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dennis100
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« Reply #1050 on: June 10, 2018, 12:52:57 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's neurologist provided clinic notes for surgery referral indicating that the patient has some gagging with vns swipe, as well as increased prominence of lead in left side of neck, with some tenderness to palpation. The patient still feels vns stimulation. The lead was very superficial with a sharp edge protruding through but not piercing the skin. The patient has neck pain and it is a concern that there is migration of the lead laterally, as well as migration of the vns in the chest. It was questioned if the patient has encountered a loss of efficacy both with normal output current stimulation and the magnet swipe as the patient had experienced an increase in seizures. The neurologist followed up with an ent surgeon for an evaluation to assess the leads. Additional information was received from the neurologist stating that the cause of the lead protrusion, migration, dysphagia, increased seizures, loss of efficacy, and pain in the left neck was unknown. The patient was experiencing an increase in seizures that was below pre-vns levels. There were no factors such as trauma or manipulation that could have contributed to the events, and lead and generator migration as well as loss of efficacy were the contributing factors for the patient¿s surgery referral. The patient's gagging, protrusion and tenderness in the left neck were not contributing factors for the patient's surgery referral. The generator¿s most recent battery status was stated to not be at end of life. No other 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=7490466

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dennis100
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« Reply #1051 on: June 16, 2018, 01:36:12 AM »

Model Number 302-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient was experiencing painful stimulation in the lead area after having a fall while playing football. System diagnostics showed everything working within normal limits. X-rays were done and sent to manufacturer for further review. No obvious anomalies were observed that could be contributing to the report of painful stimulation. Patient is not experiencing pain with every stimulation, but it occurs at certain positions. The physician believes that the lead tubing was compromised during the tackle which is possibly causing a passage for the leakage current to the body. Patient underwent a lead replacement surgery. Patient continued to have painful stimulation at the neck region after surgery but in a few days, the event disappeared. Explanted lead was returned to manufacturer for analysis. Analysis is currently pending on the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1689569

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dennis100
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« Reply #1052 on: July 06, 2018, 10:17:15 AM »

Model Number 304-20
Device Problem Mechanical issue
Event Date 06/26/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a full revision. It was reported that since the time of the patient¿s battery replacement in (b)(6) 2017, the patient has complained of intermittent shocking pain that travels from his armpit area up to his lateral left neck and only occurs when the vns is on. The device was turned off and the events stopped. X-rays were stated to show nothing. The patient underwent a full replacement. The surgeon state that the lead insulation near the generator was no longer present, causing the wires to be exposed. This was the area the patient was feeling the shocking sensations. System diagnostics were performed before surgery and impedance was ok. The generator was on prior to the surgery staring. It was stated he was on rapid cycling according to the surgeon¿s notes. However it was stated he was in patient for an emu stay at some point in the last 24 hours and his settings were changed. The explanted generator and lead were received for analysis. Analysis is underway but has not been completed to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650646
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dennis100
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« Reply #1053 on: July 06, 2018, 10:17:45 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 05/27/2018
Event Type  Injury   
Event Description
A patient began experiencing painful stimulation, prompting her to go to the er. The patient's device was programmed off due to the painful stimulation, and the pain resolved. The patient's device was then programmed on to low settings, but the patient began experiencing severe pain again in the neck and ear. Diagnostics were performed and returned results within the normal limits. The patient's device was programmed off again and referred the patient for surgery. A company representative reported that x-rays were taken of the patient's neck, and the physician did not identify any issues with the visible part of the vns. X-rays have not been evaluated by the manufacturer to date. The patient attended a surgical consult. During the appointment, the surgeon programmed the vns back on, and the patient did not exhibit symptoms of painful stimulation during the appointment. Per the patient, she did not experience any trauma to the device preceding the painful stimulation, but the patient reported that her large dogs jumped on her chest frequently near her vns implant. 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=7627365
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dennis100
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« Reply #1054 on: July 06, 2018, 10:18:28 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a physician that a vns patient¿s device was still firing even though the magnet was reportedly used to disable the device. The magnet was placed over the scar on the patient's chest, but the generator could not be felt. The physician reported that he could still see the device firing, which was determined by the patient clenching her teeth. The patient had multiple seizures during this time, which were attributed to the pain caused by the stimulation. It was reported that the seizures got worse and more frequent when the magnet was placed over the generator and that the patient had a neck muscle spasm during stimulations. The patient's device was communicated with the next day, which showed that the device was delivering therapy properly and that there had been no magnet activations during the times that the physician and patient stated that the magnet was used. The magnet was taped over the generator, and then the magnet activation was recorded properly. The physician reported that the generator was placed deep in the patient but could still be palpated, which could have caused the magnet to not activate. Follow-up was then received the next day reporting that, even with the magnet taped in place, the patient had neck and face spasms and tremors in the patient¿s cheeks during vns stimulation. Immediately following the symptoms that lasted up to 20 seconds, the patient went into a tonic seizure lasting 20-40 seconds. The patient's device was then programmed off. The patient was then referred for replacement of the device. Further follow-up indicated that the increase in seizures was not worse than before vns, but the device had been off for a week and the patient's seizures were back to one a day. The increase in seizures was stated not to be caused by vns therapy. The patient felt like the magnet didn't inhibit stimulation. The muscle spams, painful stimulation and increase in seizures resolved after the device was disabled, but the patient was still experiencing a subdermal burning sensation around the generator site. The patient had generator replacement surgery due to the painful stimulation. Diagnostics were within normal limits prior to surgery, and the surgeon found no visible anomalies with the devices prior to explant. The generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594908
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dennis100
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« Reply #1055 on: July 06, 2018, 10:19:04 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 11/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient is experiencing muscle spasms with vns stimulation. When the device stimulates, patient's muscle by the neck twitches. All of the diagnostics were within normal limits. Patient underwent parathyroid surgery and since then, the patient has had bulging of the muscle over the left side of his neck with vns stimulation. Since reducing the output current , the bulging was reported to be tolerable. Patient underwent lead revision surgery due to painful stimulation in the muscle. The explanted lead was received. Analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7574456
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dennis100
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« Reply #1056 on: July 06, 2018, 10:19:36 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient was experiencing pain in the left neck up to the ear with vns stimulation that was described as a burning sensation. The patient has concurrent ear problems that are being treated by the pcp, but the patient noted this burning as independent of the ear problems. It was also noted that the patient's generator had migrated, which created tension on the vns lead, resulting in protrusion, a lead pulling sensation, and discomfort. The patient was referred for vns replacement surgery. Follow up with the physician's office revealed that the intervention was for both the patient's comfort and to preclude serious injury. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572226
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dennis100
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« Reply #1057 on: July 07, 2018, 04:32:20 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received that the patient was experiencing pain was experiencing pain in the neck that was reportedly constant and worsened with stimulation. The device's settings were lowered due to the pain and the patient was referred for pain management. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567558
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dennis100
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« Reply #1058 on: July 07, 2018, 04:32:55 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798
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dennis100
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« Reply #1059 on: July 08, 2018, 02:04:57 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 05/15/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing some complications from her vns device and was referred for evaluation by the surgeon. The patient had acute spasmatic pain in the left neck and coughing lasting seconds whenever her magnet was swiped. However, the patient also experienced this 6-8 times per day spontaneously. The physician stated that there was no abnormality with the lead and that he suspected potential glossopharyngeal neuralgia. The physician prescribed gabapentin for the left neck paroxysmal pain. No surgery 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=7596790
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dennis100
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« Reply #1060 on: July 09, 2018, 12:53:22 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 04/06/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
Report received that a patient developed a chest wound that appeared dehisced. Additionally, the patient's neck appeared red and swollen. The patient had been implanted with a new lead and generator only about a month before these issues were seen. The surgeon reportedly admitted the patient to perform a partial explant and washout. It was later confirmed that the generator and part of the lead were explanted. Further information was received that the chest wound was caused by the patient picking at the chest incision which caused it to become infected. It reportedly developed into (b)(6). The neck redness and swelling was reportedly indicative of an infection, too. A review of the device history records for the lead and generator indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7592560
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dennis100
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« Reply #1061 on: July 10, 2018, 07:22:40 AM »

Model Number 103
Event Date 06/24/2010
Event Type  Injury   
Event Description
It was initially reported by a company rep that a vns pt was to undergo revision surgery as her neck incision had pus coming out and the surgeon was able to see the leads. The pt was implanted in (b)(6) 2010 and the surgeon plans to implant the leads deeper. Additional info was received from the surgeon's office indicating the pt was picking at the chest wound which contributed to the pus and lead protrusion. Moreover, no infection was found in the chest area at the time of revision. A post-op note was received which indicated the pt presented to the office with some mild erythema around the lateral aspect of her generator wound. Pt stated that she had a seat belt that had been irritating it for the past few weeks. The pre-operative and post-operative diagnosis from the surgeon indicated superficial wound breakdown of vns generator pocket. The surgeon pepped the chest and neck area for surgery. The chest area was opened and gross analysis of the area revealed no evidence of infection according to the note. The generator was then placed once again inside the pt after unraveling the lead and impedances were checked indicating normal impedance. Antibiotics were given and the area was irrigated and closed. Good faith attempts to obtain product info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1839556
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dennis100
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« Reply #1062 on: July 17, 2018, 03:56:41 AM »

Model Number 303-20
Event Date 08/01/2012
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
The patient's mother reported that the electrode was extruding through the patient's neck. It was reported that the patient was prescribed antibiotics and the patient was scheduled for revision surgery. Clinic notes date (b)(6) 2013 note that the patient forms keloids and has experienced chronic crusting from the site. It was noted that the patient was seen with yellowish discharge from the wound site. It was noted that the wound was not erythematous or swollen. The notes indicate that the wound has a keloid and induration, but is not red. A small area of crusting with no exudate was noted. The patient was sent home with bactrim. Operation notes dated (b)(6) 2012 note that the surgical findings were exposed vagal nerve stimulation tie-down tabs with surrounding inflamed skin and extensive subcutaneous granulation tissue surrounding the deeper tie-down tabs and superficial connecting lead, but no evidence of pus. Clinic notes dated (b)(6) 2013 note that the wound showed a chronic ulceration with exposed connecting lead through the wound. There was no drainage or evidence of infection, although there has been crusting and scabbing along the wound. The patient denies picking at the wound. The patient was seen at the emergency department on (b)(6) 2013 after the wound opened up and was sent home with bactrim. The patient denies any trauma to the area. There is no evidence of drainage. The wound is non erythematous and non tender. The notes indicate that the surgeon is going to try one more time to treat the device in situ with antibiotics solution as well as iv antibiotics. It was noted that if it fails explant will be performed. Operative notes dated (b)(6) 2013 note that the vagal nerve stimulator electrode connecting lead in the anterior cervical region is exposed and there is surrounding inflamed skin and subcutaneous granulation tissue, but no evidence of pus. The wound was debrided and a complex closure was performed. Excision of devitalized granulomatous skin was performed. The notes indicate that the mother reported that the scab had fallen off and the lead wire was exposed; therefore treatment in situ was performed. Multiple antibiotic solutions including vancomycin irrigation, half-strength hydrogen peroxide, lactated ringer's bacitracin solution and also vancomycin crystals were attempted to treat the infection and prevent recurrence. The notes indicate that it is almost as if the patient is rejecting the device. On (b)(6) 2013 it was reported that the patient came in with exposed vns generator and is getting it replaced emergently. The following day it was reported that the surgeon debrided the pocket and that there were no issues with the lead. The surgeon placed prophylactic antibiotics in the pocket and lead area. A new generator pocket was formed and the new generator was placed under the muscle to avoid patient manipulation. The patient was given a picc line for antibiotic. It was reported that if the infection persists the patient may be explanted due to body rejection. The patient's mother believes that the patient's bra underwire may have contributed to the issues initially. Operative notes dated (b)(6) 2013 note that the left anterior chest pocket is infection in the generator area due to skin breakdown and protruding generator. It was noted that the generator pocket had accumulation of purulent fluid likely related to a pinhole sized are of skin breakdown most likely related to rubbing of this area from the patient's underwire bra. It was noted that skin cultures were positive for staphylococcus aureus. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. 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.
 
Event Description
Reporter indicated a patient developed an infection at the vns lead site in the neck. The patient was given antibiotics. Exploratory surgery of the infection site was planned for (b)(6) 2012, but it is not known if this occurred. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had debridement surgery with washout performed on (b)(6) 2012. The two lead tie-downs were removed, as the tie-downs were felt to possibly be causing an allergic reaction which is believed to have caused the infection. The tie-down areas were purulent and irritated. The lead body (not electrodes) was repositioned in a different area away from the infected area. The vns was left programmed on. The patient had no known trauma, and the patient is healing well. Wound cultures were performed which grew out (b)(6) bacteria.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2768901
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dennis100
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« Reply #1063 on: July 31, 2018, 03:43:53 AM »

Event Date 09/15/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected.
 
Event Description
It was initially reported by the surgeon that he was replacing the pt's lead due to high lead impedance reported. Later, the surgeon's office indicated that the mother had reported to the neurologist that the pt was experiencing some pain and swallowing difficulties when the pt turned his neck to the left. The pt was also reporting an increase in seizures at that time. Diagnostics were performed, which showed high lead impedance, so it was at this time, the pt was referred to the surgeon. The pt's mother had indicated that the pt was wrestling with a friend, but it was unclear if this was the specific cause for the high lead impedance. The pt then saw the surgeon on (b)(6) 2010 who confirmed the high lead impedance, but no specific dcdc-value was noted. The explanted lead portions were not returned to the mfr for analysis. The explanted pulse generator was returned, which 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. Programming history reviewed from mfr's programming history database which showed last known diagnostics performed on (b)(6) 2008, which were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898610
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dennis100
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« Reply #1064 on: August 05, 2018, 02:12:27 AM »

Model Number 302-20
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so, her treating physician will determine when vns will be programmed on. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date. Mfr. Report #1644487-2010-02763 was submitted to report on the event of migration of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919375
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dennis100
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« Reply #1065 on: August 10, 2018, 03:43:24 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/19/2018
Event Type  Injury   
Event Description
It was reported by the physician that the patient was experiencing painful stimulation in the neck where the electrodes were located. The patient's settings were subsequently turned down and the patient was referred for a full revision surgery. Diagnostics were not performed at the patient's appointment. The patient's device was subsequently disabled later in the day. It was later reported that the patient was also having erratic stimulation. No additional relevant information has been received to date. No surgical intervention has been known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7721758
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dennis100
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« Reply #1066 on: August 10, 2018, 03:43:56 AM »

Model Number 304-20
Device Problem Fracture
Event Date 08/16/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes were received indicating the vagus nerve stimulator is hurting the patient with a "shocking" sensation up into her neck. When it is checked, it shows normal impedance but low battery life. The patient was referred for surgery. Replacement surgery occurred on (b)(6) 2018, and during the surgery a lead fracture was found in two places and the lead was replaced as well. The explanted devices were received 06/19/2018. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7712324
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« Reply #1067 on: August 10, 2018, 03:44:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2018
Event Type  Injury   
Event Description
Report received that a patient received a brain mri. During the mri, the patient experienced a tugging or pulling sensation" at the neck incision site. The feeling reportedly occurred in tandem with the sound of the mri machine. However, there was reportedly no burning or pain at the generator site. The mri was aborted due to this event. It was confirmed that all three outputs were disabled prior to the mri. When the patient returned to the clinic to have the vns re-enabled, she reported that the neck incision site was still sore. The vns was re-enabled without any issues. Further information was received that the vns was tested prior to and after the mri. Impedance values were normal on both tests. The patient was also reportedly "fine" after following up a couple of weeks later,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7660283
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dennis100
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« Reply #1068 on: August 10, 2018, 03:44:55 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600
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« Reply #1069 on: August 11, 2018, 01:13:05 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has neck swelling and that the patient had a recent placement of the vns on the left. The patient also has sensation of throat tightening. The patient was assessed left vocal cord paralysis was identified and abnormal asymmetric thickening of the left aryepiglottic fold which lies cephalad of the paralyzed left vocal cord. There was also a 13 mm solid nodule at the inferior pole of the left thyroid lobe. The patient¿s device has not been programmed on yet. Information was received from the patient that she can barely talk or breathe. The likely cause of the paralysis was from the surgical procedure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7678836
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« Reply #1070 on: August 11, 2018, 01:13:31 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Event Description
Clinic notes from were received providing the patient feels there may be something wrong with the vns wires. The notes clarified that when she yawns she feels like something is stabbing her in the throat, at her left neck. She states it has been occurring over the last year. There are no problems during stimulation. She is not sure if she has moved the wire during a seizure. She was referred to surgery for repositioning or revision of the lead wire. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686990
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« Reply #1071 on: August 11, 2018, 01:14:01 AM »

Model Number 304-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 06/25/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a lead revision due to a lead fracture. It was later reported that the lead revision was also due to painful stimulation in the neck area. The lead was replaced. The explanted device has not been received for analysis 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=7707636
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dennis100
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« Reply #1072 on: August 11, 2018, 01:14:29 AM »

Model Number 304-UNK
Device Problems High impedance; Therapy Delivered to Incorrect Body Area
Event Date 06/20/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the er because she was having neck pain near her vns electrodes. Diagnostics were performed, and high impedance was detected. As a result, the generator was programmed off. The patient underwent replacement surgery the next day. The impedance resolved after the generator was replaced, so the lead was not replaced. Generator diagnostics and pin reinsertion weren't performed. After surgery the patient's new generator was programmed on and the patient was fine. A few days later, the patient was admitted due to pain in the neck and ear. Therefore, her device was programmed off. Diagnostics were within normal limits, and no impedance warning messages were observed. The patient was discharged but still experiencing pain in the neck and ear. The neurologist and neurosurgeon didn't think it was related because the device was off. No further 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=7688213
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dennis100
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« Reply #1073 on: August 11, 2018, 01:14:55 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2018
Event Type  Injury   
Event Description
It was reported that the patient has complained of constant stimulation and her device had to be disabled as a result. The physician did not run diagnostics on the device, but stated that the patient had a fall and hit her neck before her visit. As a result the patient will be referred for a full revision. The patient also reported a sore neck, ear, and throat due to the vns. The physician programmed the device off on (b)(6) 2018. Notes state she feels like she has a crick in neck and ct reported as normal. The patient had a full replacement on (b)(6) 2018 and the devices were discarded per the explanting facility's protocols. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7699860
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dennis100
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« Reply #1074 on: August 11, 2018, 01:15:31 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had a consultation visit due to a "cuff complaint. " follow up with the physician's office resulted in the manufacturer receiving the consult notes for the patient. The notes indicated that the patient experienced discomfort at the left neck vns site. The patient had a prominent mass at the location and had experienced difficulty sleeping at night due to the discomfort and sensation of tightness in the neck. It was reported that there was mild bowstringing of the wire and prominence of an anchor at the neck. The patient underwent a superficial vns lead revision to remove the prominent hardware and relax the wire. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707618
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dennis100
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« Reply #1075 on: August 12, 2018, 12:20:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/25/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was in a motor vehicle accident and the vns generator migrated. The patient reported feeling the generator slipping under her arm. The patient reported having headaches that were constant and had worsened overall. The patient continued to utilize her vns for all symptoms, but it was stated that this had not helped with her headaches. The patient reported at an appointment a year following the accident that she felt a shocking pain in her neck. The patient reported that she could feel a wire and continue to complain regarding the generator slipping under her arm and causing constant pain. The patient stated that she feels shocks, which are causing more headaches. The diagnostics were reported as within normal limits. The patient was referred for full vns replacement surgery to address the migration and the painful stimulation. The physician stated that the intervention was to preclude serious injury. The patient underwent replacement surgery. The patient reported following the vns replacement surgery, the patient still feels painful stimulation despite the vns not being programmed on. The physician believed that this may be due to a pinched nerve. The patient was in a motor vehicle accident previously and had neck and back surgery in the past. The physician planned to allow the patient to heal prior to programming the vns back on. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
During attempts at product return, it was revealed that the facility does not return explanted products without a patient signed release and will not return explanted devices to the manufacturer.
 
Manufacturer Narrative
Patient problem :(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686856
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dennis100
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« Reply #1076 on: August 13, 2018, 01:10:52 AM »

Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported in a scientific article that a vns pt experienced severe neck pain synchronous with the duty cycle resistant to alteration of parameters and requiring lead revision. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
Manufacturer Narrative
Article citation: elliot, robert, a. Morsi, a. Silverberg, c. Carlson, e. Geller, o. Devinsky and w. Doyle. "vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2020352
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