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dennis100
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« Reply #540 on: April 24, 2019, 02:52:31 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2013
Event Type  Injury   
Event Description
It was reported by the surgeon the patient was going to have her vns explanted on (b)(6) 2016. The surgeon stated the patient had been implanted for over 3 years and the vns was not effective because the patient wasn't able to tolerate titrating up the vns settings. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient had requested for the device to be explanted because she didn't like it and it wasn't helping her. It was noted the device was programmed off because the patient didn't like the current, but then she just didn't like the vns. There were no issues with the vns, the patient just did not like it and requested the explant. It was later verified the patient's vns was explanted on (b)(6) 2016.
 
Manufacturer Narrative
This information was inadvertently left off of the supplemental #01 mfr. Report. (b)(4).
 
Event Description
It was later reported by the same physician that the adverse events the patient experienced during titration included pain in the neck, difficulty swallowing, uncomfortable when the current is programmed on, increased falls during her seizures, and no decrease in seizures activity. It was also noted that the patient's seizures were possibly worse with vns; however, no actual seizure rates were given.
 
Event Description
It was reported by the explanting facility that the device was discarded.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #03 mfr. Report.
 
Event Description
It was initially reported by the explanting site that the vns devices had been discarded; however, additional information was received from the site and they had requested the return number so that they could send the generator back. The generator and a portion of the lead were returned to the manufacturer. While analysis is expected, it has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis (pa) for the returned generator was completed. The device performed per functional specifications. There were no performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Note that the lead assembly (body) including a portion of the connector boot; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned portion of the lead was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6181099
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dennis100
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« Reply #541 on: April 26, 2019, 06:50:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2016
Event Type  Injury   
Event Description
It was reported that a patient was scheduled for revision surgery due to pain at the generator incision site under her arm. No further relevant information has been received to date, and no known surgery has occurred to date.
 
Event Description
The patient had generator pocket revision surgery due to pain at the generator site. The patient¿s device was not explanted as there was sufficient battery life. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6251137
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dennis100
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« Reply #542 on: April 26, 2019, 06:51:41 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/05/2017
Event Type  Malfunction   
Event Description
It was reported via clinic notes that high impedance was observed during a routine office visit. During the same visit the patient complained of difficulty swallowing and neck pain that were not associated with vns stimulation since the device had been disabled for some time. It was reported that the physician did not know what was causing the dysphagia and neck pain. The patient was referred for vns removal surgery however no surgical interventions are known to have occurred to date.
 
Event Description
It was later reported that the reason for the referral for vns explant surgery was due to the patient complaining of pain. Additionally it was unknown if diagnostics were within the acceptable range prior to the appointment where high impedance was observed. The physician had not run a diagnostic test for some time due to the device being programmed off. Therefore its unclear when the high impedance first began. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent lead and generator explant surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6288707
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dennis100
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« Reply #543 on: April 29, 2019, 06:08:57 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to a company representative that a patient¿s generator is migrating down to the armpit and the patient has complained that it¿s painful near the muscle around the armpit area when it migrates. The physician took x-rays and it showed that it was in a normal location when the x-ray was taken but the patient can feel it moving if she pushed it and it was reported that the patient could flip the generator if she tried, although it was reported that she hasn¿t flipped it. The patient later reported that she saw the surgeon and is planning surgery to replace the battery and lead, stating that the device has migrated underneath her armpit area and with her work she gets pain in the generator site with movement. The pain is constant but increases when the device goes off. The pain will radiate up to the neck area and further to the jaw at time of stimulation. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the company representative provided that after the patient had been to see the surgeon, he had concluded the device has not migrated.
 
Event Description
Further follow-up with the physician¿s office 03/06/2017 provided the patient had been scheduled for surgery. It was decided to perform the surgery after seeing the surgeon again and they were able to palpate it and find that it was moving after doing so. Generator replacement surgery occurred on (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted device was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator was programmed to the as-received settings, and the output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the output signal, and demonstrated that the device provided the expected level of output current. A comprehensive electrical evaluation showed that the pulse generator performed according to specifications. The battery measured 2. 893 volts and was not in a depleted condition. The downloaded data revealed that 55. 345% of the battery had been consumed. 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=6344391
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dennis100
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« Reply #544 on: April 29, 2019, 06:09:41 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/22/2016
Event Type  Injury   
Event Description
A report was received which indicated that the patient's generator was not working. Clinic notes were received which indicate that the patient reported that the vns was firing inappropriately causing her discomfort. The patient's device was then disabled and the patient indicated that they wanted the device removed. On (b)(6) 2016 the patient's device was disabled and the patient was referred for removal surgery, which has not occurred to date. Follow up with the neurologist's office indicated that the patient had experienced a burning sensation in her chest and throat and had pressure in her neck as well. No diagnostic information was available for the patient's device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6230392
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dennis100
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« Reply #545 on: April 29, 2019, 06:10:42 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
The surgeon's office reported that the patient was experiencing pain at the generator site. The patient had slipped in the bathtub hitting her head and chest. After this incident the patient reported that there was a stabbing pain which radiated from around the site of her device in her neck and chest to her shoulder and down her left arm. The pain resolved when the device was disabled. Diagnostics were performed on the patient's generator after her fall and it was noted that the results were within normal limits. The patient then underwent generator replacement surgery. There was no noted reason to replace the lead at the time of the generator replacement and diagnostics were within normal limits with the new generator per the implant card. Information was then received that indicated the patient had undergone lead revision surgery 7 days after the generator was replaced due the pain at her lead site. No high impedance was seen and there was no lead discontinuity observed either. The explanted products were discarded. No product return is expected. No other information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr. Device available for evaluation, corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr. Device evaluated by mfr, corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr.
 
Event Description
The patient's explanted generator has been received and is undergoing product analysis.
 
Event Description
Product analysis was completed on the generator. Testing was performed and it was noted that no functional anomalies were identified with the device. Impedance values were with in normal limits. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6358184
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dennis100
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« Reply #546 on: April 29, 2019, 06:11:53 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's generator had extruded, described as "it is hanging out. " on (b)(6) 2017, the patient was given antibiotics as her incision site looked red and infected. The next week, on (b)(6) 2017, her generator was exposed and you could see pretty much the whole generator. Therefore the generator was removed the next day. The lead was cleaned, irrigated and then placed back in the pocket. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Event problem cds (refer to coding manual), corrected data: supplemental mdr 1 inadvertently did not report patient code (b)(4).
 
Event Description
Clinic notes from the day prior to generator explant surgery were received that indicated that the patient had been feeling fine until, a week prior began to have pain at the generator site with redness and yellow drainage. The generator had reportedly migrated again and she was given keflex for infection. At this time, the patient was 2 months post-partum of note, the patient's generator had been attached with non-absorbable sutures during her repositioning surgery in (b)(6). Operative notes reported that the patient who had a generator repositioning surgery in (b)(6) (captured in initial report) had redness and swelling at the vns generator site and was placed on antibiotics. The patient's skin eroded and exposed the generator. The patient's wound was classified as dirty. Return of the suspect product is not expected. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead was explanted due to lead-pulling issues with resultant vocal cord issues that were attributed to poor strain-relief, which is captured in mfr report #1644487-2018-00885. It is possible that the strain relief of the lead was affected by the migration. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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dennis100
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« Reply #547 on: April 29, 2019, 06:12:57 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316
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dennis100
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« Reply #548 on: May 01, 2019, 01:08:25 AM »

Device Problems Fluid Leak; Fracture; High impedance
Event Date 11/18/2016
Event Type  Malfunction   
Event Description
An article entitled "vagus nerve stimulation removal or replacement involving the lead and the electrode: surgical technique, institutional experience and outcome" was sent to the manufacturer and reviewed. During review of the article, multiple reportable events were identified. The article stated that 6 patients had replacement surgeries due to broken wires (lead fractures), and 5 patients had lead surgery due to degradation of the silicone tubing causing high impedance. Of these events, 3 lead fractures and 2 cases of tubing degradation were unable to be identified as previously reported. The patients who had high impedance and lead fractures also reportedly had an increase in seizures due to the device issue. One of the patients who had a lead replacement surgery due to a lead fracture had the replacement lead implanted on the right vagus nerve. This, caused the patient pain and the device had to be removed as a result. The article also contains references to other reportable events for generators which is captured in mfr report number. Additionally, the article stated that a patient had passed away due to sudep which is captured in mfr. Report 1644487-2017-03151. One unknown generator malfunction is reported in mfr. Report 1644487-2017-03153.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309080
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dennis100
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« Reply #549 on: May 01, 2019, 01:09:15 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/03/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient was having issues with his new device. He reported pain and swelling on the left side of his neck, shoulder, jaw, and was having muscle spasms on the left side of his neck, he felt a lead pulling sensation across his neck and chest, and he had coughing associated with stimulation. The patient also said that it looks like he has an infection. The physician later reported that diagnostics were run and were within normal limits. She stated she had decreased the output current to attempt to alleviate the issues. The patient was scheduled for a follow-up appointment but did not show up. The physician noted she had referred the patient to a surgeon who is more experienced with vns. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Information was received that after the patient's consult with the surgeon, he was referred for a lead revision. The surgery was scheduled but the patient was initially a no-show. The surgery has been rescheduled but has not been completed to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Lead revision surgery occurred. The explanted device was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6316710
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dennis100
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« Reply #550 on: May 01, 2019, 01:10:16 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a patient that approximately 2 months prior, he woke up with shoulder pain and was having difficulty breathing. The patient went to the hospital and remained there for 5 days, and the physicians told him that his heart rate had decreased to 30 beats per minute. He said that the physicians determined that the shoulder pain and difficulty breathing were caused by the bradycardia and lower oxygen levels, but the physicians were unsure if the patient's bradycardia was caused by the vns. No further relevant information has been received to date.
 
Event Description
The patient's spouse reported that every time the patient's vns settings are adjusted, he goes through a period of a week where every time stimulation occurs (every minute) his heart rate drops to 30 bpm. It was reported that everything was cardiologically within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300371
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dennis100
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« Reply #551 on: May 03, 2019, 02:44:11 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2016
Event Type  Injury   
Event Description
It was reported that the patient was experiencing neck pain, discomfort, and vocal cord paralysis since the initial implant. The patient is unable to tolerate any increases in parameter settings as per the standard dosing protocol. The patient was being referred for a possible full system revision. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent an ent scope where it was confirmed that she was experiencing vocal cord paralysis and shaking of the larynx. The patient was evaluated by the surgeon who reported that he believed the patient was receiving benefit from vns therapy; even though she was unable to tolerate standard dosing she was still receiving seizure control. Since the device was functioning properly and the patient was seeing benefit the surgeon did not believe it was necessary to pursue a replacement of the vns system and the patient agreed. Further follow-up with the physician found that the likely cause of the vocal cord paralysis was related to exposure to vns stimulation since the vocal cord paralysis was occurring with vns stimulations on the left side only.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6447366
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dennis100
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« Reply #552 on: May 03, 2019, 02:44:52 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/28/2017
Event Type  Death   
Event Description
It was reported that the patient died in seizure at a hospital. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
The patient's autopsy report indicated that the patient had went to the hospital complaining of lower back pain in the left lower back and urine retention, found to be caused by a kidney stone. This was treated with a foley catheter. After a day, patient had a seizure while he was eating. He had persistent aspiration after the seizure and was later pronounced dead. The patient's autopsy showed food aspiration in the tracheobronchial tree and in the alveoli with foci pneumonitis, the latter probably due to previous small aspirations. There were associated areas of pulmonary edema and parenchymal hemorrhages. Cause of death was determined to be due to respiratory failure secondary to food aspiration during a seizure attack. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434921
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dennis100
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« Reply #553 on: May 03, 2019, 02:45:34 AM »

Model Number 304-20
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was having lead problems related to her clotting disorder. The patient believed that her physician told her that this was the case and stated that she needed to undergo full revision surgery to resolve the issue. No further relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The lead was not replaced as the surgeon reportedly did not feel it necessary to replace the lead. No additional relevant information has been provided to date.
 
Event Description
It was reported that the patient was actually experiencing a tethering sensation accompanied by pain and discomfort when she turned her head. The lead was only repositioned during generator replacement surgery. The lead repositioning was for patient comfort. The surgeon believed that scar tissue formation, and not a clotting disorder, was the cause of the patient's lead issues. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6449279
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dennis100
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« Reply #554 on: May 03, 2019, 02:46:15 AM »

Model Number 300-20
Device Problem Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for battery and lead revision. Systems diagnostics resulted in high impedance and the battery was at near end-of-service condition. The device was programmed off (b)(6) 2017. The patient had reported being woken up in the middle of the night, approximately two months ago, by an extreme pain in his left neck, that felt like a "huge punch, like a shock" for approximately one minute. Additional relevant information has not been received to-date. Full revision occurred (b)(6) 2017. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
The explanted devices were reported to have been discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6439639
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« Reply #555 on: May 05, 2019, 01:13:32 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that a patient had an infection at the vns lead site. The patient's lead was removed due to the infection, but no new device was implanted as a result. The patient first began experiencing some pain and swelling at the site previously and it was found that the patient had an abscess at the site, which led to an infection. A review of the device history record showed that the lead had been manufactured and sterilized per manufacturing specifications. The physician indicated he believed the vns device was related to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6412728
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dennis100
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« Reply #556 on: May 05, 2019, 01:14:18 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/11/2016
Event Type  Malfunction   
Event Description
It was reported by a physician that a vns patient was in referral for full revision. Clinic notes from a visit on (b)(6) 2017 provided that high lead impedance was discovered on diagnostics at that visit. The notes also stated that the patient has had a cough and neck pain for a long time. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred (b)(6) 2017. The explanted generator was received for analysis, which is underway, but has not been completed to-date. The explanted lead has not been received by the manufacturer to-date.
 
Event Description
Analysis of the generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the generator to provide programmed output currents was successfully verified. The septum was not cored, eliminating a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal. The diagnostics were as expected. An automated electrical evaluation showed that the generator performed according to functional specifications. The battery measured, 2. 875 volts and shows an ifi=no condition. The downloaded data revealed that 70. 169% of the battery had been consumed. 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=6413672
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dennis100
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« Reply #557 on: May 05, 2019, 01:15:03 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/22/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received from the patient indicating that she was experiencing her lead surfacing which was associated with pain, irritation, a lead pulling sensation, and a perception of continuous stimulation. The patient was referred to a surgeon for a revision. The neurologist's office reported that the patient's feelings of the vns constantly being stimulated may be related to the positioning of the vns wire (it is clearly visible outside of the skin). The lead appeared to be sticking up like a vein in the patient's neck. The surgeon's office reported that the lead did appear superficial and appeared to be extruding but that more diagnostic tests were needed to identify why the patient's lead was surfacing. At the patient's office visit no system diagnostics were performed on the generator. During the conversation with the surgeon's office it was noted that the patient reported experiencing a sensation like there was water constantly in her ears. No patient trauma or manipulation had been reported to the neurologist's office or the surgeon's office. To date no known medical or surgical interventions have been taken. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6415350
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dennis100
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« Reply #558 on: May 05, 2019, 01:18:13 AM »

Model Number 102
Event Date 06/24/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case mgmt. Review of the clinic notes revealed that on (b)(6) 2010, the pt was experiencing pain in their neck and shoulders on and off. The physician decreased the vns pulse width to see if it would help the pt. The physician also reported that on (b)(6) 2011 the pt had seizures at night, but did not try and swipe their magnet. In clinic notes dated (b)(6) 2011, the physician reports that the pt has a history of neck pain. The physician also reported that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. Due to the pt's flare of symptoms, the physician referred the pt for prophylactic battery replacement. In clinic notes dated (b)(6) 2011, the physician provides further info about the pt's history of neck pain, stating that it spreads into the occipital area in keeping with neuralgia. The physician again reports that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. The mfr's consultant later reported that the physician believes the pt's pain was not related to vns. Surgery has not yet been scheduled. Attempts for additional info regarding the pt's seizures have been made to the physician, but no further info has been received to date. When further info is received, it will be reported. A blc performed with the programming history in the mfr's programming history database which revealed negative yrs until eri = yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180923
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dennis100
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« Reply #559 on: May 06, 2019, 05:17:51 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/24/2017
Event Type  Malfunction   
Event Description
It was reported by a company representative that a vns patient had high impedance. The lead impedance at the last appointment in (b)(6) 2016 was reported to be high. Clinic notes were received from a visit on (b)(6) 2017, where the patient experienced a sudden, single, sharp pain in his neck, followed by a rhythmic cough. It was unclear if it was related to vns and the magnet was swiped and the pain stopped but the cough did not stop. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Relevant tests, corrected data: the specific diagnostics and settings values were inadvertently not provided in the initial report.
 
Event Description
Full revision surgery occurred. The explanted devices were reported to have been discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6403816
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dennis100
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« Reply #560 on: May 06, 2019, 05:18:25 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/09/2011
Event Type  Injury   
Event Description
It was reported that the patient's device was explanted due to it being non-functional. The patient's device was programmed off four months prior to explant. The patient's device likely had sufficient battery life through the time of explant. No anomalies were observed in a programming history review. It was later reported that the patient had requested that her device be explanted after experiencing pain and an intolerance of treatment. No further information could be provided since the patient had not seen the surgeon for several years after her explant. The patient's devices were discarded after explant and were unavailable for analysis. No further information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6402213
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dennis100
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« Reply #561 on: May 07, 2019, 07:38:06 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient underwent surgery to explant his lead and generator. The neurologist indicated that the reason for explant was lack of efficacy, the patient said that the vns was uncomfortable and because the patient was unable to tolerate increases in output current. The suspect product was received for product analysis. The generator's device output signal was monitored for 24 hours under a simulated body temperature environment. The device delivered the expected stimulation consistently. No anomalies were found. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the explanted lead. The majority of the lead body and the electrode array were not returned. Continuity checks were performed and no discontinuities were found. No other obvious anomalies were found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6396741
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dennis100
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« Reply #562 on: May 08, 2019, 10:38:19 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported by the physician that the patient had requested to have the vns explanted as it has reached end of service and it was bothering her. It was reported that the patient was experiencing an electric shock in her chest that spreads to her whole left arm and neck randomly. She had also complained of experiencing pain in her chest around her vns generator and neck when yawning. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Further follow up with the physician revealed that the explant would be for the patient's comfort. It was also reported that the generator battery is dead and that the patient's seizure control has not changed since the generator battery has died.
 
Event Description
It was reported that the suspect device was explanted. Return of the suspect device is not expected.
 
Event Description
The explanted generator was received for product analysis. Product analysis verified end of service condition. The device performed according to functional specifications of the current automated post burn test. No anomalies were identified. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr report 3 inadvertently omitted that the lead was received with the generator and was pending completion of product analysis.
 
Event Description
The explanted lead was received and underwent product analysis. Note that since a significant 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 the majority of the lead body was not returned. Beyond typical wear and explant related conditions, no anomalies were identified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374516
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dennis100
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« Reply #563 on: May 08, 2019, 10:38:58 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2017
Event Type  Injury   
Event Description
It was reported that a vns patient is planning to have her device removed as it is causing her discomfort. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up to the treating physician¿s office provided that the device was explanted. It was reported that the explant facility discards explanted devices.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378983
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dennis100
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« Reply #564 on: May 09, 2019, 07:41:04 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that a patient was experiencing an increase in depression symptoms that began nearly a year prior to the report. The patient's depression was above his pre-vns levels. The device was expected to be functional at the time of the increased depression. No additional relevant information has been provided to date.
 
Event Description
The psychiatrist reported that the patient experienced health challenges, namely, painful leg spasms, that contributed to the patient's increased depression. The leg spasms were not attributed to vns therapy. No additional relevant information has been provided to date.
 
Event Description
The patient underwent generator replacement surgery due to low battery. The explanted device has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6513415
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dennis100
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« Reply #565 on: May 09, 2019, 07:42:10 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2017
Event Type  Injury   
Event Description
It was reported that the patient's generator had migrated, and the patient was referred for surgery. It was unknown if trauma or manipulation had occurred that could have caused or contributed to the migration. The patient later reported that the patient was experiencing pain with the migration and was going to have surgery. No surgical intervention has occurred to date.
 
Event Description
Clarification was received that the pain and migration was not related to the previous trauma. The physician believed the cause of the pain and migration was musculoskeletal. The surgery was planned for patient comfort only. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient had generator replacement surgery. No analysis is necessary as the functionality of the device was not related to the reported events.
 
Event Description
As supplemental/adjunctive information, analysis was completed on the generator, and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6515064
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« Reply #566 on: May 09, 2019, 07:43:30 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2017
Event Type  Injury   
Event Description
It was reported that a patient was experiencing pain in the neck area. The patient's device was disabled in response to the pain, but the pain continued. The physician performed x-rays and found no abnormalities, and diagnostics were within the normal limits. The physician mentioned that the patient recently had a soft tissue infection in the same area she was experiencing the pain, and he believed the pain was being caused by the infection. The physician did not believe the infection was related to the vns device. It was later reported that the patient went to the er as she continued to experience pain in her neck. An ultrasound revealed that the patient did have a soft tissue mass under her vns. The patient was referred to neurosurgery. No additional relevant information has been received to date. No surgical intervention has been taken to date.
 
Event Description
A nurse reported that the patient was seen recently at the office, and no surgical intervention had been taken for the patient's pain. More imaging was performed, but a mass was not visualized in the recent images. The treating medical assistant reported that the soft tissue mass was not infected. The physician could not identify a cause of the mass. No additional relevant information has been received to date. No surgical intervention has been taken to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #01 inadvertently did not include information regarding the status of the device.
 
Event Description
The patient's device had been programmed on at a subsequent clinic visit, as the neck pain was not occurring with stimulation. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6513471
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dennis100
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« Reply #567 on: May 10, 2019, 02:05:52 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's fiancé reported that the vns was turned up too high at the generator replacement surgery. It was noted that the patient's quality of life is not good, and at the "higher" output current the patient was feeling dizzy, nauseous, and "felt like having seizures", and she "felt like she is being overmedicated". Further follow up confirmed that the patient's generator output current was reduced as a result of the patient's symptoms, and that the patient's symptoms resolved after the parameter adjustment. The physician noted that the patient was feeling "poorly" due to pain and feeling like they were getting too strong of a stimulation. The physician reported that the patient experienced increased seizures due to being very stressed and very much in pain/discomfort, which stemmed from the vns output current being set too high. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8556724
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« Reply #568 on: May 10, 2019, 02:06:32 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/05/2019
Event Type  Injury   
Event Description
It was reported that the patient was explanted because she was getting shocked even though all output current was off. Programming history was reviewed for the generator. No anomalies were seen. Information was received from a nurse with the neurologist¿s office that patient was explanted as they experienced zapping in their chest and neck. The patient¿s last settings indicate the generator was off. No diagnostic results were available. No other information was available. The device has not been received by livanova 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=8564618
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« Reply #569 on: May 10, 2019, 02:07:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Event Description
The patient was referred for explant due to hoarseness and generator migration. The hoarseness was previously reported in mfr report #1644487-2016-02809. The migration has caused significant pain. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8561603
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