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dennis100
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« Reply #1110 on: November 10, 2018, 03:49:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was hospitalized after being found in a coma. In the hospital it was reported that he was in a bad state and had thrombocytopenia. The patient had reported the day prior to hospitalization that he felt stimulation in his left neck when bending down. The physician in charge of the patient at the hospital was not sure whether the symptoms and current state of the patient could be related to vns. The manufacturer's device history records of the patient's generator was reviewed. The generator passed final quality and functional specifications prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7923538
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dennis100
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« Reply #1111 on: November 17, 2018, 04:47:20 AM »

Model Number 103
Event Date 03/29/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the vns patient's device was hanging out of the wound. It was reported that the patient had recently underwent generator replacement surgery. The patient was referred to surgeon. It was later reported that the patient had an infection that started at the lead site after the patient picked open the incision from generator replacement. It was reported that the patient picking at the incision has caused the generator to extrude. It was reported that the patient had a pustule that traveled up the lead. There appears to be a boil-looking abscess at the neck site. The patient underwent generator explant on (b)(6) 2013 due to the extrusion and infection. The lead was left in place and the surgeon debrided the chest wall and neck and performed cultures. The cultures found (b)(6) at time of explant. The surgeon indicated that the wound will be left open for a few days and will be packed with antibiotic dressing and the patient will be treated with oral antibiotics. A second set of cultures were obtained on (b)(6) 2013 which were negative. It was reported on (b)(6) 2013 that the patient was scheduled for explant of the lead due to infection. The patient was placed on iv vancomycin by infectious disease. The lead was explanted on (b)(6) 2013. Reimplant is planned at a later date.

Event Description
The generator analysis was completed on (b)(4) 2013. The diagnostic testing showed that the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081131
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dennis100
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« Reply #1112 on: November 18, 2018, 09:12:51 AM »

Model Number 304-20
Event Date 02/14/2014
Event Type  Injury   
Event Description
On (b)(6) 2012 additional information was received when it was reported that the wound was opened up by one of the registrars. The tie-down clip had moved and they also cleaned out the wound with antibiotics. When the nurse saw him, it had healed up well. The patient has seen the physician again since then and the scar was oozing a little again. A swab has been taken and dressings were put on it for the moment.

Event Description
On (b)(4) 2013, it was reported that the vns patient was turned on two weeks after implant and then increased every four weeks by 0. 25 ma up to the patient's current settings on (b)(6) 2013. All other parameters remained constant. The patient's settings were noted to be output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma. Diagnostics were last performed on (b)(6) 2013 and were all "ok" with a 1880 ohms lead impedance. There has been no known trauma since implant. It was reported that the patient is having redness and slight swelling at the site of the neck incision which is concerning the patient's parent but not giving the patient any particular discomfort. This was first noticed on (b)(6) 2013. The area was weeping slightly and the patient saw their general practitioner the week prior who prescribed a course of antibiotics which has just been completed. The nurse stated that they can palpate a hard area under the wound which could be a protrusion of a tie-down. The patient is not feeling discomfort and the "hard area" is thought to be the problem. It was later reported that the physician believes the event is due to the presence of the lead, possibly the tie-down. No cultures were taken or planned. Antibiotics were given as a precaution. There have been no changes to diet or medication that are thought to have contributed to this problem.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3072402
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dennis100
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« Reply #1113 on: November 19, 2018, 08:11:31 AM »

Model Number 104
Event Date 03/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient underwent surgery to explant the remaining portion of the lead on (b)(6) 2013.

Event Description
It was reported that the patient's generator site was infected and that the patient was referred to surgery. It was reported that the patient was originally scheduled for "closure" surgery; however, the surgeon decided to do a generator replacement to be safe and that it was being considered to place the new generator on the patient's right chest area. It was reported that the surgeon was uncertain if the infection was due to surgery or the presence of the device. There was no trauma or manipulation that occurred; however, it was reported that the patient may have picked at the incision. Clinic notes dated (b)(6) 2013 indicated that the patient had an open wound on the chest and that the patient's father reported that the wound was still draining and that the neurologist recommends that the vns be moved to the right site to allow abscess on the left to heal. Clinic notes dated (b)(6) 2013 indicated that the chest abscess was excised on (b)(6) 2013 and that the patient's mother reported that the wound was draining yellow with some odor. Further follow-up revealed that the patient underwent explant on (b)(6) 2013. It was reported that the plan is to reimplant a vns system in 5-6 months after the wound heals. Both the generator and lead were returned to device manufacturer for analysis on (b)(4) 2013. Product analysis is underway; however, had not yet been completed to date. The patient's father reported on (b)(6) 2013 that he was in the hospital with the patient due to the infection. The father reported that he was under the impression that both generator and lead were explanted; however, the patient underwent a ct scan which showed that a portion of the lead was still implanted. The father reported that the patient's infection has spread to the patient's neck where the lead portion is still implanted. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Event description, corrected data:the mfr. Report 03 inadvertently reported that the surgery was to replace the remaing portion of the lead.

Event Description
It was reported that the patient underwent surgery to replace the remaining portion of the lead on (b)(6) 2013.

Event Description
Further follow-up revealed that the patient was explanted due to possible infection at the site of incision. Reimplant is planned when the patient has healed. The returned product form indicates the generator and lead were returned; however, the reason was not marked. The op note revealed that the patient has an open wound of the chest and is for repair of chest wound from vagal nerve stimulation hematoma and possible skin flap with removal of vagal nerve stimulation. The generator and lead were received into product analysis on (b)(6) 2013. Analysis of the generator indicated that the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead will be reported in mfr report # 1644487-2013-01235.

Event Description
Further follow-up revealed that the physician did not believe that the vns system was related to the infection. Cultures were taken at the hospital; however, the results were not known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3053763
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dennis100
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« Reply #1114 on: November 20, 2018, 07:48:06 AM »

Model Number 302-20
Event Date 03/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. It was reported that system diagnostics following the replacement were without error. It was reported that the generator was replaced prophylactically and the lead was replaced due to pain. The implant card was received which confirmed that both generator and lead were replaced on (b)(6) 2013. The implant card listed prophylactic replacement and that lead impedance was ok. Both generator and lead were received by device manufacturer on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. There were abraded openings found on the outer silicone tubing which most likely provided a leakage path for what appeared to be remnants of dried body fluids found in inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. Except for the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. With the exception of the abraded tubing openings, no obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity check of the returned lead portions were performed with no discontinuities identified. Based on the finding in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the events. Since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the generator is underway, but has not been completed to date.

Event Description
It was reported that the patient's device has been causing her pain. The notes revealed that the patient grabs at the lead during a seizure. The physician noted that there is a visual change in the appearance in the lead in her neck and that surgery is recommended. The physician reported that he believes the strain in the lead was caused by the patient grabbing at the lead during a seizure. Diagnostic tests were performed and were within normal limits. It was reported that the lead is uncomfortable for the patient. The physician reported that the pain is not due to vns and that it appears to have occurred due to patient manipulation. No causal or contributory medication changes preceded the onset of the events. The physician reported that the surgery was done to preclude a serious injury and for patient comfort. It was reported that the lead strain is around the patient's clavicle and that it is unknown if the surgeon used non-absorbable suture to secure the generator to the fascia during implantation per the neurologist. The physician indicated that the lead strain does not appear to be due to initial placement. The patient has not undergone any physiological changes that may have contributed to the lead strain. The patient has been referred for surgery; however, surgery has not occurred to date.

Event Description
Analysis of the generator was completed on (b)(4) 2013. Although the reported allegation of pain cannot be evaluated in the pa laboratory settings, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In additional, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data found that 8. 059% 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=3043863
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dennis100
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« Reply #1115 on: November 24, 2018, 04:46:22 AM »

Model Number 103
Event Date 04/04/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that he was experiencing pain. Clinic notes dated (b)(6) 2013 were later received which state that the patient's seizures have never been controlled with his longest seizure free interval being two days. It was stated that the patient has several seizures per day, and that the vns worked well after it was implanted on (b)(6) 2012, until the patient had a lumber fusion in (b)(6). The notes state that as far as the patient is aware, the device was not turned off during the surgery. The patient states that his "vns is malfunctioning" as it cuts off his breath and he can feel it ¿run up (his) neck¿. It was stated that ¿when it fires, he feels like he has a frog in his throat¿. Additionally, it was stated that "it was 10 am before the vns ever went off" that morning per the patient. The notes state that when the device was placed, it helped reduce the seizure frequency from 15 - 20 per week to 10 per week as an estimate. The patient had 4 seizures the day before and two seizures so far that day per the notes. According to the clinic notes, the patient was involved in a car accident on (b)(6). The patient already had low back pain, but now there is a lot of pressure in his low back that was not there before and his back is sore. The patient has some joint pain and stiffness, and the notes state that he has a history of syncope additionally, the clinic notes state that the patient has a history of syncope and his generator will be replaced. The patient was prescribed keppra due to an increase in seizure frequency. The assessment/ plan portion of the clinic notes state "vagal nerve stimulator with malfunctioning generator". The patient has been referred to get the generator replaced. Attempts have been made for additional information; however, they have been unsuccessful. The patient was scheduled for surgery on (b)(6) 2013; however, he did not show up for this surgery. No new surgery date has been scheduled. No additional information has been provided.

Event Description
On (b)(4) 2013 it was reported that the patient was scheduled for surgery the next day. The surgery took place on (b)(6) 2013. The explanted generator has not been returned for product analysis to date. Also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable.

Event Description
An implant card was received indicating the explant was due to painful and erratic stimulation. The generator was replaced and lead impedance was ok with impedance value 3108 ohms.

Event Description
It was reported that the explanting facility does not return explanted products.

Manufacturer Narrative
Inadvertently did not include the following on the initial report, "also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118959
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dennis100
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« Reply #1116 on: November 26, 2018, 04:41:57 AM »

Model Number 102
Event Date 04/03/2013
Event Type  Injury   
Manufacturer Narrative
Initial report inadvertently listed wrong event date.

Event Description
It was reported that the patient's seizures have worsened and that the patient's symptoms such as control of head/neck movement, and drooling have been worsening. The patient underwent surgery on (b)(6) 2013 where the vns generator was replaced. Attempts to return the product to the manufacturer for product analysis are underway. Attempts to contact the physician regarding the events have been unsuccessful to date. A battery life calculation was performed using the available programming history and resulted in 3. 41 years until end of service.

Event Description
New information was received from the physician¿s office stating that the increased seizures were noted on (b)(6) 2013, and the reason of the increased seizures was that the vns generator needed to be replaced. On (b)(6) 2013 the patient¿s seizures became better and the seizures were back to normal. The patient¿s muscle weakness and the drooling were not reported to the patient¿s physician. The explanted vns generator will not be returned to the manufacturer due to the site¿s policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3097519
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dennis100
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« Reply #1117 on: December 07, 2018, 09:30:23 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient had swelling in the neck area where the electrodes are placed. It was also reported that the patient was experiencing an increase in seizures and that the patient developed a chest and respiratory infection which caused some swelling. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8088951
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dennis100
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« Reply #1118 on: December 07, 2018, 09:31:06 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8071032
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dennis100
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« Reply #1119 on: December 07, 2018, 09:31:44 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/30/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing side effects such as voice loss/ alterations, tightening of the neck muscles, the patient¿s jaw moving more, and headaches. The patient wished to have the device removed and was referred for surgery. No known surgical intervention has occurred 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=8104539
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« Reply #1120 on: December 07, 2018, 09:32:30 AM »

Model Number 304-20
Device Problem Fracture
Event Date 10/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads. X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working. Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018. Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects. Diagnostics from this visit were indicated to be abnormal because the lead impedance is high. The doctor decreased the pulse width, and it was stated that this was much better tolerated. The physician stated that the cause of the burning paint the patient is experiencing is unknown. Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time. Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time. X-rays were provided and reviewed by the manufacturer. Chest x-rays were not provided and therefore the generator was unable to be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. No sharp angles or gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s painful stimulation could not be determined based on the images provided. Note that incomplete pin insertion and the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8088687
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dennis100
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« Reply #1121 on: December 08, 2018, 02:02:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury   
Event Description
The physician's assistant (pa) reported that the patient presented with left neck pain so pain injections were attempted, which did not resolve the issue. The patient was then sent for x-rays. Per the x-rays the pa believes the generator migrated due to potential chest compressions at an er visit and the er visit was unrelated to vns. It is not "know" when the patient was in the er. The pa believed the migration caused the neck pain due to the lead tightening. The patient was referred for surgery to suture the generator higher. The pa stated the diagnostics were normal. X-ray images were assessed by the manufacturer as well. Based on the images provided, the generator was placed normally in the left chest. Due to the poor quality of the image, nothing further could be assessed concerning the generator. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. Due to the poor quality of the image, nothing further could be assessed concerning the lead. Based on the images provided, there is no obvious cause for the reported pain and generator migration. Additional information from the pa reported that the surgery will be for patient comfort and to preclude serious injury. The settings were initially turned off after the pain to see if there would be a reduction in pain, which there was not. The settings were later turned back on to lower settings. The physician later decided to replace the generator because it was already 2 years old instead of just performing a revision. No additional relevant information has been received to date.

Manufacturer Narrative
"device evaluated by manufacturer": device evaluation is not necessary as the reported events are not related to device functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8034826
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« Reply #1122 on: December 08, 2018, 02:02:38 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/12/2017
Event Type  Injury   
Event Description
It was reported that patient had a surgical procedure to drain a cyst located on the left side of patient's neck at the lead incision site. Surgeon believed that the cyst was related to the presence of a lead tie-down. The surgeon indicated that the draining procedure was performed to preclude serious injury. Patient's cyst had serious fluid. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8040020
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« Reply #1123 on: December 10, 2018, 03:20:46 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 02/01/2018
Event Type  Malfunction   
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description
It was reported by the patient that approximately 9 months ago they woke up and saw that they had developed a blister on their collarbone and could visually see the "copper wrapped vagus nerve directly below it. " by "copper wrapped vagus nerve", it was presumed that meant the lead product. The patient reported that, since this event, he had too many seizures. The patient indicated that the wire (presumably at the point of the blister) appeared visibly smaller than the rest of the wires. The patient reported that the electricity seemed to have problems going through the narrower passage and that the electricity did not reach its intended destination. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8095658
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« Reply #1124 on: December 13, 2018, 04:43:40 AM »

Model Number 300-20
Device Problem Patient-Device Incompatibility
Event Date 08/14/2013
Event Type  Injury   
Event Description
Additional information was received indicating that the cause of the left neck scarring was continued fibrosis that was observed previously in this patient. The deformed/dimpled neck scar was removed during the attempted generator repositioning surgery as part of a lead removal procedure. It was indicated that the intervention was for patient comfort and cosmetics and not to preclude a serious injury. The attempted generator repositioning surgery is reported in mfr. Report #1644487-2015-05251.

Event Description
It was reported that the patient was seen due to a lump at the electrode site that was sensitive, but not painful. There was no fever or pus, but the surgeon ordered x-rays and ct scans to determine what the issue may be. The patient was scheduled for surgery to lance the lump. The surgeon was not sure what the issue was and the cause was unclear as the patient has been implanted for some time. Additional information was received on (b)(6) 2013, during the exploratory surgery. The physician was able to perform interrogation and run diagnostics, which showed the device was within normal limits, during surgery. Per the surgeon, there was a lump of fibrous tissue around the electrodes, which he referred to as a "taboma". The surgeon indicated that he removed the tissue and performed interrogation and diagnostics again. The surgeon noticed that the outer tubing of the lead was cracked; however, the inner tubing was fine. He stated that he would not be performing a lead revision. Review of the lead device history records confirmed all quality tests were passed prior to distribution after being reworked. Follow up with the physician found that the fibrous tissue was likely related to a foreign body response. The notes indicate that there were fibrous, acute and chronic inflammation of focal giant cell reaction. The initial prognosis was "painful mass in the neck around the lead" so the surgery was taken due to the pain. Pain was not related to stimulation. The site did not indicate if the surgery was to preclude a serious injury or not. The patient's outcome is good, and there was no external trauma or manipulation of the electrode area that is believed to have caused the pain/lump. No additional information was provided.

Manufacturer Narrative

Event Description
The explanting facility indicated that the explanted generator and lead portion were discarded and are therefore unable to be returned for product analysis.

Manufacturer Narrative

Event Description
Additional information was received stating that the patient had a neck scar that was deformed and dimpled without any active inflammation in his neck incision the patient's mother asked the surgeon to revise the neck scar during a planned generator repositioning surgery. The repositioning surgery was attempted but it is unknown if the neck scar was revised. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3344698
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« Reply #1125 on: December 14, 2018, 06:47:44 AM »

Model Number 102
Event Date 08/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing spasms of the sternocleidomastoid muscle with device stimulation which was causing the patient to experience head deviations which resulted in airway obstruction. It was reported that the patient used the magnet to disable the device and that the spasms resolved for about 10 minutes, but then started back up. It was reported that it is unclear if the magnet moved off the device because the physician was not present at this time. The patient was seen by the physician at the hospital and the device was programmed off. The physician indicated that it was unclear whether or not the patient's accessory nerve was being stimulated to cause this or whether there is current leakage to the muscle. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3329805
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« Reply #1126 on: December 15, 2018, 02:30:23 AM »

Model Number 302-20
Event Date 09/27/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Preoperative device diagnostic testing for scheduled generator replacement surgery for end of service resulted in high impedance (dc dc code 7). The patient reported that he had experienced some neck "spasms"; several months prior and the physician turn the device settings down which seemed to alleviate symptoms. The surgeon programmed the generator off and cancelled the surgery. The patient will be rescheduled for generator and lead replacement. An implant card was received indicated that the patient underwent generator and lead replacement on (b)(6) 2013. The explanted devices have not been received for analysis to date. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3430851
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« Reply #1127 on: December 18, 2018, 12:53:28 PM »

Model Number 103
Event Date 07/19/2012
Event Type  Injury   
Event Description
The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

Event Description
On (b)(6) 2015 it was reported that the patient¿s generator and a lead portion were explanted on (b)(6) 2013. The hospital reported that they do not return explanted devices, therefore the explanted products could not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406219
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« Reply #1128 on: January 03, 2019, 08:47:42 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. During the surgery, the surgeon saw fluid in the lead so completed a lead revision during the prophylactic generator replacement surgery. Attempts for product return have been unsuccessful to date. The products have not been received by the manufacturer. Previously, it was reported in (b)(6) 2013 that the patient was experiencing painful stimulation in the chest and neck areas. The painful stimulation resolved when the vns was disabled with the vns magnet. X-rays dated (b)(6) 2013 were later received and reviewed by the manufacturer. There was no evidence of lead twisting, or sharp angles suggestive of a lead break. It is noted the lead appears to be ¿stretched¿ across the chest, as if it may be pulled if the head was turned to the right. No obvious lead anomalies were seen. There was no known trauma or manipulation. The painful stimulation was reported to be positional and was thought to have resolved prior to referral for surgery, and the cause of the painful stimulation was unclear to the physician.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639409
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« Reply #1129 on: January 04, 2019, 09:34:09 AM »

Model Number 1000
Device Problem High impedance
Event Date 11/13/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's device showed high impedance. X-rays had been performed and there were no observed issues with the lead or pin insertion. Per x-ray review by medical professional, there were no obvious break or crack. The patient also reported some neck pain with stimulation and the vns device was programmed off due to the high impedance. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8140647
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« Reply #1130 on: January 04, 2019, 09:34:55 AM »

Model Number 302-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 11/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's neurologist reported that they interrogated the device because the patient was having some discomfort. Upon interrogation, high impedance was observed and the neurologist thought there could be a disconnection along the electrode and stated that ¿the device cannot transmit the proper stimulation to the patient¿s vagal nerve. " additional information was received that the patient has been referred for a revision. It was stated that the patient's discomfort is occurring in the neck area and is associated with stimulation. There was no trauma reported to that area, and the physician does not have an assessment of the cause of the patient's discomfort. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8146223
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« Reply #1131 on: January 04, 2019, 09:37:57 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the physician that their patient's wires are painful under their neck and requested to have their generator removed as the therapy was no longer required. No relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8138352
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« Reply #1132 on: January 04, 2019, 09:38:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported by an emergency room physician that the patient's generator was continuously stimulating for several hours. It was reported that the physician attempted to disable the device using the vns magnet as well as a pacemaker magnet, but that the device continued to stimulate and the patient was admitted to the hospital. A company representative reported that the patient experienced neck pain and hoarseness that persisted despite the device being programmed off. The patient's device diagnostics were within normal limits. It was reported that the patient had recently had a seizure and had fallen and either hit her head or neck. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8178588
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« Reply #1133 on: January 04, 2019, 09:39:01 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8127177
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« Reply #1134 on: January 04, 2019, 09:39:50 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had exploratory surgery due to a mass on the left side of the neck at the electrode site. The attending company representative indicated that the surgeon initially thought that the mass was related to the vns lead; the company representative thought that after the surgery the doctor did not think that the mass was related to the vns, but was not sure. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8122199
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« Reply #1135 on: January 05, 2019, 03:00:20 AM »

Model Number 103
Device Problem Fracture
Event Date 11/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient's device was showing high impedance. The patient was sent for x-rays of her neck and chest. The device settings were lowered and it was stated that the device was not bothering her after that; so the device was not turned off during the visit. Further updates were received noting additional diagnostics performed on the patient's device. Two diagnostics were performed confirming the high impedance. It was stated that the device was intended to be turned off due to painful stimulation in the neck. The patient had also reported that her neck locks up at times to the left side. After device settings were adjusted, the patient was concerned that fully disabling her device would lead to increased seizures, so the settings were kept at the lower output. The patient reported no longer feeling pain with the new settings. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141647
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« Reply #1136 on: January 05, 2019, 03:00:57 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 10/11/2018
Event Type  Malfunction   
Event Description
The patient was reported to have pain in their neck. The physician believes that there was curling of the lead and that the electrode is off of the nerve. The physician believed that the pain was due to the electrode coming off of the nerve. The pain was described as intense pain when laying on their left side or leaning their head to the left, and that it would resolve when the patient¿s head was turned to the right. Per an xray report received, there was some change in the lead configuration, but it was not specified what was different. No discontinuities were seen. X-rays were reviewed. The x-rays did not capture the generator and no assessment can be made on the position, lead wires, or feed through wires. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Based on the images provided, there is no obvious confirmation of the electrode coming off of the nerve. The device was interrogated and diagnostics were within normal limits. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8133204
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« Reply #1137 on: January 05, 2019, 03:01:25 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2016
Event Type  Injury   
Event Description
Patient reported to her that she is having extreme pain in the neck with stimulation that causes her to "tear-up" in pain. Due to the pain, the patient wants the vns explanted. Follow-up by the tc revealed that the patient was seen and the output current was turned down to previous settings and the discomfort was resolved. System diagnostics were performed and were within normal parameters. Patient again reported pain and is undergoing explant due to pain and need for mri. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8140664
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« Reply #1138 on: January 07, 2019, 03:28:05 AM »

Model Number 304-20
Event Date 01/05/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device had high lead impedance. Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014. The vns device was programmed off to 0ma following the observation of the high lead impedance. The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward. The physician will not provide any additional information. Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block. Feed thru wires appear intact. Lead wires appear intact at the connector pins. The lead coils behind the generator before routing upward to the left neck. The portion of lead behind the generator cannot be assessed. The electrodes appear aligned. A strain relief bend is present and appears to be per labeling. No strain relief loop is present. Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead. No other information has been provided.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response. She indicated that depending on the slant of her head, she felt that the vns was more intense. In addition, the patient reported brain freezes when she had to take her medications with cold water. She believed it was possible that the vns was going off at that time and causing it. The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough. She said that she ended up getting pneumonia. The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance. The programming database and internal data of the patient's generator was reviewed. Per the data, it was found that the patient's generator was re-enabled. Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3622212
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« Reply #1139 on: January 08, 2019, 07:52:09 AM »

Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3701858
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