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dennis100
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« on: May 11, 2011, 01:10:05 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reported indicated that after approximately a year and a half, the vns therapy was very effective for the patient and that patient was basically seizure-free for approximately two and a half years. The patient recently began having seizures again at the same rate as before the vns therapy. It was reported that the patient had previously undergone generator replacement surgery for end of service after the seizures returned and that patient had regained seizure control with the replacement generator until recently. Normal mode output current has been increased in an effort to regain seizure control. Additionally, it was reported that the patient was initially implanted on the right side, but that the orginal device had protruded through the skin resulting in infection. The patient was explanted and re-implanted on the left side with no further problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=462969
« Last Edit: April 30, 2017, 01:34:02 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 11, 2011, 01:10:37 PM »

Model Number 302-20
Event Type Malfunction
Manufacturer Narrative
H. 6 vns therapy system labeling states that the safety and efficacy of the vns therapy system treatment have not been established for stimulation of the right vagus nerve or of any other nerve, muscle, or tissue.

Event Description
Device tracking info submitted to mfr indicates that the pt underwent revision surgery, during which the lead was replaced due to lead discontinuity. During the revision surgery, the lead connector pin was removed from the generator and then reinserted. Subsequent device diagnostic testing continued to yield high lead impedance results, ruling out generator/lead connection issue as the cause of the high lead impedance condition. The surgeon indicated that he observed a "knot" in the lead body, near the generator. He "took the knot out", after which repeat device diagnostic testing continued to yield high lead impedance readings. The lead (excluding electrodes) was then explanted and a replacement lead was placed on the right vagus nerve. Since it was previously reported that the pt did not manipulate the device through the skin, the "knot" in the lead body was likely present as a result of user error at the time of initial implant surgery. Incorrect implant technique likely resulted in a leak break and subsequent high lead impedance condition as a result of the knot. No seriois injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=675817
« Last Edit: November 03, 2015, 12:19:21 AM by dennis100 » Logged
dennis100
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« Reply #2 on: May 11, 2011, 01:11:39 PM »

Event Date 01/01/2006
Event Type Malfunction
Event Description
Manufacturer received device tracking information indicating that a pt underwent lead and generator replacement due to "high impedance-fibrosis of nerve". The generator and a portion of the lead were explanted and discarded. The original lead portion in the left neck area was left in place. The new lead was placed on the right side vagus nerve. Post operative x-rays were sent to the manufacturer to assess the placement of the new lead. During the review, the manufacturer observed an obvious lead discontinuity of the original lead portion in the left neck area. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=855901
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« Reply #3 on: May 11, 2011, 01:12:12 PM »

Event Date 02/01/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt was scheduled for explant and re-implant on right side due to infection. The pt's generator was replaced in 2002 due to end of service. The pt developed an infection following device replacement surgery. Ncp system (generator and lead) was replaced in 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=449528
« Last Edit: November 03, 2015, 12:20:13 AM by dennis100 » Logged
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« Reply #4 on: May 13, 2011, 10:21:24 AM »

Event Date 01/01/2004
Event Type Malfunction
Manufacturer Narrative
H. 6. The safety and efficacy of the vns therapy system treatment have not been established for stimulation of the right vagus nerve or of any other nerve, muscle, or tissue.

Event Description
Further follow-up revealed that the pt underwent revision surgery. It was reported that the surgeon did not explant the existing vns therapy system and that the new vns therapy system was implanted on the right side and attached to the patient's right vagus nerve due to a mass of fibrous tissue on the left vagus nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=564880
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« Reply #5 on: May 13, 2011, 12:43:19 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns pt was explanted due to infection. Re-implant surgery is planned; however, neurosurgeon is considering implanting the lead on the right vagus nerve. Investigation to date has been unable to determine the cause of the reported infection. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=580754
« Last Edit: November 03, 2015, 12:20:52 AM by dennis100 » Logged
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« Reply #6 on: May 14, 2011, 09:54:13 AM »

Model Number 102
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Further follow-up revealed that the patient was not given any pre, intra, or post op antibiotics. Infection was first noted 2 weeks after the vns implant. The infection was present at both the generator and lead sites. Neither blood nor swab cultures were collected. The patient was hospitalized for the treatment of the infection. The infection was treated with antibiotics and explant of generator and lead. The infection is completely resolved. Patient was re-implanted in 2005. Manufacturer records were reviewed and sterilization for both the generator and lead was confirmed. The surgeon reported that the patient irritating the incision site contributed to the infection event.

Event Description
Mfr received device tracking info indicating that the pt's original vns therapy system had been explanted due to infection and that the pt was reimplanted on the right side instead of the left side where the original system had been. Both the lead and generator were explanted and replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=657249
« Last Edit: November 03, 2015, 12:21:09 AM by dennis100 » Logged
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« Reply #7 on: May 15, 2011, 12:06:55 PM »

Event Date 03/13/2007
Event Type Injury
Event Description
Cyberonics rep present in operating room reported a right sided implantation of the vns system reportedly due to surgeons preference because of "scar tissue formation from previous implant, explant and infection issues. " three intraoperative system diagnostics tests preceded three episodes of bradycardia. No medical intervention were taken. No decreases in blood pressure noted. Pt remains implanted. Device is programmed on and is reportedly doing fine with stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=843157
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« Reply #8 on: May 16, 2011, 08:41:33 AM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a pt was having vns stimulation-related muscle spasms in the left neck, arm, and hand. Parameter changes were attempted to relieve the spasms but were unsuccessful. The patient underwent a right-sided vns system placement. The original vns system was left in the pt and disabled. The patient's symptoms have resolved and the patient is currently receiving right-sided vns stimulation. The original vns system will be utilized if needed in the future.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=875017
« Last Edit: November 03, 2015, 12:22:02 AM by dennis100 » Logged
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« Reply #9 on: May 18, 2011, 02:45:54 AM »

Event Date 10/29/2007
Event Type Injury
Patient Outcome Hospitalization; .
Event Description
Initial reporter indicated that, the patient's physician is inserting a "right vns", but no new generator. Additionally, it was reported the surgeon was planning on replacing the lead only and implanting it on the right vagus nerve. The patient was experiencing pain and doctor associated the pain with the lead because, when the device was turned off, the pain resolved. The physician reported that diagnostic results were "great" and x-rays revealed no anomalies. He said that he "programmed off the generator and the pain went away. " he said he "can also lower settings and the pain is less intense. " he said the "patient also has psychiatric issues and that may be contributing to her ability to tolerate it", but "the pain is still bad enough that something has to be done. " he said that the painful stimulation started out of "nowhere" and he "does not know the cause" because of the good diagnostics and x-rays. The patient underwent the lead replacement surgery and the mfr is making good faith attempts for the explanted lead to be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=954402
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« Reply #10 on: May 19, 2011, 02:11:29 AM »

Event Date 04/04/2008
Event Type Malfunction
Event Description
Reporter indicated a vns pt presented with high lead impedance. The pt is implanted on right side rather than the left as the pt, who is mr, had habit of striking his left chest. The pt underwent full revision surgery. Intra-operative troubleshooting ruled out the generator as the cause of the high impedance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1037612
« Last Edit: November 03, 2015, 12:23:06 AM by dennis100 » Logged
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« Reply #11 on: May 28, 2011, 02:43:57 AM »

Event Date 12/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the surgeon that the patient developed an infection at the generator site after her second re-implant surgery. Patient was treated with antibiotics for a few days and then, the surgeon performed a generator replacement surgery. Patient was re-implanted with a new generator on the right side of the chest since the surgeon did not want to place the new generator back into the old pocket. Diagnostics were performed prior to replacement surgery, and it showed everything working within normal limits. Good faith attempts to obtain additional information has been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1567252
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« Reply #12 on: May 28, 2011, 02:46:23 AM »

Event Date 04/27/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A patient reported that during implant surgery, the surgeon implanted the vns generator on the right side of the patient's chest as the patient was implanted with a pacemaker on the left side. During implant, the patient experienced asystole and had to be resuscitated. During surgery, the patient also experienced a large seizure when the vns was programmed on and now the patient is having more seizures than she did prior to being implanted with the device. The patient also stated that the device is pushing up against her skin which causes pain while dressing. Per the patient, the surgeon stated that the generator battery may have been used up during surgery, and he was unsure if the device was still functioning. Follow up with the neurologist revealed that the patient has a history of arrhythmia. The generator is registering magnet swipes. He does not know if the increase in seizures is above baseline levels. The protrusion response was that the device looks no different from any other patient other than it being on the right side. He will do a symptomatic therapy for the pain and possible consultation with a surgeon for a revision of the implant if desired by the patient. He does not know of any trauma or manipulation. Good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851128
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« Reply #13 on: May 31, 2011, 11:07:33 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported in a scientific article that a vns patient was explanted for the third time of vns therapy due to recurrent skin breakdown and infections at the chest generator site. After removal of the vns therapy system, the patient showed no clinical evidence of damage to the left vagus nerve and was re-implanted on the right side due to the recurring infections.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1586197
« Last Edit: November 03, 2015, 12:24:33 AM by dennis100 » Logged
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« Reply #14 on: May 31, 2011, 11:08:31 AM »

Event Date 11/20/2009
Event Type Malfunction
Event Description
It was reported that high lead impedance readings were obtained during generator revision surgery when the new generator was connected to the existing lead. Upon observation of the lead body, the surgeon noted a clean cut in the silicone tubing directly above the generator pocket. The old leads were cut at the midpoint due to excessive scar tissue around the nerve. A new lead was not implanted at that time due to the scar tissue. No x-rays were taken prior to surgery and there were no reports of pt manipulation or trauma that could have caused or contributed to the reported event. A new lead was implanted on the right vagus nerve at a later date and the high lead impedance readings resolved. The explanted lead has been returned to the mfr and device eval is in process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1603856
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« Reply #15 on: June 06, 2011, 11:48:03 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt was explanted due to infection. Further follow-up revealed that the infection was present at the neck incision site and that neurosurgeon is considering re-implant on the right vagus nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=471471
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« Reply #16 on: June 11, 2011, 10:46:07 PM »

Event Date 11/16/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
At the time of initial implant surgery, the pt's heart rate decreased by 10 bpm during intraoperative device diagnostic testing on four occasions. The implant was otherwise performed without complication. No rhythm changes were observed. The pt's vns therapy system is implanted on the right side due to previous left carotid endarterectomy and left subclavian bypass. At office visit approximately two weeks later, device stimulation was initiated under ecg observation. It was reported that the pt began coughing during stimulation, but that parameters were reduced and the coughing went away. Stimulation was initiated at. 025ma normal mode output current and 30hz, 500psec, 30 sec on, 5 min off. When the pt experienced the coughing, the frequency was reduced from 30hz to 20hz and the pulse width was reduced from 500 psec to 250psec. Tehre were no further problems with coughing and the pt reportedly tolerated the reduced settings well, although pt did cough when initiating magnet mode stimulation (0. 50ma magnet mode output current with 250 psec and 60 sec on). Magnet mode output current was then also reduced to 0. 25ma. No ecg changes were observed during this visit and the pt's heart rate remained around 75-80 bpm. No decrease in heart rate was noted during device stimulation. The pt's blood pressure was approximately 100/80 during stimulation. Investigation to date has been unable to determine the cause of the reported bradycardia during intraoperative device diagnostic testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=559934
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« Reply #17 on: June 14, 2011, 12:43:19 AM »

Model Number 300-30
Event Type Malfunction
Event Description
Further follow-up revealed that the pt underwent ncp system replacement. Both the pulse generator and bipolar lead were replaced.

Manufacturer Narrative
H. 6. The safety and efficacy of the vns therapy system treatment have not been established for stimulation of the right vagus nerve or of any other nerve, muscle, or tissue. Additionally, the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that patient's device diagnostic testing at office visit resulted in high lead impedance indicating possible device function. X-rays were taken and revealed that the lead electrodes may be off the nerve which can cause the high impedance results. The patient reportedly has not experienced any change in seizure level and has not exprienced any pain related to the electrodes coming off the nerve. Revision surgery is planned. The implanting surgeon is interested in replacing the ncp system and placing the new system on the right vagus nerve. In addition, the patient had a previous ncp system which was replaced in 2000 because of a reported similar lead issue. The implanting surgeon indicated that the reason for replacement was that the lead had "slipped off the nerve". Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine why the lead electrodes are off the nerve. This event is currently under investigation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=627565
« Last Edit: November 03, 2015, 12:26:25 AM by dennis100 » Logged
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« Reply #18 on: June 16, 2011, 06:07:40 AM »

Event Date 06/01/2005
Event Type Malfunction
Manufacturer Narrative
H6; vns therapy system labeling states that the safety and efficacy of the vns therapy system treatment have not been established for stimulation of the right vagus nerve or of any other nerve, muscle, or tissue.

Event Description
Reporter indicated that vns pt underwent generator replacement surgery due to suspected device malfunction. Device diagnostic testing at office 5 days after stimulation was initiated post initial implant surgery resulted in high lead impedance reading (dc-dc code 7 and limit). Indicating possible device malfunction. The pt underwent generator replacement surgery spprox one yr later. The high lead impedance condition did not resolve following generator replacement surgery, indicating a possible lead break or possible electrode/nerve interface issue. It was reported that during the generator replacement surgery, the surgeon noted "a lot of fibrosis on the pt's vagus nerve" and subsequently did not want to explant and replace the lead at that time. It was reported that the vns therapy system in question was implanted on the right side, as the pt had a previous vns therapy system implanted on the left side that was programmed to off due to device migration, but was explanted. Treating neurological indicated that revision surgery to replace the lead is not planned at this time because the pt's seizures are well controlled. Topamax has recently been added to the pt's medication regimen. It was reported that the pt's device was swiped with a magnet, after which eeg monitoring showed a definite change inthe waveform. Review of x-rays by treating physician did not reveal any obvious discontinuities in the vns therapy system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=723038
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« Reply #19 on: June 18, 2011, 07:09:57 AM »

Event Date 05/23/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Mfr received an implant card, reporting that pt had an infection on the left side and was reimplanted on the right side with another vns therapy system. Follow-up with the medical professionals revealed that the infection was found to be caused by staphylococcus aureus. The pt was treated with the following oral antibiotics: flucloxacilin, ampicillin & co-amoxiclav. In addition, the pt was hospitalized to receive iv antibiotics. The explanted products were discarded. Currently, it is reported that the pt has no infection, no side effects, and is having noted improvement in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=791742
« Last Edit: November 03, 2015, 12:27:18 AM by dennis100 » Logged
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« Reply #20 on: December 02, 2011, 05:19:23 AM »

Model Number 300-30
Event Type Malfunction
Event Description
Further follow-up revealed that the pt underwent ncp system replacement. Both the pulse generator and bipolar lead were replaced.

Manufacturer Narrative
H. 6. The safety and efficacy of the vns therapy system treatment have not been established for stimulation of the right vagus nerve or of any other nerve, muscle, or tissue. Additionally, the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that patient's device diagnostic testing at office visit resulted in high lead impedance indicating possible device function. X-rays were taken and revealed that the lead electrodes may be off the nerve which can cause the high impedance results. The patient reportedly has not experienced any change in seizure level and has not exprienced any pain related to the electrodes coming off the nerve. Revision surgery is planned. The implanting surgeon is interested in replacing the ncp system and placing the new system on the right vagus nerve. In addition, the patient had a previous ncp system which was replaced in 2000 because of a reported similar lead issue. The implanting surgeon indicated that the reason for replacement was that the lead had "slipped off the nerve". Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine why the lead electrodes are off the nerve. This event is currently under investigation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=627565
« Last Edit: November 03, 2015, 12:28:27 AM by dennis100 » Logged
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« Reply #21 on: December 05, 2011, 10:31:09 AM »

Event Date 08/18/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reporter event because explanted products are decontaminated prior to return; therefore, microbiological testing is not peformed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery.

Event Description
Reporter indicated that patient underwent vns therapy system explant due to infection with reimplant on the right side approximately four months later. Approximately 2 1/2 months post-implant, a pimple was noted at the medial aspect of the neck incision. This progressed to bleeding and scant drainage with redness. The patient denied any pain, increase in seizure activity or fever and had no complaints of swelling. The axilla incision was reportedly healing well at that time. The area was cleansed and a scant amount of white drainage was expressed from under the lesion. Silver nitrate applicators of 75% silver nitrate with 25% potassium nitrate were applied to the lesion. This was neutralized with normal saline 0. 9%. At that time, the patient was diagnosed with sutural wound irritation from a stitch that extruded to the surface with granulomatous tissue. Approximately 4 1/2 months later, the patient presented with complaints of inflammation along the neck incision and chronic drainage. At the time of explant surgery, breakdown of the skin over the chest incision site was noted. Purulent material was draining from this area and it appeared that the breakdown in the area of the neck incision was an ascent of infection from the chest area. The infection was present in both the pulse generator/pocket and bipolar lead/cervical areas: both the lead (including electrodes) and generator were explanted and a subsequent course of antibiotic therapy was prescribed. The infection has reportely resolved. Both preoperative and intraoperative antibiotics were utilized during initial implant surgery and a course of post-operative antibiotics was also prescribed. The patient is not implanted with any other devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=639373
« Last Edit: November 03, 2015, 12:29:02 AM by dennis100 » Logged
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« Reply #22 on: September 07, 2012, 07:43:17 AM »

Model Number 304-20
Event Date 07/31/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713825
« Last Edit: November 03, 2015, 12:29:44 AM by dennis100 » Logged
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« Reply #23 on: February 08, 2013, 06:21:32 AM »

Model Number 302-20
Event Date 04/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
Reporter indicated a patient had vns lead and generator replacement surgery performed on (b)(6) 2012 due to painful stimulation. The patient had an mri in the past that may have damaged the left vagus nerve per the reporter. The new vns lead was implanted on the right vagus nerve. The reporter and the surgeon were both aware of the manufacturer's labeling regarding not implanting the vns lead on the right vagus nerve. Attempts for further information and return of the explanted devices are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916436
« Last Edit: November 03, 2015, 12:30:14 AM by dennis100 » Logged
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« Reply #24 on: June 07, 2013, 01:08:11 AM »

Model Number 102
Event Date 09/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
On (b)(6) 2013, it was reported that the vns patient had an infection one month after implant that required explant of the vns. The patient was scheduled for re-implantation of the vns on (b)(6) 2013. The patient underwent re-implant surgery on (b)(6) 2013 and the surgeon placed the leads on her right side due to a previous surgery that caused her right vocal cord to be paralyzed. The surgeon stated that after her previous infection on the left with the original implant, he didn't want to take the chance of damaging her left vocal cord. The previous surgery that caused the right vocal cord paralysis was a cervical fusion done may years ago. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead were sterilized prior to distribution. Good faith attempts for further information from the physician have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3119822
« Last Edit: November 03, 2015, 12:31:01 AM by dennis100 » Logged
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« Reply #25 on: November 12, 2015, 08:05:16 AM »

Model Number 102
Event Date 09/26/2007
Event Type Death
Event Description
Reporter indicated a pt's death was possibly due to exacerbation of a lethal ventricular arrhythmia by vns therapy and severe underlying cardiac disease. The pt was implanted on the right vagus nerve. The pt was buried with the vns and no autopsy was performed.

Manufacturer Narrative
Clin auton res (2007), exacerbation of electrical storm subsequent to implantation of a right vagal stimulator. Doi 10. 1007/s10286-007-0440-1. Shalaby, a, et al.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006210
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« Reply #26 on: November 18, 2015, 02:25:39 AM »

Model Number 302-20
Event Date 08/24/2006
Event Type Other
Manufacturer Narrative
Vns therapy system labeling lists heart rate/ rhythm changes as a potential adverse event possibly associated with surgery or stimulation. The safety and efficacy of the vns therapy system has not been established for stimulation of the right vagus nerve or any other nerve, muscle, or tissue. The event does not meet the criteria for malfunction and/or serious injury report; however, manufacturer believes the fda should be aware of this event.

Event Description
Reporter indicated that the patient experienced very short periods of asystole during lead replacement surgery which resolved with administration of robinul 0. 2mg. Event occurred after implantation of the patient's lead on the right vagus nerve and connection to the existing generator. The asystole was attributed to a vagal response per the patient's treating anesthesiologist. Subsequent device diagnostics performed indicated proper device function. The patient's vagus nerve stimulator is currently programmed on and the patient has not experienced any further asystole events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=769204
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« Reply #27 on: November 21, 2015, 07:52:12 AM »

Model Number 302-20
Device Problem High impedance
Event Date 08/03/2015
Event Type Malfunction
Event Description
Additional information was received stating that during generator and lead replacement surgery on (b)(4) 2015, the surgeon was unable to complete the procedure due to fibrosis around the electrode site and the patient's anatomy. The replacement generator was tested to the existing lead and diagnostic results continued to show a high impedance condition. The surgeon opened up the neck incision site but was unable to explant the lead electrodes from the patient's vagus nerve due to fibrosis. The surgeon noted that the patient's vagus nerve was "tangled and bundled with other nerves" above the electrode site and was unable to locate an implant location for the replacement lead. The patient's generator was explanted along with a portion the lead. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. The patient has not been re-implanted to date.

Event Description
Additional information was received stating that the patient was re-implanted on (b)(6) 2015. The generator and lead were placed on the right side of the patient's chest and vagus nerve.

Event Description
Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. It was noted that the patient's seizures were fairly controlled at that time. The patient returned to the office on (b)(6) 2015. The patient's mother indicated that the patient's seizures had gotten worse. The patient's medication was subsequently increased. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5104713
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« Reply #28 on: November 22, 2015, 01:29:31 PM »

Model Number 304-20
Device Problem No Information
Event Date 07/02/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received which indicated that a patient was having difficulty breathing. The patient had been evaluated by a pulmonologist and an ear, nose, and throat (ent) physician who were unable to determine the cause of the breathing difficulties. The ent observed paradoxical vocal cord movement. Vns function was noted to be normal with normal diagnostics. Device settings were adjusted to try to alleviate the breathing problems but were unsuccessful. The patient's breathing problems were alleviated by disabling vns therapy. It is noted that the patient's generator and lead are both implanted on the right side following a high impedance observation on a prior lead implanted on the left side (reported in mfg. Report #: 1644487-2014-00786). The providers are considering moving the system back to the left side but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The provider reported that the patient's breathing difficulties started in (b)(6) 2014, at approximately the 3rd clinic visit after implant. The provider stated he did not know the cause of the paradoxical vocal cord movement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5071956
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« Reply #29 on: November 28, 2015, 04:56:47 PM »

Model Number 304-20
Device Problem High impedance
Event Date 06/27/2015
Event Type Malfunction
Event Description
The patient's device was programmed off after the observance of the high impedance. The patient felt stimulation differently prior to the detection of the high impedance. X-rays were received by the manufacturer and review of the images determined the lead pin was fully inserted. There is a portion of the lead that is located behind the generator and was unable to be assessed. Surgery occurred on (b)(6) 2015. The generator was programmed off. Diagnostics showed the lead impedance was >10,000 ohms and the battery status was ifi, no. A replacement generator was connected to the old lead. Diagnostics were performed and the lead impedance was reported as high. The lead was then replaced, but was implanted on the right vagus nerve as the left nerve was observed to have too much scar tissue. Diagnostics on the replacement generator and the replacement lead were within normal limits. The explanted products have not been received to-date.

Event Description
The explanted generator and lead have been received for analysis. Analysis is complete for the generator, but the lead is still pending analysis. Analysis was completed for the generator on (b)(4) 2015. Review of the data downloaded from the generator shows an indication of increased impedance, with an initial value of 2,239 ohms, increasing to a value of 13,000 ohms, on (b)(4) 2015. The septum was not cored. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An implant card was received, indicating high impedance on the lead and visible fluid in the lead observed during surgery. The generator was reported to have been replaced prophylactically.

Manufacturer Narrative
Event description, corrected data: the information from the implant card received on 09/02/2015 was inadvertently not included on supplemental report #1.

Event Description
It was reported that a vns patient's device was showing high impedance on diagnostics. The patient was sent for x-rays and referred to surgery. Follow-up from a company representative revealed that after reviewing the x-rays, it appeared that the lead pin was not completely inserted into the generator. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4950460
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« Reply #30 on: November 29, 2015, 03:52:36 PM »

Model Number 300-20
Device Problems Improper or incorrect procedure or method; Device operates differently than expected
Event Date 06/25/2015
Event Type Malfunction
Event Description
Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that. Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

Event Description
It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015. At this time the pulse width was increased from 250 to 500. Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain. Device was turned off again and it helped for a while but the issues did not resolve. System diagnostics show result of high impedance. It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the patient underwent surgery on (b)(6) 2015. It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar. Instead, the surgeon implanted a new vns generator and lead on the right side of the patient. The lead was implanted on the right vagal nerve. The patient and family agreed with the surgeon and therefore the old devices were not touched. The surgeon was informed of the cardiac risks of implanting vns system on the right side. The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected. Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907360
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« Reply #31 on: November 30, 2015, 06:57:55 AM »

Model Number 103
Event Date 05/22/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4). Additional manufacturer narrative; corrected data: the previously submitted mdr inadvertently lacked the udi number of the suspect device for the event.

Event Description
It was reported that the vns patient underwent a lead replacement due to high impedance reported in the mfr. Report # 1644487-2015-05011. The replacement lead was implanted on the right vagus nerve. The existing generator was tested upon connection to the new lead and system diagnostics returned high impedance. The existing generator was explanted and a replacement generator was connected to the new lead. The new vns system was tested and system diagnostics returned impedance within normal limits. The explanted device has not been returned to the manufacturer 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=4867413
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« Reply #32 on: December 02, 2015, 01:54:24 AM »

Model Number 304-20
Event Date 03/17/2015
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient had undergone a full vns system replacement on (b)(6) 2015 due to lead discontinuity. System diagnostics on the new vns system returned lead impedance within normal limits, 1801 ohms. Review of the available programming and diagnostic history showed diagnostics results within normal limits through (b)(6) 2012. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted generator and lead have not been received for analysis to date.

Event Description
Further information was received indicating that the generator was replaced prophylactically, as it had been implanted for four years. Furthermore, the old lead was implanted on the right side, and the new one was implanted on the left side, and the surgeon considered it was more practical and safer to implant a new generator. A lead fracture was obvious on the old lead, approximately 10 cm distal to the generator connection. The explant of the lead did not include the electrode array.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4738799
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« Reply #33 on: December 12, 2015, 01:00:09 PM »

Model Number 304-20
Event Date 04/16/2014
Event Type Malfunction
Event Description
Review of x-rays by manufactuer was unable to be determined if the connector pin of the lead was fully inserted inside the connector block on the generator. There are no apparent sharp angles or gross fractures of the lead that could be seen in the images given. There was nothing seen that would indicate there was any damage to the generator or lead causing a high impedance condition; however, the presence of a micro-fracture in the lead or incomplete pin insertion cannot be ruled out.

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

Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The generator was received by the manufacturer and analysis is currently underway. The lead will not be returning; therefore, no analysis on the lead can be completed. During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed low impedance (<=600 ohms).

Manufacturer Narrative
Review of the available programming and diagnostic history.

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

Event Description
Analysis of the explanted generator was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that device diagnostics resulted in high impedance (6585 ohms). The physician chose to leave the device programmed on because the patient has had great efficacy. X-rays were performed. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

Event Description
Clinic notes dated (b)(6) 2015 note that the patient has experienced poor seizure control for the past year. Device diagnostics again resulted in high impedance (>7,000 ohms). The notes indicate that the physician is considering right sided placement of the vns since the patient has previously undergone generator and lead replacement on the left side. It was noted that the patient will undergo vns revision and the new system will be placed on the right side. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277356
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« Reply #34 on: December 14, 2015, 10:22:03 AM »

Event Date 10/13/2014
Event Type Malfunction
Event Description
It was reported that the patient underwent lead replacement surgery due to lead discontinuity. The new lead was placed on the patient's right vagus nerve. An implant card was received indicating that both the generator and lead were replaced. The explanted devices have not been received for analysis to date.

Event Description
It was reported that the vns patient responded well to vns which reduced her seizure frequency to one per month. The patient recently began experiencing an increase in seizures and pain in her neck. During an office visit on (b)(6) 2014, the patient¿s device showed high impedance. The patient¿s medications were subsequently increased. X-rays were taken and reported by the radiologist to show lead discontinuity. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245782
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« Reply #35 on: December 14, 2015, 11:45:03 PM »

Event Date 08/20/2014
Event Type Injury
Event Description
It was reported that during planned implant surgery the surgeon was unable to locate the patient's vagus nerve, so the surgery was cancelled. The patient was referred to an ent for evaluation and mri, so the surgeon could visual the patient's anatomy at the time of implant. It was later reported that the patient has a congenital absence of the left vagus nerve (no large nerve in the sheath). The patient will undergo imaging to check vocal cord function before considering right sided implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4198932
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« Reply #36 on: December 19, 2015, 09:45:47 AM »

Model Number 103
Event Date 04/25/2014
Event Type Injury
Event Description
It was reported that the patient had an infection at the generator site. The surgeon planned on taking out the generator and "wiping it off". Further follow-up revealed that the patient underwent generator replacement at which time the new generator was implanted on the patient's right side of the chest. It was reported that the infection was observed right after the implant surgery. No cultures were performed.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3843719
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« Reply #37 on: December 20, 2015, 03:30:38 AM »

Model Number 105
Event Date 03/11/2014
Event Type Injury
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect age. Date of event, corrected data: the initial report inadvertently reported the incorrect date.

Event Description
It was reported that the patient was re-implanted with vns on (b)(6) 2015. Due to infection surrounding the left vagal nerve previously, the surgeon elected to implant on the right vagus nerve based on his medical judgment.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the recently implanted vns patient went to the emergency room on (b)(6) 2014 due to a seizure. The patient had a fever and was admitted to the hospital that day for a possible infection at her incision site. The patient was discharged on (b)(6) 2014. The patient¿s device was tested at the hospital and reported to be functionally normally. The neurologist stated that the patient¿s seizure was due to her device being programmed to a low output current (0. 25ma). The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to infection. Wound cultures from the patient¿s lead incision site were taken but the results have not been provided. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3812438
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« Reply #38 on: December 21, 2015, 12:28:44 PM »

Event Date 02/26/2014
Event Type Malfunction
Event Description
It was reported that the patient will be seen by ent for thyroid biopsy and evaluation and when that is complete the patient will be scheduled for generator and lead replacement. No surgical intervention has been performed to date.

Event Description
It was reported that the vns patient was experiencing and increase in seizures. The patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 9405 ohms). X-rays were provided to the manufacturer for review and the cause for the reported events could not be determined. There was a suspect area near the anchor tether which may be a possible break. There was nothing additional seen that would indicate there was any damage to the generator or lead. As the entire lead could not be assessed from the x-rays provided, continuity in that portion of the lead cannot be confirmed. Attempts for additional relevant information were made, but have been unsuccessful to date. No known interventions have occurred to date.

Event Description
Additional information was received indicating that the vns patient¿s increase in seizures was below pre-vns baseline levels. The patient was seizure free since (b)(6) 2011. The patient was now having 12 seizures per day that were increasing in intensity and duration. The patient was referred for surgery but no known interventions have occurred to date.

Event Description
Additional information was received that the explanted generator and lead were discarded and will not be returned to the manufacturer for evaluation.

Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014. The patient¿s generator was explanted, but the lead remained implanted due to concerns of potential damage to the patient¿s nerve. The explanted generator was discarded. A new generator and lead were implanted on the right side of the patient¿s body.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a potential lead discontinuity. 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=3705843
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« Reply #39 on: December 22, 2015, 01:26:11 AM »

Model Number 103
Event Date 02/18/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Electrocautery was used in a port-a-cath procedure on( b)(6) 2014 that caused the generator battery to drain. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

Event Description
It was reported that during an unrelated surgery the patient's generator was repositioned to the patient's right chest. The surgeon wanted to verify that the generator was working properly. The physician performed diagnostics which showed the generator was at neos. The surgeon confirmed that electrocautery was performed. The patient had not been prior consented for generator replacement; therefore, the generator could not be replaced at that time. It was later reported that the patient would be referred for generator replacement. Surgical intervention has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3688612
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« Reply #40 on: December 22, 2015, 09:20:17 AM »

Model Number 102
Event Date 01/21/2014
Event Type Injury
Event Description
It was reported that the patient was scheduled to undergo generator relocation to the right chest due to an infection. The physician reported that the generator site was washed out and the generator was relocated to the right side of the chest. No patient manipulation or trauma occurred that is believed to have caused or contributed to the infection. It was reported that cultures were taken and showed mrsa. The patient is being treated with antibiotics.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3672716
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« Reply #41 on: December 22, 2015, 09:20:57 AM »

Model Number 102
Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt experienced episodes of bradycardia. The pt is implanted with two vns therapy systems, one on the left side and one on the right side. Only the left-sided system had been programmed to on, but treating neurologist recently programmed the right-sided system to on as well, to provide additional assistance in breaking the pt's seizzure patterns. The episodes of bradycardia occured while both systems were programmed to on. This treatment plan did not change the pt's seizure pattern, so the right-sided system was programmed back to off. It was reported that the episodes of bradycardia occurred while the pt was hospitalized for treatment of sub-clinical status and that while hospitalized, their heart rate periodically dropped to approximately 40 beats per minute. The pt was reportedly intubated during their hosp stay because versed and prescribed to stop the seizures. The seizures lessened but did not stop. The pt's feeding tube came out of their stomach and pt subsequently aspirated. Versed was discontinued. Propofol was prescribed, after which the pt's brain wave pattern "calmed down", but the seizures continued. Propofol was then replaced with fentanol, in an effort to bring the pt out of the drug-induced coma. The pt began seizing again, so the fentanol was replaced with pentobarbital. The pt developed pneumonia during this time. Pentobarbital was discontinued, after which the pt experienced a few seizures that were stopped with initiation of prescribed for treatment of the vocal cord swelling. The pt's conditon slowly improved and pt was discharged home after approximately 24 days of hospitalization. Device diagnostic testing on the left-sided system was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Review of manufacturing records for both the pulse generator and the bipolar lead (left-sided system) revealed no anomalies that would adversely effect device performance. It is believed that the episodes of bradycardia were caused by excessive stimulation as a result of both the left-sided and right-sided vns therapy systems being activated at the same time.

Event Description
Patient's left vns therapy system was replaced. It is believed that a portion of the vagus nerve was 'dead' due to the scar issue build up after a prior infection. Prior to the surgery on 2/16/06, patient was hospitalized in a vegtative state, the cause of which was unknown. The patient had experienced 30+ grand mal seizures and complex partial seizures in one day prior to surgery. During the replacement surery, the lead wires were put under the muscle per family's request. The surgeon did not open up the old wound site and the lead wa placed high upon the vagus nerve. Prior to surgery, patient's device was set to 1. 75 ma, signal frequency of 25 hertz, pulse width of 250 microseconds, on time of 30 seconds, off time 0. 8 minutes, magnet current of 2. 00 ma, on time of 30 seconds, pulse width 250 microseconds. Battery life estimation using these device settings indicate approximately 1. 3 years to the elective replacement indicator (eri). During the surgery the device settings were set to the patient's settings pre-surgery and the patient was not able to tolerate them. As a result the patient suffered pain. The family used the magnet to diable the device until the device could be reprogrammed. The patient is now set at 0. 5 ma, 25 hertz (signal frequency), 250 microsecond (pulse width), on time of 30 seconds, 3. 00 minutes off, magnet setting of 250 microsecond pulse width, signal frequency of 30 seconds and magnet current of. 75 ma. Follow up indicates as of 2/23/06 the patient's grand mal seizures had reduced from 15+ per night to 1 or none. As of 3/3/06, patient was reported to be doing better from a seizure standpoint, experiencing 50-60 absence seizures a day, no drop seizure and a generalized tonic seizure at night. As of 3/13/06 the patient is not on any current medications and the seizures have drastically improved since re-implantation.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potental adverse event possibly associated with surgery or stimulation. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=578597
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« Reply #42 on: December 24, 2015, 12:33:00 AM »

Model Number 302-20
Event Date 11/12/2013
Event Type Malfunction
Event Description
It was reported that the patient underwent lead replacement due to high impedance (10,000 ohms). It was reported that x-rays did not show a lead fracture or any abnormalities. It was reported that the patient experienced a good clinical response with vns. Pre-operative diagnostics identified that the generator had not yet been programmed off. The device was programmed off prior to the patient going to the operating room. It was reported that the surgeon decided to implant the new lead on the patient's right vagus nerve. The lead was cut at the connector pin and the explanted portion was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3547746
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« Reply #43 on: December 25, 2015, 01:06:44 PM »

Model Number 304-20
Event Date 10/03/2013
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and normal mode diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was not disabled following the high impedance observation. The patient¿s physician stated that the patient¿s lead likely cracked from the patient¿s seizures. A mass was noted on the patient¿s neck during an office visit on (b)(6) 2013. The patient¿s radiology exam stated that the sonographic findings were most consistent with a hematoma at the patient¿s left neck. An abscess was not expected based on the absence of fever, wbc count, and the overlying redness and swelling.

Manufacturer Narrative

Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance was observed on (b)(6) 2013.

Event Description
On (b)(6) 2013 it was reported that the patient has high lead impedance. The patient had a fall with seizures approximately 3 weeks ago striking her neck area and developed a hematoma in the neck. When her vns was checked, she was found to have high impedance. It was stated that the surgeon was treating the hematoma with cold and warm compresses but the hematoma did not go down. No x-rays were taken due to patient¿s ¿mr¿ (possibly mental retardation). Patient went to surgery on (b)(6) 2013 to have a full revision but when the surgeon opened the left neck he saw a huge hematoma that entwined the nerve including the part where the helices were. The surgeon said he would not implant another lead/generator on the left side because of the extensive hematoma. The surgeon then elected to place the lead and the generator on the right side due to the severe hematoma and resulting scar tissue on the left side. The explanted lead and generator have not been returned to the manufacturer for product analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3494999
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« Reply #44 on: December 27, 2015, 03:40:58 AM »

Model Number 105
Event Date 09/09/2013
Event Type Injury
Event Description
It was reported that the patient was scheduled for repositioning surgery. However, it has not been confirmed to date that the surgery occurred.

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently reported this information incorrectly. Implant date, give date, corrected data: the initial report inadvertently reported this information incorrectly.

Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 to revise the generator pocket and move the generator from the patient¿s left chest to her right chest.

Manufacturer Narrative

Event Description
It was reported by the patient's husband that the vns device was "working its way out" and that this was the third time the vns generator had done this. The patient went in for surgery to reposition the device due to the migration and the skin showing signs of potential breakdown. The vns battery was not replaced. Upon follow up, it was found that the generator was not extruding from the skin and there were no causal factors noted in the dictated notes that may have caused it. The nurse's notes indicate the patient's device was implanted in (b)(6) 2013, but over the last few weeks, the patient noticed increased tenderness and redness around the generator area, as well as some irritation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3435628
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« Reply #45 on: December 27, 2015, 11:44:49 AM »

Model Number 302-20
Event Date 09/06/2013
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that high impedance was observed while the patient was still in the hospital following generator replacement (due to prophylactic reasons). During the surgery on (b)(6) 2013, diagnostics were within normal limits; however, on (b)(6) 2013, the device was showing about 7000 ohms when interrogated. Per the physician, the patient did not have any falls while in the hospital. During a review of the patient's x-rays, it was noted that the patient appears to have the lead on the right-hand side. There were no observed gross fractures noted. The lead pin insertion issue cannot be ruled out as potential cause since the surgeon has a history of quickly going through that step during surgery. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388730
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« Reply #46 on: December 27, 2015, 11:45:25 AM »

Model Number 102
Event Date 09/03/2013
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description
It was reported that the patient had an infection at the generator site. It was reported that the infection was caused by the patient's saliva and patient care. It was reported that cultures showed staph aureus. The surgeon relocated the generator to the right side of the patient's chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3381666
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« Reply #47 on: January 01, 2016, 10:13:21 AM »

Model Number 103
Event Date 12/16/2011
Event Type Injury
Event Description
On (b)(6) 2013, it was reported by the nurse that the vns patient has learning disabilities and behavioral difficulties and that keeping the neck wound clean was very difficult.

Event Description
On (b)(6) 2012 it was reported that the patient had their generator and lead explanted due to an infection and that they were going to be re-implanted. The timeline of events were provided to be the following; on (b)(6) 2011 the wound site was tender to the touch and on (b)(6) 2011 the neurosurgeon assessed the event and thought it to be a superficial infection. On (b)(6) 2012 the wound was washed out and re-sutured. On (b)(6) 2012 the vns was explanted due to the unresolved infection. On (b)(6) 2012 they attempted to implant the device again but when the surgeon opened him up, he felt that the scarring and risk of infection was too great. Therefore it wasn¿t until (b)(6) 2013 that a new vns system was able to be implanted, but on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
On (b)(6) 2013 the nurse reported that she cannot provide any further information.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3147650
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« Reply #48 on: January 05, 2016, 12:36:16 AM »

Model Number 103
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
The ap and lateral chest x-ray report was provided by the physician¿s office which reported the patient had a history of chest pain. The vns generator was observed in the anterior chest walls with leads terminating within the left lower neck. No anomalies were noted by the radiology group. The patient had a prophylactic generator replacement surgery on (b)(6) 2013. The patient wanted the generator placed on the right side versus the left side (off-label). The explanted generator was received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The implant card reported the reason for replacement as prophylactic and confirmed the date of surgery as (b)(6) 2013. Lead impedance following surgery was okay.

Event Description
The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2012 with no further seizures noted since vns increased. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. Product analysis was completed on the explanted generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead impedance prior to surgery was within normal limits.

Manufacturer Narrative

Manufacturer Narrative
The first sentence was inadvertently listed the date as (b)(6) 2013 incorrectly on the initial report as it should have read as (b)(6) 2012. Additionally, the information in the second paragraph inadvertently reported the date of events incorrectly. This information was from clinic notes dated (b)(6) 2012.

Event Description
It was reported that he patient was referred for generator repositioning surgery due to the device shifting around. Follow up with the treating ent's office revealed that the patient was at the office on (b)(6) 2013. The patient has been complaining of pain for the last year or year and a half. The pain has been so bad that the patient went to the surgeon who decided to replace the device. The plan is due replace it on the right side of the chest, off-label because the patient's skin is so irritated. The patient has been wearing a lidoderm patch all the time, and it looks like the lead wires are too close to the skin so it's been rubbing. No patient psychological changes were mentioned, nor any patient manipulation or trauma. It is unclear why the device migrated as the nurse indicated that she does not remember this being a problem after the implant in 2008. The patient is unable to function due to the irritation and pain and the patient is left-handed. The nurse indicated that there is the possibility in the future that "it could come out of the device" (detachment of lead). Attempts for additional information from the surgeon have been unsuccessful to date. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. In clinic notes dated (b)(6) 2012, it was reported that the physician's assistant (pa) adjusted the vns to tolerability on (b)(6) 2012 where the patient miscommunicated with the pa. The patient reports not having tolerability issues and did not make the request. Additionally, the pa recommended having the vns removed-something not documented in her note. The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2013 with no further seizures noted since vns increased. Side effects were denied. However, the patient was noted to have "focal pain in the chest at the site of the vns implant that she treated with a patch. The source of this pain is not clear - it is not in the neck and is not associated with device activation, suggesting more of a mechanical process, perhaps related to scar tissue or to device movement or current leak. Interestingly, she notes increased pain at the implant site when she has a seizure, which does not make physiological sense unless she has increased sensitivity associated with her seizures. Her pain was not reduced when my former pa reduced her vns settings. She prefers not to make any major changes to her vns because she feels that it has made all the difference with respect to her seizure control. Overall, the patient is doing about the same since the last visit. The patient is satisfied with seizure control. The patient is satisfied with side effects. " chest pa and lateral x-rays were planned to assess vns placement and lead integrity. The plan was to adjust vns for tolerability after (b)(6) 2012. Clinic notes dated (b)(6) 2013 reported the patient had the vns adjusted at the last visit and the patient presented on (b)(6) 2013 reporting that everything was going well and was satisfied with seizure control. No pain was noted. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3038963
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« Reply #49 on: January 05, 2016, 11:58:14 PM »

Model Number 103
Event Date 08/17/2012
Event Type Injury
Event Description
Product analysis for the explanted generator and lead was completed. 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. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Additionally, electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Corrected data: the initial report inadvertently did not report this data. Review of manufacturing history records performed. Review of manufacturing history records of the generator and lead confirmed sterilization and all quality tests passed prior to distribution.

Event Description
The physician reported that there was no infection or related symptoms. Cultures were negative for infection. The patient had a "burning lesion" on the upper thoracic region "many years ago" correlated to difficult healing which compromised the skin around the vns generator. Therefore, the generator began extruding. Antibiotics were given to the patient orally. The generator and portion of the lead were explanted on (b)(6) 2013, but the lead electrodes were not explanted due to fibrosis. A replacement generator was implanted on the right side of the chest off-label. The patient's epileptic seizures have reduced significantly. The patient has responded well to the replacement surgery with no additional complaints, per the physician. Diagnostics after replacement were within normal limits. Product return is expected, but the devices have not been received by the manufacturer to date. The implant card confirmed the date of replacement of the generator and lead on (b)(6) 2013 with the reason marked as "dehiscence". Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that the patient was being scheduled to have generator explant and to have the device replaced later in the week due to an unknown reason. Additional information was received indicating that the suture was opened, but an infection at the site was not confirmed to date. No manipulation is believed to have caused/contributed to the event. The generator and lead were both replaced. Attempts for additional information from the physician have been unsuccessful to date.

Manufacturer Narrative

Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated that the reason for explant was 'dehiscense' the patient was later reimplanted. The physician reported that 'everything was told' so no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3021530
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« Reply #50 on: January 06, 2016, 12:42:43 PM »

Model Number 102
Event Date 10/05/2010
Event Type Injury
Event Description
Reporter indicated a vns patient was to have her vns generator repositioned to the right chest wall due to needing treatment for left breast cancer. The patient later had vns repositioning surgery. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1892281
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« Reply #51 on: January 08, 2016, 02:31:39 AM »

Model Number 103
Event Date 11/12/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was being scheduled for emergency surgery. The generator was extruding through the skin. The surgery occurred on (b)(6) 2015 for generator replacement. The extrusion was attributed to the numerous past surgeries the patient experienced at the site of her generator and subsequent scar degradation. The surgeon chose to implant the generator on the right side to avoid aggravating the site of the injury. The explanted generator was discarded after the surgery, so product return and analysis is not possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5275266
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« Reply #52 on: January 14, 2016, 12:53:14 PM »

Model Number 302-20
Event Date 11/14/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portions and lead break was confirmed. Note that the electrodes 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 381mm and 25mm portions the outer / inner silicone tubes appeared to be abraded open / torn. During the visual analysis of the returned 381mm portion the ends of the connector pin and connector ring quadfilar coils appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. During the visual analysis of the returned 25mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. Visual analysis was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. 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.

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

Event Description
A vns patient was referred for a battery change and when a new battery was used, high impedance was discovered. The surgeon noted that during electrode removal he found the lead was completely severed. Due to scar tissue and placement of electrode, a new lead was implanted on the right side. Their explanted lead has been returned for analysis. Completion is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870688
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« Reply #53 on: January 23, 2016, 04:48:14 AM »

Model Number 102
Event Date 01/25/2013
Event Type Injury
Manufacturer Narrative

Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914
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« Reply #54 on: January 24, 2016, 03:19:45 AM »

Event Date 04/27/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A patient reported that during implant surgery, the surgeon implanted the vns generator on the right side of the patient's chest as the patient was implanted with a pacemaker on the left side. During implant, the patient experienced asystole and had to be resuscitated. During surgery, the patient also experienced a large seizure when the vns was programmed on and now the patient is having more seizures than she did prior to being implanted with the device. The patient also stated that the device is pushing up against her skin which causes pain while dressing. Per the patient, the surgeon stated that the generator battery may have been used up during surgery, and he was unsure if the device was still functioning. Follow up with the neurologist revealed that the patient has a history of arrhythmia. The generator is registering magnet swipes. He does not know if the increase in seizures is above baseline levels. The protrusion response was that the device looks no different from any other patient other than it being on the right side. He will do a symptomatic therapy for the pain and possible consultation with a surgeon for a revision of the implant if desired by the patient. He does not know of any trauma or manipulation. Good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851128
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« Reply #55 on: January 25, 2016, 12:50:59 PM »

Model Number 103
Event Date 09/14/2012
Event Type Injury
Event Description
It was reported that the vns patient had developed an infection a few weeks after having vns generator replacement and required explant of the vns lead and generator. The site indicated that they plan to re-implant the patient a few weeks after the infection had resolved. Attempts for additional information have been unsuccessful to date.

Event Description
The lead and generator product information was obtained. The device history records for the patient's lead and generator were reviewed and sterilization of both products, prior to shipment was confirmed. Additionally all attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received indicating the patient was scheduled for vns re-implant on the right side. Re-implant surgery reportedly occurred on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2786728
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« Reply #56 on: February 01, 2016, 05:48:41 AM »

Model Number 104
Event Date 05/08/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was initially reported that a vns patient underwent a full revision surgery due to an unknown reason. During the surgery, the surgeon elected to not remove the patient's previously implanted m302 lead and implant a new m304 lead on the right vagus nerve. Instead of utilizing a generator model that was compatible with the new lead, the surgeon opted to implant a dual pin m104 generator (on the left side of the chest) by inserting the single lead pin into one of the two connector blocks. As expected, subsequent diagnostic testing resulted in high impedance results and the patient has reportedly received no efficacy from therapy since the surgery. Additionally, the patient has expressed the presence of neck pain as a result of the lead extending from the left chest to the right side of the neck. The reported high impedance issue is a result of the incorrect implantation technique which has created an open circuit in the system, and not the result of a device malfunction. This is not an unexpected performance of the device, given the implant circumstances. Additionally, product compatibility is clearly listed in product labeling. Additional information from the area representative indicated the patient underwent generator replacement surgery for a single pin generator. Impedance value after replacement was ok. The explanted device will not be returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592674
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« Reply #57 on: February 18, 2016, 04:26:18 AM »

Model Number 302-20
Event Date 04/26/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through an implant card that a vns patient underwent lead replacement due to fibrosis. At the moment good faith attempts to obtain further information regarding the event with the reporting physician have been unsuccessful to date.

Event Description
Additional information was received through the area representative indicating the patient went to the hospital based on symptoms felt. Interventions taken according to the area representative were to disconnect the electrode and then remove it at the time of replacement. A second lead was implanted on the right vagus nerve in order to continue therapy. The explanted lead will not be returned to the manufacturer for analysis. Moreover, information from the treating physician indicated the cause of the fibrosis was likely due to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2418601
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« Reply #58 on: March 20, 2016, 03:17:27 AM »

Event Type Malfunction
Event Description
A vns treating physician in (b)(6) reported that they had a pt that had undergone a right sided vns implantation after a left sided lead break. Good faith attempts are underway for further details about the reported event.

Manufacturer Narrative
Device info 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=1952051
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« Reply #59 on: March 20, 2016, 03:17:58 AM »

Model Number 30X-UNK
Event Type Injury
Event Description
A vns treating physician reported that he had a pt who had undergone a right sided vns implantation after left sided lead break. Lead break reported in mdr report number: 1644487-2010-02958. It was reported that the pt was asymptomatic but experienced regular bradycardiac episodes during vns stimulation, lasting 30 secs. The event was observed repeatedly with drops in heart rate from 70bpm to 30bpm with stimulation, while pt was asleep and monitored. Good faith attempts are underway for further details about the reported event.

Manufacturer Narrative
Labeling recommends implantation of the lead on the left vagus nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953679
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« Reply #60 on: April 28, 2016, 01:50:28 AM »

Model Number 300-20
Event Date 03/12/2007
Event Type Malfunction
Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck and generator site and felt that the generator was pulling on the leads. Diagnostics were within normal limits. The device was programmed off at the request of the patient. X-rays were reviewed and no anomies were noted. The patient underwent generator replacement surgery. The lead was not replaced because the surgeon did not believe a problem existed with the generator. The patient's painful stimulation persists. The patient is planning on vns lead replacement surgery. The lead will be implanted on the right vagus nerve. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1297765
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« Reply #61 on: June 05, 2016, 06:59:30 AM »

Model Number 106
Event Date 01/26/2016
Event Type Malfunction
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
A provider reported that a patient who had previously received a right-sided vns system had been in the hospital for gastrointestinal bleeding and esophagus erosion testing. It was reported that the gi bleed and esophagus erosion developed after right sided placement. The patient's seizures have increased over the past month as the vns titration process is evolving. It is unknown if any of the reported conditions are due to vns. Diagnostic testing of the device revealed all measured values were within normal limits. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5597943
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« Reply #62 on: June 08, 2016, 01:46:29 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 09/24/2015
Event Type Malfunction
Event Description
The patient still has not seen the ent to evaluate the vocal cord paralysis, therefore at this time there is no confirmation of the reported vocal cord paralysis. The physician wants the ent to evaluate the right side for vocal cord paralysis since he wants to put the electrodes on the right side.

Event Description
It was reported that the surgeon never opened the patient's neck to visualize the lead. He stated that there was too much scarring and he didn¿t have time to revise the lead. It was assumed that the lead would be scarred in during the next replacement. The surgeon decided that he wants to do a right sided implant a next times a result of the incision scarring. It was reported on 01/19/2016 that the patient¿s neurosurgeon is referring her to an ent to assess right and left side paralysis of the vocal cords. The neurosurgeon¿s plan is to re-implant the vns on the right side. The relationship of the vocal cord paralysis and high impedance is unknown.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative

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

Event Description
It was reported in (b)(6) 2015 that the patient was in surgery and the lead pin was reinserted but this did not resolve the high impedance issue. The patient is scheduled for lead replacement although this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5162668
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« Reply #63 on: September 09, 2016, 04:21:47 AM »

Model Number 106
Event Date 07/27/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4). Serial #, corrected data: (b)(4). Initial mdr inadvertently did not list the product serial #. Lot #, corrected data: 203490. Initial mdr inadvertently did not list the product lot #. Expiration date (mo/day/yr), corrected data: 02/18/2017. Initial mdr inadvertently did not list the product expiration date. Device manufacture date (mo/day/yr), corrected data: 05/26/2016. Initial mdr inadvertently did not list the device manufacture date. (b)(4).
Manufacturer Narrative

Event Description
It was reported that the surgeon had to implant the m 106 generator on the right chest of the patient on (b)(6) 2016 and that the heartbeat verification was unsuccessful. It is unknown if a pre-surgical evaluation was performed and if all the troubleshooting steps were completed. Attempts for additional relevant information were made but no additional relevant information was received.

Event Description
Product information was received on 08/08/2016. A review of device history records for the generator shows that no unresolved non-conformances were found. The r-wave verification step was successful per the device history records. The generator is not a laser routed device. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5890558
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« Reply #64 on: December 14, 2016, 10:15:34 AM »

Event Date 12/01/2005
Event Type Injury
Manufacturer Narrative
Khurana, divya s. Et al (2005) vagus nerve stimulation in children with refractory epilepsy: unusual complications and relationship to sleep-disordered breathing. American epilepsy society meetings in washington dc, 2-6.

Event Description
It was reported that a vns patient was explanted for a second time due to staphylococcal infection that did not resolve with antibiotic therapy. The patient was reimplanted several months later on the right vagus nerve. "there were no specific risk factors for staphylococcal infection, such as immune compromise, noted in this case. " good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1007400
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« Reply #65 on: January 23, 2017, 08:13:17 AM »

Event Date 02/15/2011
Event Type Injury
Event Description
I developed brain cancer in my right frontal lobe, found in (b)(6) 2011. The doctor was inserting screws to my skull bone. He tightened one of the screw and it broke so the surgery went longer. I developed an infection with radiation on the area of my previous surgery and the dehisced extending my radiation treatments, these 36 radiation treatments made me very sick. I had to have an emergency surgery to see what was going on in my brain. This surgery revealed that my skull bone was infected and they removed 1/4 or more of my skull and used more screws than they anticipated. I had some kind of infection prior to this and had drains in my head to get excess fluid out of my swollen brain. After this surgery i developed another infection and another hospital stay. Throughout the whole ordeal of dealing with this situation i had six to eight infections, and at least three to four stays in the hospital, some up to 2 weeks. I am not sure what the name of the plates were or what the company was called for these (i have all my notes from this time, i could look through notebooks and files for a day, to find this out). The last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totalled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529168
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« Reply #66 on: February 25, 2017, 01:27:25 AM »

Model Number 102
Event Date 11/15/2005
Event Type Injury
Manufacturer Narrative
Article reference: epilepsy research, 2008; 08, 003, right-sided vagus nerve stimulation in humans: an effective therapy? spuck, s. , et al.

Event Description
Reporter indicated via a published journal article that a patient experienced intraoperative self-limiting short-term (10 seconds) asystole and short-term (20 seconds) bradycardia during the systems diagnostics test during implantation of the vns therapy system on the right vagus nerve. The patient's normal heart rate was 70 and the rate dropped to 52 during the bradycardic episode. The patient was under medium anesthesia. Atropine was administered as an intervention. The asystole and bradycardia events did not recur during the surgery or postoperatively. The patient did not have pre-existing history of asystole or bradycardia. The patient's hospitalization was prolonged due to observation and correction of vns settings under cardiac monitoring. No additional post-operative adverse events or cardiac-related events have occured.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1260036
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« Reply #67 on: March 03, 2017, 08:49:22 AM »

Model Number 104
Event Date 12/13/2011
Event Type Malfunction
Event Description
Reporter indicated the increased seizures the patient experienced were due to the high lead impedance. The seizures were not above pre-vns baseline level and the seizure type was not known.

Manufacturer Narrative
Describe event or problem, corrected data: information regarding the increased seizures was inadvertently omitted from follow-up mdr #1.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Per the patient's caregiver, on (b)(6) 2012, the patient's incision sites appeared purple and the patient had debridement and irrigation of the vns generator area, and the generator was moved to a new pocket. The patient then had vns prophylactic generator and lead replacement surgery performed on (b)(6) 2012, due to desiring a newer vns model. The vns may have been placed in the right chest due to the patient's continued wound healing problems and possible infection. An implant card was received indicating the vns generator and lead had been replaced due to "malfunction". The explanted vns generator and lead remnant were received for analysis on (b)(6) 2012 and are pending analysis. The vns generator was interrogated successfully in the product analysis lab and did not display any abnormalities upon interrogation. Attempts for further information regarding the wound healing and possible infection are in progress.

Manufacturer Narrative

Event Description
Reporter indicated the new vns generator was implanted in the right chest due to the previous poor healing issues in the left chest incision area. The new lead was tunneled diagonally across the chest. It was unknown what to attribute the poor wound healing to, as the patient had no trauma and it was not felt there had been any device manipulation by the patient. The patient was last seen on (b)(6) 2012, and has been released back to the care of her neurologist, with instructions to call the surgeon's office if issues arise. There have been no calls about the patient since she was seen on (b)(6) 2012. There was no infection present in the wound, but the lead was extruding through the skin prior to the (b)(6) 2012 surgery. The cause of the poor wound healing is unknown, and there was no known trauma or device manipulation by the patient. Additional manufacturer follow up with the treating neurologist's office revealed, the patient is doing well since the surgery, and there have been no issues with the wound healing. Product analysis of the explanted lead and generator was completed. Note that since the majority of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. However, the generator and lead were received connected together, and the generator was programmed on; the generator was outputting to an open load. Other than the above mentioned observations and the typical wear and explant related observations, no product related anomalies were identified in the returned lead portion. Results of generator diagnostic testing and monitoring indicated the device was operating properly and that the battery was at an "ifi = yes" condition. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Reporter indicated a patient presented on (b)(6) 2011, with swelling around the vns generator site, increased seizures, and high lead impedance with vns diagnostics testing. The patient recently had vns generator replacement surgery performed on (b)(6) 2011, and all vns diagnostics were normal at the surgery. The patient had vns lead pin reinsertion surgery performed on (b)(6) 2011, which resolved the high lead impedance. It was noted during the surgery that one of the lead pins had "popped out" of the generator header. The lead pins were then secured appropriately into the generator header. Vns diagnostics following the lead pin reinsertion were within normal limits. Attempts for further information are in progress.

Event Description
Reporter indicated the patient's vns generator site incision had opened up (wound dehiscence), and the vns lead was visible within the wound. There was not an infection present, and it is unknown why the wound opened up. There was no trauma, and it is not felt the patient manipulated the vns, though she is developmentally delayed. There does not appear to be any hygiene issues, as it was felt the patient was very well cared for at home by her mother. The patient had exploratory surgery performed on (b)(6) 2012. The patient is on antibiotics because she had an open wound. At the (b)(6) 2012, surgery, the wound was washed out and debrided and closed, but no devices were explanted. The patient was seen on (b)(6) 2012 and is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2408227
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« Reply #68 on: March 03, 2017, 08:50:16 AM »

Model Number 102
Event Date 12/01/2011
Event Type Injury
Event Description
It was reported that the patient had her generator moved to her right chest from her left chest due to pain at the generator implant site. Per physician, there is no reason to explain the pain and patient was benefiting from vns therapy, so it was decided to move the device. Diagnostics were run during surgery and everything was fine.

Event Description
Information from the treating surgeon indicated the intervention was not taken to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2406192
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« Reply #69 on: March 10, 2017, 04:24:36 AM »

Device Problems Fluid leak; Fracture; High impedance
Event Date 11/18/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
An article entitled "vagus nerve stimulation removal or replacement involving the lead and the electrode: surgical technique, institutional experience and outcome" was sent to the manufacturer and reviewed. During review of the article, multiple reportable events were identified. The article stated that 6 patients had replacement surgeries due to broken wires (lead fractures), and 5 patients had lead surgery due to degradation of the silicone tubing causing high impedance. Of these events, 3 lead fractures and 2 cases of tubing degradation were unable to be identified as previously reported. The patients who had high impedance and lead fractures also reportedly had an increase in seizures due to the device issue. One of the patients who had a lead replacement surgery due to a lead fracture had the replacement lead implanted on the right vagus nerve. This, caused the patient pain and the device had to be removed as a result. The article also contains references to other reportable events for generators which is captured in mfr report number. Additionally, the article stated that a patient had passed away due to sudep which is captured in mfr. Report 1644487-2017-03151. One unknown generator malfunction is reported in mfr. Report 1644487-2017-03153.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309080
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« Reply #70 on: March 10, 2017, 04:25:27 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/30/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported (b)(6) 2017 that a vns patient was scheduled for a prophylactic replacement. High lead impedance was observed prior to the case. The new generator was connected to the lead and diagnostics were repeated. High lead impedance was still observed. The patient had a full revision, with the placement of the new lead and generator on the right side. A portion of the lead was explanted. It was noted by the patient's neurologist that high lead impedance was also observed in clinic after the patient reported some falls. The explant facility does not return the devices without a patient release per policy. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6356440
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« Reply #71 on: April 21, 2017, 02:53:07 AM »

Model Number 102
Event Date 10/25/2007
Event Type Injury
Event Description
Reporter indicated a vns pt's generator was explanted for infection. The pt was later reimplanted with a new generator in the right chest with the original lead. The explanted generator has been requested for return. Further attempts for info are in progress.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964260
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« Reply #72 on: April 25, 2017, 01:24:02 AM »

Event Date 01/01/2006
Event Type Death
Manufacturer Narrative
Shalaby aa, el-saed a, nemec j, moosy jj, and balzer jr. "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator". Clin auton res. (2007).

Event Description
It was reported via scientific article "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator" by shalaby aa, et al. That a pt with advanced ischemic cardiomyopathy underwent implantation of a vagal stimulator in an attempt to control recurrent drug refractory ventricular tachycardia. Four years prior, the pt had an implantable defibrillator (icd) inserted. Electrical storm was exacerbated after the implant of vns and continued after neurostimulation was discontinued. Stimulation was discontinued 24 hrs following implant of vns. Per article, "all vt events after vagal stimulator implant were noted to follow a peculiar diurnal distribution with a clear morning bias (3-11 am) not noted in previous events". The pt subsequently requested to have his icd turned off following events and he died 2 weeks later in hospice care. The report aims to provide a cautionary note to application of vagal stimulation for control of cardiac arrhythmia. However, per the article, "it is possible that the relapse of electric storm after vagal stimulator implant was unrelated to the implant but rather to progression of underlying disease, fluctuations in drug levels or possibly intracellular electrolyte levels". No conclusion could be drawn based on the article. Attempts for further info are in progress.

 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564916
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« Reply #73 on: April 28, 2017, 12:21:33 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that the vns pt had surgery a "few years back" where the pulse generator was moved from the left to the right chest, due to a burning sensation at the generator site. The pt's current treating physician was not seeing the pt at the time the event occurred, and is attempting to retrieve additional info from the pt, such as the pt's physician at that time, so that attempts for additional info can be made with the appropriate medical professional. In addition, the physician has indicated that the pt is a poor historian and that it is very difficult to get clear description of historical events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552700
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« Reply #74 on: April 30, 2017, 01:35:10 AM »

Model Number 105
Event Date 07/11/2014
Event Type Injury
Event Description
The patient has decided not to re-implant the vns device for fear of infection recurring.

Manufacturer Narrative
Conclusions, initial report inadvertently omitted. Conclusion code for device discarded.

Event Description
It was reported that the patient was scheduled for surgical exploration of the generator incision site. It was reported that the patient's wound was not healing poorly. The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder. It was noted that the generator is implanted on the right side of the patient's chest. It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed. Further follow-up revealed that cultures were negative for infection. The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again. The patient underwent generator explant. It was reported that the lead was left in place. The patient requested explant of the device. The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator. There was no known cause for the impaired incision healing. It was reported that the patient has had good healing prior to vns implant. The explanted generator was discarded; therefore, will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051959
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« Reply #75 on: May 03, 2017, 12:14:10 AM »

Model Number 104
Event Date 11/08/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient under went a full re-implant after healing from infection on (b)(6) 2015. The patient's generator was reimplanted in the right chest with a new lead still present on the left nerve. At this time it appears that at the time of explant in (b)(6) 2014 for the known infection, the lead was likely clipped as there is no indication of the lead being salvaged for future use. Additionally, it would be likely that the lead was partially removed at this time as the report doesn't indicate use of an accessory kit.

Event Description
It was reported that the patient underwent explant due to an infection. It was later reported that the device was extruding. It was reported that there was no adverse event or trauma that may have caused the extrusion of the generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318047
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« Reply #76 on: May 06, 2017, 02:06:31 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 01/26/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery in (b)(6) 2016, the surgeon observed an abraded opening on the outer silicone tubing. The inner tubing was noted to be still intact initially and pre-operative system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s lead had been placed on the right vagus nerve at the previous lead replacement surgery due to scarring on the left vagus nerve. The physician elected to replace the lead prophylactically during the procedure and implanted the replacement lead on the right vagus nerve. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Additional information was received from the caregiver that during the past lead revision surgery in (b)(6) 2016, the lining around the wire came off, frayed and was stuck in patient's chest, which required a 6 hour surgery. Per mother, the surgeon stated that he had never seen this happen before with vns. Upon investigation, the operative time was 3. 77 hours with the incision starting on 11:47 and closing 15:33. Operative notes were provided, which indicated that the surgeon found the lead to be degraded. Per notes, finding of degraded leads required replacement of the entire device rather than simple replacement of the left-sided battery. The leads coming from the right side, traversing the clavicle, were found and these plunged through the muscle where they traveled to the implantable pulse generator which was under the muscle in the axilla. When these were found, the exposed leads appeared to be intact. The generator was disconnected from the leads. Surgeon then pulled the disconnected lead toward the medial incision and, at this point, saw that the portion of the lead that had been under the muscle was frayed and bare wires were exposed. Surgeon cut the excess lead out, irrigated the wounds copiously with bacitracin-containing solution, and closed the subcutaneous tissue with. The surgeon was able to see the vagal nerve stimulator leads around the vagal nerve which was encased in abundant scar tissue. A new lead was then implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6495945
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« Reply #77 on: May 11, 2017, 12:16:40 AM »

Model Number 102
Event Date 12/01/2007
Event Type Injury
Event Description
It was reported that a vns patient experienced pain at the generator site and underwent revision surgery to have the device location revised. Further follow up with the surgeon revealed that the patient was "not satisfied with the placement of the device and requested that the surgeon replace it on the right side so that it was more symmetrical. " the surgeon then placed the generator on the right side, in a more subclavicular position. The surgeon believes that the pain reported is due to the implant surgery. Diagnostics were performed during surgery revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989665
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« Reply #78 on: May 13, 2017, 03:01:53 AM »

Model Number 102
Event Date 08/25/2008
Event Type Injury
Event Description
It was reported to the manufacturer that the vns patient was experiencing tachycardia. The patient's heart rate was consistently around 99-108. The patient has her pacemaker implanted on the left and her vns generator on the right with more than 7-10 inches away. We were informed that every time the patient's vns device delivered stimulation, the patient's heart rate dropped and the pacemaker attempt to correct this by firing to increase heart rate. The physician suggested the patient turn the vns device off by taping the magnet over the generator. The patient was informed to visit with her neurologist and cardiologist to resolve the issue. Good faith attempts to obtain additional information regarding this event are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1175970
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« Reply #79 on: May 17, 2017, 12:17:35 AM »

Model Number 302-20
Event Date 01/01/2008
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 the patient experienced an increase in seizures in (b)(6) 2008. It was reported that the patient underwent surgery where a new vns system was placed on the right side. The revision surgery was previously reported in mfr. Report # 1644487-2009-00566. It was reported that the right sided vns was not as effective as the left system previous had been so the physician has agreed to explant the left vns system and implant a new system on the left side. Surgery is likely, but has not occurred to date.

Event Description
Further follow-up revealed that the underwent generator and lead replacement on (b)(6) 2013. It was reported that only the lead implanted on the right vagus nerve remains implanted and that the left vagus nerve system was replaced. Only the generator from the left system was returned for analysis on 09/25/2013. Analysis of the generator was completed on 10/15/2013. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Reporter indicated that pt received high lead impedance on system diagnostics. Chest and neck x-rays were reviewed by physician. No obvious lead breaks were found. Pt will have revision surgery.

Manufacturer Narrative
Corrected data: the lead and generator were explanted and the generator was returned to manufacturer for analysis. This information was inadvertently left off of supplemental mfr. Report #1. Corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1062981
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« Reply #80 on: July 02, 2017, 06:28:48 AM »

Model Number 104
Event Date 07/27/2010
Event Type Injury
Event Description
Reporter indicated a vns pt had an infection at the generator and electrode sites. The vns generator and lead were removed, and a new generator and lead were placed in the pt's right chest and right vagus nerve. The cause of the infection was unk. Cultures of the generator chest pocket resulted in pseudomonas and (b)(4) bacteria. No trauma or device manipulation occurred. Antibiotics were also given as an intervention for the infection. The pt did not show for his post-operative office appointment, and attempts to contact the pt for further eval by the office have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1842099
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« Reply #81 on: August 05, 2017, 11:14:43 PM »

Model Number 302-30
Event Date 05/24/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2011, indicating that the patient's surgeon was inquiring about right sided re-implants if necessary. It was indicated that the surgeon was concerned about the effects or continued re-implants on the left nerve as the patient has already had two vns implants on the left side. Additional information was received from the neurologist's office indicating that x-rays were ordered, however they were uncertain if they were performed as they did not receive a copy. It was also indicated that the high impedance was first observed on (b)(4) 2011, with a dc/dc code of 7. The neurologist's office believed that the patient may not have been receiving intended therapy. No other information was provided by the neurologist. Revision is likely but has yet to occur to date.
 
Event Description
The patient went for revision surgery on (b)(6) 2012, however the revision was not completed. Pre-op interrogation indicated that the output and magnet currents were both set to 0. 0 ma. Pre-op system diagnostics test on the generator indicated high impedance. X-rays were reviewed by the surgeons and they stated they did not see any obvious discontinuity in the lead. The surgeons then proceeded with the neck incision and planned removal of the old lead. Upon opening the neck incision, the surgeons indicated that there was an obvious break in the lead immediately on top of the sternocleidomastoid muscle. The surgeons did not know what may have caused the break in this location but suggested it may have been due to the neck contractures of the patient. Heavy scarring was identified in the neck and in the process of further dissecting the lead wire for removal, the surgeon encountered a bleeding issue and decided they did not want to proceed any further. The surgeon's also noted that there was previous damage to the left vagus nerve. At the time of the surgery, a portion of the lead was removed however the generator was left in. Both surgeons stated they would speak with the patient's family about further options regarding re-implanting the patient.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received indicating that the nerve damage was likely due to multiple previous vns implants on the left side nerve. The portion of the lead that was explanted was discarded following surgery. Per the patient's family, they are not considering re-implant at this time as the patient's seizures have been stable.
 
Event Description
It was reported by a neurologist that a vns pt had high lead impedance and his seizure pattern had changed (increased duration and intensity). Prior to vns, the pt had seizures which lasted about 45 minutes but after the vns implant, the seizure duration reduced to only seconds. The frequency of seizures however has not changed. Recently, pt started having seizures which lasted 1. 5 minutes indicating a change in his seizure pattern. It was also noticed that pt had high lead impedance. There was no known trauma or contributory factor which may have led to pt's high impedance. Pt was referred for x-ray but manufacturer hasn't received the images. Pt will likely have a full revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2255846
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« Reply #82 on: September 03, 2017, 12:37:25 AM »

Model Number 103
Event Date 05/18/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received that patient's vns generator was explanted on (b)(6) 2011, on (b)(6) 2012 the leads were explanted. The patient was not re-implanted with another generator or leads. Currently they are investigating possibly performing a right-sided vns implantation for this patient. No surgery is planned at this time.
 
Event Description
It has been decided not to reimplant the patient's vns. No right sided surgery planned.
 
Manufacturer Narrative

Event Description
A vns treating physician reported that they had a patient whose device lead and generator was explanted for a wound infection in the chest wall pocket. The patient had (b)(6) confirmed by cultures. No patient manipulation or trauma preceded the event. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2471136
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« Reply #83 on: September 05, 2017, 01:10:05 AM »

Model Number 102R
Event Date 09/15/2011
Event Type  Injury   
Event Description
It was reported that the vns patient would be having surgery to move the patient's generator to the right side of the chest as the patient initially had an infection due to a spine surgery unrelated to vns that spread to the left chest. It was initially unknown if the generator had been infected. Additional information was later received confirming that surgery had occurred. On (b)(6) 2011, the patient had presented with an exposed device and infected wound post the spine surgery. The patient's parents indicated that the device site became inflamed one week following the spine surgery. During the surgery to replace the generator, the generator was removed from the pocket and treated with betadine. It was then re-implanted in the right chest. Cultures taken during surgery indicated antibiotic resistant staphylococcus. The patient was last seen on (b)(6) 2012 during which it was observed that the left wound was still open and the right site was intact. No further interventions have been indicated at this time.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2445195
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« Reply #84 on: September 13, 2017, 01:02:42 AM »

Model Number 302-20
Event Date 03/06/2012
Event Type  Malfunction   
Event Description
Additional information was received as an implant card indicating that surgery to replace the patient's vns generator occurred on (b)(6) 2012. The lead was not replaced at that time. Additional information was later received indicating that the surgeon plans to implant a second lead on the right side instead of replacing the previous lead. The previous lead implanted on the left side likely has a fracture since the high impedance did not resolve following generator replacement. The generator implanted for the replacement on (b)(6) 2012 will be placed on the new lead. Surgery for lead revision and generator repositioning is likely.
 
Event Description
It was reported that the patient's vns was now indicating high impedance on system and normal mode diagnostic tests. Source code from the generator from the last available date to the manufacturer on (b)(6) 2011, shows normal device function. Attempts for additional information have been unsuccessful to date. No adverse events have been reported. Surgery to replace the patient's lead and generator is likely.
 
Event Description
Additional information was received as an implant card indicating the lead and generator had been replaced. The explanted products will not be returned per hospital policy. Follow-up with the site found that it is believed that the previous system was explanted and the patient only has one vns system in place contrary to the previous indication by the site.
 
Event Description
Additional information was received as clinic notes including the most recent note dated (b)(6) 2012, that indicated that the patient has not had any seizures. The note on this date also details the high impedance being found and the patient indicating that she does not feel the device working likely as a result of the high impedance. A note dated (b)(6) 2012, indicates the physician checked the device on (b)(6) 2012 and it was noted that it "seems to be working well. " the vns was later checked and adjusted on (b)(6) 2012, however, no diagnostics or observations on the device performance were noted. The notes indicate the patient had an mri of her shoulder on (b)(6) 2012, which manufacturer labeling does not recommend.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Initial report inadvertently did not indicate 30-day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2518527
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« Reply #85 on: September 16, 2017, 12:07:08 AM »

Model Number 102R
Event Date 04/04/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient was experiencing breakthrough seizures at the patient's previous visit. On (b)(6) 2012 the patient's generator was reported to have physically slipped about 1 inch downward and was causing the patient significant pain at the generator site. The patient was referred to a surgeon for evaluation and possible re-implant to fix the migration. Additional information has been requested from the physician but no further information has been received to date.
 
Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op normal mode diagnostics showed a dcdc code of 4 and lead impedance=ok. The patient's old settings were output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=2ma/magnet pulse width=500usec/magnet on time=60sec. The generator was relocated to the right side of chest per patient request. System diagnostic performed in or with new generator showed results within normal limits of dcdc=2/lead impedance=ok. The patient's device was turned on in the o. R. And programmed to output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted generator was returned to the manufacturer on (b)(4) 2012 for product analysis that is still underway and has not yet been completed.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and 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=2561466
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« Reply #86 on: September 23, 2017, 03:19:38 AM »

Model Number 102R
Event Date 06/20/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 a vns implanting surgeon's scheduler reported that the vns patient had an infection and is having surgery to move the generator from the left to the right side. The patient had recently undergone battery replacement on (b)(6) 2012 due to end of service. Surgery took place on (b)(6) 2012 and the generator was repositioned to the right side only; no replacement of the generator occurred. The patient's lead product information was requested from the implanting hospital but they stated they do not retain records over 10 years and since the leads were implanted in 2001 they do not have the records. Attempts for the patient's generator product information were also unsuccessful as the implanting hospital stated they would not give out this information without patient consent. Since patient consent is not available, the information cannot be obtained. (b)(4) attempts for further information from the surgeon were made but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2680579
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« Reply #87 on: November 14, 2017, 01:39:20 AM »

Model Number 106
Event Date 12/17/2014
Event Type Injury
Manufacturer Narrative
(b)(4). Additional manufacturer narrative; corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received that patient underwent lead and generator re implant on (b)(6) 2016. The implantation was on the right vagus nerve. Lead impedance of the new vns system was normal.

Event Description
It was reported that the vns patient developed an infection and would undergo device explant. It was reported that the infection was a post-operative infection and pus was seen at the generator site and superficially at the neck incision. The generator and majority of the lead were explanted on (b)(6) 2015. The surgeon plans to re-implant the device in 4-6 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532835
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« Reply #88 on: November 23, 2017, 01:35:10 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/11/2015
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was referred for surgery to clean the generator surgical wound site due to infection. No known surgical interventions have occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Manufacturer Narrative
Suspect device udi: (b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Information was received from a physician's office that the patient will be re-implanted with a full system. The office believed that the generator and lead were previously explanted. A company representative confirmed that on (b)(6) 2015 the generator was moved to the right side and the lead was left in place. The patient had a very good response to vns and his parents did not want the system removed. He was unable to confirm that the patient was explanted.

Event Description
The patient was re-implanted on (b)(6) 2015. The vns system was explanted previously due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4909155
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« Reply #89 on: November 23, 2017, 01:35:58 AM »

Model Number 103
Event Date 12/15/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the vns patient presented an infection that required surgical full vns system replacement. It was reported that the new vns system was implanted on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Further information was received indicating that the generator and the lead were explanted in two separate interventions. The health care professional waited 3 months for the infection to resolve and a new vns system was implanted on the right side. The explanted devices have not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4921001
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« Reply #90 on: November 25, 2017, 08:04:33 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/28/2015
Event Type Malfunction
Event Description
An additional x-ray image was received and reviewed. The 103 generator was seen in the left chest. The filter feedthru wires were intact. The connector pin was inserted into the connector block, but it cannot be determined if it had been inserted to the fullest extent. The lead wire was intact at the location of the connector pin; however, there was a portion of the lead located behind the generator that could not be assessed. The electrode placement was done per labeling. The strain relief bend was present but the strain relief loop was not present. Instead, another bend was in place of the loop. Two tie-downs appear to be present holding the strain relief bend. A possible twist in the lead was noted at the top of the left rib. Between the top left rib and the second left rib, there was a suspect area. It is unknown if this is artifact or if one of the lead wires had been bent. There is an additional suspect area over the left clavicle where the lead appears to have been pinched. It is unclear if a fracture has occurred at this point. The cause of the reported high impedance could not be determined based on the x-ray image received. It was also reported the patient had lead revision surgery on (b)(6) 2016. The lead replacement was due to the high impedance observed and the generator was replaced without any problems. It was noted there were two surgeons present and they had both agreed it was too dangerous to remove the electrodes from the left vagus nerved and decided to implant the new lead on the right vagus nerve. The surgeons had tried for several hours to see if there was a possibility to implant the lead on the left vagus nerve, but were unable to do so. A portion of the lead was removed, but the electrodes remained implanted. After re-implant of the new vns system, impedance values were noted to be fine. No patient adverse events were noted during surgery. The explanted devices are expected to be returned to the manufacturer for analysis; however, they have not been received to date.

Manufacturer Narrative

Event Description
Both the lead and the generator were received by the manufacturer for analysis. Analysis on the generator was completed and a review of the ram/flash data download from the generator shows an indication of increased impedance from 2412 ohms to 13902 ohms on (b)(6) 2015. Various electrical loads were attached to the generator and the results of the diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Product analysis of the returned lead is expected but has not been completed to date.

Event Description
A/p and lateral images of the chest and neck of the vns patient dated (b)(6) 2015 were reviewed. The generator was seen in the chest. The filter feedthru wires were intact. The connector pin inside the connector block was confirmed to be completely inserted. The lead wire was intact at the location of the connector pin; however there was a portion of the lead located behind the generator that could not be assessed. No gross fractures or sharp angles were noted. The radiologist suspected a possible fracture on one of the lead wires at the level of the 2nd posterior rib on the ap view. This was not confirmed on the lateral view per the radiologist. It was noted that the two lead wires intertwine at the 2nd posterior rib but an obvious fracture is not noted. A suspect area was identified in the a/p image taken on (b)(6) 2015. In the lead portion on the clavicle, the lead wires appear to be intertwining again. However, a kink on one of the lead wires is suspected. There did not appear to be any other lead discontinuities in the portion of the lead that could be visualized. However, the presence of a micro-fracture in the lead cannot be ruled out.

Event Description
The product analysis for the lead was completed and it was found that the high impedance reported was verified. A break was identified in both the positive and the negative lead coils. Scanning electrode microscopy images of the positive and negative lead coils showed that pitting or electro-etching conditions have occurred at the break locations. Also, the positive lead coil showed minor appearance suggesting that a stress-induced fracture occurred in at least one strand of the positive quadfilar coil. However, due to metal dissolution, mechanical distortion, and/or surface contamination, the fracture mechanism of the broken strands cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation with resulting commentary could not be made on that portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
It was reported that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. The device subsequently disabled. No known surgical interventions have occurred to date.

Manufacturer Narrative
This information was inadvertently reported incorrectly on supplemental #03 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5041455
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« Reply #91 on: November 30, 2017, 01:47:35 AM »

Model Number 103
Device Problem No Information
Event Date 08/25/2015
Event Type Injury
Event Description
Product analysis was completed on the generator on 12/10/15. In the product analysis lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2016 the physician reported that there is no relationship between the patient's cancer and vns. The physician declined to provide the date the cancer was first observed.

Event Description
On 10/23/2015 it was reported that the patient underwent prophylactic generator replacement and the new generator was moved to the right chest wall due to the patient's left breast cancer. Pre-operative diagnostics showed results within normal limits. The explanted generator was returned for product analysis on 11/12/2015. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5079025
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« Reply #92 on: December 01, 2017, 01:39:02 AM »

Model Number 304-20
Device Problem High impedance
Event Date 08/10/2015
Event Type Malfunction
Event Description
Additional information was received that the patient underwent vns generator and lead implant surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. Pre-op interrogation indicated that the device outputs were programmed off. Pre-op system diagnostic on the patient' device indicated impedance > 10,000 ohms. It was decided to implant this patient's new system on the right side, without removal of the original left side implants. Impedance results were within normal limits on the new device after implant. No additional relevant information ahs been received to date,.

Manufacturer Narrative

Event Description
It was reported that the patient had high impedance detected on his vns system per interrogation from the neurologist's programming system. Device manufacturing records were reviewed and confirmed that the lead passed all functional tests prior to distribution. It appears the vns device has been disabled. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5050090
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« Reply #93 on: December 11, 2017, 01:30:18 AM »

Model Number 102
Event Date 01/28/2016
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2016 the patient had a prophylactic generator replacement. The surgery was done in conjunction with a left breast biopsy. The lead was tunneled and relocated to the right breast.

Event Description
The patient was being referred for possible revision because she is getting ready to do radiation for breast cancer. She had previously had a tumor removed on her left breast. No additional relevant information has been received to date.

Event Description
It was reported that the patient is scheduled for a prophylactic generator change and lead reposition. She has a left breast tumor that is also being removed at the same time. Good faith attempts to the physician for additional information regarding the tumor have been unsuccessful. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Follow-up #, corrected data: supplemental #1 inadvertently had the follow-up # as blank and not selected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5450833
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« Reply #94 on: December 12, 2017, 01:35:41 AM »

Model Number 302-20
Event Date 01/12/2016
Event Type Malfunction
Event Description
Further information was received indicating that the patient underwent a full replacement surgery on (b)(6) 2016. The lead was replaced due to high impedance. The generator was replaced due battery depletion. It was reported that the vns new system was implanted in the right side of the patient's body. The explanted lead will not be returned to the manufacturer as it was discarded by the facility. Therefore, no analysis could be performed. The explanted generator was returned to the manufacturer on (b)(6) 2016. Analysis of the returned generator was completed. The reported battery depletion was not duplicated in the product analysis laboratory. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that high impedance (dcdc-7) was observed on vns patient's system. The device was then switched off. X-rays were taken and sent to manufacturer for review. Review of the x-rays identified that the lead pin was fully inserted into the generator header. The filter feed-through wires appeared to be intact. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the part of the lead that could be assessed. A micro-fracture could not be ruled out. Further information from the physician was received indicating that the patient had a big fall with chest impact on a door, in early (b)(6) 2016, due to seizure. Since, the magnet is no longer effective. It was reported that the patient has an increase in seizures at pre-vns level. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that an intervention is planned. No known surgical interventions have been performed to date. No additional relevant information has been received to date.

Event Description
Further information was received indicating that the patient is subject to a vns study. It was reported that the patient had status epilepticus from (b)(6) 2016. It was reported that the severity of the event was mild. The event was not related to implant but possibly related to vns stimulation. It was reported that the treatment was modified and as other action taken: a lead replacement. It was reported that the event was a serious adverse event since it resulted in an initial or prolonged hospitalization. But it did not cause the subject to discontinue from the study. Additional information indicated that the patient had status epilepticus in the period when high impedance was observed. Therefore, the physician concluded that there was a relationship between both events. Both events are now solved.

Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong conclusion codes for the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5406587
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« Reply #95 on: December 17, 2017, 01:42:40 AM »

Model Number 102
Event Date 05/13/2013
Event Type Injury
Event Description
Medwatch report mw5061274 was received by the manufacturer. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. " mfr. Report# 1644487-2013-01470 reports an infection that occurred for the patient in (b)(6) 2012 on her right chest. The patient had generator replacement surgery on (b)(6) 2013 and it is unclear if she is stating in this report that replacement surgery led to infection. Attempts for additional information have been made, but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685677
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« Reply #96 on: December 18, 2017, 01:06:43 AM »

Model Number 103
Event Date 02/10/2016
Event Type Injury
Manufacturer Narrative
Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. This information was inadvertently left off of the initial mfr. Report.

Event Description
Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. It was reported the physician wanted to re-implant the generator on the patient's right side and tunnel the lead to the left vagus nerve as to avoid compromising the original pocket on the left side that had been treated with antibiotics. Product analysis for both the lead and the generator were completed and no anomalies were noted.

Manufacturer Narrative

Event Description
It was reported the patient's neurologist believed there was an infection at the generator site. The patient was then referred to the surgeon for confirmation. The surgeon referred the patient for explant due to the infection. Clinic notes were later received and it was found the patient stated there was a blister, wires were exposed, and still brown drainage. It was also noted the surgeon was going to perform a vocal cord evaluation due to vns placement on the left, and possible place the new vns on the right. The surgeon stated he wants to evaluate the recurrent laryngeal nerve to verify the nerve is stable on both sides. The patient had his generator and lead explanted on (b)(6) 2016. It was noted the generator was completely out of the pocket upon arriving to the hospital. The lead and generator were returned to the manufacturer. Analysis is expected but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5670914
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« Reply #97 on: December 31, 2017, 01:38:43 AM »

Model Number 106
Event Date 07/01/2016
Event Type Injury
Event Description
It was reported that the patient was experiencing a lead pulling sensation which appeared related to the previously migration of the generator. Therefore the physician intended to perform another repositioning surgery where the generator pocket would be moved to the right side of the patient's chest. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

Event Description
It was reported that the patient was planned for a generator revision and that the placement of the generator would be moved. Additional information from the physician's office indicated that the reason for the revision was the generator had migrated medially and inferiorly and was causing pain and discomfort to the patient's sternum. The surgery was being done to preclude patient injury. The migration began spontaneously, and the physician had used tichron 30 non-absorbable sutures to anchor the generator in the initial surgery before the migration. Additional relevant information has not been received to date.

Manufacturer Narrative
(b)(4).

Event Description
Additional information was received on 10/28/2016. Per the physician, the repositioning was being done because the generator was rubbing against the patient's manubrium and not being done to preclude serious injury. Information was also received from a company representative on 11/01/2016. He stated that the patient felt that stimulation was being triggered when raising her left arm due to the device migration and has shortness of breath and coughs because of this. Before the revision surgery, the patient saw her physician and the physician lowered the output current to 1. 0ma. The change was noted as to have been done for the shortness of breath and cough. The frequency was noted as 15hz, the pulse width as 250 micro seconds, and the off time as 1. 1 min. The patient only had 5 autostimulations in the last 102 days prior to the visit. System diagnostics were noted as normal. It is known that stimulation cannot be triggered by the patient's hand or arm movement unless the patient is using a magnet to trigger magnet activation. The device was repositioned on (b)(6) 2016. No additional relevant information has been received to date.

Event Description
It was found out that the patient was in a car crash which is suspected to be the cause of the migration of the device. The adverse events previously reported are stated to have been occurring for some time which predated the accident. Therefore those events appear to be unrelated to the accident and migration of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6063772
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« Reply #98 on: January 01, 2018, 01:28:14 AM »

Model Number 106
Event Date 09/17/2016
Event Type Injury
Event Description
Follow up information received that the patient has been implanted on right vagus nerve because it was impossible to find a place to attach the electrode on the left side when the previous lead had been removed. This was due to adherences on the vagus nerve. The generator has been implanted on the right side as well. Both right and left vocal cords are paralyzed and physician believes this is definitely related to vns surgery. The left vocal cord was completely paralyzed, the right vocal cord partially paralyzed. The implanted generator has never been programmed on. No diagnostic test results available. The patient has had tracheostomy and still has his tracheostomy with a tracheal cannula in place.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a vns patient is having vocal cord paralysis. The paralysis began after the patient underwent a full vns system replacement surgery. Information was received that the patient was implanted on the right vagus nerve. Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6066750
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« Reply #99 on: January 06, 2018, 03:27:35 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/30/2017
Event Type Malfunction
Event Description
It was reported that this patient was going in for a generator replacement due to battery depletion, and high impedance was found during pre-op. The patient was taken in for a full lead revision, and the original lead electrodes were so scarred down that they could not be removed safely. The new lead could not be implanted on the left side due to the fibrosis, and therefore the new generator and lead were implanted on the right side. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7120774
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« Reply #100 on: March 10, 2018, 01:24:22 AM »

Device Problem No Known Device Problem
Event Date 12/10/2017
Event Type Injury
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description
A research article was received that compared seizure outcome from early (<= 5 years of age) and late (> 5 years of age) implantation of vns in children. This report captures a report of one patient, who was part of the late implant group, postoperative infection that resulted in implantation on the right side of the chest in addition, one patient in the study experienced an increase in seizures, captured in mfr. Report # 1644487-2018-00165. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7241147
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« Reply #101 on: April 02, 2018, 12:10:56 AM »

Model Number ASKU
Event Date 11/14/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the nurse practitioner at the neurologist's office reporting the patient did come in for clinic visits and diagnostics were done on her vns which is typical. She was exhibiting behavior that they thought were seizure related. The seizure activity is not believed to be above pre-vns baseline levels but no additional information was provided regarding the seizures. Diagnostics revealed high impedance on (b)(6) 2012, and chest/neck x-ray was performed on this date which found a fractured wire. The device was subsequently turned off on (b)(6) 2012. Lead was replaced in another town so the additional follow-up was performed by another physician's office. Attempts for additional information from the currently treating/local nurse practitioner have been unsuccessful to date.
 
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the date incorrectly due to new information received.
 
Event Description
It was initially reported that the patient had vns replacement on (b)(6) 2012 placed on the right side. Follow-up with the implanting surgeon was performed which revealed that the lead was replaced on (b)(6) 2012. (the generator was not replaced as it was recently implanted on (b)(6) 2012. ) the lead was implanted on the right vagus nerve rather than the left vagus nerve, which is off-label. Manufacturer labeling indicates the lead to be implanted on the left vagus nerve. The lead was implanted on the right vagus nerve due to 'high risk for nerve injury with a third neck dissection, particularly given the prior injury' of vocal cord paralysis. The vocal cord paralysis is reported in mfg report number: 1644487-2004-00262. The lead was replaced due to high lead impedance first observed in (b)(6) 2012, and x-ray images performed on (b)(6) 2012 reportedly showed a fracture of one of the lead wires. There was no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. A copy of the x-rays will not be provided to the manufacturer without patient signed release. The generator was turned off prior to surgery sometime in (b)(6) 2012. The patient exhibited atonic seizures with the high impedance, but it is unclear if there was an increase in frequency or change in seizure pattern. Attempts for additional information from the treating nurse practitioner at the physician's office who found the high lead impedance have been unsuccessful to date. Additionally, attempts to medical records for lead product information have been unsuccessful to date. Attempts for product return have been unsuccessful thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2933487
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« Reply #102 on: May 02, 2018, 01:32:25 AM »

Model Number 302-20
Event Date 06/07/2013
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)(6) 2013 it was reported that the patient has not been seen yet by the physician.
 
Event Description
It was reported that the patient was seen on (b)(6) 2013 and diagnostics were fine.
 
Event Description
On (b)(6) 2013 it was reported that high impedance was observed after the patient had her duty cycle increased on (b)(6) 2013 from 30sec on and 3min off to 30sec on and 1. 8min off. System diagnostics had been performed which showed a high impedance value of 7200ohms. When a subsequent system diagnostics test was performed the result was approximately 3000ohms and two more system diagnostics tests also showed the same results. No changes were observes or clinical manifestations and there were no falls or other trauma reported. It was stated that the patient is bed/wheelchair bound. The patient¿s current settings were noted to be output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time-1. 1min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. X-rays were performed and it was stated that there were no problems observed; they did not want to send them to the manufacturer for review. The device was left on. It was stated that the generator is located in the right side of the chest so the lead is positioned across the chest. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3221239
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« Reply #103 on: May 09, 2018, 12:27:42 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/14/2012
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed on (b)(6) 2012. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was not programmed off after observing the high impedance reading. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
An article titled "resultados de la estimulación del nervio vago en pacientes con epilepsia farmacorresistente en un centro de referencia nacional de epilepsia" ( results of vagal nerve stimulation in patients with drug-resistant epilepsy at a national referral center for epilepsy) was received and provided additional information for this patient. The patient was noted to have had a new vns device implanted on the right vagus nerve after the extensive fibrosis was found on the left vagus nerve. The replaced lead has not been sent to the manufacturer to date and the exact date of the surgery has not been noted to date. No further relevant information has been received to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and diagnostic results showed high impedance. X-rays were taken and were reported by the physician to be unremarkable. The patient underwent surgery on (b)(6) 2014. Upon opening the neck incision site, an abundant amount of fibrosis was observed and the surgeon determined that surgery could not continue so the patient was closed. No known surgical interventions to resolve the reported high impedance have 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=3404837
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« Reply #104 on: August 11, 2018, 12:44:37 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 07/06/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
High impedance was observed on a patient's device. A lead revision surgery was performed for the impedance issue, and was placed on the right vagus nerve as the left nerve could not be found due to patient anatomy. The generator was not changed, and post-operation diagnostics indicated ok impedance. This was reported in mfg report #1644487-2018-00771. It was later reported that about two weeks after the surgery, high impedance was noted again and the physicians believed there may be an issue with the generator. It was stated that the patient was not very active, so it was not likely any trauma occurred to the site. It was unknown if the patient manipulated the device. A generator replacement, and possible full revision, surgery was scheduled. The surgery occurs and it was noted that various troubleshooting was performed, including lead pin reinsertion and testing the generator with a test resistor. Both the lead and generator were replaced, and post-operation diagnostics indicated ok impedance. It was reported by the representative at the surgery that fluid was found in the tubes of the lead. Device history records were reviewed for the explanted devices and each device was indicated to have passed all quality inspections prior to distribution. No explanted devices were returned to date. No additional information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7692269
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« Reply #105 on: November 09, 2018, 02:20:38 AM »

Device Problem High impedance
Event Date 09/24/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient was hospitalized due to increased seizures, and increased seizure duration and intensity. A company representative then checked the patient's generator and found high impedance and that the current was not being delivered. A new lead and generator were implanted on the right side of the patient. The generator was explanted, but the old lead was left in the patient in its entirety. Per the surgeon, no fluid or visible defects were seen on the lead. The physician believes the high impedance to have been due to scar tissue on the left vagal nerve. Attempts have been made for lead product information, but no relevant information has been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7975863
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« Reply #106 on: December 04, 2018, 01:51:15 AM »

Model Number 105
Event Date 08/05/2013
Event Type  Injury   
Event Description
It was reported that the patient had a complete revision surgery on august 5, 2013 and was returning to the operating room on (b)(6) 2013 for another procedure. Operation notes dated (b)(6) 2013 indicate the patient has developed swelling over his pulse generator site over the last 24 hours the patient's mother denies any trauma to the area. The patient¿s axillary incision was opened and yellowish cloudy fluid was observed in the subcutaneous pocket, which was sent for microbiologic analysis. The pulse generator was removed and the pocket was irrigated with large amounts of antibiotic saline. Per the notes, due to the extreme dependency of this patient on his vagal nerve stimulator pulse generator procedure control and his history of refractory epilepsy, it was the surgeon's decision to attempt at first to try to treat the likely infection with a revision of the patient's pulse generator and intraoperative aggressive washout. After soaking the pulse generator in the antibiotic saline tub for a protracted period of time, the device was reconnected to the electrode lead with the torque wrench. It was then re-implanted into the subcutaneous pocket. The device was interrogated and found to be okay. Antibiotic ointment and sterile dressings were placed over the closed skin. The patient left the operating room in stable condition. Operative notes dated (b)(6) 2013 indicate the patient had a postoperative wound infection. Removal of vagal nerve stimulator pulse generator, as well as partial removal of electrode leads and complete drainage postoperative wound was performed. Per the notes, the patient developed a postoperative wound infection which has been shown to be a staph aureus wound infection. Swelling in the patient's chest pocket recurred despite operative washout and neurosurgical intervention was indicated now for removal of the vagal nerve stimulator. The patient was receiving intravenous antibiotics during surgery. During surgery, there was no evidence of obvious purulence in the neck region; however, the physician swabbed the area for intraoperative culture. When entering the subcutaneous pocket, yellowish cloudy fluid was observed. The specimen was sent for microbiologic analysis. The pulse generator and lead were explanted and the pocket was irrigated with large amounts on antibiotic saline. Antibiotic ointment and sterile dressings were placed over the incisions and the patient was taken to recover in the recovery room. No additional information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found and sterility was confirmed with the generator and lead prior to distribution and sterility.

Event Description
The explanted generator and lead were returned to the manufacturer for analysis. The reason for explant was due to infection and no malfunction suspected/identified. Results of diagnostic testing indicated the generator was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Scanning electron microscopy images of the positive coil of the lead show that pitting or electro-etching conditions have occurred on the coil cut end. The most likely cause for the observed pitting condition is that the generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load (cut leads). However, the exact point in time of when this occurred is unknown. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

Manufacturer Narrative
Suspect medical device explant date, corrected data: the initial report inadvertently reported the incorrect date.

Event Description
It was reported that the patient underwent re-implant surgery. The new lead was placed on the patient's right side.

Event Description
It was reported that the patient has been scheduled for reimplant of a new vns system. The reimplant surgery has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3316559
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« Reply #107 on: January 21, 2019, 11:28:07 AM »

Model Number 102
Event Date 05/28/2014
Event Type  Injury   
Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on follow-up mfr. Report #01.
 
Event Description
Product information was obtained.
 
Event Description
It was reported that the patient underwent vns reimplant on (b)(6) 2014.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient underwent explant due to infection. The physician noticed redness following the path of the lead and decided to explant.
 
Event Description
It was reported that following generator replacement surgery, the patient had an infection at the generator site within approximately twenty days of the replacement surgery. An additional surgery was performed to move the generator out of the infected pocket and to a new site on the patient¿s right side.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the infection was caused by skin contaminant. The infection has resolved and reimplant will occur in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3937896
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« Reply #108 on: February 07, 2019, 08:16:41 PM »

Event Date 02/27/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The generator was programmed off and the patient was referred for x-rays. The patient may be referred for surgery. No known surgical intervention has been performed to date.
 
Event Description
X-rays dated on (b)(6) 2015 were provided to the manufacturer for further review. The generator appears in the right chest in an abnormal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
 
Event Description
It was reported that through the programming history database periodic review high impedance occurred on vns patient's generator model 102 serial number (b)(4).
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect gender. The previously submitted mdr inadvertently provided an incorrect event date. The previously submitted mdr inadvertently provided an incorrect event description. The previously submitted mdr inadvertently provided an incorrect data.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong evaluation codes.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The available programming history data of the patient¿s device (model 102 sn (b)(4)) was reviewed. The data was observed from (b)(6) 2013 through (b)(6) 2014. The device was last programmed on (b)(6) 2014 to 8% duty cycle. The last parameters recorded were 0 ma/20hz/250¿s/21sec/5min and magnet mode was1. 25 ma/21sec/250¿s. Diagnostic data was also found. Last diagnostic recorded was on (b)(6) 2014. The lead impedance was high (dcdc 7) and eri no. The parameters data also indicated that the stimulation ok. The review of the available programming history revealed high impedance observed on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4427254
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« Reply #109 on: February 11, 2019, 01:17:54 AM »

Model Number 103
Event Date 11/18/2014
Event Type  Injury   
Event Description
The reimplanted vns system was placed on the left vagus nerve.
 
Event Description
It was reported that the patient was scheduled for vns debridement. The patient had recent generator and lead replacement surgery on (b)(6) 2014. The surgeon¿s office reported that the patient had a post-operative infection. As a result, the plan was to debride and drain the spot on skin. The patient had surgery on (b)(6) 2015 to debride, and the patient was subsequently referred to the infectious disease doctor.
 
Event Description
It was reported that the patient was scheduled for re-implant surgery. However, surgery has not occurred to date.
 
Event Description
An implant card was received which reported that the patient was re-implanted with a vns therapy system.
 
Event Description
It was reported that the patient was scheduled for revision surgery. The surgeon planned to remove the vns system due to the infection, let it heal for a couple of weeks, and then go back in and either place the generator on right with electrodes on left vagus nerve or completely re-implant the system on the right side anatomy. It was reported that during surgery on (b)(6) 2015, the surgeon nicked the jugular vein when trying to cut the lead with less than 2 cm remaining. The bleeding was controlled with the use of a clip that was inserted. The pocket site culture that was completed was positive for an infection. The plan was to treat the patient with antibiotics. It was reported that the patient first presented with a staph infection on (b)(6) 2015 with a fluid-filled chest pocket. The nurse was unsure if the neck incision was also infected at that time. Antibiotic bactrim was prescribed but not successful as the patient was unable to tolerate. The patient was seen again on (b)(6) 2015 and was referred to infectious disease. The patient was seen on (b)(6) 2015, and keflex was prescribed at that time. After the patient was seen by the surgeon on (b)(6) 2015 again, the decision was made to explant.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing history records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4476743
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« Reply #110 on: February 25, 2019, 02:24:26 AM »

Model Number 304-20
Event Date 05/04/2015
Event Type  Malfunction   
Event Description
The patient¿s mother reported on (b)(6) 2015 that the patient has had poor seizure control lately, and that she was hospitalized over the prior few days. She was admitted to the hospital. At that time, the vns was checked and x-rays were taken. The mother reported that she was told that there may have been an issue with the patient¿s vns leads. Additional information was later received that diagnostics confirmed high impedance on (b)(6) 2015, and the device was subsequently turned off. The patient's mother said seizures increased once "medicines started being adjusted. " the surgeon reported that the x-ray appears to show a kinking-issue with the lead. It was reported that there appears to be a slight fracture above the superficial strain relief loop near the sternocleidomastoid muscle. The surgeon suspected that the lead may have gotten kinked and subsequently fractured. No known surgical intervention has occurred to date.
 
Event Description
The patient underwent full explant on (b)(6) 2015. Per the surgeon, the scar tissue and remaining length of the nerve were such that re-implantation could not be completed. The patient is currently seizure free with her current medication regimen so at this point the patient is going to continue with clinical management and not pursue right sided vns placement at this time. The explanted devices are not available for return therefore product analysis will not be completed.
 
Event Description
On (b)(6) 2016 it was reported that the patient under went a full right-sided nerve placement and left chest placement of the vagal nerve stimulator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4767189
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« Reply #111 on: February 28, 2019, 03:09:14 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently reported incorrect information, as it stated that a replacement pulse generator had been implanted. No replacement device was implanted during the reported intervention.
 
Event Description
No replacement generator was implanted during the surgical intervention.
 
Event Description
It was reported that the patient¿s vns system was tested and system diagnostics returned low impedance results with <600 ohms. The pulse generator had been implanted on (b)(6) 2011. The patient underwent revision surgery and it was found during the intervention that the lead was fractured in its upper portion and that the lead appeared to be twiddled. The pulse generator was replaced during the intervention. It was reported that the lead could not be replaced due to lack of an adequate implant site on the left vagus nerve above or below the pre-existing lead electrodes and that implant on the right vagus nerve would be considered. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Further information was received indicating that low impedance was discovered in (b)(6) 2014. The explanted generator was not available for return. Manipulation of the device was not suspected. No known further surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4878237
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« Reply #112 on: March 02, 2019, 03:43:42 AM »

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 the vns patient underwent a lead replacement due to high impedance on (b)(6) 2015. The existing generator was tested upon connection to the new lead and system diagnostics returned high impedance, reported in the mfr. Report #1644487-2015-05010. A new generator was implanted as a replacement and system diagnostics on the new device returned impedance within normal limits. Further information was received indicating that the previous lead was not explanted, but the new lead was implanted on the right vagus nerve. No x-rays had been taken. No known further surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4867412
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« Reply #113 on: March 09, 2019, 01:39:49 AM »

Model Number 1000
Device Problem High impedance
Event Date 01/21/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's m1000 generator. It was stated that on approximately two weeks after the date of implant, the impedance was within normal limits. At the end of that month, the impedance value was within normal limits but approaching the high impedance threshold. Diagnostics performed at the next office visits fluctuated between high impedance and within normal limits remaining near the high impedance threshold. It was stated that the patient is a physically large person and has a right side implant due to a pacemaker on his left side. The leads have to travel "quite a distance" to get to the vagal nerve. No adverse events associated with this high impedance were reported. It was later reported by the company representative that the physician felt the lead was too short as the lead was pulling and was visible across the patient's neck. The patient was referred to the implanting surgeon for evaluation of the lead and high impedance. A review of device history records revealed that the generator passed quality control inspection prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8375426
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dennis100
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« Reply #114 on: March 23, 2019, 01:10:51 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the physician ran a system diagnostic test and received high impedance. The patient was referred to the surgeon. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2016 the patient underwent a full revision. The surgeon first just replaced the generator but high impedance was still observed. The surgeon decided the left side was too scarred so he proceeded with right sided implant of the lead and generator. The old leads were cut with less than 2 cm of lead with electrodes left on the nerve. The explanted devices were requested for return but they have not been received to date.
 
Event Description
On (b)(6) 2016 it was reported that the explanted device cannot be returned for product analysis as the hospital requires a patient signed release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297166
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dennis100
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« Reply #115 on: March 28, 2019, 07:03:19 AM »

Model Number 106
Event Date 01/27/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed staph infection at the generator site that required system explant. The physician indicated that during explant she found signs of infection at the generator site and along the lead. It was reported that the tissue was "like concrete" and required her to cut the lead into pieces to remove it. The surgeon indicated that all of the infection was removed and indicated that prior to, during and after surgery they used several precautions to avoid infection. The surgeon indicated that initially after implant the patient was healing fine; however, over time the redness started and the infection became much worse. No patient manipulation or trauma is suspected to have caused the infection. The surgeon indicated that the patient was very cautious about the incision. The surgeon plans to reimplant the patient when the infection resolves. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 03/11/2016. There were no performance or any other type of adverse condition found with the pulse generator. Analysis of the lead was completed on 03/21/2016. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Clinic notes dated (b)(6) 2016 note that the patient's incisions are all healed. It was noted that the patient would like to proceed with re-implant. The generator will be placed on the right chest given the adhesions on the left chest wall. There is no pain over the patient's scars.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5451173
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dennis100
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« Reply #116 on: April 15, 2019, 12:16:54 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported the patient needed to be scheduled for a full vns revision due to high impedance. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient underwent full revision surgery on (b)(6) 2016. It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant. It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed. After the new generator and lead were replaced, the diagnostics were confirmed as ok. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received noting the devices were discarded after surgery. Therefore, the devices are not expected for return and no analysis will be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857766
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dennis100
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« Reply #117 on: April 24, 2019, 01:35:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/06/2016
Event Type  Injury   
Event Description
It was reported that a patient had a significant infection at her vns site shortly after implant. The infection was treated with antibiotics and got better, but the patient presented later with drainage from her vns site and signs of infection. Cultures were performed, and the patient was referred to the surgeon. The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? no. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Additional information was received that the patient underwent generator replacement surgery. The generator was replaced because patient's skin at generator site eroded and the generator was exposed. The surgeon removed it from the pocket on the left side and implanted the new generator on the right side. The explanted generator was discarded. According to the neurologist, the infection was ongoing. It would clear up for sometime and then come back. Based on that he made decision to replace the generator and move pocket to right side of her chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6193059
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dennis100
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« Reply #118 on: May 11, 2019, 01:27:40 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2014
Event Type  Injury   
Event Description
The patient was referred for vns generator replacement to move their generator back to their left side. The patient had most recently been implanted on the right side, which caused pain in neck when making settings adjustments, wheezing / shortness of breath, and less efficacy than the left side due to the inability to titrate the generator to therapeutic settings. It was reported that the adverse events experienced by the patient were due to the vns stimulation when settings were increased and that the adverse events did not occur previously when the generator was implanted on the left side. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8527189
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« Reply #119 on: June 06, 2019, 01:45:08 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 07/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The patient's device was also at a low battery indicator and was referred for a full revision surgery to address both events. Further information was received that the high impedance was first seen around the beginning of july according to the patient's mother. The physician's office had diagnostics recorded from earlier which were ok. There was no reported/observed traumatic event for the patient that could have led to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient had a full revision surgery to replace the lead and generator. It was stated that high impedance was observed during pre-op diagnostics. It was stated the surgeon implanted the new lead on the right vagus nerve due to too much scar tissue on the left side. The explanted products have not been received by the manufacturer to date.
 
Event Description
The products were received and analysis was completed on the generator. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Product analysis was completed on the lead. The lead was returned in 3 portions with one tie down attached. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. During continuity checks it was noted that the coil was broken close to the electrode bifurcation. The electrodes were not returned with this portion of the lead body. Sem was performed on the suspected coil break and it was noted that there was extensive pitting in the area making it not possible to identify the cause of the fracture. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6874986
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dennis100
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« Reply #120 on: June 11, 2019, 12:40:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.
 
Event Description
Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245
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dennis100
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« Reply #121 on: June 28, 2019, 10:05:46 PM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 02/13/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient's device was found to show high lead impedance. It was noted that if the leads were revised, the generator would also be prophylactically replaced to minimize number of surgeries for the patient. No surgery has occurred to date. No additional relevant information has been received to date.
 
Event Description
A full revision surgery occurred. It was noted that the patient's replacement lead was implanted on the right vagus nerve due to fibrosis on the left vagus nerve. It is indicated per labeling that fibrosis between the nerve and electrode is a possible cause of high lead impedance. Follow up with the physician's office provided the settings and diagnostics of the patient's device prior to replacement. The system diagnostics indicated high impedance, end of service (eos) = no. No devices were received to date. No additional relevant information was received to date.
 
Manufacturer Narrative

Event Description
The patient's explanted devices were returned for analysis. Product analysis was completed for the generator and lead. The generator performed according to functional specifications and analysis of the device found no abnormalities or malfunctions. The explanted lead was returned in five portions. Visual examination of the portions found that the setscrew marks were observed on the connector pin, indicating a proper mechanical contact between the conductive surfaces of both the generator and connector pin, ensuring a good electrical connection with the lead. The quadfilar coil 1 appeared to be broken near the anchor tether. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, with pitting and residual material. Pitting was observed on the coil surface, and was likely related to stimulation present for a certain period of time. No other anomalies were noted. Based on the findings from product analysis, there was evidence to suggest a discontinuity in the returned portions of the device. Note that since the positive and negative electrodes were not returned, no analysis could be performed on those portions of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7326901
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