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dennis100
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« Reply #30 on: May 03, 2012, 02:49:39 AM »

Model Number 300-20
Event Type  Malfunction  
Event Description
Vns patient was experiencing an intermittent feeling that her device turns on and off by itself, independent of the cycling program. Device diagnostic testing (normal mode test) was not performed at required setting and is therefore inconclusive in determining whether the divce is functioning properly. The patient has not experienced any recent injury or trauma that may have damaged the ncp system. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Review of x-rays did not reveal any obvious discontinuities in the ncp system.
 
Event Description
Further follow-up revealed that the patient can feel device stimulation when the device activates; however, that about 10 percent of the time the device will not activate with use of the magnet. It was reported that when the patient uses the magnet and device stimulation does not activate, she can push on the generator moving it slightly and the device will then activate. The patient later underwent revision surgery. During the surgery after the patient was anesthetized, device diagnostic testing was performed. Device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device function. Surgeon then decided to replace the entire ncp system. Both the pulse generator and bipolar lead were replaced. Device diagnostic testing with the new system was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=658840
« Last Edit: February 15, 2016, 10:14:37 PM by dennis100 » Logged
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« Reply #31 on: May 03, 2012, 02:50:09 AM »

Model Number 101
Event Date 07/22/2005
Event Type  Malfunction  
Event Description
Reporter indicated that vns patient's device was "continuously firing" and that utilizing the magnet was not working to stop stimulation. Device diagnostic testing was within normal limit, indicating proper device function. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. The patient's device had been programmed to the same settings for approximately one year. Treating neurologist reduced device settings to help relieve some of the patient's discomfort. The patient reportedly tolerated the change in device settings. It was reported that the patient was operating a nail gun earlier in the day and had some strain in their left arm, but it is unk whether this was related to the reported event.
 
Event Description
Further follow-up revealed that the pt believes that the nail gun he was using prompted the erratic vns stimulation. The pt stated that the nail gun was very close to the generator when he was using it. The pt attempted to stop the stimulation with the magnet, however, it did not stop the stimulation. The pt went to the physician's office where the generator was turned off and the pt felt instant relief. The pt subsequently experienced a sore neck and hoarseness for a few days. Approx 14 weeks later, the pt was seen for follow-up. The device was turned back on. A series of magnet activations were performed and the device was found to be properly functioning. The pt requested that the device be left on because he had experienced an increase in seizures since the generator had been turned off. There have been no further issues reported to the manufacturer regarding this event. The cause of the event is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=636722

« Last Edit: February 15, 2016, 10:15:05 PM by dennis100 » Logged
dennis100
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« Reply #32 on: May 03, 2012, 02:50:45 AM »

Model Number 102
Event Date 01/01/2005
Event Type  Malfunction  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that vns pt's device was continuously stimulating causing hoarseness, difficulty swallowing, nausea, and vomiting. The pt reports that approx four months prior, they got shocked when changing a light bulb and that this same issue occurred after that, but that it eventually went away. The device was programmed to off with plans to see the pt again three days later. All of the pt's symptoms subsided after the device was programmed to off; however, the pt continued to complain of a sore neck and chest. Generator replacement surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=627002
« Last Edit: February 15, 2016, 10:15:44 PM by dennis100 » Logged
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« Reply #33 on: May 03, 2012, 10:39:50 AM »

Model Number 302-20
Event Type  Malfunction  
Event Description
Reporter indicated that vns pt was sceduled for revision surgery due to suspected device malfunction. It was reported that treating physician believed that the lead may be 'not in the right place or split'. Approx three months post implant, the pt began to experience 'sensations in neck and strong pull in vocal cord area' that were later described as feelings of painful and erratic stimulation with muscle contraction in her neck area. It was reported that the pt had recently been involved in a motor vehicle accident (date unknown). The day after these sensations began, they became intense and uncomfortable so the pt was seen in hospital emergency room because her neurologist was not available. The pt was seen by her neurologist the following day, at which time the device was programmed to off. Review of x-rays by manufacturer revealed that the lead electrodes were implanted at c6-c7 with one tie down and strain relief present. The generator was implanted in the left chest with lead connector pin fully inserted past the generator connector block with feedthroughs intact. The lead wire appeared to be intact at the connector pin. There were no visible gross lead discontinuities or acute angles, though the entirety of the lead could not be seen as some of it was behind the generator; therefore, a lead discontinuity there could not be ruled out. The pt underwent lead replacement surgery approx two months after she first experienced the painful and erratic stimulation with muscle contractions in her neck area. Intraoperative device diagnostic testing prior to explanting the original lead was within normal limits upon first test, but resulted in dc-dc code 7 amd limit upon repeat testing, indicating possible device malfunction. The explanting surgeon did not attempt to confirm proper lead/generator connection prior to explanting the original lead. Intraoperative device diagnostic testing performed after lead replacement (with the new lead connected to the original generator) was within normal limits, indicating proper device function. Visual inspection of the explanted lead at the time of surgery did not reveal any obvious discontinuties in the lead body. Lead break is suspected.
 
Event Description
The lead was returned and analyzed. Analysis summary: the electrode portion of the lead was not returned. The conditions of the lead portion returned are consistent with conditions that typically exist following an explant procedure. The connection between the setscrew and lead pin showed evidence that proper mechanical and electrical connection was present at one time. It cannot be determined if proper mechanical connection is present during the life of the implant. Results of the product analysis investigation were unable to identify any lead discontinuities or anomalies of any kind which would have contributed to the reported high impedance and erratic stimulation. There were no issues identified with the lead, however, the entire lead was not returned. The high impedance was not confirmed. Potential causes of high impedance events include: device failure, pt movements, bad connection, electrode to vagus nerve interface, device approaching end-of-service, training, design durability or corrosion of the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660364
« Last Edit: February 15, 2016, 10:16:14 PM by dennis100 » Logged
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« Reply #34 on: May 03, 2012, 10:40:56 AM »

Model Number 102
Event Date 11/01/2005
Event Type  Malfunction  
Manufacturer Narrative
H. 6. Treating physician believes that the twitch is related to vns stimulation.
 
Event Description
Painful and continuous stimulation. The patient was reportedly also experiencing muscle twitch on the right side of the neck. The patient's symptoms resolved after the device was programmed to off, and returned when the device was programmed back to on. The patient's device was subsequently programmed back to off. Device diagnostic testing was within normal limits, indicating proper device function. It was reported that the patient had experienced a fall approximately one month prior. Review of x-rays by manufacturer revealed that the lead electrodes are implanted at c6 with strain relief and one visible tie down. The generator is implanted in the left chest with feedthroughs intact and lead lead intact at the connector pin. The lead connector pin could not be verified as fully inserted past the generator connector block. There were no visible gross lead discontinuities; however, some portion of the lead was behind the generator. A lead discontinuity behind the generator could not be ruled out. The likely cause of the lead/generator disconnection is the fall experienced by the patient. Revision surgery is likely.
 
Event Description
The lead was analyzed. Product analysis summary: an analysis was performed on the returned lead portions, and no conditions that support the reported high impedance were identified. Since no anomalies in the lead performance were identified, no root cause could be determined. The condition of the returned lead portion are consistent with condition that typically exist following an explant procedure. Continuity checks were performed successfully with no discontinuities identified. The connection between the setscrew and lead pin showed evidence that proper mechanical and electrical connection was present. The concomitant device (pulse generator) was analyzed. Product analysis summary: no electrical or visual anomalies were identified that could adversely affect device performance. The generator is operating within limits; meeting the mfr's final electrical test specification. The cause of the reported high impedance is unk. Possible causes of high impedance include: broken lead, pt movements, bad connection, electrode to vagus nerve interface, generator approaching end-of-svc, physician/pt training. Damaged during mfg, design durability, or corrosion.
 
Event Description
Further follow-up revealed that the vns system (generator and lead) was explanted due to the reported high impedance event. The patient reportedly did not experience any trauma or manipulated the device. The patient had experienced an increase in seizures due to not receiving the vns stimulation. However, per the treating physician, the patient reportedly is doing reasonably well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=644157
« Last Edit: February 15, 2016, 10:16:57 PM by dennis100 » Logged
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« Reply #35 on: May 03, 2012, 10:42:04 AM »

Model Number 101
Event Date 10/31/2005
Event Type  Malfunction  
Event Description
The pulse generator was analysis. Product results: the generator was found to be at end of service based on a depleted battery voltage. The reported "communication difficulties" are likely the result of the low battery voltage. The reported "continuous stimulation" cannot be directly addressed by product analysis. As received, the generator would not interrogate and no output was observed prior to decontamination. The generator was implanted for 5. 22 years. The battery longevity was calculated to be 4. 85 years. However, due to the lack of a complete programming history, the longevity prediction may not be representative of the actual conditions of use. There is no evidence of electrical overstress or damage to generator components resulting from the reported "shock" experienced by the patient. No anomalies were identified that could adversely affect device performance. The concomitent device (lead) was also analyzed. Analysis was performed on the lead portions returned and the reported stimulation related event could not be verified. Continuity checks of the returned lead portions were performed and no discontinuities were identified. The condition of the lead portions returned is continued is consistent with conditions that typically exist following an explant procedure. No coil breaks were found. The connection between the setscrew and lead pins showed evidence that proper mechanical and electrical connection was present. Based on the product analysis findings, there is no evidence to suggest an anomaly with returned portions of the lead which may have contributed to the reported event. Full programming history for this generator was not received, therefore, a adequate estimation of end of service could not be performed. The cause of the reported stimulation related events, pain, and no communication were likely due to the generator reaching end of service. The generator may act erratically immediately before it reaches end of service.
 
Event Description
Vns patient had an accident that caused him to be shocked (not severely). The patient reportedly had an accident while welding that caused "high frequency" to travel throughout his body. After the incident, the patient reportedly felt continuous stimulation from the device, even when he used the magnet to inhibit stimulation. It was reported that treating neurologist attempted to program the device to off, but that he was unable to communicate with the patient's device. The patient also experienced feelings of continuous pain at both the generator and electrode sites, for which he went to the hospital emergency room. The next day the continuous stimulation and pain had decreased slightly and the patient reported that he could feel device stimulation and experienced his typical voice change during stimulation cycles. Treating neurologist has reportedly been unable to communicate with the patient's device since the incident, even after attempting to reset the patient's device and after using a different programming system. Review of x-rays did not reveal any obvious discontinuities in the ncp system. The patient underwent revision surgery, during which both the generator and lead (including electrodes) were replaced.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=648732
« Last Edit: February 15, 2016, 10:20:07 PM by dennis100 » Logged
dennis100
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« Reply #36 on: May 03, 2012, 10:42:34 AM »

Model Number 101
Event Date 10/29/2005
Event Type  Malfunction  
Event Description
Reporter indicated that vns pt's device "started going off by itself" and making her cough more than usual. The pt reported that she had fallen down some stairs on the same day that the erratic stimulation began, but that the feelings of erratic device stimulation began before she fell. The pt reports no feelings of erratic stimulation since that one day and has not experienced an increase in seizure activity. Report is incomplete because the pt has not been seen by her treating neurologist for over a year and has not scheduled an appointment with her neurologist due to transportation issues. Investigation to date has been unable to confirm proper device function as the pt has not been seen by treating neurologist for device diagnostic testing. Additionally, normal end of life has not been confirmed as a possible cause of the feelings of erratic device stimulation as no response has been received to manufacturers's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=663731
« Last Edit: February 15, 2016, 10:20:40 PM by dennis100 » Logged
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« Reply #37 on: May 15, 2012, 12:51:35 PM »

Model Number 102R
Event Date 01/01/2006
Event Type  Malfunction  
Event Description
Reporter indicated that the generator is stimulating erratically and causing throat pain. Diagnostic testing at different times have yielded dcdc codes of 5, 6, and 7 with eri=no. Generator has been explanted. Good faith attempts for additional info have been unsuccessful to date.
 
Manufacturer Narrative
Device malfunction 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=950651
« Last Edit: February 15, 2016, 10:21:13 PM by dennis100 » Logged
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« Reply #38 on: May 15, 2012, 12:52:04 PM »

Model Number 101
Event Date 10/01/2006
Event Type  Malfunction  
Patient Outcome  Required Intervention
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that the pt experienced "feelings of continuous stimulation when she turned her head to the side" and an increase in seizures with pre-vns baseline unk. It was also reported that the pt cannot feel magnet mode stimulation and normal mode "stimulation feels weaker. " in response to the continuous stimulation event, the phsycian advised the pt to stop stimulation immediately by placing the magnet over the device because the pt could "get nerve damage from continuous stimulation. " during the next office visit, the vns device's off time was increased from 0. 3 mins to 0. 5 mins. The physician indicated that the pt "was not sleeping enough and had increased stress at the time". A medical professional indicated that all of the events have resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=838543
« Last Edit: February 15, 2016, 10:22:17 PM by dennis100 » Logged
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« Reply #39 on: May 15, 2012, 12:52:27 PM »

Model Number 302-20
Event Date 03/07/2007
Event Type  Malfunction  
Event Description
Reporter indicated, that device diagnostic testing at office visit on 03/16/07 resulted in high impedance reading, indicating possible device malfunction. The pt reported, that nine days earlier, device stimulation "did not feel right" and that the following day, she experienced feelings of irregular or erratic stimulation. It was reported that on 03/16/07, system diagnostics testing was within normal limits, indicating no discontinuities in the system. Repeat testing four days later, yielded high impedance on the system diagnostics testing, indicating possible device malfunction. X-rays reviewed by mfr showed no anomalies. No adverse event was reported in conjunction with the high impedance condition. Revision surgery is likely.
 
Manufacturer Narrative
X-rays reviewed by mfr. Review of x-rays by mfr did not reveal any anomalies in the vns therapy system. Device malfunction is suspected, but did not cause or contribute to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=938057
« Last Edit: February 15, 2016, 10:22:49 PM by dennis100 » Logged
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« Reply #40 on: May 15, 2012, 12:52:52 PM »

Model Number 102
Event Date 02/01/2007
Event Type  Malfunction  
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a serious injury or death.
 
Event Description
Initial reporter indicated that the pt's vns therapy sys was not stimulating "at the programmed settings". The pt had been timing her vns with a stopwatch and stated "sometimes the device stimulates at 5 min and sometimes 12 minutes. " a sys diagnostics test was performed yielding normal results. The physician's assistant reported that he believed that the pt's "sensation" was actually the device functioning erratically". No medical intervention is planned and no serious injury was reported in conjunction with this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=871029
« Last Edit: February 15, 2016, 10:23:15 PM by dennis100 » Logged
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« Reply #41 on: May 15, 2012, 12:53:17 PM »

Model Number 102R
Event Date 06/01/2007
Event Type  Malfunction  
Event Description
Manufacturer received report that a vns patient was experiencing erratic stimulation. Follow up with the treating physician revealed that there is no believed cause for the event. Diagnostics testing were within normal limits. Monitoring with the programming wand indicated that generator was stimulating at irregular stimulation cycles which coincided with what the patient was reporting. The patient has been referred for generator replacement surgery at an unknown date.
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=882494
« Last Edit: February 15, 2016, 10:23:43 PM by dennis100 » Logged
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« Reply #42 on: May 15, 2012, 12:53:41 PM »

Model Number 302-20
Event Date 06/01/2007
Event Type  Malfunction  
Patient Outcome  Other
Manufacturer Narrative
X-rays reviewed by the manufacturer, lead break visualized near generator. Device malfunction occurred, but did not cause or contributed to a death or serious injury.
 
Event Description
Reporter indicated that, the pt presented with erratic stimulation and diagnostic testing resulted in high lead impedance indicating a possible lead malfunction. Pa and lateral x-rays of the chest and neck were taken and sent to manufacturer for review. Review of x-rays revealed that a lead fracture had occurred near the generator. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=882586
« Last Edit: February 15, 2016, 10:24:15 PM by dennis100 » Logged
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« Reply #43 on: May 15, 2012, 12:54:10 PM »

Model Number 300-20
Event Date 01/17/2007
Event Type  Malfunction  
Patient Outcome  Hospitalization
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contributed to a death or serious injury.
 
Event Description
Reporter indicated that the pt presented at a routine office visit with high lead impedance, output status ok. This indicates that the device is able to deliver the intended therapy. Follow-up revealed that the pt's "vns seems to come on whenever, and she has experienced a worsening in seizure activity recently. " physician's office reported that the problem was "not the seizures, but the erratic stimulation. " x-rays were taken and reviewed by the physician who indicated that "everything looked ok. " the pt underwent full vns therapy system replacement surgery. Pre-operative diagnostic tests yielded high lead impedance, output status ok. An implant and warranty registration card was received by the mfr indicating that the vns therapy system was replaced for lead discontinuity. Good faith attempts are being made to have the explanted products returned to the mfr for product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=912814
« Last Edit: February 15, 2016, 10:24:49 PM by dennis100 » Logged
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« Reply #44 on: May 15, 2012, 12:54:35 PM »

Model Number 102
Event Date 08/01/2007
Event Type  Malfunction  
Event Description
Manufacturer received report that a vns patient was experiencing erratic stimulation, "at least every 15 minutes. " patient states "using a microwave, walking through security doors at the bank or mall, and standing by a freezer cause vns to stimulate constantly for 10 minutes. " the patient has not been seen for vns follow-up since reported events. There was no report of the patient experiencing any injury or trauma, that may have damaged the vns therapy system. Attempts to obtain additional information have been unsuccessful.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a serious injury or death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=910261
« Last Edit: February 15, 2016, 10:25:16 PM by dennis100 » Logged
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« Reply #45 on: May 15, 2012, 12:55:04 PM »

Model Number 300-UNK
Event Date 05/25/2007
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported to the cyberonics representative that high lead impedance resulted from a systems diagnostic test at a follow up visit. Additionally, the patient reported sensing erratic stimulation of the device. No other adverse events were reported. There was no believed cause of the high lead impedance provided by the treating physician. The patient had surgery where the problematic lead and generator were removed and a new device was implanted. It was observed during surgery that when the chest pocket was opened, the surgeon visualized the lead tangled up and looked "like a bird's nest" and was knotted. The lead was fractured near the connector boot, but it was reported that it may have occurred while the chest pocket was being opened. The lead and generator were explanted and a new system was implanted. The explanted devices are expected to be returned to manufacturer for analysis. Attempts to obtain pre-operative x-rays to assess the continuity of the system are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=912627
« Last Edit: February 15, 2016, 10:25:37 PM by dennis100 » Logged
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« Reply #46 on: May 17, 2012, 04:18:26 AM »

Model Number 102
Event Date 09/01/2007
Event Type  Malfunction  
Event Description
Reporter indicated that a vns pt was experiencing erratic stimulation. It was reported that the pt felt like the vns device was "shutting off" 7-8 times per day. Review of programming history indicates that the generator settings have been changed frequently throughout duration of implant, and last known programmed off time was 120 minutes. Attempts to gather add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=926550
« Last Edit: February 15, 2016, 10:25:53 PM by dennis100 » Logged
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« Reply #47 on: May 17, 2012, 04:18:59 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that the pt experienced continuous stimulation and painful stimulation following a lead revision surgery. This led to the generator being programmed off. Good faith attempts for add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=926554
« Last Edit: February 15, 2016, 10:26:25 PM by dennis100 » Logged
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« Reply #48 on: May 17, 2012, 04:19:24 AM »

Model Number 101
Event Date 01/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
Reporter indicated a patient was experiencing erratic vns stimulation, painful stimulation, and generator migration. Revision surgery is planned. No further information is known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=922724
« Last Edit: February 15, 2016, 10:28:09 PM by dennis100 » Logged
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« Reply #49 on: May 17, 2012, 04:19:58 AM »

Model Number 302-20
Event Date 01/01/2007
Event Type  Malfunction  
Manufacturer Narrative
X-rays reviewed by mfr, no gross lead discontinuities visualized but noted the lead pin appears to not be fully inserted. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a patient had high lead impedance readings at an office visit, and that the patient was experiencing erratic stimulation. The reporter elected not to disable the vns but was aware of the mfr's recommendation to turn off the vns when high lead impedance is discovered. The patient underwent a left carotid catheterization procedure earlier this year. The reporter believes this procedure may have contributed to the high lead impedance. X-rays reviewed by the mfr did not reveal any lead discontinuities, but did identify that the lead pin does not appear fully inserted past the generator connector block. The plan of care for the patient is pending per the reporter.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=943360
« Last Edit: February 15, 2016, 10:28:30 PM by dennis100 » Logged
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« Reply #50 on: May 17, 2012, 04:20:25 AM »

Model Number 102
Event Date 10/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that a vns patient was involved in a motor vehicle accident and since the accident has experienced erratic stimulation, muscle spasms, generator migration, painful stimulation, and a seizure increase, below pre-vns baseline. Diagnostic test results from after the onset of the events are within normal limits. The treating medical professional is unsure of what the cause of the events is. The patient is being referred for revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=940413
« Last Edit: February 15, 2016, 10:28:53 PM by dennis100 » Logged
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« Reply #51 on: May 17, 2012, 04:21:00 AM »

Model Number 302-20
Event Date 01/01/2007
Event Type  Malfunction  
Manufacturer Narrative
X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a pt was experiencing erratic stimulation and intermittent neck pain. The vns has been disabled. X-rays reviewed by the mfr did not identify any lead anomalies. Possible lead revision surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=947204
« Last Edit: February 15, 2016, 10:29:15 PM by dennis100 » Logged
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« Reply #52 on: May 17, 2012, 04:21:27 AM »

Model Number 102
Event Date 11/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that a vns patient was experiencing painful stimulation. It was reported that the patient felt a "shocking" sensation from his diaphragm to his chest and back. It was reported that the patient was "almost panting" and "trembling. " it was then reported that the device was "stimulating erratically" and that after the patient swiped the magnet to initiate magnet modes stimulation, he would feel erratic stimulation. The patient then underwent generator replacement surgery in response to the events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=969856
« Last Edit: February 15, 2016, 10:29:35 PM by dennis100 » Logged
dennis100
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« Reply #53 on: February 17, 2016, 09:32:03 AM »

Model Number 304-20
Event Date 12/14/2011
Event Type Malfunction
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient underwent full revision surgery on (b)(6) 2012, in which the lead and generator were explanted and replaced. It was stated that the device was replaced as it was "firing when it shouldn't have causing strong stimulation". The explanted lead and generator were returned to the manufacturer and device evaluation was completed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. There were no adverse functional, mechanical, or visual issues identified with the returned generator and the generator performed according to functional specifications.

Manufacturer Narrative

Event Description
It was reported via complaint form dated (b)(6) 2012 that a vns patient was in the er three weeks prior due to neck discomfort. When x-rays were taken, a lead discontinuity was observed, therefore, the device was programmed off and the patient was referred to a surgeon. Surgery has not occurred at this time. Good faith attempts to obtain additional information including the specific diagnostics results obtained and details surrounding the pain and observed lead discontinuity have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2433231
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dennis100
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« Reply #54 on: February 17, 2016, 09:32:32 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient was complaining of erratic stimulation and pain in the left arm that were making it difficult to breathe. The physician advised the patient to disable the device temporarily and to either have the generator replaced or explanted. The physician informed the patient that the device battery could be wearing down and causing the erratic stimulation. The patient chose generator replacement and was referred for surgery. It was later reported that the patient was hospitalized for pneumonia and that the generator replacement surgery had been cancelled and not yet rescheduled. Surgery is still planned; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3330760
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dennis100
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« Reply #55 on: February 19, 2016, 04:27:20 AM »

Model Number 102
Event Date 09/02/2012
Event Type Injury
Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769409
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dennis100
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« Reply #56 on: February 25, 2016, 06:37:52 AM »

Model Number 102
Event Date 09/04/2011
Event Type Injury
Event Description
The patient's generator was replaced on (b)(6) 2011, and was returned to the manufacturer on (b)(6) 2011. Product analysis is not yet complete. Attempts for additional information have been unsuccessful as the physician refused to provide any additional information.

Event Description
Product analysis on the generator was completed on (b)(4) 2012. In the (b)(4) 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. An end of service condition was not found during product analysis. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Event Description
The implant card was received on 12/28/2011. The implant card indicated that lead impedance was ok on the day of surgery and that the generator was replaced due to battery depletion. Product analysis is still underway.

Event Description
On (b)(6) 2011, the manufacturer received clinic notes, dated 10/04/2011, which indicated that the patient was experiencing "erratic vns activity, which is disturbing the patient. " it was noted that the patient had one seizure since her last visit. The physician indicated that the patient may need a battery change due to the seizure and the "erratic vns activity. " no adjustments to the patient's medications or settings were made, and it was noted that the generator's battery life was not at end of service. Additional clinic notes dated (b)(6) 2011 and (b)(6) 2011 were also received. It was noted on both dates that the patient had experienced two seizures since her previous appointments, and was not feeling stimulation in her neck. It was indicated that since the patient was having a slight increase in her seizures, was no longer able to feel stimulation, and was tired the physician referred the patient for revision surgery. The physician noted that the vns was checked and the parameters were within a normal range with the elective replacement indicator flag set to no. The relationship between the increase in seizure frequency and the patient's pre-vns frequency rate is currently unknown, as is the cause of the increase in seizures. It is also unknown what the physician meant by "erratic vns activity. " attempts for additional information regarding these events have been unsuccessful to date. Revision is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355473
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« Reply #57 on: February 26, 2016, 03:41:35 AM »

Model Number 102
Event Date 10/17/2011
Event Type Injury
Manufacturer Narrative

Event Description
All attempts for further information from the reporter have been unsuccessful to date. A vns battery life estimate performed with available programming history yielded approximately 11. 78 years remaining, indicating the generator is not likely at end of service.

Event Description
Reporter indicated a vns patient was hospitalized overnight due to chest pain. The next two days, he then was experiencing erratic vns stimulation. Vns diagnostics tests were reported as normal. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2342405
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« Reply #58 on: February 27, 2016, 06:44:32 AM »

Model Number 102
Event Date 07/16/2011
Event Type Malfunction
Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. The explanted vns generator has been returned and is currently pending product analysis.

Event Description
Product analysis of the vns generator was completed. No anomalies were identified during the analysis and the generator performed per specifications. The generator was not at end of service.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated a patient had vns generator migration, neck, shoulder, and chest pain, swelling over the generator site, erratic vns stimulation, and increased seizures. The vns generator was also reported to be nearing end of service and not working at full power. The patient had vns generator replacement surgery performed on (b)(6) 2011. A battery life estimation for the generator performed by the manufacturer yielded approximately 2. 69 years remaining, but 1. 5 years of programming history was missing. Attempts for further information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2330300
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« Reply #59 on: February 29, 2016, 06:46:53 AM »

Model Number 102
Event Date 02/22/2011
Event Type Malfunction
Event Description
Reporter indicated the patient presented at clinic on (b)(6) 2013 with pain, burning, itching and "random firing of the vns. " surgery to replace the vns appears likely. Attempts for additional information are in progress.

Event Description
Reporter indicated that vns generator replacement surgery is still planned. The vns generator is to be replaced for patient comfort and to preclude a serious injury.

Manufacturer Narrative
Event is both a serious injury and a product problem. Overall reportability of event is a malfunction. Manufacturer reviewed x-rays of implanted device. This code was inadvertently omitted form the initial mdr report. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. This code was inadvertently omitted form the initial mdr report.

Manufacturer Narrative

Event Description
Reporter indicated a vns patient was having painful, erratic stimulation in the neck and chest. Vns settings were lowered and the painful stimulation improved. The patient had no known trauma. Current vns diagnostics cannot be performed as the patient cannot tolerate the 1ma output current necessary to complete the test. X-rays were reviewed by the manufacturer and no obvious anomalies were identified. A vns generator battery estimate performed yielded approximately 7. 97 years remaining. Vns generator replacement appears likely, but has not been scheduled to date. Attempts for further information are in progress.

Event Description
Analysis was completed on the returned vns generator. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
Reporter indicated the patient's vns generator replacement surgery was on hold due to insurance issues, but surgery is still planned. Although vns diagnostics are within normal limits, the reporter feels there may be a "problem with the generator" and that the patient may benefit from having generator replacement surgery performed prophylactically.

Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. Preoperative vns diagnostics indicated normal device function. It was the opinion of the current surgeon that the original implanting surgeon ¿probably had the coils a little close to the laryngeal nerve¿. The explanted generator was received back to the manufacturer on (b)(4) 2013 and is pending analysis.

Event Description
The reporter indicated that the patient had no trauma or events that led up to the pain, burning, itching, and "random firing of the vns. " surgery to replace the vns appears likely and is tentatively scheduled for (b)(6) 2013. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2299589
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