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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
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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
« Last Edit: March 19, 2016, 01:58:19 AM by dennis100 » Logged
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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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dennis100
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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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dennis100
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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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