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dennis100
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« on: June 06, 2014, 12:56:18 PM »

Model Number 302-20
Event Date 03/24/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury. Additional information indicates that the suspect device is the lead. Additional information indicates that the operator of the device was the patient. Additional information indicates that user error did not cause event.

Event Description
Additional information was received indicating that the vns patient's device was programmed off following the high impedance observation. Diagnostic tests were not performed after generator replacement surgery and prior to the high impedance observation. The physician stated that trauma possibly caused or contributed to the reported high impedance. Further follow-up revealed that during generator replacement surgery, the surgeon had to remove fibrous tissue from both electrodes. The replacement generator was tested with the existing lead and diagnostic results revealed good connection. No known surgical interventions have occurred to date.

Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value ¿ 9737 ohms). The patient recently underwent generator replacement surgery on (b)(6) 2014 and the impedance value prior to and following generator replacement surgery reportedly showed lead impedance within normal limits. X-rays were provided to the manufacturer for further review. The generator is seen in the left chest. With the images provided, it appears that the connector pin is not fully inserted inside the connector block. The filter feedthru wires appear to be intact. The lead wire appears to be intact at the location of the connector pins. There is a portion of the lead located behind the generator that could not be assessed. The lead is routed upwards to the left side of the neck, and the electrodes appear to be alignment. There do not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized; however, the presence of a fracture cannot be ruled out due to the quality of the images. No known interventions have occurred to date.

Manufacturer Narrative
X-rays reviewed by manufacturer, lead pin not fully inserted past the connector block of generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3797363
« Last Edit: December 20, 2015, 12:33:07 PM by dennis100 » Logged
dennis100
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« Reply #1 on: June 06, 2014, 12:56:51 PM »

Model Number 105
Event Date 04/04/2014
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Adverse event or product problem, corrected data: previously submitted mdr indicated that the event was only a product problem; however, this should have also been reported as an adverse event. This report is being submitted to correct this information.

Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms) on (b)(6) 2014 and again on (b)(6) 2014. It was reported that x-rays did not show an obvious lead break. It was reported that device diagnostics during generator replacement in (b)(6) 2013 were within normal limits (2640 ohms). There was no trauma or patient manipulation that is believed to have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. Review of x-rays identified that the lead pin did not appear to be fully inserted into the generator header. Clinic notes dated (b)(6) 2014 note that device diagnostics showed impedance value - >10,000 ohms. It was noted that the patient suffered a bad fall approximately one months prior and that the patient has a tendency of striking his fists against his upper chest. The patient also uses his fingers to tug on his clavicles. It was noted that any of these activities may have dislodged the lead pin or produced a fracture in the lead. The patient was referred for surgery. During surgery, the lead pin was removed and then reinserted into the generator header. Device diagnostics were then within normal limits. The high impedance is related to the lead pin not being fully inserted into the generator header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3793934
« Last Edit: December 20, 2015, 12:34:14 PM by dennis100 » Logged
dennis100
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« Reply #2 on: June 10, 2014, 07:21:27 PM »

Event Date 03/06/2014
Event Type Malfunction
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the device was programmed off after observing the high impedance. It was reported that there was no trauma that is believed to have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. No discontinuities with the vns system were seen in the x-rays. It was unable to determine whether or not the lead pin was fully inserted into the generator header due to the orientation of the generator in the images. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3724441
« Last Edit: February 06, 2015, 03:43:54 AM by dennis100 » Logged
dennis100
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« Reply #3 on: June 23, 2014, 03:37:31 AM »

Model Number 104
Device Problems Connector pin failure; Device Issue
Event Date 04/12/2010
Event Type Malfunction
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed no issues with the generator prior to shipment. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
During revision surgery to address high lead impedance (reported in mdr 1644487-2010-00238), it was noted by the surgeon that the header of the m104 implanted in the pt had become detached. The surgeon replaced the generator and obtained acceptable diagnostics results; therefore, the lead was not replaced. Good faith attempts to obtain the explanted generator for analysis have been unsuccessful to date. The device history record for the explanted generator was reviewed. No unresolved issues were found with any of the components used in the mfg of the generator that would have impacted device performance. Additionally, the hosp submitted voluntary mdr (b) (4) providing info regarding the revision surgery including the observation that the header was detached from the generator. The report also stated that the generator was believed to be the cause for the high lead impedance and since the high lead impedance resolved with generator replacement, the lead was not replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1719559
« Last Edit: February 06, 2015, 03:44:26 AM by dennis100 » Logged
dennis100
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« Reply #4 on: June 23, 2014, 04:22:09 AM »

Model Number 104
Device Problems High impedance; Malposition of device
Event Date 10/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the patient had recently undergone a generator replacement surgery. At the patient's first visit to the neurologist, it was noted that the device was registering high impedance. X-rays were taken and sent to the manufacturer for analysis, which found that there may have been an issue with proper insertion of one of the lead pins into the generator. The patient was taken into surgery to reseat the lead pin to see if the high impedance resolved. Once the lead pin was removed and reinserted properly, the high impedance resolved. Attempts for information as to whether diagnostics were performed at the original replacement surgery, were unsuccessful, thus the cause for the lead pin not being properly connected to the generator cannot be determined.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1549618
« Last Edit: February 06, 2015, 03:45:33 AM by dennis100 » Logged
dennis100
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« Reply #5 on: June 23, 2014, 05:26:33 AM »

Device Problems High impedance; Loose or intermittent connection
Event Date 09/29/2009
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
It was reported to the manufacturer that high lead impedance resulted from both system and normal mode diagnostic test results at a follow up visit. X-rays were taken and sent to the manufacturer for review. Review of the x-rays revealed that the lead connector pin did not appear to be fully inserted into the generator's connector block. The pt subsequently had surgery where the lead connector pin was re-inserted inside the generator connector block, and the high lead impedance resolved. Further follow up with the site revealed that all diagnostic tests were ok at the initial implant surgery that took place in (b) (6) 2009.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1644487
« Last Edit: February 06, 2015, 03:46:08 AM by dennis100 » Logged
dennis100
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« Reply #6 on: June 23, 2014, 06:23:06 AM »

Model Number 302-20
Device Problem Connection issue
Event Date 04/01/2009
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
It was reported that a vns pt rec'd a high impedance warning during device diagnostic testing. The pt's treating vns therapy physician indicated that the pt had been unable to perceive vns stimulation and that her lead had recently become visible under the skin of her neck prior to receiving high impedance results. The physician indicated that device diagnostics had been performed a month prior to these results and had confirmed proper device function, and the pt experienced a tonic clonic seizure prior to the onset of these events, but that she was unsure whether this has been a contributing factor. X-rays of the pt's device were rec'd and during a review of these images, it was identified that the pt's lead connector pin did not appear to have been fully inserted within the generator's connector block. The pt will reportedly undergo exploratory surgery by the end of the month.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1461100
« Last Edit: February 06, 2015, 03:46:46 AM by dennis100 » Logged
dennis100
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« Reply #7 on: June 23, 2014, 07:05:51 AM »

Model Number 103
Device Problem Connection issue
Event Date 09/01/2009
Event Type Malfunction
Event Description
During investigation in reference medwatch number: 1644487-2009-01743 for high impedance short circuit report x-rays were received for review. Manufacturer review of films noted the lead connector pin did not appear to be fully inserted into the generator connector block based on the view available. Based on the x-rays reviewed the appearance of the lead pin not being fully inserted could possibly be the cause of the high lead impedance, but a lead fracture cannot be ruled out. Surgical exploration has been planned for the patient on (b) (6) 2009. The patient in (b) (6) 2009 had high lead impedance that resolved in the or during their vns generator replacement and postoperatively was discovered to have high lead impedance again. The vns was programmed off.

Manufacturer Narrative
Manufacturer review of x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities noted. Appeared based on one view only, pin to not be fully inserted into the header of the generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1551036
« Last Edit: February 06, 2015, 03:47:19 AM by dennis100 » Logged
dennis100
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« Reply #8 on: June 23, 2014, 07:06:43 AM »

Model Number 300-20
Device Problem Detachment of device component
Event Date 08/10/2009
Event Type Malfunction
Event Description
It was reported to mfr that during surgery for generator replacement due to normal end of service, the lead connector boot became detached from the lead pin body. It is unclear the cause of this event. The surgeon was using a hemostat clamp to hold on to the lead while loosening the setscrews to remove the lead pins from the generator header. When the surgeon was trying to remove the positive lead pin, the lead connector boot became detached at the lead pin. The pt subsequently had a full revision where a new lead and generator were implanted. The explanted lead and generator have been returned to manufacturer where analysis is underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1496941
« Last Edit: February 06, 2015, 03:47:47 AM by dennis100 » Logged
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« Reply #9 on: June 23, 2014, 04:35:01 PM »

Model Number 302-20
Device Problem Battery impedance issue
Event Date 05/01/2009
Event Type Malfunction
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
Reporter indicated that high lead impedance readings were obtained during a follow up office visit following a generator revision surgery. The physician indicated that the pt did not have issues with high lead impedance prior to the date of the report and the diagnostic testing performed twice resulted in high lead impedance. Add'l info received from a company representative who was present during the generator revision surgery revealed that diagnostics were performed on the newly implanted generator and stated that high lead impedance readings were initially received; however, once the connector pin was reinserted the high lead impedance readings resolved. X-rays were taken and sent to the manufacturer for analysis; however, the quality of the images was not ideal. No anomalies were observed; however, the entire lead could not be viewed. This info was shared with the physician's office. It is likely that the pt will undergo revision or exploratory surgery to further investigate the issue; however, no date has been set.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471775
« Last Edit: February 06, 2015, 03:48:18 AM by dennis100 » Logged
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« Reply #10 on: August 07, 2014, 11:51:28 PM »

Model Number 105
Event Date 06/04/2014
Event Type Malfunction
Event Description
It was reported that device diagnostics resulted in high impedance (5348 ohms). The generator was programmed off and x-rays were taken. It was reported that the patient has been digging at the incision site since implant. It was reported that the patient was recently implanted. The patient was seen by the physician again and device diagnostics were performed which resulted in impedance values from 5200 ohms to high in the 5000 range. The physician indicated that the x-rays were ok. X-rays were sent to manufacturer for review. Based on the x-rays received, it appears that the lead pin not being fully inserted may be the cause of the device¿s high impedance. 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. Surgery is likely, but has not been performed to date.

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
It was reported that the patient underwent revision surgery at which time the lead pin was reinserted into the generator header. It was reported that device diagnostics after the lead pin was reinserted was within normal limits (2888 ohms and 2740 ohms).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910595
« Last Edit: December 18, 2015, 12:46:43 PM by dennis100 » Logged
dennis100
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« Reply #11 on: September 04, 2014, 11:09:32 PM »

Model Number 105
Event Date 06/17/2014
Event Type Malfunction
Patient Outcome Required Intervention,Hospitalization
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, complete lead pin insertion cannot be confirmed.

Event Description
It was reported that the vns patient was admitted to the hospital due to status epilepticus. The patient had previously been seizure free. At the hospital, the patient¿s device showed high impedance. The output current was decreased but the high impedance did not resolve. The patient¿s device was subsequently disabled. X-rays were provided to the manufacturer for review. The lead connector pin could not be confirmed to be fully inserted into the generator connector block. The patient underwent surgery on 07/11/2014. The surgeon was able to disconnect the lead pin from the connector block without loosening the setscrew. The surgeon re-inserted the lead pin into the connector block and the high impedance resolved (impedance value - 2453 ohms). The surgeon elected to replace the patient¿s generator during the procedure. The explanted generator has not been returned to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3977523
« Last Edit: September 18, 2015, 05:38:25 AM by dennis100 » Logged
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« Reply #12 on: September 05, 2014, 06:26:43 AM »

Event Date 05/22/2013
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 that during replacement surgery on (b)(6) 2013, the patient¿s device was tested and diagnostic results showed high impedance. The lead pin was reinserted into the generator header multiple times, but the device continued to show high impedance. The patient¿s generator was explanted and generator diagnostic showed end of service. No issues were noted with the lead electrodes attachment to the vagus nerve. The surgeon elected to replace the patient¿s generator and lead. Following replacement, diagnostic results continued to show high impedance. The vagus nerve was irrigated and the impedance value was reported to be decreasing; however, the patient device continued to show high impedance. The lead pin was reinserted into the generator header and diagnostic results finally showed lead impedance within normal limits. The surgeon attributed the high impedance to fibrosis. X-rays prior to surgery were reported by the surgeon to be unremarkable. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012761
« Last Edit: September 18, 2015, 05:38:47 AM by dennis100 » Logged
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« Reply #13 on: September 05, 2014, 06:27:17 AM »

Model Number 105
Event Date 07/22/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value - 7503 ohms). The patient¿s device was tested a second time and the device continued to show high impedance. The neurologist had the patient¿s device programmed on during the office visit. Diagnostic results from the implant procedure showed lead impedance within normal limits. X-rays dated (b)(6) 2014 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 does not appear fully inserted into the generator connector block. The electrodes appear to be aligned at a steep angle away from the nerve, nearly perpendicular to the nerve. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance is likely due to incomplete lead pin insertion. The patient experienced a seizure cluster so she swiped her magnet. Immediately, she began feeling intense chest pain and went to the er. The patient was hospitalized overnight. No known surgical interventions have occurred to date.

Manufacturer Narrative
Corrected data: the initial manufacturer report inadvertently did not include that the patient device had been disabled.

Event Description
Follow-up revealed that the patient was experiencing a ¿pinching¿ sensation across her chest and down her left side during stimulation on-times. The patient¿s device frequency and pulse width were decreased from 30hz to 20hz and from 500usec to 250usec, respectively. The patient¿s symptoms subsequently improved. The patient reportedly continued to have pain in her chest, but the physician indicated that the pain was not related to vns.

Event Description
Follow-up revealed that the patient铠device was disabled. Additional information was received indicating that the vns patient's medications were increased and the patient had gone to the er on two occasions to received iv anti-epileptic medications. The patient's seizure frequency was back to pre-vns baseline levels (2-3 small seizures per week). The patient's seizure cluster is not believed to be due to vns. Prior to the seizure cluster, the patient was given a new medication. After the seizure cluster, the patient was taken off the medication but it is unknown if this medication was the source of the seizure cluster. It was noted that the patient had poor seizure control prior to implant surgery. The patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostic results showed high impedance (impedance value - 7076 ohms). The surgeon noted that the lead pin was not fully inserted into the generator header. The patient's lead pin was reinserted and multiple diagnostic results showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013657
« Last Edit: December 17, 2015, 05:46:49 AM by dennis100 » Logged
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« Reply #14 on: October 10, 2014, 12:04:31 AM »

Model Number 105
Event Date 02/18/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was subsequently disabled. Diagnostic results two weeks prior to the high impedance observation showed lead impedance within normal limits. No trauma was reported to have occurred and the patient¿s seizures were well-controlled. X-rays were taken and were reported by the physician to be unremarkable. X-rays dated (b)(6) 2014 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 cannot be confirmed to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Follow-up revealed that the patient underwent surgery on (b)(6) 2014. The lead pin was reinserted into the generator header and diagnostic results show lead impedance within normal limits. The patient¿s device was not programmed on during the procedure.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4101750
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« Reply #15 on: October 10, 2014, 12:05:11 AM »

Model Number 102
Event Date 01/17/2006
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device showed high impedance. X-rays were taken and showed that the lead pin may not be fully inserted into the generator header. The patient¿s parents elected to disabled the patient¿s device not and pursue surgery. The patient¿s seizure control did not change due to the disablement; however, it was noted that the patient may not have had any efficacy with vns prior to the event. No known surgical interventions have occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4100841
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« Reply #16 on: October 10, 2014, 06:25:06 AM »

Model Number 102
Event Date 11/23/2009
Event Type Malfunction
Event Description
It was reported that the vns patient was experiencing pain at his electrode site. The patient¿s device was disabled and the patient was admitted to the hospital for x-rays and further evaluation. The patient¿s physician stated that the patient¿s pain was related to vns. Follow-up revealed that the patient¿s device was disabled because it showed high impedance (dc dc ¿ 7). The patient reported that his pain had improved and was intermittent. The patient was referred for surgery but no known surgical interventions have occurred to date. X-rays dated (b)(6) 2014 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 does not appear to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, high lead impedance may be due to incomplete lead pin insertion. Review of the available programming and diagnostic history showed normal diagnostic results on the date of implant.

Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 3784 ohms). As result, no lead issue was suspected and the reported high impedance was believed to be due to incomplete lead pin insertion. The explanted generator has not been returned 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=4095469
« Last Edit: December 16, 2015, 10:13:34 AM by dennis100 » Logged
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« Reply #17 on: October 10, 2014, 06:25:43 AM »

Model Number 103
Event Date 08/12/2014
Event Type Malfunction
Event Description
It was reported that three days following generator replacement, the patient was seen and x-rays identified that the lead pin was not fully inserted into the generator header. It was later reported that device diagnostics during generator replacement surgery when the new generator was attached to the existing lead were within normal limits (~3000 ohms). The patient was closed and surgery was ended. Postop diagnostics were performed which again were within normal limits. It was reported that the patient's parents called the nurse the following friday and reported that the suspected something was not right with the vns. X-rays were then arranged. It was reported that x-rays were not available for manufacturer to review. The patient was sent for surgery the same day and the generator and lead connection was rectified. It was reported that the surgeon indicated that he did not hear two clicks when tightening the set screw into the new generator at the generator replacement surgery. The surgeon felt that he had been tightening the set screw for a while and did not want to over do it.
Manufacturer Narrative

Event Description
Patient and product information was obtained. Patient trauma is not believed to have occurred but the physician noted that the patient was on a trampoline two days following replacement surgery.

Manufacturer Narrative
Brand name; corrected data: additional information revealed the product information for the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089829
« Last Edit: December 16, 2015, 10:14:45 AM by dennis100 » Logged
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« Reply #18 on: November 07, 2014, 06:45:16 AM »

Model Number 302-20
Event Date 08/26/2014
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 that during surgery for high impedance on (b)(6) 2014 (mfr. Report # 1644487-2014-01301), a new generator was connected to the lead which resulted in device diagnostics within normal limits (impedance value 3470 ohms). It was determined that the prior high impedance measurement was due to a lead pin insertion issue, so the existing lead was left in place. The next day, (b)(6) 2014, the patient's device was programmed on. System diagnostics were run, and the impedance was 2764 ohms. The patient was seen for follow-up on (b)(6) 2014. System diagnostics were performed, and the impedance was greater than 10,000ohms. It was advised that a likely intermittent lead fracture existed and the lead should be replaced. No known surgical intervention has been performed to date. No additional relevant information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164299
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« Reply #19 on: December 05, 2014, 03:33:58 AM »

Model Number 105
Event Date 09/24/2014
Event Type Malfunction
Event Description
It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value = 10,000 ohms). System diagnostic showed lead impedance within normal limits during implant surgery on (b)(6) 2014 (impedance values ¿ 1653 ohms and 1585 ohms). The patient was admitted to the hospital on (b)(6) 2014 and the patient¿s device showed lead impedance within normal limits (impedance values ¿ 4632 ohms, 4306 ohms, and 4197 ohms). On (b)(6) 2014, the patient underwent surgery in which incomplete lead pin insertion was confirmed. After the pin was reinserted, system and generator diagnostic results showed normal device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4232000
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« Reply #20 on: January 09, 2015, 03:54:42 AM »

Model Number 105
Event Date 11/19/2014
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
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). X-rays were performed which identified that the lead pin did not appear to be fully inserted into the generator. It was reported that the patient had recently undergone generator replacement surgery. The patient underwent revision surgery on (b)(6) 2014. The surgeon disconnected the lead from the generator and reinserted the lead pin into the generator header. It was reported that device diagnostics were within normal limits after reinserted the lead pin. Device diagnostics performed on (b)(6) 2014 were again within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4329923
« Last Edit: December 12, 2015, 07:56:46 AM by dennis100 » Logged
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« Reply #21 on: January 09, 2015, 07:13:11 AM »

Model Number 102R
Event Date 11/10/2014
Event Type Malfunction
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were taken and showed that the lead pin was not fully inserted into the generator header. X-rays were sent to manufacturer for review. Review of the x-rays confirmed that the lead pin did not appear to be fully inserted into the generator header. No other obvious discontinuities with the vns system were identified. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4317763
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« Reply #22 on: February 06, 2015, 03:48:56 AM »

Model Number 304-20
Event Date 12/16/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s device was tested and showed normal device function. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The patient underwent generator replacement surgery on (b)(6) 2015 due to painful stimulation. The lead was not replaced during the procedure. The painful stimulation event will be captured in manufacturer report #1644487-2015-03658.

Manufacturer Narrative

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

Event Description
It was reported that, during initial implant surgery, the surgeon had difficulty inserting the lead pin into the generator header. The surgeon stated that the end of the lead was flimsy and felt as if there was air behind the lead pin that created a vacuum which would not allow pin insertion. The surgeon was able to insert the lead by twisting it into the generator header. No further information relevant to this event has been received to date.

Event Description
Analysis of the returned generator reported in manufacturer report #1644487-2015-03658 did not observe any obstructions in the header lead cavity or the connector blocks. In addition, the in-line cavity go gauge test passed and a bench in-line lead was able to be fully inserted into the pulse generator header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4412968
« Last Edit: December 08, 2015, 10:14:34 AM by dennis100 » Logged
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« Reply #23 on: February 06, 2015, 07:44:17 AM »

Model Number 103
Event Date 12/09/2014
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator and lead confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that during initial implantation surgery, the surgeon connected the lead to the patient's vagus nerve and then connected the lead to the generator prior to tunneling the lead to check the lead impedance. The impedance was within normal limits (1979 ohms) so the surgeon attempted to disconnect the lead pin from the generator header to tunnel the lead under the patient's skin; however, the surgeon was unable to disconnect the lead from the generator. The surgeon removed the lead electrodes from the patient's vagus nerve and then retrieved a new generator and lead to implant. No difficulties were experienced with the newly obtained generator and lead and the patient was successfully implanted. It was reported that another attempt was performed to disconnect the lead pin from the generator header; however, this was again unsuccessful and during the attempt the lead was broken. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4391101
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« Reply #24 on: September 18, 2015, 02:49:53 AM »

Model Number 106
Device Problem High impedance
Event Date 08/03/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
High impedance was found at a patient铠first vns dosing appointment after initial implant. The device was not turned on and the patient has not experienced any discomfort. X-rays of the implanted device were reviewed by the manufacturer. The connector pin did not appear fully inserted into the connector block. The lead wires appeared intact at the connector pin.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5039651
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« Reply #25 on: September 18, 2015, 05:40:00 AM »

Model Number 105
Event Date 06/24/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
A provider reported that a patient's device was exhibiting high lead impedance. X-rays were provided to the manufacturer for evaluation. X-ray evaluation indicated that the generator placement appeared normal in the left upper chest area and the feedthru wires appeared to be intact. It appeared that the connector pin was not fully inserted into the connector block of the pulse generator. Although the lead wires appeared to be intact at the connector pin, this could not be fully assessed due to the image quality of the x-ray image. A portion of the lead was behind the generator and was therefore unable to be evaluated. There were no obvious lead breaks identified in the visible lead portion, however the presence of a micro-fracture could not be ruled out. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027471
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« Reply #26 on: September 18, 2015, 05:40:57 AM »

Model Number 105
Event Date 10/20/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the vns patient's device showed high impedance. The patient underwent surgery on (b)(6) 2015. The surgeon did not observe discontinuity in the lead during the procedure. A new generator was opened and tested with the existing lead, and diagnostic results revealed lead impedance within normal limits. The surgeon attributed the previously observed high impedance condition to incomplete lead pin insertion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5022569
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« Reply #27 on: September 18, 2015, 05:41:47 AM »

Model Number 106
Device Problems Fracture; High impedance
Event Date 07/30/2015
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
(b)(4).

Event Description
It was reported that during the surgery the lead pin was reinserted into the generator header which resolved the high impedance. The cause of the high impedance was a lead/generator connection issue.

Event Description
It was reported that high impedance was observed 15 days following generator replacement. X-rays were taken and sent to manufacturer for review. Review of x-rays were unable to determine whether or not the lead pin was fully inserted into the generator header due to the angle of the images. There were no obvious discontinuities in the portion of the lead that could be seen. The presence of a micro-fracture in the lead also cannot be ruled out. It was reported that the patient was seen by the surgeon at which time high impedance was again confirmed. The patient was scheduled for revision surgery. It was reported that the lead pin would be reinserted into the generator header; however, if this does not resolve the high impedance then lead revision would be performed. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5025253
« Last Edit: November 23, 2015, 09:38:47 AM by dennis100 » Logged
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« Reply #28 on: October 05, 2015, 11:02:26 AM »

Model Number 102
Event Date 11/07/2009
Event Type Malfunction
Event Description
Product analysis was performed on the returned generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. A bench lead inserted past the connector blocks. In addition, the in-line cavity go gauge test passed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the product analysis 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. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Additional information was received which changes the product the report is reported on.

Event Description
The patient reported on (b)(6) 2013 that he felt his vns device was ¿not working right¿ because he was feeling his stimulation since a couple of days prior which he had never experienced before. He started to feel his device turn on and can feel it pulsating in his neck where his scar is which had never happened previously. He reported that the treating neurologist did increase the vns settings a few weeks ago, but he did not notice any problems then. He reported that he believed everything was fine at his last visit. The patient denied any trauma or event that would have initiated the symptoms. Later, the vns company representative attended the patient¿s follow-up appointment on (b)(6) 2013 with a treating vns physician to assess the patient¿s symptoms and check the vns device. The patient reported about six months prior, the patient started feeling pain with stimulation by his clavicle and that about a month ago, the painful stimulation got more intense and he described it as a ¿spreading pain¿ which began in the clavicle area. The patient also started experiencing intense voice alteration with stimulation and was not able to talk when the device was stimulating. Upon performing diagnostics on the patient¿s device on (b)(6) 2013, high lead impedance was obtained with impedance value greater than 10,000 ohms. Therefore, the patient¿s device was disabled on this date, per manufacturer labeling recommendations. Clinic notes from (b)(6) 2013 reported that the patient¿s output current was increased on (b)(6) 2013 from 2. 25ma to 2. 5ma. The patient continued to complain of a ¿vibrating sensation in the left cervical region which would be consistent with the area of the lead. ¿ the physician notes that ¿it appears the patient¿s lead is faulty and therefore the device is being turned off. ¿ the patient was referred for replacement surgery. However, the surgery has not occurred to date. The cervical spine and pa/lateral views of the chest x-ray report dated (b)(6) 2013 reported no anomalies regarding the vns device. Attempts for a copy of the x-rays and additional information have been unsuccessful to date.

Event Description
On (b)(6) 2013 it was reported that the patient¿s surgery ended up just a battery replacement. The surgical team could visually inspect that the lead pin was not fully inserted and full of fluid. When the pin was dried off and reinserted, the system diagnostics showed results within normal limits. On (b)(6) 2013 further details were received when it was reported that the patient¿s revision surgery was underway when the surgeons noted the pin on the generator was not fully inserted. The pin was cleaned and reinserted and the surgeons noted the pin came loose very easily when unscrewing the set screw. After pin reinsertion, the device was within normal limits with no high impedance observed. The surgeons, by referral from the neurologist, went forth with a prophylactic generator replacement. Again, diagnostics showed all systems within normal limits. The surgeons elected to not move forward with a lead revision at this point. The explanted generator was returned for product analysis on july 29, 2013. Product analysis is underway and has not yet been completed.

Manufacturer Narrative
Date of event; corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3199351
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« Reply #29 on: October 06, 2015, 12:24:47 AM »

Model Number 304-20
Event Date 07/02/2012
Event Type Malfunction
Event Description
The implant card reports that the patietn had generator and lead replacement surgery on (b)(6) 2013 due to lead discontinuity.

Event Description
Upon further follow-up by the physician¿s assistant, it was reported the increased seizures in (b)(6) 2012 were not related to vns. No programing changes were made at that time, and diagnostics were within normal limits. Product analysis for the generator confirmed the end of service of the battery. An end-of-service warning message was verified in the pa lab and found to be associated with the pulsedisabled by the pulse generator. Therefore, providing evidence that the depleted battery may have been a contributing factor to the increased seizures as reported. Further review revealed that the explanted generator was returned with the output current programmed to 3. 00 ma. The data from the internal memory of the generator shows a impedance of 6357 ohms (previous recorded impedance value was 4814 ohms), estimated occurrence on (b)(6) 2012. The vns programming history database shows the last known diagnostic data was on (b)(6) 2012, lead impedance was 1014 ohms. The combination of a high impedance value and output current setting required a ¿vboost¿ compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v). This condition contributes to the disparity between the end of service condition and % battery capacity that has been consumed, based on the device¿s internal end of service projection system. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. Other than the noted conditions, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator device history records confirmed that all quality tests were passed prior to distribution. Analysis of the lead was also completed on the returned portion of the lead. During the visual analysis, multiple quadfilar coils appeared to be broken with areas of extensive pitting which prevented identification of all coil fracture types. Broken coil strands had evidence of stress induced fracture (torsional appearance) which most likely completed the fracture with mechanical damage and pitting, in addition to mechanical damage, secondary break lines, stress marks, and residual material. Pitting was observed on the coil surface along coil break. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During the visual analysis a large portion of the lead assembly appeared to be compressed and twisted. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the lead had not been fully inserted into the cavity of the generator. No other sets of setscrew marks were observed on the connector pin.

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr inadvertently omitted additional clarification from the product analysis results.

Event Description
Supplemental report 01 reported that setscrew marks were observed near the end of the connector pin, indicating the lead had not been fully inserted into the cavity of the generator. Additional review of the product analysis results shows that the connector pin was reinserted into the cavity of the a model 103 pulse generator (since the original generator was not available) to verify an obstruction wasn¿t preventing the connector pin from being fully inserted. No obstructions were noted. 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.

Event Description
It was initially reported on (b)(6) 2013 that the patient was scheduled for vns replacement surgery on (b)(6) 2013, but the reason was unknown. An implant card was later received from the company representative indicating that the patient had generator and lead replacement surgery on (b)(6) 2013 with the reason marked as ¿lead discontinuity. ¿ lead impedance following replacement surgery was within normal limits. Review of the manufacturer¿s available diagnostic history of the device shows high lead impedance was present on the date of implant but resolved via intraoperative replacement/troubleshooting. The patient¿s lead was replaced on (b)(6) 2009 as previously reported in mfg report #: 1644487-2009-01787. System diagnostics following full revision surgery on this date resulted in okay results, indicating proper device function. The last available diagnostics on (b)(6) 2012 also indicate the device was functioning as intended at that time. Follow up with the treating physician¿s office revealed that the patient and caregiver came in to the clinic on (b)(6) 2013 due to the patient¿s increased seizure activity and the magnet appearing to not abort seizure activity so the caregiver was concerned. The device was found to be at end of service condition. ¿the patient's magnet and output current being delivered was noted as 0ma but should be 3. 0ma and 3. 5ma. " it was reported that there was no current delivery from the generator, so the patient was not receiving the intended therapy. The caregiver reported the increased seizures began in the early spring of 2013, and the physician¿s office attributes it to ¿no therapeutic vns settings. ¿ the patient¿s anti-seizure medications remained the same during this time. The patient¿s best seizure control was after corpus callosotomy and vns therapy between 2010 and 2012, per the caregiver. No interventions were taken for the increased seizures as the family refused more medication. There were no recent changes anti-seizure medications before the onset; it was noticed once the vns ¿had no current delivered¿ due to end of service. No x-rays were taken prior to surgery. The patient was last seen on (b)(6) 2012. Per the physician¿s notes, the mother thought the seizures were increased, so the physician increased medication. Clarification was received indicating the device was at end of service condition at eos=yes where the device is at a pulse-disabled state and therefore not delivering therapy. The patient was referred for generator replacement due to end of service of the generator. No high impedance was detected by the treating physician¿s office. Therefore, the device was not intentionally programmed off prior to replacement. There was no patient manipulation or trauma was reported. The explanted generator and lead were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The return product form indicated the reason for replacement was ¿lead discontinuity. ¿.

Manufacturer Narrative
Device failure occurred and may have contributed to the increased seizures.

Manufacturer Narrative
Review of device history records. Review of the lead device history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194576
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