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dennis100
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« Reply #180 on: February 20, 2017, 07:41:23 AM »

Model Number 302-XX
Event Date 01/01/2011
Event Type Malfunction
Event Description
It was reported that a dc/dc code of 0 was obtained on system diagnostics. The pt was also experiencing an increase in seizures and was not feeling normal or magnet mode stimulation. It was also reported that the pt had a fall approx 6 months ago. Based on this, short circuit condition is suspected with the lead. X-rays of the device were reviewed by the mfr, but no anomalies were noted. Attempts for further info have been unsuccessful to date.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2024761
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dennis100
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« Reply #181 on: March 02, 2017, 12:25:12 AM »

Model Number 300-20
Event Date 11/22/2010
Event Type Malfunction
Event Description
It was initially by a company rep reported that a vns pt was to undergo battery replacement due to unk reason. The company rep followed up with the office of the treating neurologist and found that in (b)(6) 2004, system diagnostics were ok dcdc=0. The patient reports an increase in seizures (still below pre-vns baseline) and feels very tired. Moreover, the patient stated that he feels like when his last battery became near end of service as there is also a feeling of pinching in his neck near the leads and stimulation is not as strong as before. Info in the mfr's programming history revealed that a system diagnostics on (b)(6) 2004, which was ok, dcdc=2. No add'l diagnostics were available at the time. Based on info received to date, a short circuit condition is suspected based on clinical symptoms, however, no conclusion can be drawn at the time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956833
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dennis100
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« Reply #182 on: March 04, 2017, 10:15:44 AM »

Model Number MODEL 250
Event Date 12/10/2014
Event Type Malfunction
Event Description
Product information received.

Event Description
It was reported that the physician's handheld was not charging and it was believed that the cable had a short in it. The nurse reported that the handheld was able to be charged if the cord is wrapped around the plug. A new charging cable was provided to the physician's office. The charging cable is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393789
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dennis100
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« Reply #183 on: March 10, 2017, 04:32:19 AM »

Model Number 300-20
Device Problem Low impedance
Event Date 10/18/2010
Event Type Malfunction
Event Description
It was reported that a patient was having generator replacement surgery due to normal battery depletion, and low impedance was identified during diagnostics. The surgeon used the test resistor in the new generator, and the impedance was within normal limits. The lead was not replaced at that time. Programming history indicated that there could have been a short circuit condition in the lead with the previous generator. No further surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6342618
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dennis100
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« Reply #184 on: April 18, 2017, 10:56:43 PM »

Model Number 300-20
Device Problem Low impedance
Event Date 12/13/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Information was received indicating that the patient was not feeling stimulation like she did before. She was now feeling pain in her ear and jaw when stimulation was delivered along with an increase in gagging and choking sensations. The patient also reported that she was experiencing a shocking sensation when she turned her head to the right occasionally which resulted itching at the electrode site. The patient also reported that the muscles in her neck would tense up for 30 seconds and then relax. The patient's generator was disabled and the tension resolved. Diagnostics showed that the impedance on the patient's generator was at dcdc 0, which could be indicative of a short circuit issue under certain circumstances. The patient then had her device prophylactically replaced in (b)(6) 2017. No additional relevant information has been received to date. The explanted generator and lead have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404233
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dennis100
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« Reply #185 on: April 24, 2017, 03:32:41 AM »

Model Number 302-20
Event Date 09/01/2009
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 initially reported by the physician that patient showed high lead impedance with lead impedance 7116 ohms. Normal mode showed ok, lead impedance 6993 ohms. Surgeon had ordered x-rays and treating physician wanted total revision because patient had a hard fall after prophylactic battery replacement surgery in (b) (6)2009. Follow-up with the company rep revealed that the patient had a full revision surgery. It was indicated that the last good diagnostics were obtained at the time of initial battery replacement surgery ((b) (6)2009) which showed everything within normal limit. Company rep stated that the treating physician believed that the reason for high lead impedance was due to a fall which might have caused the lead to break, however, the surgeon indicated that the reason was due to a build of a lot of scar tissue around the electrode region. She indicated that x-rays were taken, and it did not show any lead break. X-rays were not available for manufacture review. Lead was discarded by the hospital since they were torn into pieces at the time of revision surgery. The surgeon did not notice any break on the lead while removing it but he did notice a lot scar tissue around the electrode region. Patient's previous generator programming history was reviewed and it was observed that the dcdc code had dropped to 0. Given the fact that the dcdc code had dropped from 2 to 0, it is suspected that a short circuit condition likely existed which eventually lead to a lead fracture. It is unlikely that fibrosis could be a part of the high lead impedance given that the dcdc code cannot jump from a 0 to such high ohms value unless there is a lead failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581033
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dennis100
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« Reply #186 on: May 01, 2017, 12:23:10 AM »

Model Number 302-20
Event Date 06/27/2014
Event Type Malfunction
Event Description
During prophylactic generator replacement it was reported that prior to the surgery low impedance (668 ohms) was observed. The generator pocket was opened and low impedance (322 ohms) was again observed. It was reported that fluid was observed inside the lead wire. It was reported that lead replacement would be performed at a later date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date. No known surgical interventions have been performed to date.

Manufacturer Narrative
Date of this report, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014. Date received by manufacturer, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014.

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted lead was returned to the manufacturer for analysis which confirmed openings in both the inner tubing sections in adjacent areas that exposed the conductive quadfilar coils, creating an intermittent short-circuit condition. The abraded openings and slice mark found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. The generator replacement surgery on (b)(6) 2015 was reported in manufacturer report #1644487-2015-04111.

Event Description
Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3994857
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dennis100
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« Reply #187 on: May 01, 2017, 12:24:08 AM »

Model Number MODEL 250
Event Date 07/11/2014
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Evaluation codes: no device failure occurred that would contribute to the computer powering down during use. User interface caused the crack in the screen; however, the crack did not inhibit use of the computer.

Event Description
Analysis of returned tablet device was completed. A visual inspection of the tablet verified that the display was cracked. No anomalies associated with the software or battery was identified during the analysis.

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

Event Description
It was reported that during surgery, the tablet kept shorting out and would power down while attempting device interrogation. A second programming tablet was used to successfully interrogate that patient's device. It was reported that the tablet had been accidentally dropped some time ago which caused a small crack in the screen, but this was not believed to cause the sudden power down. The programming tablet was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3995031
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dennis100
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« Reply #188 on: May 03, 2017, 12:21:53 AM »

Model Number 302-30
Event Date 11/26/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(4) 2014, product analysis was completed on the lead which confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition. Small portions of the (+) white and (-) green inner silicone tubes and quadfilar were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 31mm portion, abraded openings were observed on both of the inner silicone tubes, past the electrode bifurcation, and both of the quadfilar coils appeared to be exposed. During the visual analysis of the returned 3mm portion the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed tissue-covered (+) white electrode ribbon and the inner tubing abraded openings, 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 sets 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. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. The positive electrode condition may have contributed to the reported high impedance. Product analysis was completed on the generator on (b)(4) 2014. The end of service condition was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

Event Description
On (b)(6) 2014, it was reported that the patient was referred for generator replacement due to battery depletion and that prior to the replacement, system diagnostics were performed on the existing generator and results were normal. However, when the new generator was attached to the leads, the impedance was high. The lead was disconnected and re-inserted, and the impedance was high again. The test resistor was connected to the generator and the impedance was normal. The physician re-attached the generator to the lead and the impedance was then low. A new generator was then connected to the lead and the impedance was high again. The physician therefore replaced the lead as well. The explanted lead and generator were received for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334261
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dennis100
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« Reply #189 on: May 10, 2017, 12:38:20 AM »

Model Number 300-20
Event Date 05/01/2014
Event Type Malfunction
Event Description
Analysis of the returned lead portion was completed and confirmed lead discontinuity. Abraded openings of both inner tubing sections were found. There is evidence to suggest that both coils were in contact with each other, leading to a potential short circuit condition.

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

Event Description
The slice mark and abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes.

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 low impedance. The patient¿s device settings were increased but the patient did not exhibit any signs of receiving therapy. The physician¿s handheld device showed that low impedance was first observed at generator replacement surgery on (b)(6) 2014. The device impedance value fluctuated between < 600 ohms and 869 ohms since the replacement procedure. It was noted that the patient¿s previous generator showed low impedance (dc dc ¿ 0) prior to replacement. The physician stated that the patient had been experiencing an increase in seizures since (b)(6) 2014. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The surgeon observed a lead break during explant. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead portion is currently underway.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.

Manufacturer Narrative
Device manufacture date, corrected data: the supplemental report #2 inadvertently did not report this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4195520
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dennis100
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« Reply #190 on: May 23, 2017, 12:58:16 AM »

Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that patient had a "broken lead = short causing loe and left chest wall pain. Was sent to surgeon to repair it. " patient underwent generator and lead replacement. Three good faith attempts were made with this physician to obtain further information. No further information has been received. Explanted leads were discarded by hospital therefore product analysis cannot be performed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030358
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dennis100
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« Reply #191 on: June 02, 2017, 12:24:26 AM »

Model Number 201
Event Date 07/24/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that the site's wand had a short and was unable to be used. When the physician shook the cord, it would work for a second. Troubleshooting was performed, but the problem persisted. Product was returned to the manufacturer for analysis. Upon analysis, it was found that the battery cable had an intermittent connection at the positive battery connector; thereby, causing intermittent power to the device. After the positive battery cable connection was secured, the device performed according to specifications. No other anomalies were noted with the device.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1491977
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dennis100
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« Reply #192 on: June 04, 2017, 07:53:30 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the patient was experiencing a slight increase in seizures (below pre-vns baseline), she can no longer feel stimulation, and her voice does not change like it used to with stimulation. The magnet still aborts seizures, however. Diagnostics resulted in dc/dc code = 0. Based on the information received, a short circuit condition is suspected with the lead. No patient manipulation or trauma is suspected, but the patient has been under a lot of stress lately. Attempts for further information have been unsuccessful 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=1497723
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dennis100
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« Reply #193 on: June 05, 2017, 01:25:03 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type  Malfunction   
Event Description 
It was reported to the mfr that the vns pt has began experiencing a slight increase in seizure activity not above pre-vns baseline. Review of programming history revealed that system diagnostics test performed on the pt's device showed a dcdc code of zero. If present, an intermittent short-circuit could have potentially contributed to the pt's slight increase in seizure activity. Good faith attempts to obtain additional info regarding the reported event are underway.
 
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=1533077
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dennis100
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« Reply #194 on: June 06, 2017, 12:20:12 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type  Malfunction   
Event Description 
It was reported that the patient has been having an increase in seizures for the last four months, but the relationship to pre-vns baseline levels is unknown. The patient does not currently have a vns physician who is following him, so no further information is available at this time. Diagnostic results and the increase in seizures suggest the possibility of a short circuit condition in the lead, but this cannot be confirmed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1618755
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dennis100
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« Reply #195 on: July 02, 2017, 01:27:39 AM »

Model Number 302-20
Event Date 08/06/2010
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 a vns patient experienced pain in the neck area due to unknown reason. Additional information was received from a company representative present at a follow-up appointment with the treating nurse and patient. The company representative indicated the patient had been complaining of intermittent pain in her neck for the past 2 weeks. The nurse and company representative performed system diagnostics with ok results and dcdc=2. The nurse indicated the patient' settings are 2. 0/20/250/30/5 and performed normal mode diagnostics with a dcdc=0. The neurologist said due to the pain and the dcdc=0, he believes there is a short circuit of the device and scheduled the patient for a full revision. The patient did some heavy lifting recently (oxygen tanks) and the neurologist believes that could have caused a problem. Additional information was received from the explanting site indicating the patient underwent generator and lead replacement surgery due to painful stimulation and lead problem. The patient was re-implanted and the explanted generator and lead were returned to the manufacturer to undergo product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845862
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dennis100
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« Reply #196 on: July 06, 2017, 08:17:09 AM »

Model Number 300-20
Event Date 11/01/2010
Event Type Malfunction
Event Description
It was initially reported that vns patient was having increase in seizure activity. Follow up with the neurologist revealed that the seizure increase was at pre-vns baseline. However, after receiving patient's programming history, it was revealed that the device dcdc=0, indicating possible short circuit based on the patient's clinical symptoms. The patient suffers from mental retardation and it is unknown if he can perceive the normal/magnet stimulation. The magnet is still on and surgery has been planned with possible lead replacement because of the dcdc of 0.

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=1963858
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« Reply #197 on: July 08, 2017, 03:51:04 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 08/26/2005
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns device never worked for the patient. It was stated that it didn¿t work since after swiping the magnet they stated it did not help or lessen the seizure. The battery was reported to be depleted. A review of the manufacturer¿s in-house programming history database revealed there is evidence of fluctuating lead impedance levels, indicating a short circuit or low impedance condition. An estimate of battery life calculation was performed with the available history which indicated the battery to be depleted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6645915
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« Reply #198 on: July 28, 2017, 07:11:00 AM »

Model Number 302-20
Event Date 01/01/2010
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 mentioned in a pt's clinic notes on (b)(6) 2010 that the "vagal nerve stimulator had been terribly effective initially but has worn off to the point where [the pt] is not sure it is working anymore". Also, the pt expressed concern that the device may be malpositioned, but this claim was refuted as the physician examined the location and found it to be adequately placed. Diagnostics on the date of the report were within normal limits. A subsequent system diagnostic test on (b)(6) 2010, also found the device to be properly functioning. However, a review of the pt's past diagnostic history in light of the pt's most recent diagnostic results given in the clinicals found a dcdc code suggesting a potential short circuit condition since the pt's efficacy has reportedly "worn off". Good faith attempts to date for more info have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2050183
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« Reply #199 on: August 02, 2017, 08:36:46 AM »

Model Number 102
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that vns pt had increase in seizures and could not perceive stimulation. Diagnostics were within normal limits. Pt's seizure activity has not changed since the last office visit on (b)(6) 2011. Pt's mother said that the pt no longer coughed like she used to. Pt stopped feeling stimulation about 2 - 3 months ago, despite the increase in settings on (b)(6) 2011. The settings were further increased to 2ma on (b)(6) 2011 but pt still was not able to perceive stimulation. The treating neurologist stated that he saw a dcdc = 0 when he performed sys diagnostics and was concerned about a short circuit and pt not feeling stimulation. Thus, pt will likely be referred for surgery. X-rays were taken and reviewed by the mfr. Generator placement appeared normal. The lead connector pin appeared to be completely inserted into the generator connector block. The generator feed-through wires appeared to be intact. The electrodes appeared to be in proper alignment. No gross fracture or lead discontinuities could be visualized on the lead portion assessed, however, there was a suspicious area noted in the bend caudal to electrodes, but cannot be confirmed due to a lack of clear lateral view of the chest. There was a portion of the lead body behind the generator that was unable to be assessed. Additionally, the previously placed electrodes and a small portion of the lead body were still present. The location of this portion of the device was cephalad to the most recent lead body.
 
Event Description
Additional information received revealed that the patient has not achieved the same efficacy since this current generator was implanted in that since surgery in 2009, the patient has experienced a slow gradual increase in seizure frequency. There were no reports of trauma or manipulation and the patient is tentatively scheduled for revision surgery later this month.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the explanted lead and generator has been completed. During analysis of the lead, puncture and slice marks were found on the outer silicone tubing which provided a leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During analysis of the explanted generator, it was noted that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through the body fluids (addressing the allegations of pain and painful stimulation). The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2172670
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« Reply #200 on: August 03, 2017, 01:20:23 AM »

Model Number 302-20
Event Date 11/16/2010
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 a vns patient had low impedance with vns diagnostics testing (<600 ohms). The vns was disabled. Further review of vns programming history noted low impedance has been occurring since at least (b)(6) 2010, when it was noted to be 410 ohms. A short circuit condition of the lead is suspected. No trauma has been reported, but the patient's parents did manipulate the vns lead in the neck as they felt it was protruding under the skin. It is not known if this contributed to the low impedance. No x-rays have been performed. The plan of care is to refer for a surgical consult and revision surgery may occur in the future. The patient is currently stable on medications and doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2185413
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« Reply #201 on: August 06, 2017, 01:21:57 AM »

Model Number 103
Event Date 07/04/2011
Event Type  Malfunction   
Event Description
It was reported that the pt started feeling painful stimulation at generator site a few weeks prior. Pt's current setting are 2. 5/30/500/30/5 magnet 30/60/500. Diagnostics were performed and results were within normal limits, 2595 ohms, ifi: no. The green light showing battery consumption was showing half full and the physician does not think this is correct. Based on pt's current settings, the pt's device should last about 4 years and half green light means the battery has 25% to 50% remaining battery life which is not expected. X-rays of the pt's device were taken and reviewed by the mfr. No anomalies were seen on the x-rays. The physician ran diagnostics with pt's head turned different ways. When the head was turned to the right, the pt did not feel painful stimulation, but when the head was turned to the left, the pt felt the painful stimulation. Diagnostics in all positions were ok. The physician lowered the settings and the pain resolved. Attempts for further info have been unsuccessful to date.
 
Event Description
Further information reveals the patient has a consult for the painful stimulation issue and a decision will be made on how to proceed. Attempts for further information have been unsuccessful to date.
 
Event Description
Decoder spreadsheet analysis was performed for the patient's vns programming history. A review of patient programming data revealed that on (b)(6) 2011 the initial interrogation of the device resulted in a measured battery voltage of 2. 849v, indicating that a 25% battery status indicator was displayed to the user during this interrogation (e. G. 25% remaining is displayed at measured voltages of 2. 85v with demipulse generators). All subsequent communication operations resulted in a measured voltage of 2. 68v at the same programmed settings, based on charge accumulation this would have resulted in the expected 100% status indicator. Based on this data, it is possible that battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life. The manufacturer addressed this issue with demipulse generators by adding a 0. 5v offset to measured battery voltage during the first 7. 5% of battery consumption to mitigate the potential for artificially low voltage measurements during this period. The fact that the voltage measurement of 2. 894v was received at 9. 560% of consumption may indicate that battery impedance for this particular generator was longer than most (e. G. An outlier). Based on all subsequent programming data the device appears to be functioning as intended.
 
Manufacturer Narrative
Analysis of programming history. The battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life.
 
Event Description
Further manufacturer investigation revealed that the root cause of the observed battery voltage behavior has been determined to be the result of either an extended duration of the reduced conductivity (i. E. High battery impedance) experienced by cfx batteries during the beginning of life (bol) or a minute internal short that managed to "burn" itself out resulting in the observed voltage rebound following 10% of discharge (e. G. Consumption). No change to risk has occurred as a result of this investigation, which continues to be "low. " change request numbers (b)(4) were created as a result of this investigation. (b)(4) proposes that the duration of the 0. 5v offset, implemented by the firmware for model 103/104/105/106 generators be extended from 7. 5% to 15% of consumption within 11. X programming software in order to mitigate such events in the future. (b)(4) proposes that this issue be mitigated either through the firmware (as the device is still under development) or through the programming software as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245770
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dennis100
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« Reply #202 on: August 06, 2017, 06:12:25 AM »

Event Date 07/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a company representative that a nurse suspected a short circuit condition on a vns pt that had dcdc of 0 since 2006, but prior to that, dcdc was 2. Furthermore, it was thought the pt's seizures had worsened slightly since then, but the change in dcdc code was not associated with the possibility of therapy not being delivered. The pt had a new generator implanted and was seen in clinic due to unawareness of stimulation. X-rays were performed and examined by the hospital and company representative. No strain relief bend and no tie downs were visualized and possibly the anchor tether was not on the nerve. The x-rays were received by the manufacturer and evaluated. The generator was visualized in the left upper abdomen, with its front part facing the front side of the abdomen. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The state of the lead wires at the connector pin could not be assessed due to high density areas in the x-rays. The negative electrode appeared to be placed in normal arrangement. The positive electrode appeared to be partially detached from the nerve. The lead could not be fully assessed because of high density areas in the x-rays that concealed portions of the lead. No acute angles or lead breaks were observed in the assessed portions of the lead. Review of programming history with the pt's last generator indicated that system diagnostics dc dc had always been at 0 while normal diagnostics was indicative of 2. Programming history was not available for the recently implanted generator. The pt was referred for lead revision surgery and possible generator replacement surgery due to lead compatibility. No trauma was reported to have contributed to the event. Furthermore, information from the area representative indicated that no interventions have been planned even through replacement is needed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2241014
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« Reply #203 on: August 08, 2017, 01:46:13 AM »

Model Number MODEL 250
Event Date 07/13/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that they believed they had a short in their serial adapter cable because the programming system worked when they held it a certain way but otherwise it did not. The serial adapter cable was returned for product analysis which was completed on (b)(6) 2011. No anomalies associated with the serial cable were noted during testing. The serial cable performed according to functional specifications and provided consistent successful communication sequences in the product analysis lab. The mfr's consultant reported that the physician's programming system worked fine with a new serial cable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2219823
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« Reply #204 on: August 15, 2017, 01:05:45 AM »

Model Number 302-20
Event Date 02/05/2009
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem, corrected data:follow-up report #2 inadvertently indicated attempts for the return of the explanted generator are in progress; instead of attempts for the return of the explanted lead are in progress.
 
Event Description
Attempts for the return of the explanted lead have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history. Device failure suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the neurologist indicating that the patient has been experiencing a return of seizures for some time. The physician was not sure if any trauma or manipulation had occurred. Patient's seizure frequency is known to fluctuate which makes difficult to determine if any medication changes or other factors may be contributing to the increased seizures. An implant card was later received indicating that the lead has been replaced. The reasons for replacement were noted as "pre-op high impedance" and "insulation stripped off. " lead impedance was noted as "ok" following surgery. Attempts for the return of the explanted generator are in progress.
 
Event Description
Analysis of the returned lead has been completed. The majority of the lead was not returned. A suspected abraded opening was observed at the end of the returned portion of the lead. Slight pitting was observed on the negative lead pin. No discontinuities were observed.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. An abraded opening is suspected at the returned end however device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. (b)(4).
 
Event Description
Review of the pt's vns diagnostics history found that on (b)(6) 2009, systems diagnostics indicated the pt's impedance value was 586 ohms which is below the current low impedance threshold (i. E. 600 ohms) indicative of a short circuit condition of the lead. No adverse events have been reported. A review of programming history associated with the pt's previous generator revealed a dramatic drop in dcdc code between (b)(6) 2003 and (b)(6) 2005. Attempts to the pt's physician for further info on any effects on the pt's condition have been unsuccessful to date.
 
Event Description
The explanted lead has been received and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266022
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dennis100
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« Reply #205 on: August 16, 2017, 04:07:47 AM »

Model Number 300-20
Event Date 06/02/2009
Event Type  Malfunction   
Event Description
On (b)(6) 2011, the patient's programming history was reviewed and it was discovered that the patient has an impedance value of 558ohms on (b)(6) 2009. An impedance value less than 600 ohms indicates the potential presence of a short-circuit condition. (b)(4) attempts are underway by the manufacturer's consultant, but no further information has been received from the physician to date. When additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2013 when it was discovered that the patient underwent a full revision surgery on (b)(6) 2013. The lead impedance after surgery was noted to be "ok". The explanted products could not be returned to the manufacturer for product analysis as the hospital does not return them.
 
Event Description
Additional information was received on (b)(6), 2011 when the manufacturer's consultant reported that the physician is going to have the patient come back in for a clinical visit to run diagnostics since the last time the patient was seen was sometime in 2009. The patient was seen on (b)(6), 2011 and the physician saw a low impedance warning message upon interrogation. The manufacturer's consultant reported that the normal mode diagnostics test showed an impedance value of 602ohms and a systems diagnostic test showed low impedance. The programming history was sent to the manufacturer for review. The manufacturer's consultant reported that the patient is doing well and not having any adverse events; therefore no surgery will occur right now.
 
Event Description
On (b)(4) 2011, additional information was received when the manufacturer's consultant reported that she is trying to get the patient to see the physician in order to have diagnostics performed. The physician was not there last time the patient and manufacturer's consultant visited him to have diagnostics performed. The physician was not aware of any low impedance or clinical symptoms resulting from the low impedance. When additional information is received, it will be reported.
 
Event Description
On (b)(4) 2012 clinic notes were received dated (b)(6) 2011. Review of the notes revealed that the patient had borderline low impedance value of 558ohms. The patient's vns had not been checked since 2009. The patient's settings were noted to be output=1. 5ma/frequency=20hz/pulse width=250usec/on time=7sec/off time=0. 2min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. System diagnostics showed the lead impedance to be 602ohms which was within normal limits although borderline low and the output status was "ok. " the lead impedance was checked again and it was found to be 600ohms. It was decided that this would be watched carefully. The physician checked the battery position and the leads and did not see any evidence of any abnormalities. The magnet test was also performed and was normal with an impedance value of 602ohms. Tympanic membranes showed some scarring but no acute anomalies. The patient's mother noted some possible drainage from the right ear but the physician did not see anything acute. The physician later reported on (b)(6) 2012 that the patient was shown to have "lead impedance as well as nearing end of service on his generator. " the patient was referred for surgery. Clinic notes from the (b)(6) 2012 visit were also received which indicated that the lead impedance was gain borderline low, around 600ohms. The patient's on time was decreased to 0. 3sec and the patient's lead impedance was re-checked with it still showing borderline low. The patient is having 3+ seizures a day according the patient's mother; they have not really changed in character over the last year. 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=2232395
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« Reply #206 on: August 23, 2017, 02:24:25 AM »

Model Number MODEL 250
Event Date 10/18/2011
Event Type  Malfunction   
Event Description
The suspect flashcard was sent to the flashcard manufacturer, and an analysis of the flashcard identified that the cause of the flashcard anomaly is associated with a bad (shorted) capacitor. Once the capacitor was replaced with a known good capacitor, no further anomalies were identified. Additionally since the short was a power to ground failure, the current drain from the flashcard would cause the handheld to lockup when the flashcard was inserted.
 
Event Description
The vns computer and flashcard were returned for analysis. An analysis was performed on the returned computer. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. During the flashcard analysis it was identified that the flashcard was unresponsive and causing the computer to lock-up when it was inserted. The flashcard was sent to the flashcard manufacturer to determine an exact root cause for the anomaly. Once it is determined, an amendment will be added to the analysis identifying the root cause and the results will be reported.
 
Event Description
Reporter indicated a dell x50 vns computer screen was not responding to the stylus. The screen lock button was off. A hard reset resolved the issue, but the reporter was not able to advance past the "align screen" prompt. Attempts for product return are in progress.
 
Manufacturer Narrative
Device evaluated by flashcard manufacturer.
 
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=2337348

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« Reply #207 on: August 29, 2017, 01:08:04 AM »

Model Number MODEL 250
Event Date 11/29/2011
Event Type  Malfunction   
Event Description
It was initially reported that the physician's handheld was not functioning properly and there was a suspected "short" in the serial adaptor cable. No further information was provided. (b)(4) attempts for more information and product return have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the handheld was lost by the physician and will not be returned to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2383808
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dennis100
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« Reply #208 on: September 07, 2017, 03:21:29 AM »

Model Number 302-20
Event Date 08/21/2009
Event Type  Malfunction   
Event Description
Reporter indicated the current high lead impedance is dcdc = 4 with systems testing and dcdc = 6 for normal mode testing. The patient's increased seizures may be due to the high lead impedance per the reporter. The patient's "regular" seizures are increased, but the relationship to pre-vns baseline is unknown. The patient was seizure free for 18 months after initial vns implant, and is now having one seizure a week. The vns has not been disabled. The patient has had no known trauma. Vns revision surgery is planned for (b)(6) 2012.
 
Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.
 
Event Description
Reporter indicated the patient had vns lead and generator replacement surgery performed on (b)(6) 2012. The explanted lead and generator were discarded by the hospital after the surgery.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected.
 
Event Description
Reporter indicated a vns patient had high lead impedance with diagnostics testing and was also having increased seizures. The patient has had high lead impedance with dcdc = 4 for vns systems testing since at least (b)(6) 2009. At that time, no adverse patient events were occurring and no interventions were planned. X-rays previously reviewed on (b)(6) 2010, did not reveal any lead anomalies. Vns generator and lead replacement surgery appears likely, but has not occurred to date. Attempts for further information are in progress.
 
Event Description
An implant card was received back to the manufacturer documenting the vns lead and generator replacement surgery on (b)(6) 2012. Vns diagnostics prior to the explant indicated a dcdc = 0. As the dcdc code had previously been 4, it is suspected the high lead impedance had progressed to a short circuit (low impedance) condition of the lead. The diagnostics with the new vns lead and generator were 909 and 849 ohms, which is within the normal range.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2503832

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dennis100
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« Reply #209 on: September 08, 2017, 10:53:30 AM »

Device Problem Low impedance
Event Date 07/13/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a medical professional that a vns patient was experiencing discomfort over the medial side of the generator, and on palpation describes some tenderness when palpating that area. She reported that when she checked the device the diagnostics she was concerned of a short circuit condition. The patient was noted to have had 2 seizures that have been more severe over the past 2 months. A chest x-ray was taken and nothing abnormal was reported by the clinician. The x-rays have not been received by the manufacturer for review to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6772168
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