 2015, 06:32:44 AM »

Model Number 302-20
Event Date 03/01/2006
Event Type Malfunction
Event Description
Initial reporter indicated that a system diagnostics test on a patient's device resulted in high lead impedance, indicating a possible lead malfunction. X-rays reviewed by manufacturer revealed lead pin not fully inserted. Revision surgery is likely.

Manufacturer Narrative
Review of x-rays by the manufacturer revealed lead pin not fully inserted. Device malfunction 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=912543
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dennis100
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« Reply #51 on: November 14, 2015, 08:18:29 AM »

Model Number 102
Event Date 07/18/2007
Event Type Malfunction
Manufacturer Narrative
X-rays reviewed by the manufacturer. X-rays reviewed by the manufacturer, lead pin appears to be not fully inserted past the connector block of generator. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated that a system diagnostics test on a patient's device resulted in high lead impedance, indicating a possible lead malfunction. There was no report of the patient experiencing any injury or trauma that may have damaged the vns therapy system. Patient reported an increase in seizure but not above pre-vns level. X-rays obtained. It was noted that the connector pin was no fully inserted. No revision surgery has been scheduled at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=899076
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dennis100
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« Reply #52 on: November 14, 2015, 08:19:21 AM »

Model Number 102
Event Date 08/02/2007
Event Type Malfunction
Event Description
It was reported to the manufacturer that the patient was referred to surgery for a generator replacement due to end of service. Communication was not established preoperatively with the generator which was believed to be due to a depleted battery. Intraoperatively, communication was not established with the generator outside of the chest pocket. Therefore, the surgeon attempted to loosen the set screw to disconnect the lead from the generator. The set screw was loosened but when the surgeon attempted to pull the lead pin out, the surgeon was not able to remove the lead pin from the header. Upon visual inspection, it appeared as though the lead pin as "fused" to the connector block inside the header. Following several attempts to remove the lead pin from the header unsuccessfully, the surgeon opted to then remove the entire system. The neck incision was opened and the lead was cut below the bifurcation and the electrodes remain attached to the vagus nerve. The lead and generator were explanted. The surgeon removed the header from the generator and the lead was cut just after the pin. A reimplant was not performed at that time, but is planned. The explanted portions of the lead and the generator have been returned to manufacturer and are pending analysis. The lead pin was inside the header which was not connected to the generator can upon arrival to manufacturer. Analysis of the device history records for both the lead and the generator were reviewed and the products passed all inspections prior to shipping and no anomalies were noted.

Manufacturer Narrative
Review of the device history record was performed. Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=906231
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dennis100
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« Reply #53 on: November 15, 2015, 11:05:24 AM »

Model Number 102
Event Date 06/12/2007
Event Type Malfunction
Event Description
Reporter indicated that the silicone septum plug had become detached from the generator while attempting to insert the lead pin into the lead pin cavity during implantation. Another generator was implanted successfully, and there were no reported adverse effects on the patient. Product analysis was completed on the returned generator. It was found that the lead pin cavity was blocked with adhesive, which prevented complete lead pin insertion. This would have caused the surgeon to have difficulty fully inserting the lead pin into the generator. Per labeling, the surgeon would have likely attempted to back out the setscew due to the difficulty inserting the lead pin. Backing out the set screw too far most likely lead to the reported septum plug becoming dislodged.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed proper generator function prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=879446
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dennis100
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« Reply #54 on: November 15, 2015, 02:23:18 PM »

Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Ap and lateral x-ray views of neck and chest evaluated by manufacturer. Positive lead connector pin not fully inserted past the pulse generator connector block. A device malfunction occurred but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a system diagnostics test at the office visit resulted in a high impedance reading indicating a possible device malfunction. It was also reported that the patient was experiencing an increase in seizures. Ap and lateral x-ray views of the neck and chest evaluated by manufacturer. It was noted that the positive lead connector pin did not appear to be fully inserted past the pulse generator connector block. Patient underwent revision surgery. The positive lead connector pin was fully re-inserted past the pulse generator connector block and the reported high impedance subsequently resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=858501
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dennis100
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« Reply #55 on: November 16, 2015, 02:41:50 AM »

Model Number 102
Event Date 04/26/2007
Event Type Malfunction
Event Description
Reporter indicated that lead pin would not insert into the pulse generator receptacle during initial implant surgery. Lead pin was successfully inserted into another pulse generator receptacle and implanted.

Manufacturer Narrative
A device malfunction 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=855029
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dennis100
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« Reply #56 on: November 16, 2015, 02:42:28 AM »

Model Number 102
Event Date 04/16/2007
Event Type Malfunction
Event Description
Rptr indicated that pt had high lead impedance diagnostic testing results on second office visit following implantation. Diagnostics were performed because the pt reported not being able to feel stimulation anymore. Diagnostic testing at the following visit resulted in both 'high' and 'okay' lead impedances. X-rays were performed and sent to the mfr for review. Mfr noted that lead connector pin was not fully inserted. Revision surgery is likely.

Manufacturer Narrative
X-rays reviewed by the mfr, lead pin not fully inserted past the connector block of generator. 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=851156
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dennis100
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« Reply #57 on: November 16, 2015, 02:43:12 AM »

Model Number 302-20
Event Date 04/05/2007
Event Type Malfunction
Event Description
Reporter indicated that during a revision surgery, a kink in the lead and a "water bubble" in that area of the lead was visualized. The revision surgery was to address a lead pin not being fully inserted and a report of patient not feeling stimulation. Pre-operative diagnostics were all within normal limits. The lead was replaced and returned to the manufacturer for analysis.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=966186
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dennis100
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« Reply #58 on: November 16, 2015, 02:43:51 AM »

Model Number 102
Event Date 04/05/2007
Event Type Malfunction
Event Description
Reporter indicated difficulty with the setscrew during a revision surgery. The revision surgery was to address a lead pin not being fully inserted and a report of patient not feeling stimulation. Pre-operative diagnostics were all within normal limits. During the surgery, the physician reported difficulty loosening the setscrew to allow the lead pin to be removed. A generator test was performed with the test resistor with no reports of difficulties. The lead pin was then inserted into the generator. The physician reported difficulty in tightening the setscrew. The physician then decided to replace the lead due to a lead issue that he visualized. The physician was unable to loosen the setscrew to allow removal of the lead pin. The physician then explanted the existing lead and generator and implanted a new lead and generator.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861221
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dennis100
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« Reply #59 on: November 16, 2015, 02:44:34 AM »

Model Number 302-20
Event Date 04/03/2007
Event Type Malfunction
Event Description
Reporter indicated that system diagnostics at a routine office visit resulted in high lead impedance. The patient was asymptomatic. X-rays were obtained and reviewed by the physician. Physician reported there were no obvious lead discontinuities. Revision surgery was performed in which the lead was replaced. It was observed in surgery that the portion of the lead coming out of the header right after the connector pin was bent at an acute angle and lying on top of the generator. The existing lead and generator were tested in the or and an intermittent lead discontinuity was noted. The existing lead was removed and a new lead was implanted successfully and connected to the existing generator. System diagnostics tests indicate normal device function. The device was turned off following the lead revision surgery. Attempts to obtain the explanted lead for product analysis are underway.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861209
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