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Author Topic: Numbness/Tingling  (Read 30604 times)
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dennis100
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« Reply #60 on: May 05, 2016, 04:14:29 AM »

Model Number 103
Event Date 01/11/2016
Event Type Injury
Event Description
Further information was received indicating that the patient was seen by the physician on (b)(6) 2016. It was reported that the patient was doing well; the reported events have stopped. It was reported that the physician decided to increase the output current from 0. 75ma to 1ma. The device was tested and system diagnostics returned impedance results within normal limits with 3401 ohms.

Event Description
It was reported that a patient, recently implanted with vns, had side effects: a very trembling voice, sore throat and tingling sensations. It was reported that the device settings (frequency and pulse width) were modified due to those side effects, without success. It was reported that the patient has never had this event prior vns implantation. Programming history of the patient's device was provided to the manufacturer for review. It appears that on (b)(6) 2016, the device was programmed at output current 0. 75ma, pulse width 250-sec, frequency 20hz, on time 30sec and off time 5min. The device system diagnostic test was not performed. Additional information was received from the physician, indicating that the patient was implanted on (b)(6) 2016. The adverse events began when vns was turned on, on the implant date. It was reported that the patient started to have pain when the output current of 1ma was reached. This occurs during the on time, never during the off time. It was also reported that the voice alteration occurs whatever the output current value was, and during only the on time. The patient will be seen in clinic in mid-(b)(6). The impedance will be tested. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No additional information was provided to date.

Manufacturer Narrative
Udi number: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5566664
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dennis100
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« Reply #61 on: May 05, 2016, 04:15:01 AM »

Model Number 106
Event Date 01/22/2016
Event Type Injury
Event Description
On (b)(6) 2016 it was reported that the patient is having shocking from her vns. The vns was reported to be off and lead impedance ok with no recent magnet activations. The patient was referred for vns explant. Previously, on (b)(6) 2016 it was reported that the patient has a tingling sensation at the neck incision site. The patient was seen by the physician and is being considered for possible wound infection. The patient was seen for follow-up and no longer described any tingling or anything that was first reported. The patient reported having consistent burning sensation in the back of her head, and headaches and was concerned that it was being caused by vns. These events were not during stimulation cycle, but more on a consistent basis. All system diagnostics were ran, and came back ok. The physician said that her issues are not related to vns. The physician increased the patient's output current and magnet current by 0. 125 each. On (b)(6) 2016 the physician reported she is still having pain and the only thing that the physician can attribute it to is vns. He has referred patient back to the surgeon, for vns explant. The patient saw the surgeon who also spoke with the neurologist and there has never been a time that there has been any issue showing with vns or diagnostics, and device had been turned off. The patient is still complaining of pain, and even though both physicians think it probably isn't related to vns, and is probably more than likely something different, the surgeon still wants to move forward and have the vns removed at the request of the patient. Apparently this patient has a past history of being a pain management patient. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5567540
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dennis100
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« Reply #62 on: May 07, 2016, 05:12:25 AM »

Model Number 302-20
Event Date 09/17/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a patient presented with painful stimulation, hyposthesia, and a seizure increase, below pre-vns baseline. Diagnostic tests were performed, resulting in high impedance. Trauma and patient manipulation are not thought to be factors. The patient is likely to undergo revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=928315
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dennis100
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« Reply #63 on: June 06, 2016, 01:17:13 AM »

Event Date 02/15/2011
Event Type Injury
Event Description
I developed brain cancer in my right frontal lobe, found in (b)(6) 2011. The doctor was inserting screws to my skull bone. He tightened one of the screw and it broke so the surgery went longer. I developed an infection with radiation on the area of my previous surgery and the dehisced extending my radiation treatments, these 36 radiation treatments made me very sick. I had to have an emergency surgery to see what was going on in my brain. This surgery revealed that my skull bone was infected and they removed 1/4 or more of my skull and used more screws than they anticipated. I had some kind of infection prior to this and had drains in my head to get excess fluid out of my swollen brain. After this surgery i developed another infection and another hospital stay. Throughout the whole ordeal of dealing with this situation i had six to eight infections, and at least three to four stays in the hospital, some up to 2 weeks. I am not sure what the name of the plates were or what the company was called for these (i have all my notes from this time, i could look through notebooks and files for a day, to find this out). The last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totalled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529168
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dennis100
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« Reply #64 on: June 08, 2016, 01:57:49 AM »

Model Number 106
Event Date 08/11/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
A provider reported that a patient was experiencing numbness under his left jawbone that was believed to be related to the implant procedure. Numbness was experienced before and after vns stimulation was initiated. Lowering vns output did not alleviate the reported numbness. The provider described the numbness as a serious side effect but not a serious injury per se. Lead impedance values via system diagnostics from the date of implant were normal and diagnostics were reported to be normal at subsequent device checks. The patient was to be evaluated by the implanting surgeon. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5164141
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dennis100
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« Reply #65 on: June 09, 2016, 01:08:49 AM »

Model Number 102
Device Problem Device operates differently than expected
Event Date 09/05/2015
Event Type Malfunction
Event Description
The patient had generator replacement on (b)(6) 2015 due to pain. The explanted device was received by the manufacturer. However, analysis has not been completed to date.

Manufacturer Narrative

Event Description
Information was later received that near the time of the initial event, the patient was undergoing a procedure unrelated to vns when an anesthesiologist noticed some spots on her throat and referred her to an ent physician. The patient saw the ent physician sometime near (b)(6) 2015 and noticed that her vocal cords were not opening or closing like they were supposed to. Patient did not have any symptoms from this event. The ent physician did not take any intervention for this and told patient to come back in 6 months for a checkup. Additional relevant information has not been received to-date.

Event Description
It was reported that a patient was experiencing erratic stimulation constantly and tingling pain at neck/clavicle area. Diagnostics were performed and were within normal limits. The patient¿s generator was programmed off, but the pain persisted. The (b)(6) wants the device replaced due to the issue. The device remained programmed off. Per clinic notes from (b)(6) when the patient followed-up with her physician, the patient was seen in the hospital with pain in her neck and throat. The device stimulation caused ¿intense pain¿ in her throat. The patient was unable to speak and felt as if the device was ¿squeezing¿ her throat. After the device was programmed off, the patient reported that the squeezing sensation in her throat became ¿unacceptable stinging in the left neck¿. The magnet was taped to the patient in the hospital to stop the stimulation, but was unsuccessful.

Event Description
Analysis was completed on the generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. 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=5118141
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dennis100
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« Reply #66 on: July 04, 2016, 01:06:39 AM »

Model Number 103
Event Date 02/18/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789910
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dennis100
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« Reply #67 on: July 08, 2016, 02:20:47 AM »

Model Number 302-20
Event Date 03/10/2015
Event Type Malfunction
Event Description
Additional information was received that the high impedance was first noticed on follow up visit on (b)(6) 2015. Patient was complaining of tingling and itching in the chest around the site of the generator. On initial interrogation, the lead impedance was 9666 ohms. Nurse switched off the stimulator and the itching and discomfort in the chest abated very quickly. The explanted lead only was received and analyzed. During analysis, lead fracture was verified. The outer and inner silicone tubing (positive coil) are punctured open most likely by an electro-cautery tool. Though difficult to state conclusively it is believed that this was most likely caused at explant. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained. Also, one strand of the positive coil shows appearance suggesting that the coil was exposed to some type of electro-cautery tool (most likely at explant). Since the closest electrode to the bifurcation was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative

Event Description
It was reported that patient underwent full vns system revision surgery on (b)(6) 2016 due to lead discontinuity and prophylactic replacement for the generator. The explanted products were received by the manufacturer. Analysis of the devices is underway, but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5719983
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dennis100
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« Reply #68 on: July 19, 2016, 11:00:57 AM »

Model Number 303-20
Event Date 05/09/2014
Event Type Injury
Event Description
It was reported that the vns patient would at times experience numbness under her chin and hot flushes in her left arm after her device was programmed on during an office visit on (b)(6) 2014. The patient¿s device showed lead impedance within normal limits (impedance value ¿ 2304 ohms) at the time. The patient was seen on (b)(6) 2014 and reported having some pain in her left arm after her device settings were increased. The patient¿s device showed increased lead impedance but still within normal limits (impedance value ¿ 4649, 4622 and 4701 ohms). X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in an abnormal arrangement as they do not align with the spine but rather perpendicular to the spine. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events may be due to the abnormal placement of the electrodes. However, no definitive conclusions can be made. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized but identified abnormal placement of electrodes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899453
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dennis100
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« Reply #69 on: November 28, 2016, 10:38:50 AM »

Model Number 103
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities. The physician tested the vns and found high impedance. The vns was programmed off and the patient was referred for surgery. The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016. It was noted that the lead pin was not fully inserted into the generator. The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket. Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019996
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« Reply #70 on: November 28, 2016, 10:40:33 AM »

Model Number 102
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month. The patient could not talk due to cyanotic lip. The patient has 5 times of seizure where 3 were stopped by magnet. The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline). The patient parameters are currently at: 1. 75ma, 30hz, 250usec, 30sec on and 1. 8min off. Follow up indicated that the patient¿s parameters were changed to 1. 25ma; 250's; 30s on; 5mins off. The patient feels very little numb during stimulation. The patient will come back after 3 months for the next follow up visit. The drugs were not changed. The seizure start area in the brain is still unknown for the physician. It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe). Further follow up indicated that the vns system works fine. Numb feeling disappeared after the parameters decrease. However; the patient has several general seizures after this parameters change. Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns). It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6016651
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dennis100
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« Reply #71 on: January 06, 2017, 08:31:16 AM »

Model Number 304-30
Event Date 06/01/2016
Event Type Malfunction
Event Description
The patient reported experiencing painful stimulation when he turned his head to the left. The painful stimulation progressed to caused the patient to fall to the floor. The patient then had revision surgery on (b)(6) 2016. During surgery there was visible fluid inside the lead casing observed by the surgeon. There were no observed abraded openings or beaks in the lead. The patient's lead was removed. The lead was then discarded by the facility. The physician stated that the patient is a very violent patient and the patient's seizures may have contributed to the event. No high impedance was observed prior to the surgery. No other relevant information has been received.

Event Description
Clinic notes received indicate that the patient had a fall in (b)(6) 2016 and afterwards the patient reported being electrocuted from his vns. It was noted that the tingling and numbness worsened when the patient turned his head to the left. The physician then attempted to lower the patient's settings to mitigate the pain however it did not resolve and the patient was referred to the previously reported surgery. Diagnostics were within normal limits as of (b)(6) 2016.

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial mdr inadvertently checked an outcome; however, there was no reportable adverse event so there was no outcome. Date of event, corrected data: initial mdr inadvertently included a date that did not best represent the time of the event.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6142022
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dennis100
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« Reply #72 on: February 07, 2017, 02:38:33 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.

Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.

Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.

Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
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« Reply #73 on: February 13, 2017, 04:40:04 AM »

Model Number 302-20
Event Date 10/31/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(4) 2012, when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op system diagnostics showed results within normal limits of output=ok/lead impedance=ok/dcdc=2/eri=no. System diagnostics after generator replacement again showed results within normal limits of output=ok/lead impedance=ok/impedance value=2366ohms and output=ok/lead impedance=ok/impedance value=2381ohms. The patient was then programmed to the same settings as prior to surgery; output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The explanted generator was returned to the manufacturer on (b)(4) 2012, for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
"type of report", corrected data: inadvertently did not check "30-day" on initial report.

Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2011, revealed that the vns has been very helpful with the patient's seizure control but that at the patient's last visit, the patient had feelings of neck discomfort associated with stimulation. The pulse width was lowered which provided relief of the discomfort, but now the patient is experiencing feelings of "insecurity". She perceives that she may be at a greater risk for seizures since the pulse width was lowered and stated that she would like to have the pulse width increased again. Upon increasing the pulse width, the patient experienced a sensation of numbness and tingling down her left arm with stimulation. The pulse width was therefore turned back down to 250 usec and the signal frequency was increased to 25hz. The physician stated that if the patient continues to have these premonition-type feelings the output current may be increased. The physician states that he is concerned that the sensation she is getting upon stimulation are indicative of a lead fracture. He states that x-rays were taken which showed no evidence of a lead discontinuity. The patient's settings were output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The physician further states that if there are any worsening of the patient's symptoms or decreased seizure control they will have a full revision surgery. The physician later stated that the painful stimulation, numbness, and hypoesthesia were first noticed on (b)(6) 2011. No causal or contributory programming or medication changes preceded the events. No patient manipulation or trauma occurred. The patient's most recent settings are output=1. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The physician stated that she does not have a medical history of numbness or hypoesthesia prior to vns. The patient is having a full revision surgery due to a likely fractured lead according to the physician although no diagnostics were reported that would confirm high impedance. Although surgery is likely, it has not yet occurred.

Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2504493
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« Reply #74 on: February 18, 2017, 03:45:42 AM »

Model Number 302-20
Event Date 03/04/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to our country rep in (b)(4) by a vns treating physician that they had a pt who was having high lead impedance. Reported that they were having tingling sensation and their dcdc code was 7 back to a 6 and then a 7 again. The pt's vns will be programmed off at their next office visit. No fall or injury was reported prior to their high impedance being attained. Surgery has not been planned at this time. X-rays were received for review but based on the picture clarity, were not able to be assessed fully. There was a suspect area in the neck region and it could not be seen if the lead pin was fully inserted. Further investigation is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2031200
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« Reply #75 on: March 02, 2017, 12:34:24 AM »

Model Number 103
Event Date 11/30/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that an error message was received with diagnostics were run on the pt. A company representative came to the site to troubleshoot the issue. The warning message and result were duplicated by the company representative on her programming system. A generator reset was perform and appeared to correct the issue. The patient's previously programmed parameter cause painful stimulation, hoarseness and tingling which it has not done before. Pt was programmed to lower output current to allow them to adjust to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956837
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« Reply #76 on: March 10, 2017, 06:07:49 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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« Reply #77 on: April 18, 2017, 11:28:40 PM »

Model Number 304-20
Device Problem Fracture
Event Date 02/28/2017
Event Type Malfunction
Event Description
It was reported by a patient that he was experiencing painful stimulation near the generator site and was told by the physician that the lead might be broken. The generator was turned off. Follow-up from the physician provided that diagnostics within normal limits on (b)(6) 2017. The patient had since had a fall and was in the er and had some chiropractic manipulation. The patient has been scheduled for surgical consult. Clinic notes from a visit on (b)(6) 2017 were received which provide the patient experiences discomfort and tingling at the generator site with electrical stimulation, but has not had any seizures. The lead impedance was noted to be high. 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=6434933
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« Reply #78 on: May 02, 2017, 01:51:35 AM »

Model Number 300-20
Event Date 04/30/2014
Event Type Injury
Event Description
Initially, tt was reported that the patient is feeling a throbbing in the area of the left where the lead is when she turns her head to the right. The patient denied any trauma to the area. It was reported that device diagnostics were within normal limits (dc dc code - 1). It was later reported that the patient experiences a tingling sensation in the left neck when the patient turns her head to the right. The magnet was placed over the device to temporarily disable stimulation and the tingling went away. X-rays were taken and reportedly "looked good". It was later reported that the patient's mother wants the patient to undergo vns replacement. The patient was referred to surgeon for consult. No surgical interventions have been performed to date.

Event Description
It was reported that the patient underwent generator and lead replacement on (b)(6) 2015. Pre-operative device diagnostics were within normal limits. The surgeon indicated that there were two small water bubbles in the lead when the neck incision was opened. There was condensation in the generator header where the lead was attached to the generator. Both generator and lead were replaced. The device was confirmed to be programmed off prior to the completion of surgery. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/09/2015. 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. Analysis of the lead is underway, but has not been completed to date.

Manufacturer Narrative

Event Description
Additional information was received from the patient¿s treating physician. The believed cause for the patient's report of pain on the left side of the neck when she turns her head to the right has never been clear. The unit has been interrogated numerous times with the patient in different positions, and the unit appeared to be functioning correctly at all times per the interrogation. She has not experienced any pain during any of the times she was having the unit interrogated. The patient¿s surgery was done to relieve discomfort. She continued to complain of twitching sensations. She and her family were also concerned because the vns did not seem to be functioning as it once had. They consistently reported that when the magnet was swiped across the vns unit, it no longer seemed to have any impact on the seizure and she just had to go through the full seizure. The settings prior to surgery were: output current-1. 25 ma, and magnet output current-3. 25 ma analysis of the explanted lead was completed on 02/17/2015. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4341794
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« Reply #79 on: May 02, 2017, 01:52:19 AM »

Model Number 104
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient reports that the vns wires shock her even when the device is off. The patient indicated that she feels like she has lost all use of her left side. It was noted that the patient suffered a fall on (b)(6) 2014, striking the area near the vns. There was no bruising or edema that resulted from the trauma. The patient begun to complain of weakness in her left arm and occasional tingling in her left leg. It was noted that this has not impacted the patient's activity level. The physician programmed the device off on (b)(6) 2014 and x-rays were performed to check for possible damage or movement of the vns caused by the fall. The physician referred the patient to the surgeon because he believed the device has migrated significantly lower than initially placed. The physician reported that he felt the device had migrated some time ago because an x-ray from (b)(6) 2014 showed the device in the same location as the current x-ray. The patient underwent prophylactic generator replacement. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4348399
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« Reply #80 on: May 03, 2017, 12:40:03 AM »

Model Number 103
Event Date 10/20/2014
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
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491
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« Reply #81 on: May 04, 2017, 12:47:57 AM »

Model Number 304-20
Event Date 06/06/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and the lead prior to distribution.

Event Description
It was reported that the recently implanted patient¿s neurologist noticed drainage at the patient¿s neck incision and noted that there may be an infection. The patient was advised to call the surgeon. The patient was referred to the emergency room for treatment by the surgeon, and given antibiotics. The neurologist later reported that the infection was mild and he believed it had resolved. No additional relevant information has been received to date.

Event Description
Additional information was received indicating that the patient had facial numbness and swelling that was unrelated to vns stimulation. The patient was referred to the emergency room (er) and treated. Additional information received from the physician indicated that the infection was mild and he believed it was resolved. The physician believed that the reported facial numbness and swelling was a result of the infection as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3917276
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« Reply #82 on: May 04, 2017, 12:48:53 AM »

Model Number 103
Event Date 07/08/2014
Event Type Injury
Event Description
Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events remains unknown. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3970627
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« Reply #83 on: May 06, 2017, 02:37:47 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 03/16/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a physician that a patient was experiencing painful stimulation. Diagnostics were reportedly okay. The patient currently had placed the magnet over the device to disable stimulation. It was stated the pain began suddenly. From what the patient told him, it was not associated with increase in settings. The plan was to turn off the generator and perform revision surgery. Follow-up from the case manager provided the patient may have had trauma to the neck. Clinic notes were received from a visit on (b)(6) 2017. Within the notes it was provided that the patient has been experiencing shortness of breath and numbness and tingling in the left side of her throat where the leads run through. She feels as if the stimulator is going off all the time. The patient stated she never had similar problems with her previous vns. Diagnostics were provided as ok and battery life was stated as ¿green¿. 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=6484561
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« Reply #84 on: May 09, 2017, 12:56:01 AM »

Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
Additional information was received from the treating physician. He reported that the patient had reached decent settings and requested that his devices get turned off as it was felt to not be helping. The physician reported that the patient was a non-responder. Then, after aed polytherapy failed to improve his seizure control, the physician suggested to turn on his device as it has no role when not active. Once the patient agreed, he displayed a high sensitivity to very low initial stimulations and responded with coughing immediately upon an adjustment that he could not tolerate. Thus, this precipitated the patient¿s requests for a vns removal. The physician reported that this may have represented a psychological response and lack of motivation, but that it was speculative.

Event Description
It was reported on (b)(6) 2014 that the patient reported pain near the generator that persisted mildly even when the device was off for several months. The patient did not believe it improved his seizures, although the surgeon¿s nurse indicated that it may have after it was initially implanted. The patient¿s device was explanted on (b)(6) 2014. The explanted device could not be returned for product analysis as the hospital does not return. Good faith attempts for further information were unsuccessful. It had been reported on (b)(6) 2014 that the patient was on low settings, output=0. 25ma, and felt a pressure in the chest and tingling in the left arm. The physician didn¿t know if the issues were related to the vns.

Manufacturer Narrative

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not report this outcome, as explant occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4191919
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« Reply #85 on: May 17, 2017, 12:35:36 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description 
Reporter indicated that pt had their device explanted. The physician indicated that the pt's generator had migrated, and was subsequently causing paresthesia in her left arm. The physician additionally noted that the original placement of her generator was unusual, i. E. Subpectoral muscle, to accommodate the pt's work requirements.
 
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« Reply #86 on: July 07, 2017, 03:18:05 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568
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« Reply #87 on: July 24, 2017, 01:13:53 AM »

Model Number 102
Event Date 03/26/2011
Event Type  Malfunction   
Event Description
A physician reported that a vns pt was experiencing some tingling numbness around her generator site and the pt wanted the device disabled. There had been no reported trauma recently. A company rep was able to visit with the pt and found the pt to have high impedance. Furthermore, the pt occasionally had painful stimulation in her chest, but she now did not want the device to be disabled. The pt did not have a neurologist at the time. The pt underwent a revision surgery. The surgeon opened up the pt's chest site and noticed the setscrew was loose. The surgeon tightened the screw and ran system diagnostic tests and received within normal limit results. The surgeon prophylactically replaced the generator and all diagnostics were again within normal limits. The pt was reported to be "fine" post surgery. Furthermore, an update indicated that the physician felt the pt's tingling numbness was related to the setscrew's looseness. Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092180
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« Reply #88 on: August 04, 2017, 06:14:42 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 06/07/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an episode where he experienced choking, and puking which he explained as a sensation that the generator was continually in magnet mode. He also reported a tingling sensation in his left arm associated with stimulation. X-ray images were reviewed and repealed no relevant information regarding the events. Additional clinic notes were received indicating that the patient reported that he experienced choking and shortness of breath sometimes. He felt scared during sleep. Patient complained of choking, shortness of breath, neck pain radiating left upper extremity. It occurred once in 10-15 minutes. In addition, he complained of pain in left chest and one episode of numbness in the left arm. The normal output current was disabled and magnet mode was left on. The physician notes that there was no abnormality on x-ray. The physician tried lowering the output current and adjusting the frequency, pulse width and duty cycle but the patient could not tolerate. Therefore the normal output current was disabled while leaving the magnet output current on. Patient has no symptoms when the device is disabled. No other contributory or casual events that preceded the reported events. The neurologist plans to refer patient to neurosurgery for a consult in regards to the electrode placement on the nerve. No known surgical interventions have occurred to date.

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« Reply #89 on: August 04, 2017, 08:27:12 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/23/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient was complaining of pain and numbness in the chest wall around the site of the generator. The physician believed that the patient's generator may have "loosened up". Clinic notes indicated that the patient had woken up and began to feel pain at the apex of the generator. He also felt numbness around the generator site that extended to the left side of his lower neck. The physician noted erythema at the left chest and neck. The physician believed that there may have been a dislodgement of the vns generator. The patient's system diagnostics were within normal levels with impedance at 2804 ohms. Approximately 6 months prior, the patient had had a physical alteration with his brother and his chest was hit, and the patient had been worried that the generator was damaged. Impedance was within normal limits. The patient was referred for replacement. On a fax from the physician, it appeared that the patient was referred for surgery to preclude a serious injury and for patient comfort. He indicated that trauma to the vns during the patient's fight with his brother was the believed cause of the migration. 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=6753210
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