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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
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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
« Last Edit: November 03, 2015, 12:19:54 AM by dennis100 » Logged
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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
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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
« Last Edit: November 03, 2015, 12:25:27 AM by dennis100 » Logged
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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
« Last Edit: November 03, 2015, 12:25:57 AM by dennis100 » Logged
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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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