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dennis100
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« on: May 15, 2012, 12:44:28 PM »

Model Number 300-20
Event Date 09/01/2006
Event Type  Malfunction  
Event Description
Reporter indicated patient referred to surgery for "high impedance" by "treating physician". System diagnostics test ran during the or procedure indicated proper device functioning. No lead discontinuities noted during procedure. Surgeon closed patient and device remained implanted. Further follow-up by manufacturer indicated "when the surgeon got into the neck, the part of the lead had scared to the jugular, so they had to dissect that off. Then, when he did get to the nerve, he didn't think there was room to put the new electrodes above the previous electrodes so he cleaned off the electrodes a little and closed her up". Follow-up with treating physician indicated the patient presented approximately 7 months later with increased seizures and stimulation not perceived. Systems diagnostics test resulted in high lead impedance, indicating a possible lead malfunction.
 
Manufacturer Narrative
Chest x-ray reviewed by manufacturer. No anomalies seen by manufacturer upon review of x-rays.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=921294
« Last Edit: December 14, 2015, 10:16:06 PM by dennis100 » Logged
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« Reply #1 on: May 15, 2012, 12:44:59 PM »

Model Number 302-20
Event Date 01/10/2006
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention
Event Description
Reporter indiced that vns patient experienced excessive bleeding, during implant surgery. It was reported that the procedure began with a transverse incision in the left neck, with subsequent dissection to the left vagus nerve. During the dissection to the vagus nerve, it was noted that the patient began to experience increased bleeding and that blood was pooling in the neck incision. A different surgeon took over at this time and reportedly got the bleeding under control after approximately 45 min. The first surgeon then continued with the procedure. The patient's hospital stay was not prolonged as a result of the reported event and the patient reported no difficulties at follow-up office visit, 15 days post-op. It was reported that the external jugular vein was the source of the excessive bleeding.
 
Manufacturer Narrative
Vns therapy system labeling lists damage to nerves or vasculature in the surgical area, including the carotid artery and jugular vein as a potential adverse event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=673010
« Last Edit: December 14, 2015, 10:17:32 PM by dennis100 » Logged
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« Reply #2 on: July 25, 2012, 07:24:16 PM »

Model Number 302-20
Event Date 04/25/2008
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Reporter indicated that a pt protrusion of the lead body, increased seizures, pain and painful stimulation secondary to a bad cold where she experienced severe coughing, sneezing, and vomiting. The pt underwent surgery and the pt's vagus nerve was found to be bent at an angle and attached to the jugular vein. The surgeon provided more strain relief in the neck and straightened the nerve. The pt's generator was also replaced prophylactically.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1051741
« Last Edit: December 14, 2015, 10:17:54 PM by dennis100 » Logged
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« Reply #3 on: August 10, 2012, 01:53:28 AM »

Model Number 303-20
Event Date 06/11/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
It was reported that a vns patient was going to have their lead replaced related to neck pain and migration of their electrodes. The patient had been complaining, for almost 1 month, of increasing neck pain and obvious increasing prominence of the lead anchors under her skin. There didn't seem to be an effect of stimulation on the pain and there was no increase in seizure frequency. There was no history of trauma that preceded the lead migration or pain. X-rays confirmed the leads being almost horizontal in the neck, suggesting that some/all leads were not on the vagal nerve. X-rays were not provided to the manufacture for review. In the operating room, the generator was inconsistent on interrogation - sometimes the surgeon could get a baseline read on the settings, and other times would get an eos warning, or no response. Based upon this, the generator was replaced with a new m103. During surgery, the anchors in the neck were still in position with non-dissolvable sutures still in place. The anchors appeared to have been anchored to the surface of the sternocleidomastoid muscle, explaining their obvious prominence. The leads were still wrapped on a nerve, but the incision was very low, and the nerve was not the main trunk of the vagus, likely a distal branch. The jugular vein was not present lower in the neck and was a tiny vein higher up. The lead was removed and the anchor and the surgeon was able to follow the carotid upwards and isolate a length of vagal nerve above the previous surgery site. He then hooked up the leads to generator and reprogrammed the new generator to the last known settings. The physician felt it was possible the vns leads were implanted too low in the neck on a distal branch of the vagus, and anchored just under the skin. He also wondered if the jugular vein was injured or sacrificed during that surgery. The patient will be monitored following surgery to see if their pain resolves. Good faith attempts were made for the explanted product and it was not returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2643048
« Last Edit: December 14, 2015, 10:18:17 PM by dennis100 » Logged
dennis100
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« Reply #4 on: November 12, 2012, 01:47:06 PM »

Event Date 01/01/1994
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients. " was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the first of the two jugular vein puncture events that occurred during lead explantation or replacement. No further information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2808630
« Last Edit: December 14, 2015, 10:18:45 PM by dennis100 » Logged
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« Reply #5 on: November 12, 2012, 01:47:55 PM »

Event Date 01/01/1994
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
A poster of an article titled 'surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of 143 patients. ' was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994- (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the jugular vein puncture that occurred during first time insertion. No further information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2808624
« Last Edit: December 14, 2015, 10:19:05 PM by dennis100 » Logged
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« Reply #6 on: November 12, 2012, 01:48:44 PM »

Model Number 102
Event Date 11/11/2010
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
On (b)(6) 2011, additional information was received when the physician's assistant reported that the lead infection was first noticed on (b)(6) 2010 when the patient's family noticed a knot on the left side of neck and chest. The patient was told to go to the hospital for evaluation and the lead was removed around (b)(6) 2011. The patient was given iv antibiotics. The patient's family reported that the patient had had (b)(6). No patient manipulation or trauma had occurred that was believed to have caused or contributed to the infection. The physician's assistant did not know if it was the same infection as the infection at the generator site. He also was not aware that the patient was having any pain but said that it was probably related to the surgery and infection.

Event Description
Additional information was received on (b)(6) 2011 when the manufactures consultant reported that the patient had a neck exploration surgery that day to determine whether or not the patient would be reimplanted with vns. The surgeon decided not to implant a new vns system as he found that the vagus nerve was adhered with scar tissue to the internal jugular. The surgeon stated that he did not think it was possible to dissect the vagus from the internal jugular without damaging the internal jugular.

Event Description
Additional information was received on (b)(6) 2011 when clinic notes from the patient's physician were received. In the clinic notes dated (b)(6) 2011, the patient reported that not only had the generator become infected, but the lead also became infected and he had to have the lead explanted as well and go on more antibiotics. He reported that the infection was a (b)(6). Since the explant he reported that he has been having some dizziness and is unstable with ringing in his ears and dots in his vision and sometimes feel like he is going to black out. He also reports pain under his left axilla that goes down across his chest and stomach. Clinic notes dated (b)(6) 2011 revealed that the patient wants a vns re-implanted. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

Event Description
Reporter indicated that his vns generator was explanted due to infection at the generator site in the chest, and the vns lead was left intact. The pt is currently on antibiotics for the infection. All attempts to the treating surgeon for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943766
« Last Edit: December 14, 2015, 10:19:34 PM by dennis100 » Logged
dennis100
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« Reply #7 on: December 14, 2015, 10:20:32 PM »

Model Number 103
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887104
« Last Edit: October 14, 2018, 12:51:50 PM by dennis100 » Logged
dennis100
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« Reply #8 on: December 23, 2015, 01:10:06 PM »

Model Number 300-20
Event Date 12/18/2013
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records and programming history 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 system diagnostics showed dcdc=0. Device settings were noted and there had been no change in seizures (still seizure-free); however, the patient was no longer feeling the stimulation since an unknown date. The patient¿s settings were increased, but the patient still could not feel the stimulation. Diagnostics were again performed, which showed dcdc=0 on system and dcdc=1 on normal mode. It was decided at that time that the patient would be referred for lead revision due to a suspected short circuit. Clinic notes dated (b)(6) 2013 were received. Diagnostics on this date showed unclear diagnostic results; however, it is believed that the results were within normal limits with neos: yes. Attempts will be made for additional information. No other information has been received to date. Surgery is likely, but has not occurred to date.

Event Description
On (b)(6) 2014, it was reported that following an increase in settings, the patient still could not feel stimulation in the neck but could now feel stimulation in the chest. Diagnostics showed dcdc=0, but there was no ¿limit¿ output status. On (b)(6) 2014, the patient underwent surgery. A battery and lead inspection reportedly showed a lead impedance issue. The lead and generator were explanted but not replaced at this time due to significant scarring around the jugular. Additional information was received stating that surgery was performed due to short circuit condition evidenced by dcdc=0 and clinical effect of stimulation in the chest. The surgery also involved repair of the side wall of the jugular vein and a general surgeon was called in to assist. It is unknown whether the injury occurred before or during surgery. X-rays have not been taken and the patient has not been re-implanted to date. Patient manipulation or trauma is not believed to have occurred. Attempts to have the product returned for analysis were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3570955
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« Reply #9 on: December 25, 2015, 02:40:44 AM »

Model Number 300-20
Event Date 12/31/2014
Event Type Injury
Event Description
Hospital procedure notes dated (b)(6) 2014 note that during generator and lead replacement surgery (mfr. Report # 1644487-2014-03136), during dissection of the electrodes from the patient's vagus nerve the surgeon experienced brisk venous bleeding from the jugular vein. The surgeon identified a small hole in the vein and controlled the bleeding with direct pressure and then closed the hole with a 5-0 prolen interrupted suture. The surgeon then placed surgicel over this. It was noted that the patient tolerated the procedure well and was transferred to pacu in stable condition. The physician assistant indicated that the bleeding is a known complication when removing old lead and that the risk was discussed prior to surgery. It was reported that the vns caused this in the fact of it's presence and the leads scared down to the surrounding anatomy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4476773
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dennis100
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« Reply #10 on: December 29, 2015, 08:41:39 AM »

Model Number 102
Event Date 07/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient would undergo surgery on (b)(6), 2013 for vns replacement; however, the device was not replaced during surgery. The surgeon elected to not implant the patient after the device was explanted, because the patient experienced a lot of bleeding during the surgery. Although this bleeding issue was fixed, the surgeon did not feel comfortable performing the implant at this time. Follow up with the surgeon found that the patient had multiple prior neck surgeries with scarring of the vagus nerve and jugular vein. The bleeding necessitated ligation of the jugular vein and explantation. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3287692
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« Reply #11 on: December 30, 2015, 03:54:53 AM »

Event Date 06/24/2013
Event Type Injury
Event Description
Attempts for additional information from the initial reporter have been unsuccessful. No additional information was provided.

Manufacturer Narrative

Event Description
During routine case management discussion with a mother who is considering vns implant for her child, the mother related a concern she heard about vns. A friend told her that her niece reportedly had stunted growth of the carotid artery and heart issues following implant of vns. No patient information or physician information was provided. Attempts for additional information from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232904
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« Reply #12 on: December 31, 2015, 05:07:53 AM »

Model Number 304-20
Event Date 05/13/2003
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, they physician reported that the patient had vocal cord paralysis, but it was improving. He also noted that the surgeon had reported to him that the patient was having swallowing difficulties and that the patient's jugular vein was nicked during implant surgery. It was unknown if the patient had been evaluated by an ear nose throat doctor. The patient's device was turned on sometime after surgery, but the exact date was unknown. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has bene received.

Manufacturer Narrative
Previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Previously submitted mdr indicated that the patient was the user; however, this should be the medical professional.

Event Description
Additional information was received from the physician in response to the good faith attempts. The physician confirmed that the jugular was nicked during lead removal and repaired. The vns was activated the same day, as is their standard procedure, at minimal settings and not the patient's previous settings. Per the telephone, the patient appeared hoarse continuously several days after the lead replacement, but this resolved. The physician interpreted this as transient vocal cord paralysis related to lead removal from the nerve. The physician believes that the patient is not well. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3191517
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« Reply #13 on: January 28, 2016, 11:23:04 PM »

Model Number 302-20
Event Date 06/01/2012
Event Type Malfunction
Event Description
On (b)(4) 2012, it was reported that there were complications during this vns patient's surgery on (b)(6) 2012, and high impedance was seen. Follow up with the physician on (b)(4) 2012 revealed that high impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service; however, the high impedance was not acknowledged. Pre-operative diagnostics were not run as the surgery was scheduled to be a battery replacement. Operative notes were also received on (b)(4) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient's surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced. On (b)(4) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death.

Event Description
On (b)(6) 2012, it was reported that no patient manipulation or trauma was known to have preceded the high impedance event. The explanted lead was received on (b)(6) 2012. Product analysis was approved on (b)(6) 2012. The reported fracture of lead allegation was not verified within the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the discolored region noted in the vicinity of the coil cut end. The exact reason for this condition is unknown. Also, it was verified that the coil was cut. The lead assembly had remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was noted other than the cur end of the returned lead portion. Four sets of setscrew marks were seen on the connector pin, provided evidence that proper contact between the setscrew and the lead pin existed at least once. 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 typical wear and explant related observation, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Device failure is likely, 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=2676357
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« Reply #14 on: January 31, 2016, 01:17:56 PM »

Model Number 103
Event Date 06/12/2012
Event Type Malfunction
Manufacturer Narrative
Description of event, corrected data: previously submitted mdr inadvertently omitted information that the patient's generator implanted and explanted on (b)(6) 2012 was received. This report is being to correct this information.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, confirmation of surgery on (b)(6) 2012, was received for this patient. Additional information was received on (b)(6) 2012, that there were complications during the surgery and high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-01923 follow up with the physician on (b)(6) 2012, revealed that on (b)(6) 2012, diagnostics were normal and ifi=yes was seen. High impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service. Operative notes were also received on (b)(6) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve a, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient¿s surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced on (b)(6) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr stated that the patient was re-implanted on (b)(6) 2012; however, the patient was actually re-implanted on (b)(6) 2012. This report is being submitted to correct this information.

Event Description
The patient was re-implanted on (b)(6) 2012.

Event Description
On (b)(6), 2012, the patient's explanted generator was returned for product analysis. Product analysis was approved on (b)(6), 2012. The generator was returned for a reported demipulse eos and failure to program condition. The reported failure to program was not duplicated in the pa lab. Results of diagnostic testing indicate the battery status shows neos=yes in the pa lab. The battery was found to be partially depleted and at ifi and neos.

Event Description
Product analysis for the generator implanted on (b)(6) 2012 and explanted on (b)(6) 2012 was approved on (b)(6) 2012. The device was returned at shipping settings indicating that the device was not programmed on. Results of diagnostic testing indicated the device 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. (this generator was returned along with the suspect medical device - generator on (b)(6) 2012. ) design history files for the explanted m103 generator (suspect medical device) were reviewed and showed that the device passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2615021
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« Reply #15 on: February 18, 2016, 04:44:43 AM »

Model Number 102R
Event Date 01/01/2011
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2011 were received and during the review of the notes, it was observed that bradycardia was observed when the patient wore a holter monitor with a bpm of 39 and a tilt table test was positive with bradycardia per the family. The patient does have carotid stenosis and is taking statin and aspirin (81 mg) therapy. The carotid ultrasound in (b)(6) 2011 appeared stable with moderate right carotid plague but no significant stenosis. 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=2420530
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« Reply #16 on: February 25, 2016, 07:20:45 AM »

Model Number 304-20
Event Date 11/07/2011
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2011, the manufacturer's consultant reported that during the patient's implant surgery on (b)(6) 2011, the vns implanting surgeon somehow nicked or tore the patient's jugular or carotid artery. The surgeon had noticed some scarring from the patient's previous implant around the vagus nerve and while the surgeon was cleaning up the scar tissue around the vagus nerve either he nicked the artery or the scar tissue was attached to the artery and tore some tissue from it. The surgeon was able to repair the artery this during the surgery and the patient was implanted as intended. The diagnostics were all within normal limits and no other problems were encountered during the implant. The surgeon later clarified that it was the carotid artery where the damage occurred and it was torn from scar tissue removal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2352130
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« Reply #17 on: March 04, 2016, 08:59:28 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 01/18/2011
Event Type Injury
Event Description
A patient reported to a company representative that she had a sonogram in order to check for a stroke and it was observed that the vns lead wire had punctured her jugular vein at the time of implant and the sonogram could see blood clots present at the site of the reported puncture. Review of the manufacturing records for the lead revealed no anomalies during manufacture of the device. No additional relevant information has been received to-date.

Event Description
Follow-up from the surgeon who implanted the device revealed there was no issue related to vns regarding the jugular vein at the time of surgery or after a one-week post-operative check-up. The surgeon stated the vns lead wire did not puncture the jugular vein and cause blood clots afterward. The surgeon stated he has not seen the patient in 5 years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5447165
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« Reply #18 on: March 08, 2016, 01:48:47 AM »

Event Date 06/15/2011
Event Type Injury
Event Description
On (b)(6), 2011 the manufacturer's consultant attended the vns pt's implant surgery. During surgery the surgeon nicked an artery in the pt's neck that had to be repaired. The surgeon tunneled from chest to neck instead of neck to chest which is the instruction in the manufacturer's implanting procedure. After surgery the vns was working as intended and the pt was fine. The generator product information was able to be obtained and the pt was fine. The generator product information was able to be obtained from the implanting hospital but they did not have any record of the pt's implanted lead information. If further information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2162049
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« Reply #19 on: March 09, 2016, 03:15:59 AM »

Model Number 103
Event Date 06/18/2009
Event Type Injury
Event Description
It was reported by a physician that a vns pt had carotid occlusion after vns surgery which lead to stroke. The physician believed that stroke was related to vns surgery. Pt was referred to rehab and is currently tolerating vns therapy well. There was no device failure associated with the newly implanted device per physician.

Manufacturer Narrative
Review of programming/device diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2149638
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« Reply #20 on: March 10, 2016, 05:23:40 AM »

Model Number 100
Event Date 04/21/2011
Event Type Injury
Event Description
It was reported to the manufacture from explanting physician in (b)(6) that he had a patient with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular. In the last 2 years, the patient had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 years due to battery exhaustion. The patient insisted on having their vns system explanted related to their pain events. It is unknown if this surgery was for patient comfort or to preclude a serious injury to the patient. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted here as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Their explanted generator was returned for analysis. In the product analysis laboratory, it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specification. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133608
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« Reply #21 on: March 18, 2016, 12:29:49 AM »

Model Number 304-20
Event Date 12/17/2010
Event Type Injury
Event Description
Reporter indicated a newly-implanted vns pt was hospitalized for a jugular inclusion. No complications occurred during the surgical procedure itself. Vns diagnostics with the newly implanted vns system were within normal limits. Per the reporter, the pt was taking valproic acid and depakote medications prior to the surgery. Depakote medication is nonspecific cox2 inhibitor (similar to aspirin) and causes oozing during neurosurgical procedures. It is a known practice to give a small dose of desmopressin medication to pts on valproic acid and depakote prior to surgery. Desmopressin medication is believed to cause a release of von willebrand factor, thereby transiently correcting platelet aggregation defects. It is believed the jugular inclusion was caused by blood hypercoagulation from the medication given preoperatively. The pt was placed on heparin medication and the pt was reported as stable. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1963310
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« Reply #22 on: March 19, 2016, 01:58:41 AM »

Lot Number 300-20-17644
Event Date 01/10/2010
Event Type Injury
Event Description
X-ray showed excessive scar tissue at the electrode site. A sonogram revealed that the scar tissue has built up to a point where it is compressing the carotid artery, restricting blood flow. My dr seems very concerned and is weighing her options. Dates of use: (b)(6) 2000 - (b)(6) 2006.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1994994
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« Reply #23 on: March 23, 2016, 08:43:31 AM »

Model Number 103
Event Date 09/28/2010
Event Type Malfunction
Event Description
It was initially reported by a nurse that a vns pt experienced "complications" due to unk reason. The pt just had her vns re-implanted on (b)(6) 2010 due to high lead impedance. During f/u with the surgeon's office, it was found that there had been "complications" during the replacement surgery including fibrosis present around the lead body and bleeding that occurred when the surgeon accidently nicked the jugular vein (addressed in mfr report# 1644487-2010-02173). The surgeon's office stated that they did not have any product info regarding the lead. The pt had stayed overnight in the hosp for monitoring but no actions were needed. Moreover, additional info from a company rep indicated there was still high lead impedances after replacement surgery which took place on (b)(6) 2010. The surgeon and nurse indicated that everything was fine in the operating room and system test was ok. The treating nurse checked the pt when she came in for a f/u and said there were still high impedance (>10kohms/eos=10 yrs). The pt was referred for a pin re-insertion and possible lead replacement with a different surgeon. Info from the initial surgeon through a company rep indicated that there was no report of pt trauma or manipulation. Additional info was received from a company rep who indicated the pt underwent pin re-insertion surgery with a different surgeon. There was no high impedance noted after the re-insertion and after using another pulse generator. System diagnostics after generator replaced were ok with dcdc 2 and eos no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898616
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« Reply #24 on: March 28, 2016, 01:29:21 PM »

Model Number 302-20
Event Date 03/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported by the surgeon that the pt was taken into surgery for battery replacement due to end-of-service (eos). Surgeon also indicated that the device was turned off as pt was experiencing stabbing pain at the generator site. When pt was taken into surgery, preop diagnostics on the device showed high lead impedance and not eos. Diagnostics were performed twice and same results were obtained. The surgeon decided to replace the generator and the lead. Pt's neck was opened and the surgeon was able to visualize a complete lead break near the bifurcation of the old lead. New generator and lead were placed in the pt and post-op diagnostics showed everything working within normal limits. The surgeon accidentally nicked the left intra-jugular vein during surgery. A vascular surgeon was called to repair the vein and pt was closed up. No x-rays were taken prior to the surgery. Painful stimulation at the generator is likely related to the high lead impedance. Good faith attempts to obtain add'l info has been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1659924
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« Reply #25 on: March 30, 2016, 08:05:55 AM »

Model Number 300-20
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was initially reported by the nurse that the pt was referred to them for a battery replacement surgery due to end of service (eos). However, the surgeon performed diagnostics prior to surgery and got high head impedance on normal mode and system mode diagnostics. Pt was then taken into surgery for a full revision but the surgeon ended up not implanting anything since the nurse stated that the surgeon may have nicked the jugular vein which resulted in a lot of bleeding. The surgeon sutured the nick, closed the pt and stated he would implant vns after 6 months. Follow up with the treating physician's nurse revealed that they were not aware about the high lead impedance prior to surgery. Last diagnostics was done in 11/2009 which showed everything working within normal limit. No further info was received.

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=1613558
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« Reply #26 on: April 05, 2016, 03:13:09 AM »

Event Date 06/24/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
During routine case management discussion with a mother who is considering vns implant for her child, the mother related a concern she heard about vns. A friend told her that her niece reportedly had stunted growth of the carotid artery and heart issues following implant of vns. No patient information or physician information was provided. Attempts for additional information from the reporter have been unsuccessful to date.

Event Description
Attempts for additional information from the initial reporter have been unsuccessful. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232904
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« Reply #27 on: April 19, 2016, 04:18:21 AM »

Model Number 302-20
Event Date 05/01/2008
Event Type Malfunction
Event Description
It was reported that a vns pt received a high impedance warning during system diagnostic testing. Follow up with the pt's treating vns therapy physician revealed that x-rays of the pt's device were reviewed by the site and that a lead break had been identified during an assessment of the images. The physician indicated that the cause of the event was unk, though the pt was known to "rough play" with his father and siblings. The physician indicated that the pt's chart noted that a high impedance warning had been received a year prior to this report, x-rays were taken and no anomalies were reportedly identified. The pt was scheduled for a full vns revision surgery and during the surgery the implanting surgeon indicated that he pt's lead was found to have evidence of a lead fracture. While attempting to remove the pt's lead, the surgeon reportedly "nicked" the pt's jugular vein prompting the aid of a vascular surgeon for repair. As a result of the incident, the implant of the pt's new vns device could not occur. The product was returned to the mfr and is currently awaiting analysis.

Manufacturer Narrative
Treating medical facility reviewed x-rays of implanted device. Review of x-rays by the treating medical facility revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1438437
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« Reply #28 on: June 06, 2016, 01:21:10 AM »

Model Number 102
Event Date 10/12/2015
Event Type Injury
Event Description
It was reported, during the tunneling portion of the surgery, the surgeon nicked the patient's artery which caused the patient to bleed profusely. The surgeon had to make a larger incision to get to the area to cauterize and stop the bleeding. There is no additional relevant information.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5229058
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« Reply #29 on: July 19, 2016, 02:52:34 AM »

Event Date 03/14/2014
Event Type Injury
Patient Outcome Other
Manufacturer Narrative
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the surgeon observed a large mass in the patient¿s neck overlaying the carotid and nerve making it impossible for the surgeon to even locate carotid. The surgeon subsequently decided to abort the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3738583
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« Reply #30 on: July 20, 2016, 02:21:48 AM »

Event Type  Injury   
Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on 09/03/2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. This report involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116386
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« Reply #31 on: August 05, 2016, 09:41:29 AM »

Model Number 302-20
Event Date 05/01/2016
Event Type Malfunction
Event Description
It was reported that vns patient has increased in seizure frequency and does not feel the stimulation anymore. Vns system was checked and high lead impedance was found on both normal mode and system diagnostics. Xrays were taken and reviewed by the manufacturer. No obvious cause of the high impedance was observed on the xrays images. The generator is placed in a normal position in the upper left chest. The filter feed-through wires appeared to be intact. Lead connector pin seems to be fully inserted. The lead wires at the connector pin appeared to be intact. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles, no breaks were found in the parts of the lead that could be assessed. Review of manufacturing records confirmed all tests passed for the lead prior to distribution. No known surgical interventions have occurred to date.

Event Description
Additional information received that the lead has been successfully replaced on (b)(6) 2016. It was reported that during explant procedure, the surgeon "nicked" patient's carotid artery and decided to not remove the coils of the lead. The explanted lead is not expected to be returned for analysis. No patient trauma or manipulations have been reported. The reported increase in seizures was first noticed (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5797793
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« Reply #32 on: March 10, 2017, 05:43:49 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/23/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient underwent explant of vns. Notes from explant surgery were received indicating that the reason for the explant was due to infection and cellulitis in the neck and chest. Patient presented with complete dehiscence of the neck wound in the early postop period and underwent closure of the wound (previously reported in mfr. Report # 1644487-2016-00905). Since then, patient has developed symptoms of recurrent infection in her neck and chest wounds and this has been refractory to antibiotics. Infectious disease service was consulted and they recommended device explantation and iv antibiotics. During the surgery, the surgeon observed dense scar tissue. As he removed this tissue in the carotid sheath, there was profuse bleeding from the side wall of the internal jugular vein that result in rapid blood loss. The surgeon was able to control this and then repaired the defect in the wall. The electrode was cut after it was removed from around the vagus nerve. The neck wound had dense scar tissue but no fluid or granulation tissue. In the chest, the pulse generator was removed with the cut half of the electrode still attached. The surgeon then removed extensive granulation tissue from the chest wound subcutaneous tissues and muscle. The surgeon obtained fluid from the chest wound and this was sent for culture and sensitivity. The chest wound was debrided and granulation tissue was sent for pathological examination. The neck and chest wounds were copiously irrigated with bacitracin irrigation and the wounds were then closed. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Products were received for analysis but not completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6330818
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« Reply #33 on: April 21, 2017, 03:47:58 AM »

Model Number 302-20
Event Date 11/01/2007
Event Type Malfunction
Event Description
Initial rptr indicated, that they had just seen the pt in the office for the first time. It was reported "that they were having more voice alteration during on time and now pain with stimulation (no location provided). This had been at the same settings for a year. " add'l info was provided from the site "the pt is experiencing continuous voice change and pain around the carotid when the device stimulates, the pt was seen in the office and the settings were lowered and the pt would be brought back to have diagnostics performed. " it was later reported, the pt underwent complete revision surgery for a "lead break". Good faith attempts will be made for add'l info and prod return for analysis.

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968151
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« Reply #34 on: August 03, 2017, 01:37:46 AM »

Model Number 300-20
Event Date 04/21/2011
Event Type  Malfunction   
Event Description
It was reported to the manufacture from a explanting physician in (b)(6) that he had a pt with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular area. It was reported that in the last 2 yrs, the pt had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 yrs due to battery exhaustion. The pt insisted on having their vns system explanted related to their pain events. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted her as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Therefore the entire lead body was not explanted. Their explanted generator was returned for analysis. In the product analysis laboratory it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator. Addressed in medwatch report number: 1644487-2011-01362. A portion of the pt's explanted lead was returned for analysis. There was a confirmed lead discontinuity. Note that a portion of the lead assembly (body), including the electrodes was not returned for analysis; therefore a complete eval could not be performed on the entire lead product. During the visual analysis of the returned 258mm portion the end of the marked connector quadfilar coil appeared to be broken approx 154mm from the connector bifurcation. Visual analysis was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unk if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The abraded openings found on the outer and inner silicon tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to their reported pain. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, and eval 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2194878
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« Reply #35 on: August 04, 2017, 08:36:50 AM »

Event Date 01/02/2017
Event Type  Injury   
Event Description
An article was received that reported multiple adverse events and a malfunction. The current report captures the adverse events associated with the lead. Mfr. Report # 1644487-2017-04155 captures the malfunction reported by the article. Mfr. Report # 1644487-2017-04153 captures adverse events associated with the generator. There was one intraoperative event associated with the lead. This patient experienced mild oozing from the jugular vein that was controlled by bipolar cautery. One patient had a prominent electrode in his neck which presented as pain and discomfort within a week post operatively. Two other patient's also had pain due to prominent electrodes, but these were associated with trauma to the vns area. These three patient's neck wounds were revised and the electrodes repositioned. The article later describes these electrodes as being "dislodged. " no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6723266
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« Reply #36 on: September 14, 2017, 12:59:11 AM »

Model Number 302-20
Event Date 07/29/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the correct event date for the high lead impedance is provided. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated the painful stimulation was felt to be related to a "short-circuit" of the vns. X-rays were taken but were not forwarded to the manufacturer. The high lead impedance was first noted on (b)(6) 2011, and the patient had reported feeling electrical shock sensations in her neck when turning her head to the left for the previous month. Vns diagnostics were last within normal limits in (b)(6) 2010. Analysis of the explanted vns generator and lead was completed. No anomalies were identified with the vns generator and the generator performed per specifications. During the lead visual analysis of the returned 35mm lead portion, the green (-) electrode quadfilar coil appeared to be broken approximately 12mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged and pitted 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. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead 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.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Reporter indicated a patient was noted to have high lead impedance with vns diagnostics in (b)(6) 2011. The patient was also experiencing painful vns stimulation in her shoulder. The vns was disabled, but no other interventions were done as the patient was pregnant at the time. The patient does have a history of falling with her seizures. The patient delivered her baby in (b)(6) 2012 and surgical replacement of the vns lead and generator occurred on (b)(6) 2012. Diagnostics with the new generator and resident lead still indicated high lead impedance, ruling out a lead pin issue and making a lead fracture more likely. Diagnostics with the new lead and new generator were within normal limits. However, during explant of the resident lead, the jugular vein was nicked which required a vascular surgeon to assist with the repair. The new vns system was left disabled. The explanted generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2513252
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« Reply #37 on: September 19, 2017, 03:01:35 AM »

Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Event Description
Clinic notes were received for review on a vns patient. In the notes dated (b)(6) 2012 they reported that the patient had right-sided carotid endarterectomy (stroke-preventative surgery due to vessel collapse). The patient had also been hospitalized previously for tia symptoms. Her md did not feel her symptoms on admission were suggestive of tia as they lacked any unilaterality, so they did not pursue further stroke work up. Also noted as having sleep apnea. It is unknown the start date of these events nor the relationship to their vns therapy. (b)(4) attempts were made and no further information was attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2674213
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« Reply #38 on: October 06, 2017, 10:16:17 AM »

Model Number 303-20
Device Problem High impedance
Event Date 08/09/2017
Event Type  Malfunction   
Event Description
Report was received that high impedance was found in the operating room. The patient was receiving a full revision surgery. After the old generator and lead were removed, a new generator and lead were implanted. Prior to the conclusion of surgery, system diagnostics were run on this system and resulted in high impedance. Proper pin insertion was reportedly verified and the nerve was irrigated. Generator diagnostics were performed using a test pin and the results returned were normal. The surgeon decided to try another lead, but the surgeon reportedly had difficulty placing the electrodes on the lead. Prior to completing the surgery, the patient began to show signs of arrhythmia (captured in mfr. Report #1644487-2017-04402) the anesthesiologist reportedly recommended that the surgery be terminated because the arrhythmia was likely related to vagus nerve manipulation in conjunction with duration under anesthesia. The patient returned for surgery at a later date to complete the lead revision, but it was found that vagus nerve was attached to the jugular vein by scarring. The scarring could not be dissected and the lead revision could not be completed. The device history record was reviewed and showed the lead passed all quality specifications prior to release for distribution. No known surgical intervention has been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6843758
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« Reply #39 on: October 25, 2017, 02:11:13 AM »

Model Number 103
Event Date 06/01/2013
Event Type Injury
Event Description
It was reported that the patient's generator has been programmed off since (b)(6) and the patient now wants the device explanted. The neurologist indicated that the vns has never helped the patient and has caused her pain. It is unknown if the pain occurred with device stimulation. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely, but has not occurred to date.

Event Description
The explanted generator and lead were reported to be available to return to the manufacturer. The products were received. However, analysis has not been completed to date.

Manufacturer Narrative
Date of event, corrected data: previously submitted mdr indicated an event date of (b)(6) 2013; however, additional information was received that the event date is (b)(6) 2013. This report is being submitted to correct this information.

Event Description
Follow up with the physician found that the patient's pain was first observed in (b)(6) 2013 following the motor vehicle accident. The lack of efficacy was seen since vns implant in 2010. In response to the question about the relationship of the vns to the patient's pain, the physician said that the vns device was turned off on the initial visit on (b)(6) 2013. The pain was associated with stimulation and was occuring on the left side of the neck. The lack of efficacy from the vns was attributed to injury during motor vehicle accident, per the physician. The physician stated that the device was disabled by taping the magnet over it on the first visit. No other information was provided.

Event Description
Analysis was completed on the returned generator and lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.

Event Description
Clinic notes dated (b)(6) 2014 were received stating that the patient had a vns device which was turned off one year earlier due to discomfort and without relief of seizures. The patient wanted the device removed. Follow up with the tc showed that the device was actually programmed off. Explant surgery has not occurred to date. Programming history in the in-house database was reviewed again on (b)(6) 2014 for updates. The last available settings are from (b)(6) 2013 showing that the device was programmed to: output current: 1. 75 ma, frequency: 30 hz, pulsewidth: 500 usec, on time: 30 seconds, off time: 5 minutes, magnet output current: 2 ma, magnet pulsewidth: 500 usec, on time: 60 seconds. The device was programmed to these settings on (b)(6) 2012.

Event Description
It was reported that the patient's physician kept trying to increase her vns programmed settings. As a result of settings programmed up too high in the patient's opinion, she reported having a "miserable" three months. After a severe accident which left her trauma icu care, she received a mri and the device went to "full force. ".

Event Description
It was reported that the patient had generator and lead explant surgery on (b)(6) 2014. The operative notes reported that the patient was involved in a car crash trauma over two years ago. "her seizures have resolved. Vagal nerve stimulator has been turned off for nearly 2 years. She has not had seizures and is desiring removal of her vagal nerve stimulator. " the lead was dissected free from scar and fibrous tissue. The lead was divided from adherence to the jugular vein and carotid artery, "allowing the metallic portion to reside within the inflated outer portion in a position close to the muscle away from the vessels. " the electrodes remained along the vagus nerve. The remaining generator and portion of the lead were removed. It was reported that the explanted devices are believed to have been discarded. The hospital representative reported that he did not receive the devices after the procedure to return to the manufacturer. Therefore, analysis cannot be performed.

Manufacturer Narrative

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative
Describe event or problem, evaluation codes, corrected data: the supplemental report #4 inadvertently reported this data incorrectly. The product was not discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3559261
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« Reply #40 on: November 14, 2017, 02:50:22 AM »

Model Number 103
Event Date 12/19/2014
Event Type Injury
Event Description
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On 03/11/2015 it was reported that the physician lacerated the carotid artery of the patient during the re-implant surgery. A vascular surgeon was called in to assist. After 7 hours, the patient appeared to be stable and was sent to the icu to stay the evening.

Event Description
It was reported that the patient developed an infection at the generator site and would undergo generator explant. It was reported that the surgeon would clean the generator pocket and then making a new generator pocket and implanting another generator. It was later reported that the patient presented to surgery with a badly infected generator pocket with an open wound and the generator missing. It was reported that the lead was sticking out of the pocket with the lead pins torn off. It was presumed that the lead pins were still connected to the missing generator. The surgeon decided to explant the lead and let the mrsa infection heal before re-implanting in 2-4 weeks. It was reported that the patient did not know what happened to the generator. The surgeon indicated that the chest wound broke down and extruded. The patient initially had a seroma, but that the generator eventually extruded through the skin. No additional relevant information has been received 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532501
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« Reply #41 on: December 04, 2017, 02:00:00 AM »

Event Type Injury
Manufacturer Narrative

Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116364
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« Reply #42 on: March 10, 2018, 02:59:59 AM »

Model Number 300-20
Device Problem No Known Device Problem
Event Date 01/24/2018
Event Type Injury
Event Description
A patient underwent replacement surgery to resolve high impedance present on her vns device, as reported in mfr. Report # 1644487-2016-01548. The surgery was aborted because the explanting physician accidentally punctured the patient's jugular vein, requiring another physician to repair the patient's vein. Per a company representative, the patient stayed in the icu overnight to recover. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7275417
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« Reply #43 on: March 18, 2018, 01:20:47 AM »

Event Date 01/01/1994
Event Type Injury
Manufacturer Narrative

Event Description
A poster of an article titled 'surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of 143 patients. Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994- (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the second of the two jugular vein puncture events that occurred during lead explantation or replacement. No further information has been received to date.

Event Description
Additional information was received on (b)(6), 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2808761
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« Reply #44 on: April 12, 2018, 12:55:44 AM »

Event Date 07/23/2008
Event Type  Injury   
Event Description
Vagus nerve stimulator implanted: 2006, turned on: the following month, explanted the following month: coil/electrodes not removed. Er visit: infection at incision site on my neck: a month after the original month. I told the nurse practitioner that something felt wrong with the lead in my neck. It felt like something had moved, it just didn't fell right. The first time i told her was in five months later, i believe. Er visit: nerve stimulator malfunction: the following month, no one there knew what to do, taped my magnet on and went home. Had x-ray, that was sent to cyberonics i had it turned off for at least a month. I was so afraid of turning it back on. Once i had it turned back on, i started having migraines almost everyday. I put up with it for several more months, then i asked for it to be turned off, and i asked about getting it removed. I believe it was turned off in 2007. After it was turned off, i started getting severe cramps in my neck. I had an appointment with dr at medical center in 2008 to discuss removal of my vagus nerve stimulator. He said the surgery was too dangerous, there could be scar tissue entangled around the carotid artery and or jugular vein. Surgery could result in a stroke or even death. He also said surgeons do not like to remove items implanted by other surgeons, because he doesn't know how it was put in. He suggested i do some stretching exercises. He said a muscle relaxer might help, but would not be good for my bi-polar. He said if it were him, he would leave it in until i couldn't bear the pain any longer. He also said, he thought there may be something else going on, the leads may not be causing the spasms. I told him that if i were not able to stretch my neck and get the cramping to stop, i would have to go to the er. I am afraid of that happening more, so now after what he has said about the surgery. I had to go to the er after an adjustment caused severe electrical shocks. The doctor in the er didn't have a clue what to do, and had never heard of the vns. They told me to go to the doctor that implanted it. That doctor is in missouri! the cramps/spasms are becoming more frequent. What happens if i do have to go to the er, are they going to have a doctor-neurosurgeon- there to do emergency surgery! my asthma is worse. I have to use inhaler every night. As soon as i lay down, i start to wheeze and cough. I wake up coughing and have to use the inhaler again. I don't need the inhaler during the day? - my abdomen has sharp pains when i turn over during the night. -the abdomen pain comes and goes - happened during the day only a couple of times - i am having terrible sneezing attacks that last 12-15 hours per day. But, if i sit completely still, i will not sneeze. These attacks are about every other week, or more. They completely wear me out! i have not felt well for a couple of months, fatigue, nausea and lots of bouts of diarrhea. I have pain - comes and goes - in both my breasts, like electrical shocks from the top all the way to my nipples. They are sore to touch, comes and goes. May be: the vagus nerve stimulator has aggravated my vagus nerve - and who knows what else - and is causing some of the problems i listed above. I called the surgeon in missouri - i live in nc now - and the nurse told me the doctor said the leads should not be removed. She said the doctor said surgery would cause more scar tissue. I was never told that the complete device couldn't be removed. Had to remove device approx four months later. Dates of use: 2006 -- 2007. Diagnosis or reason for use: depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1100549
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« Reply #45 on: April 12, 2018, 01:00:47 AM »

Type of Device: stimulator, autonomic nerve, implanted for epilepsy
Device Brand Name: vns lead
Device Manufacturer's Name: Cyberonics, Inc
Date of this Report: 11/23/2011
(mm/dd/yyyy)

Describe the Event or Problem: Pt had a vagus nerve stimulator placed in approximately 2005 or 2006. Pt has a seizure disorder & hydrocephalus; traumatic birth. Pt recently had an increase in his frequency and type of seizures. Battery was interrogated by Dr. and found to be completely depleted of voltage. Pt presented here recently for generator replacement but we found that the lead was completely disconnected from the wires up in the neck. It appeared that there was fluid that filled the channel indicating that this was longstanding. The wound had been closed and the patient sent home for a week while we arranged for a time to bring him back to do the longer surgery were we need to explore the vagus nerve and scar tissue and remove his broken lead and place a new one. Surgery recently completed for this procedure: dissection made down to the scar to the platysma, which we freed up and undermined. Worked way through scar just medial to the sternocleidomastoid muscle and identified the broken wires protruding upward. There was one anchor that was holding this electrode, which is the reason that this fractured at this point. There was no strain release loop left in the neck. We released the anchor, divided the lead, and then followed the lead down towards the vagus nerve. The jugular vein was identified and freed up as was the carotid artery. We worked our way on the more proximal and where there was not as much scar tissue and came down to the vagus nerve. We then worked our way cranially up the vagus nerve and then along the wire with a 15 blade until we came to the junction of the wire in the vagus nerve. Under loupe magnification, able to release the scar over the lead and then unwind the lead from around the nerve. There was quite a bit of scar tissue around the nerve and we were not sure how well a new electrode would work so we made sure we had a long segment of nerve, especially with some on the more proximal end to accept the local lead. The wound was irrigated, new lead wrapped around the vagus nerve carefully so as not to touch the wires and as well as its anchor. Slight strain releasee inferiorly and then looped the thick end of the electrode upward and secured it in 2 places with anchors under the paracervical musculature. We made a pocket for upward loop of the electrode. Tunneler to pass electrode. Tested lead; impedances were all good. Generator was zeroed out and will have to be set by Dr. some time in future. Wounds irrigated, sutured. Pt to recovery in stable condition.

the device(s) may have caused or contributed to: Potential for patient harm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?id=27968
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« Reply #46 on: May 18, 2018, 07:01:05 AM »

Model Number 103
Event Date 01/07/2013
Event Type  Death   
Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient was admitted to the hospital for implantation of the device. Pre-surgical clinical findings included patient complaint of mild chest pain with dyspnea, left shoulder pain, and right lower limb pain and numbness. The patient underwent general anesthesia and implantation of a left vns therapy system on (b)(6) 2013 with model 103 generator serial number (b)(4) and model 304-20 serial number (b)(4) on the left vagal nerve. Per the operative notes, the patient's neck vessels were severely engorged, but there was reportedly no severe bleeding during surgery. (of note, the patient was on anti-platelet medications which inhibit thrombus formation). Two normal mode diagnostic tests were performed intra-operatively per labeling which were within normal limits. The vns system was not programmed on, that is there was no stimulation, at any other time during or after the implantation procedure of (b)(6) 2013. After completing the operation on (b)(6) 2013, the patient did not regain consciousness and was found to have lateralizing neurological signs. An initial ct scan of the head on (b)(6) 2013 revealed a non-hemorrhagic left fronto-tempero-parietal-occipital infarction and evidence of intra-cerebral swelling. The patient was treated with anti-edema measures and pulmonary ventilation was continued post-operatively. Treatment included iv drugs piracetam, mannitol, citicoline. However, the patient's neurological condition deteriorated. A second ct scan of the head on (b)(6) 2013 revealed hemorrhagic transformation of the large infarct. In response to this event, the patient underwent neurosurgery for decompression craniotomy of intra-cerebral swelling. As of (b)(6) 2013, the patient was placed on a ventilator and was haemodynamically stable with worsening renal functioning. The patient was appropriately managed by intensivists, neurologists, neurosurgeon, and cardiologist. In spite of the efforts, the patient was declared expired and was removed from the ventilator on (b)(6) 2013. Per the death certificate, the cause of death was acute left internal carotid artery infarct with haemorrhagic transformation with cerebral edema and dilated cardiomyopathy, acute respiratory failure, peripheral vascular disease, tricuspid heart dysplasia, old anterior wall myocardial infarction leading to cardio-respiratory arrest. In the opinion of the investigator, the relation of the death to the implant procedure was determined to be probable; however, there were clinical factors that likely contributed to the death. The patient had significant coronary and peripheral vascular disease that consisted of severe, three-vessel coronary artery disease and severely impaired left ventricular systolic function, carotid atherosclerosis, bilateral claudication with total infra-renal occlusion of the aorta. The patient also had pre-existing severe mitral regurgitation. The overall impression of the clinical event adjudication committee was that the patient was severely compromised as a result, with risks factors for general anesthesia complications that included previous myocardial infarction, severe ischemic cardiomyopathy, ongoing heart failure, severe mitral insufficiency, total aortic occlusion, and renal insufficiency, and risk factors for thromboembolism that included severely compromised left ventricular function including left ventricular dyskinesis, mitral insufficiency, carotid atherosclerosis, and renal insufficiency. The death is not believed to be related to vns stimulation, as the device was not turned on following implant. Implantation surgery has known potential risks, complications, and side effects identified in both the investigator's brochure and the device labeling. The generator was explanted on (b)(6) 2013. Product return to the manufacturer is expected, but the generator has not been received to date. The lead was not explanted prior to the patient's cremation.
 
Event Description
It was reported that the patient had prolonged hospitalization.
 
Manufacturer Narrative
Describe event or problem: patient (b)(6) male was enrolled in (b)(4), a randomized, multi-site, open-label feasibility study designed to collect data on patients with stable symptomatic heart failure ((b)(6) functional classification class ii/iii) implanted with the model 103 and model 304 vns therapy system from baseline through 34 weeks post-baseline. The clinical trial is being conducted in (b)(6) and has been approved by (b)(6). The vns therapy products used are the same products used in commercial distribution. The patient was randomized to cervical vns implantation on the left vagal nerve. Common device name: product code nke (congestive heart failure) is an unapproved indication.
 
Event Description
The explanted generator was receieved by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated the device was returned due to 'acute ica left infarct with heamorrhagic transformation with cerebral edema leading to death. ' explant date was also listed as (b)(6) 2013.
 
Event Description
Product analysis was completed on the explanted generator. The returned model 103 generator performed within all specifications during electrical testing. There were no adverse functional, mechanical, or visual issues identified with the generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to manufacturer functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2939332
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« Reply #47 on: June 09, 2018, 02:43:44 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 04/27/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during vns implantation surgery, the surgeon punctured the patient's jugular when using the tunneler to pass the vns lead through to the generator pocket. It was stated that the surgeon was tunneling from the neck to chest as recommended. The bleeding was stopped using pressure intra-operatively and the surgeon was to monitor the patient prior to discharge. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7532669
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« Reply #48 on: June 20, 2018, 01:02:14 AM »

Model
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« Reply #49 on: October 06, 2018, 06:11:03 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/20/2018
Event Type  Injury   
Event Description
It was reported that the surgeon had nicked the carotid artery during lead implant. They planned to use thrombin gel or foam gel to close the artery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7879143
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« Reply #50 on: October 14, 2018, 12:52:48 PM »

Model Number 103
Event Date 08/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient developed an infection after recently being implanted. The patient underwent emergency explant surgery. During the explant the patient's artery was torn and the patient sustained significant blood loss which required a blood transfusion. The explanted lead and cut portion of the lead were discarded during the surgery. No reimplant is planned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4200536
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« Reply #51 on: December 02, 2018, 02:07:23 AM »

Model Number 102
Device Problem Extrusion
Event Date 06/20/2008
Event Type  Malfunction   
Event Description
A vns patient reported that she began experiencing numerous issues with vns therapy since implantation including weight loss, continuous abdominal pain and painful stimulation. The patient indicated that she had attempted to inhibit vns stimulation by taping her vns therapy magnet to her chest, but this had only resulted in the initiation of magnet stimulation and added that she would be seeking surgical consult for device explantation. Additional information was received from the patient who reported that in addition to developing a new seizure type, her seizures have increased "a thousand fold" since implantation. The patient also indicated that her carotid artery had been cut during implant surgery and added that she has lost around "2/3rd of her body weight" since implantation without any changes in diet or exercise. The patient stated that due to this weight loss, her generator and lead are now visible under the skin. Follow up with the patient's implanting surgeon revealed that the patient's carotid artery had not been cut during her implant surgery and that she has actually only lost around (b) (6), since being implanted with her vns device. The surgeon indicated that he had agreed to remove the device at the patient's request and added that explant surgery would occur within the week. Device diagnostics were performed at the patient's recent surgical consult and reportedly confirmed proper device function. Good faith attempts to the patient's past and present treating vns therapy physicians for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473053
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« Reply #52 on: December 07, 2018, 11:16:40 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/25/2018
Event Type  Injury   
Event Description
It was reported that after a patient underwent vns revision surgery, the patient suffered a stroke due to the patient's jugular vein being nicked at the time of surgery. The patient is also experiencing arm weakness which the neurologist attributes to have been caused by the stroke. The patient was reported as undergoing occupational and physical therapy for the arm weakness. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8072513
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« Reply #53 on: December 14, 2018, 07:29:58 AM »

Model Number 300-30
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned on (b)(6) 2013 and are pending product analysis.
 
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.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis, which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during generator replacement for eos = yes system diagnostics were run with the new generator and existing lead which resulted in high impedance reading. It was reported that the generator was completely dead in pre-op therefore diagnostics could not be run before the new generator was implanted. The surgeon then replaced the lead. A new generator and lead were implanted. It was reported that the explanted devices will not be returned to manufacturer for analysis per hospital policy. The surgeon reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The neurologist indicated that the patient had scar tissue on the vagus nerve and that there was partial erosion into a small area of the medial aspect of the left internal jugular vein which is believed to have caused or contributed to the high impedance.
 
Event Description
The lead assembly was returned in one portion. A portion of the lead assembly (body) including the electrodes and tie downs was not returned. Setscrew marks were observed on the marked and unmarked connector pins. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. White deposits were observed on the outer silicone tubing. The generator was returned as it was not implanted in the patient. Visual examination showed no visual anomalies. The septa were not cored. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. 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. The battery, 2. 995 volts as measured during completion of the final electrical test, shows a non-ifi condition. 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=3325040
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« Reply #54 on: December 20, 2018, 02:13:48 AM »

Model Number 302-30
Event Date 01/27/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator replacement surgery due to battery depletion and that high impedance was observed after the generator was connected to the existing lead. The explanted generator was completely depleted; therefore, high impedance was not observed prior to replacement. The patient did not undergo lead replacement at that time. The patient underwent lead replacement on (b)(6) 2016. The explanted lead was discarded therefore, no product analysis can be performed.

Event Description
It was reported that the surgeon could not remove much of the old lead due to normal scar tissue as result of the healing process. Upon follow-up with the company representative that attended the surgery, it was reported that the lead pin was confirmed to be fully inserted into the generator header. The header was checked and appears to be free of obstruction and fluid during the surgery. There did not appear to be any visible damage to the explanted lead. Generator diagnostics with the replacement device were within normal limits which ruled out a generator issue. The lead was not replaced on (b)(6) 2016 because the patient had not approved prior to surgery to replace the lead. It was mentioned the patient had vocal cord damage from a prior vns implant surgery, as reported previously in mfg report #: 1644487-2004-00831. At that time, it was clarified that the surgeon had accidently hit the jugular vein, as reported in mfg report #: 1644487-2004-00831. No additional relevant information has been received.

Event Description
The company representative reported that the patient indicated that she had "damage" from a previous vns surgery. This is what was referred to in the previous report as "vocal cord damage. " the damage was previously reported in mfg report #: 1644487-2004-00831.

Event Description
The explanted generator was received by the manufacturer. An end-of-service warning message was verified in the (b)(6) lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant. In addition, review of the ram/flash data downloaded from the pulse generator shows an indication of pre-explant increased impedance; on approximately (b)(6) 2014, impedance had a 62;25% change of 7355 ohms to 9316 ohms, and the time of change detection (b)(6) 2014. No anomalies were identified with the performance of the generator and the device performed according to specifications.

Manufacturer Narrative

Manufacturer Narrative
The initial report inadvertently did not report the information about the scar.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817438
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dennis100
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« Reply #55 on: January 04, 2019, 11:40:15 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Injury   
Manufacturer Narrative
Adverse events caused by the surgical procedure are not related to functionality of the vns.
 
Event Description
It was reported that a lead revision due to high impedance had to be aborted due to complications. The high impedance event is captured in mdr #1644487-2018-01964. The surgeon reported that the patient's electrode coils had formed scar tissue due to the initial lead implant that had attached to the jugular vein. It was reported that when the surgeon would attempt to manipulate the vagus nerve the jugular vein would suffer "small cracks" and bleed. After a long time trying to form open space on the nerve to implant another lead, the surgeon became concerned for the patient's health due to the bleeding. As a result he made the decision not to proceed with the lead or generator replacement. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8166999
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dennis100
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« Reply #56 on: January 15, 2019, 03:30:07 AM »

Model Number 304-20
Event Date 04/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed ct scans of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Ct scans reviewed by manufacturer, unable to assess lead continuity or lead pin insertion. 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's device was disabled on (b)(6) 2014. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. Due to the poor quality of the images, lead pin insertion and the filter feed-through wires cannot be assessed. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc - 7). The patient¿s device was not programmed off following the high impedance observation. Ct scans were provided to the manufacturer for review but were unable to determine the integrity of the lead and whether the lead pin was fully inserted into the generator header. The last known good system diagnostic results were from the date of implant. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. Further follow-up revealed that the implant surgeon hit the patient¿s jugular as he tunneled from chest to neck. The patient was seen 15 days after implant surgery and presented with severe voice hoarseness. The patient¿s device was programmed on during an office visit on (b)(6) 2013. During the office visit on (b)(6) 2014, the patient¿s device settings were increased. A diagnostic test was subsequently performed and a warning message appeared indicating high impedance and limited output current. The neurologist misinterpreted the diagnostic results and increased the patient¿s device settings. A second diagnostic test was performed which revealed the high lead impedance. It was reported that the patient was doing well. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3823884
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« Reply #57 on: February 11, 2019, 02:49:07 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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dennis100
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« Reply #58 on: February 25, 2019, 02:41:39 AM »

Model Number 302-30
Device Problem High impedance
Event Date 04/14/2015
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the report of fluids and wear on the lead observed during surgery was inadvertently not provided on follow-up report #01.
 
Event Description
It was reported that the lead showed wear and moisture inside the casing observed during the revision surgery.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2015 note that high impedance was observed. The device was programmed off after observing the high impedance. The patient was referred for surgery. No known surgical interventions have been performed to date.
 
Event Description
Operative notes were later received indicating that the generator was not replaced during the lead replacement surgery. During surgery, the generator was removed from the pocket and disconnected from the lead. The lead was cleaned and reconnected to the generator and the device was re-interrogated. The lead was found to still have high impedance. While dissecting towards the lead while using electrocautery brisk bleeding occurred from the jugular vein, which was controlled with a suture. The surgeon decided not to pursue the lead further superiorly because of the scarring. As the surgeon dissected inferiorly, the vein began to bleed again from that point and another suture was placed which stopped the bleeding. The new lead was placed and the generator was re-attached and interrogation revealed the parameters were normal. No additional relevant information has been received to-date.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The generator was replaced prophylactically. The generator and lead were discarded by the explanting facility; therefore, product analysis cannot be performed.
 
Event Description
A review of the manufacturer's in-house programming history database provided more specific data from regarding the high impedance, and that the device was programmed off on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762548
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« Reply #59 on: March 07, 2019, 02:30:00 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/12/2015
Event Type  Malfunction   
Event Description
It was reported the device will not be returned per hospital procedure.
 
Event Description
It was reported that high impedance was observed on the patient's vns device when she went in for a prophylactic vns generator replacement. The vns generator replacement was not completed due to the observed high impedance. The patient was referred for a possible full revision. No known surgical interventions have been performed to date.
 
Event Description
It was reported the patient underwent a full revision surgery on (b)(6) 2015. It was noted the surgeon nicked the patient's jugular on two separate occasions and each time sutures were used to repair the tear. The old lead coils were able to be removed and a new lead was put into place. The generator was then connected to the lead and diagnostics were performed, twice, with good readings. No additional relevant information has been received to date.
 
Manufacturer Narrative
Adverse event or product problem; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
It was reported the vns generator was programmed off on (b)(6) 2015, the date the high impedance was initially found.
 
Manufacturer Narrative
Device failure 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=4973180
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dennis100
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« Reply #60 on: April 06, 2019, 02:39:49 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/29/2018
Event Type  Malfunction   
Event Description
It was initially reported that the patient was scheduled for a full revision surgery for an unknown reason. Information was later received that the patient¿s generator and lead were replaced due to high impedance. It was also reported that during the surgery the patient¿s jugular vein was nicked which resulted in bleeding and was repaired by a general surgeon. A review of device history records for the lead and generator shows that no unresolved non-conformances were found. The devices met all specifications for release prior to distribution. The explanted generator and lead have been received. Analysis is underway but has not been completed to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8390122
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