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Author Topic: Misc. Pain  (Read 26641 times)
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dennis100
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« on: July 11, 2018, 07:29:06 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 07/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The physician reported that the opioid painkillers were administered to the patient prophylactically. The physician also noted that the patient was non-verbal, so it could not be determined if or where the patient was experiencing post-surgical pain. No additional relevant information has been received to date.
 
Event Description
Clinic notes indicated that a patient went into cardiac arrest with associated respiratory arrest when he was given opioid pain medication shortly after his initial vns implant surgery. The medical team was administering the medication every 6 hours after surgery had occurred. Around midnight on the date of surgery, the staff noticed that the patient's breathing pattern had changed, leading to the cardiac arrest. An ambulance was called, and the patient was defibrillated. The physician concluded that the cardiorespiratory arrest was an adverse reaction to the pain medication and not caused by the placement of the vns. Clinic notes from later clinic visits indicated that the device was functioning properly. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820596
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dennis100
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« Reply #1 on: July 11, 2018, 07:29:39 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/11/2008
Event Type  Injury   
Event Description
It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. No further relevant information has been received, to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7497099
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dennis100
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« Reply #2 on: July 11, 2018, 07:30:16 AM »

Model Number 302-20
Event Date 04/13/2010
Event Type  Injury   
Event Description
Additional information was received from the physician. No x-rays of the patient's vns have been taken. The patient did not experience paresis or difficulty swallowing prior to vns implantation which the physician suggests that there is therefore a relationship of these events to vns implantation. The paresis is reportedly associated with stimulation. However, the dysphagia is apparently not associated with stimulation. The patient has also complained of difficulty breathing when the room temperature is hot or cold since the time of implantation. No patient manipulation or trauma has been reported or has been apparent that may have contributed to the events. No interventions have been taken except examinations by her implant surgeon and by ents.
 
Manufacturer Narrative
The initial report inadvertently reported the incorrect event date. The physician has indicated that the symptoms occurred following implant surgery. The initial report inadvertently did not include the patient's age.
 
Event Description
It was reported that the patient had continued neck pain and lead pulling when she turned her head. The patient also had pain/burning in throat and difficulty when swallowing. She said that food seemed to get stuck in her throat. The patient had evaluation by an ent in late 2011 which showed left sided laryngeal paresis and retention of food in the right valleculae with no aspiration. Physician notes that the patient has had improved seizures control with vns, but continued discomfort has distracted from benefit. No patient manipulation of vns has occurred. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2443233
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dennis100
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« Reply #3 on: July 11, 2018, 07:30:57 AM »

Model Number 302-20
Event Date 07/31/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Analysis of the lead was completed on 10/09/2014. Note that the electrodes were not returned for analysis, with the exception of the spot-weld / slug still attached to the end of the (+) connector ring quadfilar coil and therefore a complete evaluation could not be performed on the entire lead product. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the (+) connector ring quadfilar coil attached to a portion of the ribbon. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut / torn ends that were made during the explanted process. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
It was reported that the patient's device has not been programmed back on yet. The patient is no longer experiencing pain in the neck. It was reported that the pain was more of an all over pain and was not related to vns. The patient believes that the use of a heating pad on the neck contributed to the discomfort.
 
Event Description
It was reported that the patient was experiencing pain in the neck since generator replacement on (b)(6) 2014. It was reported that the pain was constant and was not only occuring with device stimulation. The patient's generator was programmed off which did not resolve the pain. The patient was scheduled for revision surgery. The patient underwent surgery at which time the surgeon identified that the lead was frayed. It was reported that device diagnostics did not show high impedance. The lead was replaced. The lead was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4101523

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dennis100
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« Reply #4 on: July 11, 2018, 07:31:40 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 the physician reported that the patient had gastroparesis and laryngeal difficulty. Per the physician, the patient¿s entire vns system was removed in (b)(6) 2013 with nothing in the operative note indicating nerve damage.
 
Event Description
On (b)(6) 2013, the patient reported that she has been having very bad digestion issues and difficulties swallowing since (b)(6) 2010. She stated that both issues started around the same time and said she has been to many specialists and physicians for the issue. The patient described the difficulty swallowing as "her food won't go down"; and confirmed that she was not vomiting her food back up, but was having a difficult time getting it to her stomach. Per the patient, solid foods will not digest at all and only liquids go down, but they go down very slowly. The patient stated that she has had many tests performed and has tried several different diets (e. G. The gluten-free diet, sugar free-diet, and dairy-free diet); however, nothing has worked and there has been no improvement. The patient explained that she has been diagnosed with gastroparesis and stated that several physicians believe her vagus nerve has been damaged. Per the patient, her physicians have stated that the vns device has caused nerve damage to her vagus nerve which has caused her to stop digesting food to her stomach. The patient's device stimulates for 30 seconds every 3 minutes, but the difficulty swallowing and digestion problems occur constantly and not just with stimulation. Per the physician's suggestion, the patient's device was turned off on (b)(6) 2013. Additionally, the patient stated that she has gained weight since (b)(6) 2012 as a result of the various diets she has been placed on. The patient stated that since this time she experiences shortness of breath with exertion that occurs all the time and not just with stimulation. Secondly, the patient began experiencing pain under her right rib which started when she gained weight in (b)(6) 2012. The pain was described as a constant pain that has gotten worse over time. This pain gets worse when the patient tries to eat or drink anything. At the time of this report, the patient stated that she had only had her vns device programmed off for a couple hours, but the pain has already lessened, though it was still present. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
This device was implanted to treat fibromyalgia which is an unapproved indication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3096041
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dennis100
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« Reply #5 on: July 11, 2018, 07:32:22 AM »

Model Number 302-20
Event Date 03/24/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient was presenting with high lead impedance from a systems diagnostic test that showed limit/high/7/no that day. The physician said that the patient doesn't know of any specific incident that could have resulted in a potential lead fracture. The physician was advised to disable the patient's device, which she did later in the appointment. She was then told that if the patient were to continue therapy, his lead would likely need to be replaced. The physician noted that recent diagnostics performed were within normal limits, but she didn't have the results in front of her. On (b)(6) 2011, the patient's spouse requested information on the coverage for explanting the patient's device due to the need for an mri. The patient's wife said, they have decided not to replace the device due to a device malfunction, which she said was a fracture. She then went on to explain that prior to the high lead impedance, the patient was experiencing pain the neck and some visual issues where he couldn't see very well. The visual issues were later determined to be the result of a stroke so the patient needed to be referred for an mri, but her understanding was that because, he had an implantable device, he could not get one. Just the pain in the neck was thought to be related to vns, not the patient's stroke. The patient had been referred for multiple cat scans, which did not show a stroke so far; now the family wants the vns removed so they can do an mri. She was told that an mri could be performed, but there are specific precautions listed in our labeling. The wife then said that the vns id card said they couldn't do mris, but when asked to verify that the statement is present, she confirmed it was not. She then changed it to it was the physician who also said that an mri could not be performed, so she was informed that an mri is possible with certain limitations, as they are performed regularly by mri facilities. She was also told that the device can remain implanted and is not required to be removed, just disabled. Since the device has not been explanted and x-rays have not been received, a lead fracture has not been confirmed as the cause for the patient's high impedance. The patient's physician reported that the patient had gone to the emergency room for the pain in the neck and that a ct and an angiogram were performed which showed nothing abnormal. The physician does not know where the pain is related to vns or not. It is not known whether, the patient will have the device removed or replaced. The physician said that they will discuss it during the patient's next appointment; the specific date of the patient's next appointment was unknown. The physician said that after the patient returned from the hospital, the patient noticed that he wasn't having any voice alteration with stimulation. The patient was worried that his device wasn't working since he could not perceive any voice alteration. The physician does not think that the pain is associated with stimulation because, the patient could not be receiving stimulation due to the high impedance since the device may not be able to deliver the full current. The patient used to always have voice alteration with stimulation but it was not serious and no interventions were ever taken. The patient denied any trauma or fall that could have caused this. The physician could not provide any more settings or diagnostics. Additional information regarding the next steps the patient and physician were going to take for the patient's high impedance and pain was requested. The physician reported that x-rays were taken on (b)(6) 2011 and that they showed no anomalies. However the x-rays were not sent to the manufacturer for review. If additional information is received, it will be reported.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2073724
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dennis100
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« Reply #6 on: July 11, 2018, 07:33:07 AM »

Model Number 104
Event Date 02/01/2012
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(4) 2012. The notes indicated that the patient had a history of several different seizure types with complex partial seizures, occasional drop attacks, and rare generalized tonic-clonic events. The patient continued to have one to two seizures per month until the months of (b)(6). At this point, the patient had frequent attacks where she passed out and fell. The patient had not injured herself. In the month of (b)(6), the patient had five seizures. The patient's device was interrogated and changes to the settings were made. A letter from the patient's physician dated (b)(6) 2012, also stated that the patient's seizure frequency was one to two per week, the majority of which were complex partial seizures but also drop attacks. A fax was received on (b)(6) 2012, from the physician; however, no information was provided regarding the increase in seizures. Attempts for product return have been unsuccessful.
 
Event Description
An implant card from the patient's (b)(6) 2012, surgery was received on (b)(6) 2012. The document indicated that the lead was replaced due to lead discontinuity. Additional follow up was performed, and it was confirmed that the lead was replaced prophylactically due to infection.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, information was received indicating that there was some infection at the site. The physician moved the pocket and decided to replace the leads. Additional follow-up showed that the infection was located in the upper left chest, no cultures were taken, and the infection was not believed to not be associated with the vns system, but probably the job the previous surgeon had done. It was also stated that the lead was replaced prophylactically due to infection. Attempts for product return have been unsuccessful.
 
Event Description
On (b)(6) 2012, it was reported that this vns patient was having trouble with her vns "coming out" from under her skin. This was not the first time this event occurred: one to two years ago, the patient had to have the implant redone because it was not implanted deep enough. (this was previously reported in mfr report # 1644487-2011-00804. ) the patient was reported to be, again, having the same issue. The area appeared infected and was described as red and agitated. The patient was also experiencing pain radiating down her left side and arm. On (b)(6) 2012, it was confirmed that this vns patient underwent full revision surgery. There was also an allegation of device migration. A fax was received from the physician on (b)(6) 2012. The protrusion began two months prior. The patient is implanted with vns and has a local pain which is constant/all the time. The interventions planned included follow up with the implanting surgeon. No causal or contributory programming, medication changes, patient trauma, manipulation, physiological changed (i. E. Weight gain or loss) preceded the onset of the events. The generator was the device protruding. Additional follow up was performed on 07/24/2012 and revealed that no migration was reported. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated the event date was (b)(6) 2012; however, additional information shows that the event date is (b)(6) 2012. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2667386
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dennis100
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« Reply #7 on: July 11, 2018, 07:34:00 AM »

Model Number 101
Event Date 04/17/2009
Event Type  Injury   
Event Description
Pt has had an implanted vagus nerve stimulator initially placed in 2000. It was used successfully and helped improve seizure control initially. A few years ago, pt had an mri with transmit and receive head coil and vns device was turned off before the test, as required. When this author tried to turn device back on after the mri, he complaint of pain and was more sensitive to vagus stimulation in general. Multiple attempts over time were not successful in getting his vns settings back to premri settings. He did however, continue to use the vns at lower settings with fair control of seizures. In 2009, this author received a phone call from pt, stating that he had throat pain and dysphagia each evening lasting about 3 hours for the preceding four days. He was seen by his epileptologist that day and vns was turned off with relief of pain and dysphagia. Pt had recalled that he had received diathermy treatments from a physical therapist at least on two known dates - the same month prior to original date, for treatment of plantar fasciitis. Pt states that he was not aware that the treatment involved diathermy and didn't recall the warning about diathermy and vns until original date. Further information obtained by dr. Reveals that patient noted some intermittent pain near the vns site after the first diathermy treatment. Over the past 1. 5 weeks at night, right after taking his bedtime pills, he would develop pain in upper chest and neck on left in the region of his vagus nerve stimulator. Then pain would last 1-2 hours, described as sharp, pulsating pain in left neck and upper chest. He also noted some increased voice hoarseness for a few days and increased coughing after taking pills. Pt was sent to the emergency room the same day, xrays of neck done and patient examined. No other complications were found. He was also seen by ent specialist in early the following month - no evidence of vocal cord paralysis found. Seizures worsened without the vns. Seizures used to be considered minor by patient, but without vns, seizures increased in frequency and were more intense. He would awaken from sleep 2 to 3 hours after onset with a startle with a change in breathing, feeling of anxiety, funny feeling in stomach. This could last 45 minutes intermittently before he would fall asleep. During remainder of night, sleep would have restless quality and he would awaken frequently with stomach feeling off. He would also feel more fatigued during day, requiring frequent rests, generalized weakness, and seizures occuring during daytime naps. Frequency of seizures increased to 1 to 3 times per day, on average of 5 to 6 times per week. Since vagus nerve stimulator was 9 years old and possibly contributing to the above symptoms, surgery was done the same month, to replace the vns generator. During surgery, system diagnostics were done with patient under anesthesia with results within normal limits. Device was removed -model 101, and upon visual examination by the neurosurgeon, one of the two screws -the one corresponding to the positive sign- was very loose and there was fluid within the cavity of where the lead contact should be going. A new vagus nerve stimulator was implanted - model 102r. The patient tolerated the procedure well. In the recovery room, the vagus nerve stimulator was turned on to very low settings. This did not trigger pain or other symptoms. Patient has since reported that sleep and seizures have improved in past 2 days.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386564
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dennis100
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« Reply #8 on: July 11, 2018, 07:35:40 AM »

Model Number 304-20
Event Date 02/18/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported on social media that her vns caused to her almost die due to "catching fire" inside her, causing her to lose 58 pounds in 2 weeks, threw up blood every day for 2 months, and the wires were cut too short in her neck. It was previously reported that the patient felt a burning sensation at her chest, which is most likely what the patient meant by the device "catching fire" inside her. No further relevant information has been received to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental report #1 inadvertently listed the incorrect date of 05/22/2013, which should have been 06/18/2013 as it was a correction only. Follow-up type, corrected data: supplemental report #1 inadvertently did not list the report as a correction.
 
Event Description
Additional information was received that the patient's device is off, but she is complaining of pain "radiating throughout her whole body," the patient was scheduled to have either a lead revision or vns removal. Additionally, the patient claims that the lead going up to her neck is "too tight" and her device is flipping over. The patient showed the physician how she can manually manipulate it to "flip over. " additionally, it was also reported that the device could easily be manipulated in the pocket. The patient's device was explanted on (b)(6) 2013. The explanted device was discarded by the hospital after the surgery. Attempts have been made for additional information; however, they have been unsuccessful.
 
Event Description
Further follow-up revealed that the patient's device was explanted "because she has had several problems since the device was placed. The physician's office also reported that the patient experienced excessive nausea, vomiting, tightness of the lead, choking sensations, coughing, and burning pain at the generator site. It was reported that the neurologist recommended removal of the vns system because the neurologist felt that the amount of problems the patient experienced did not seem to outweigh the benefits of having vns therapy. Attempts to obtain additional information have been unsuccessful to date. Attempts to have the explanted devices returned for analysis have been unsuccessful to date.
 
Event Description
On (b)(6) 2013, it was reported that this vns patient was hospitalized after implant surgery due to a cough. The patient¿s device was not programmed on at the time. Follow-up showed that the condition was not pre-existing and not occurring with stimulation at the present time; however, it could not be determined if the event was related to vns. Currently, the coughing was not occurring with stimulation. It was stated that on occasion, the patient would cough and have a little bit of blood in her sputum. The patient also reported lead protrusion in the neck when turning her head to the right. The patient was seen and the lead appeared very tight when the patient turned her head. The generator was placed in the upper chest, under the clavicle, but the lead just may have been too short. The patient was referred to a surgeon for evaluation but this was for patient comfort. Surgery is likely but has not taken place.
 
Event Description
It was reported that the patient was seen by another physician for a second opinion. It was reported that the patient had experienced a weight loss of 35 pounds due to the nausea, vomiting following vns implant surgery. The patient¿s device was programmed on in approximately (b)(6) 2013. System diagnostics were reportedly within normal limits (lead impedance ok and approximately 3,500 ohms. The patient reported that her symptoms have not changed since the device was programmed on. The physician believes that the symptoms are probably due to trauma to the nerve during the implantation as the surgery lasted approximately 5 hours. The physician felt that time will probably alleviate the symptoms. The physician informed the patient to come back in if the symptoms persist in 3-6 months.
 
Event Description
Follow up with the physician found that he did not believe the choking was related to the vns. The choking was not associated with or occurring with stimulation. During explant, the patient's generator was found to be sutured to the fascia at implant with a non-absorbable suture. The physician believes the patient was manipulating the device. It did not appear that the device had migrated since implant. It was unknown when the device was turned off. The explant surgery was taken for patient comfort. The patient also felt the device was causing "electrical disturbances" in her house. The symptoms have improved since explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125097
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dennis100
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« Reply #9 on: July 11, 2018, 07:36:18 AM »

Model Number 102
Event Date 10/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
Initially, the surgeon's office reported that the patient was getting explanted because per the psychiatrist and patient, the device was not controlling her mood disorder and she has been having neck problems recently. They were planning to explant the lead, so the patient could get a neck mri. Later, it was reported that the patient tried to remove her vns system with a knife. She cut herself in the collarbone area. The patient was admitted to the er because she was bleeding. She did not reach or remove the device. The psychiatrist said that the patient said she tried to remove the device because it wasn't working and said that this was how the patient was. The surgeon reported that the patient removed it due to pain. The surgeon was unsure if the reported pain was due to actual pain or caused by her mental health. The surgeon did not believe anything was wrong with the vns to cause the pain. The patient received a full explant of lead and generator, reportedly due to lack of efficacy and need for a neck mri. No further relevant information has been received to date. No product has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6178449
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« Reply #10 on: July 11, 2018, 07:36:59 AM »

Model Number 106
Event Date 04/12/2016
Event Type  Injury   
Event Description
It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system. Clinic and operative notes were received on 04/21/2016 regarding the patient's infection. The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck. The patient started having drainage at the neck area. After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis. There was evidence of inflammatory changes/edema in soft tissue of the left check and neck. The patient was diagnosed with sepsis secondary to left chest wall cellulitis. The patient's vns system was explanted on (b)(6) 2016 due to the infection. The patient was treated with antibiotics for a streptococcus pyogenes (group a). The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision. The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted. Irrigation and debridement of the cervical wound and a revision of the wound was performed. It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing. The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016. The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck. The ct of the chest identified focal induration within the left breast which was nonspecific. There was no pathologically enlarged adenopathy or mass. In the neck. There was no evidence of discrete fluid collection or mass. The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle. There was no discrete fluid collection to suggest abscess. The patient also had a picc line placed from the right arm for the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655090
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« Reply #11 on: July 11, 2018, 07:37:41 AM »

Model Number 102
Event Date 04/07/2010
Event Type  Malfunction   
Event Description
Clinic notes were received from a visit on (b)(6) 2015 indicating a patient was in referral to have his vns replaced due to the device reaching near end-of service. Device diagnostics were within normal limits on (b)(6) 2015. A call was later received on (b)(6) 2015 from a friend of the patient at their request stating that the patient was experiencing pain in his neck and he believes the device is trying to boost energy as the battery is about dead. It was reported that the feeling began that day after the neurologist visit. The physician had provided a new seizure medication until he can get the vns replaced as she had observed seizure activity at the visit. The generator was explanted on (b)(6) 2015. It was reported on (b)(6) 2015 that the reason for replacement was "unable to interrogate due to battery depletion". An estimate of battery life calculation was performed with the available history which estimated 6. 5 years remaining until near end of service. However, the full history was not available in the programming database, and does not taken into account any programming changes since the last date of programming available, (b)(6) 2012, or magnet usage. The explanted generator was received and analysis was completed 01/14/2016. The reported failure to program was duplicated and measurement of the battery voltage determined that the battery was depleted. The supply current wait measurement did not meet the specification requirement. Analysis on the test bench identified and confirmed the c4 capacitor component as the root cause for the increased current drain. After the c4 capacitor component was cut out of the circuit and bridged with a known good bench c4 capacitor component, the generator module performed according to the functional specifications. The c4 capacitor leakage current demonstrated an increased current consumption for the device and potentially contributing to a premature end of the battery life. The reason for the c4 capacitor's increase in leakage current could not be determined. Review of the device manufacturing records revealed no anomalies during the manufacture of the device. The supply current tests, and all other tests met all specifications at the time of manufacture. No additional relevant information has been received to-date.
 
Manufacturer Narrative

Event Description
A review of the manufacturer¿s in-house programming data showed additional information from 10/22/2015. On (b)(6) 2015, a system diagnostic was performed and resulted in a ¿fault¿ in communication. On (b)(6) 2015 the device was interrogated and the settings had been changed to unintended parameters.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5375108
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« Reply #12 on: July 11, 2018, 07:38:19 AM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the patient has had increased seizure activity in the past three months. The patient was noted to be having refractory complex partial seizures and now needs a battery replacement. The patient was referred for generator replacement and it was stated that the patient's battery is dead. Clinic notes dated (b)(6) 2013 mention that the patient is not currently complaining of any pinching or pain from vns that he had in the past. The patient had reported on clinic notes dated (b)(6) 2012 that "it hurts when he rolls over" and he wants his vns removed. The clinic notes dated (b)(6) 2012 stated that the paint has been having multiple seizures all day; the patient had 7 seizures between 3:45pm and 4:05pm. The nurse stated that there have been no missed doses and no new medications. The clinic notes dated (b)(6) 2012 state that the patient was seen for a follow-up because of an increased number of spells. The patient did have at least 6 of those seizures that morning, but the physician found that the patient was spending most of his nights awake watching tv or playing video games. The physician stated that the patient has worn his vns out. The clinic notes dated (b)(6) 2012 indicated that the patient has pain when lying on the left side at his vns stimulator site and again the patient expressed desire for its removal. On (b)(6) 2012 the patient underwent a 4 day video eeg as the patient recently started having different type of spells. The new spells were described as humming, drooling, aphasia, and trembling. They were noted to last about 10 seconds, but can happen multiple times a day. The spells were suspected to be behavioral especially that changing his seizure medications was not helpful. The patient underwent generator replacement surgery on (b)(6) 2013 and it was noted that there was no end of service warning upon interrogation in pre-op. The explanted generator was returned for product analysis on (b)(6) 2013. It was later reported that the reason for generator replacement was for prophylactic reasons. The physician later reported that the increased seizures were first observed around (b)(6) 2012. The physician stated that the pain the patient feels is a "pinching" sensation in the vns neck site that occurs with stimulation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the pain. No further information was provided from the physician. Product analysis on the generator is still underway and has not yet been completed. A blc was performed with the programming history available which showed 9. 05 years remaining until eri=yes.
 
Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. The septum 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. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001934
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« Reply #13 on: July 11, 2018, 07:39:06 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing pain and muscle spasms in her neck and shoulder after her device settings were increased. The device settings were subsequently decreased and the pain resolved; however, the patient began experiencing an increase in seizures reported by the patient to be above pre-vns baseline levels. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Patient underwent generator replacement on (b)(6) 2016 due to battery depletion. The explanted generator was received on 7/29/2016. Analysis is underway but has not been completed to date.
 
Event Description
Further follow up indicated that the patient¿s settings were lowered, and the neck and shoulder pain subsided. The vns was interrogated and results again showed normal device function. The patient then experienced an increase in seizures reportedly above the vns pre-therapy levels. An x-ray was reviewed by the patient¿s neurologist, and the leads appeared intact, it was unknown what the cause for the patient¿s pain. No additional relevant information has been received to date.
 
Event Description
On (b)(6) 2015 it was stated that all non-vns issues were ruled out for the patient's pain. The patient continues to have pain when she turns her head to the left; however, she is unable to correlate the pain to stimulation. It was noted that the patient's increase in seizures were temporary and did not start with the pain. Further attempts have been made for additional information but have been unsuccessful to date.
 
Event Description
On (b)(6) 2015, the patient reported that she is having an increase in seizures. The patient has been cleared of any cardiac or other medical causes for her symptoms. The nurse turned down the dosing at the most recent visit. The nurse wishes to keep decreasing the settings and perhaps even disable her device. However, the patient states she has always had excellent seizure control from vns and refuses disablement. Further follow-up with the patient's physician showed that the patient is very vague in her descriptions of her adverse events. The physician states it is unclear if the increase in seizures is related to vns therapy. The patient has had no obvious medication changes that would be contributing. The physician stated that it is hard to assess the seizures as it isn't always clear from her report if she had an actual epileptic seizure or just thinks that she did. Therefore baseline level is hard for him to assess. According to the physician, at this point, any surgical intervention would be based on patient request only.
 
Event Description
Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation", "muscle spasm(s)", and "pain"). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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 battery, 2. 755 volts, shows an ifi=yes condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Follow-up with the physician's office showed that they do not feel that the vns device made the patient's seizures worse. External factors of stress and possible thyroid disease may have contributed to the seizures. Their records show the vns device to be operational. The patient was always able to perceived stimulation and it is only a painful sensation now. According to the physician, the etiology of the pain continues to be unclear. The feel it is unlikely related to vns. The emg is negative and patient was referred to pcp for evaluation of musculoskeletal pain. The nurse clarified what was mean by the "magnet was not working" by stating that they do not suspect any issues with the patient's magnet and have discussed magnet technique as well. She was not sure if the patient maybe could not feel the stimulation at times but the magnet and vns has worked for the patient and everything from their records shows that the device is functioning normally.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4723849
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« Reply #14 on: July 11, 2018, 07:39:51 AM »

Model Number 102
Event Date 04/04/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 this vns patient reported that her battery was low and that there had been no indication that it would occur. The patient was waiting to see a surgeon and had been experiencing pain, discomfort, and blackout spells. The patient reported experiencing aura-like sensation, stomach pain, urinary incontinence, tachycardia, and had blacked out once since generator had become depleted. Clinic notes dated (b)(6) 2013 stated patient reported that vns seemed to stop working on (b)(6) 2013. The patient attempted swiping the magnet several times on (b)(6) 2013, which only barely activated the vns device. The patient attempted a swipe on (b)(6) 2013, which produced tingling in the scalp and tachycardia almost instantly. The patient took 2 lorazepams and went to the emergency room. The patient had been prescribed potiga several months prior, but never started as the potential side effects scared the patient and the patient felt that seizures were under control. Additionally, the patient had obtained a bottle of clonazepam several months prior and overdosed on it while also taking regularly prescribed lorazepam on (b)(6) 2013. At the (b)(6) 2013 visit, the vns was successfully interrogated, programmed and diagnostics were performed. The results were provided. The patient was referred for vns replacement surgery. On (b)(6) 2013 the patient reported that she went to the emergency room the night of (b)(6) 2013 because of complications. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106486
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« Reply #15 on: July 11, 2018, 07:40:33 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury   
Event Description
The vns patient recently had surgery to replace the vns device in (b)(6) 2010 (previously reported in manufacturer report # 1644487-2010-01171), and since surgery, the patient had been experiencing pain in the left neck and the face. The physician had lowered the device settings to help with the pain. Over the next week the pain had resolved and the patient was doing well. It was then reported that the patient began experiencing intermittent seizure activity and confusion on (b)(6) and went to the emergency room. The patient was transferred to a different hospital, and the physician had made minor adjustments to the vns settings, and she was observed for several days but became very ataxic. After the physician's reviewed, the patient's medication, it was noted that the patient had taken an older (expired) bottle of lyrica to the hospital and was receiving twice the prescribed amount. After realizing the issue with the medication, it was corrected and the ataxia resolved and the patient was discharged. The patient was then for a follow up appointment at (b)(6) and the patient was experiencing migraine headaches, which per the physician is usually a sign of latent seizure activity. The physician opted to increase the device settings. Several days later, the patient then experienced a fairly severe migraine with confusion for the majority of the day, which seemed to resolve with no interventions. The patient is being closely monitored by the physician. At the time the patient was experiencing the migraines and confusion, it was also noted that the patient has not had a bowel movement for approximately a week, and the patient's appetite was diminished. The physician additionally explained that the patient is under a great deal of stress in her life at the moment, which could also be a contributory factor. At this time, the physician's assessment regarding the relationship of the events to vns is unclear. Good faith attempts to obtain additional information from the treating physician are currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828271
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« Reply #16 on: July 11, 2018, 07:41:46 AM »

Model Number 103
Event Date 02/09/2015
Event Type  Injury   
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report.
 
Manufacturer Narrative

Event Description
The patient experienced dull pain and swelling at the electrode site on (b)(6) 2015 after the pulse width was increased soon after the infection occurred. The physician believed that this was an expected event because of the infection. The incision was reported to be well healed. There was no reported intervention for the infection after the antibiotics.
 
Event Description
It was reported that the patient's lymph node was swollen at the site of the electrode. The physician started the patient on prophylactic antibiotics in case the swelling was indicative of an infection. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the cause for the swollen lymph nodes was due to infection, but it is not known what the cause for the infection was. Planned intervention was to refer the patient to the physician and provide antibiotics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4592599
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« Reply #17 on: July 11, 2018, 07:42:26 AM »

Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type  Injury   
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.
 
Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394
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« Reply #18 on: July 11, 2018, 07:43:48 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/12/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient has stomach pain, vomiting, difficulty swallowing, difficulty eating and has lost a lot of weight. The patient mentioned that they are vegan and that they have always tried to do cleanses but it doesn't matter what they ate, they would find it difficult to eat. They mentioned that the difficulty eating has gotten so bad that the gastro physician has given them pills that make them really sleepy and they really don't want to be on any other medication. Lastly the patient mentioned that before these events they used to have 3-4 bowel movements a day and now they no longer has them as often. Complete gi work up was performed for patient and myocardial infarction/heart attack was ruled out. Patient was provided a prescription for medications reglan, nexium, and another medication. There are no known history of these events prior to vns implant and no known risk factors. There were no medication changes or other factors that could have caused or contributed to these events. The physician does not know the cause of these events or its relation to vns therapy. Physician plans to turn vns off at patient's request. Patient's vns normal output current and magnet output currents were decreased from 1. 0 and 1. 25 ma to 0. 5 and 0. 75 ma respectively. Diagnostics were within normal limits. Additional information was received that the medical interventions were taken for patient's comfort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822039
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« Reply #19 on: July 11, 2018, 07:44:23 AM »

Event Date 10/01/2010
Event Type  Injury   
Event Description
It was initially reported by a radiologist that the pt's sternoclemastoid muscle appeared to be larger than normal below the electrodes and normal size above the electrodes. He denied the appearance of any infection at that time. He also stated the pt is complaining of pain at the neck incision. F/u with the treating physician revealed that the pt showed infection after a few days. Cultures were taken and they showed signs of infection. Physician did not know the result of cultures. He stated that the infection was likely related to surgery. No pt manipulation or trauma was reported. They treated the infection with antibiotics and drained out the pus. Per physician, pain was likely related to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894925
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« Reply #20 on: July 11, 2018, 07:45:00 AM »

Model Number 103
Event Date 05/23/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received. The patient came in for a follow up for the vns implant which occurred on (b)(6) 2013. The notes state that the patient attends today with plication of a small amount of the skin at both incisions which was necrotic and sloughed off. Now these areas are wider. The subcutaneous tissues are clearly exposed. The physician states that he did not see any evidence of the device. The physician exam found no evidence of surrounding infection. The skin is healthy and clean. The neck incision looks well healed. Per the notes, the surgeon states that the best thing to do is to take the patient back to the operating room and reclose the skin, as this would hopefully prevent infection, particularly in view of the patient's past history of infection (the patient's first vns was "lost due to infection" of (b)(6) - previously reported in manufacturer report #: 1644487-2012-00700). Clinic notes dated (b)(6) 2013 indicate that post vns insertion is complicated by infection removal. The vns placement was done okay, apart from the chest incision, where the skin has dehiscenced slightly. A physician exam indicates the incision on the chest dehiscenced in two places. Operative notes from (b)(6) 2013, indicate the patient's generator was explanted. When the chest incision was opened, there was a large amount of pus in the pocket around the generator. This was all evacuated and sent for culture and sensitivity. The neck incision was opened and pus was seen to be around the lead. The three electrodes were individually removed with the lead in its entirety. The lead and generator were both completely removed. Pulse irrigation was then used on both the neck and chest incisions to significantly clean this out and half inch gauze was then placed into the incisions. The patient was seen on (b)(6) 2013 and her incisions were treated with dressing changes. A physician exam indicated that her incisions were open, but red and granulating. The notes indicate that the isolated organism is staphylococcus aureus, which is sensitive to cipro and clindamycin i. The physician gave the patient this for 21 days in addition to further hydrocodone for pain. Notes dated (b)(6) 2013, found that the patient said she was unable to take the clindamycin and was not able to afford the cipro. Per the notes, the patient now has enough money to start the cipro again and has no new problems. Per a physical exam, the neck incision was well healed and the chest incision is still open but is granulating. There is no evidence of infection. The plan at this juncture, per the notes, is that the patient should restart cipro and would be seen in three months. The device manufacturing records for both the generator and lead were reviewed. Sterilization was confirmed. The patient's last programmed settings from (b)(6) 2013 was found in the manufacturer's internal programming history database.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3292619
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« Reply #21 on: July 11, 2018, 07:45:58 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices have not been received to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/09/2016. Supplemental mdr #7 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 7 is 09/09/2016. Date received by manufacturer (mo/day/yr), corrected data: 10/26/2016. Supplemental mdr #8 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 8 is 10/26/2016.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
The explanted generator and lead were received on 10/26/2016. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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 battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of; ¿fracture of lead(s) / explanted / due to lead break / high impedance¿ (lead section) and ¿pain¿ (lead section) were confirmed. A condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The ¿increased seizures¿ (patient section) allegation is beyond the scope of activities performed in the pa laboratory environment: however, the observed discontinuities may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During the visual analysis abraded openings were observed on the outer and inner silicone tubes and the quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break (found at 99mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strand was identified as being mechanically damaged with no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the areas on the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 160mm portion quadfilar coils 1 and 2 appeared to be broken. Scanning electron microscopy performed on the quadfilar coil 1 coil break identified the areas on the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. Scanning electron microscopy performed on the quadfilar coil 2 coil break identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strand. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. With the exception of the discontinuities and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to support the ¿fracture of lead(s) / explanted / due to lead break / high impedance / low impedance / low impedance message, short circuit condition¿ allegations.
 
Event Description
On (b)(6) 2016, it was reported that low impedance with <600 ohms was observed on patient's device. Possible causes were discussed and patient manipulation was ruled out. X-rays were planned to be sent for review. Programming history for the device was reviewed. The device was temporarily disabled sometime after (b)(6) 2012 till (b)(6) 2013 due to high impedance. It is suspected that the current low impedance may be related to the previous high impedance observed in 2012. No known product replacements have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that interrogation of the device resulted in high impedance >10,000 ohms. It was reported that the patient underwent generator replacement in (b)(6) 2012. The patient has been experiencing an increase in seizures and behaviors. The patient is being evaluated for replacement surgery. The patient was sent for neck and chest x-rays which were reviewed by the radiologist. The radiologist's review noted that the patient was experiencing neck pain. The review identified that the lead appears to be intact over the left lateral chest. The lead was coiled and was difficult to evaluate. Clinic notes dated (b)(6) 2013 noted that the patient's seizures have increased since the last visit in (b)(6) 2012. It was reported that the did well for several months following the last visit; however, 2 months ago she started experiencing an increase in seizures up to three to four generalized tonic-clonic seizures per week. It was also noted that the patient's mother reported that the patient's speech seems to have deteriorated and that the patient is having severe behavioral problems. The notes indicated that the recent increase in seizure frequency may be secondary to the vns malfunction. The notes indicate that the physician reduced the patient's settings from 1. 5ma/1. 8 min off to 1ma/3 min off. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely; however, has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent surgery on (b)(6) 2013. During the surgery after the patient was anesthetized, diagnostic tests resulted in normal impedance readings. The patient's head was turned in different orientations to rule out positional high impedance which were all within normal limits. Different programming systems were also used which also resulted in normal readings. The surgeon decided that he will not replace the lead since diagnostics were within normal limits. The surgery was aborted and the patient taken to recovery.
 
Event Description
Clinic notes were received for patient's full revision surgery referral. Notes dated 7/15/2016 indicate that the lead impedance was greater than 10,000 in 2013 and patient was referred to surgeon for a lead revision. On the day of surgery on (b)(6) 2013, intraoperative device showed that the lead impedance was not over 10,000 but rather was okay at 3069ohms. The surgeon tested the device several times with the different programming systems but all of the tests showed the lead impedance was okay and the lead impedance values ranged from 3060 to 3179 ohms. As a result, the surgeon did not revise the lead at that time. More recently, patient was seen by the neurologist and the lead impedance was less than 600 ohms, and so patient was referred back to surgeon for evaluation and management. A chest x-ray was performed, which showed a lead fracture. According to caregiver, patient's seizures have been increasing in frequency. Patient had done quite well over the past couple of years, but more recently, within the past six months, experienced an increase in seizure frequency. Patient has had no real behavioral concerns until just recently likely related to the vns not working because of the lead fracture. Lead revision is planned but has not occurred to date.
 
Manufacturer Narrative
Describe event or problem: supplemental mdr #3 incorrectly reported that the high impedance was observed in 2012, when in fact, it was only observed in 2013.
 
Event Description
Lead product information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3115964
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« Reply #22 on: July 11, 2018, 07:46:38 AM »

Model Number 102
Event Date 07/18/2008
Event Type  Injury   
Event Description
It was reported that the vns pt was hospitalized due to pain in right lower extremity and bumps in the right forearm. The pt was diagnosed with deep vein thrombosis at the level of the popliteal vein and thrombus in the greater saphenous vein. The right upper extremity showed some non-occlusive thrombus in the right cephalic vein. Further follow-up revealed that the pt has a history of thrombosis post surgically, therefore it has been determined by the physician that the event is a result of the implantation procedure, and the event is not related to the vns device.
 
Manufacturer Narrative
Implantation procedure caused event, no device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147204
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« Reply #23 on: July 11, 2018, 07:47:10 AM »

Model Number 102R
Event Date 02/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain. The patient¿s asthma had exacerbated at the time. The patient was given steroids and an inhaler and the symptoms resolved. The patient later reported experiencing pain at the lead site and pain from laughing and coughing. The patient also reported discomfort at night and began snoring. The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night. The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort. Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing. The patient is expected to receive antibiotics and a follow-up x-ray. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800594
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dennis100
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« Reply #24 on: July 11, 2018, 07:47:53 AM »

Model Number 103
Event Date 06/22/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt reported a "tickle" in her ear with stimulation. Pt underwent cardiac pacemaker implantation and post operatively her neck pain became severe. Consequently, pt's generator settings were lowered from 1. 25ma to 0. 75ma and pt's neck pain was resolved. The physician believed that he may have titrated the pt generator settings too fast.
 
Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the patient's cardiac events were not related to vns. On (b)(6) 2011, the physician reported that the patient has not complained of any neck pain or ear tickle and that they are improved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2190432
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dennis100
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« Reply #25 on: July 11, 2018, 07:48:37 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 12/02/2016
Event Type  Injury   
Event Description
Patient underwent full revision surgery due to experiencing hiccups constantly for 8 days. Patient had the device disabled previously. The explanted devices were reported to have been discarded.
 
Manufacturer Narrative

Event Description
It was reported that this patient has experienced hiccups for 7 days since (b)(6) 2016. Per his neurologist, the hiccups might be vns related. Patient has been implanted for a substantial amount of time and the hiccups presented "randomly" as there had been no change in generator settings for a while. Patient's neck was also mentioned to be tender to the touch at the site of the electrode. This "pain" was persistent and is not associated with stimulation. Additional information was received that the hiccups subsided after using the magnet to disable the device. When a system diagnostic test was run, patient experienced a bad coughing attack. As a result of these recent issues, the patient¿s device was disabled on (b)(6) 2016. Diagnostics showed impedance of 2986 ohms with no warning messages. The physician is considering a full revision as a result of these symptoms. There are no known catalytic events that occurred preceding these events. Neck, chest and spine x-rays were received along with an assessment. Per the assessment, there is no apparent change in position of neurostimulator leads over the anterolateral aspect of the left neck base compared to the prior x-rays on (b)(6) 2014. The lead wires appear intact. The appearance of the electronic device and wires is unchanged since prior films. Per internal assessment of the x-rays, the placement of the generator and lead, strain relief and tie downs were all present per labeling. There were no apparent sharp angles or gross fractures of the lead that could be seen in portion of the lead that could be visualized in the images given. Based on the x-rays received, the cause for the pain and muscle spasms could not be determined. The presence of a micro-fracture in the lead also cannot be ruled out. Per decoder data reviewed, patient had a recent change in vns settings on (b)(6) 2016, where the normal output current was increased from 1. 25 to 1. 5 ma. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6220428
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dennis100
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« Reply #26 on: July 11, 2018, 07:49:42 AM »

Model Number 103
Event Date 08/12/2014
Event Type  Injury   
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.
 
Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.
 
Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278678
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dennis100
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« Reply #27 on: July 11, 2018, 07:50:51 AM »

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

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
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
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
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 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.
 
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 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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
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dennis100
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« Reply #28 on: July 11, 2018, 07:53:10 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 02/20/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to pain shooting up her neck and back of her head that had been occurring for a few hours. The patient also had spasms and twitching on the left side of her body. The physician wanted to disable the device, so instructions on how to use the magnet to disable it were given. The patient was then admitted to the icu and intubated due to unknown reasons, and it was reported that most of the patient's seizures were pseudo-seizures. The physician stated that the patient was reporting that her vns was misfiring, but he did not seem to believe the patient based on her report of false seizures. Because the patient had no insurance or following neurologist, the physician requested that the device be programmed off until it could be properly managed. No further relevant information has been received to date.
 
Event Description
It was reported that the patient was found at a bus stop in status, so she was hospitalized. The patient's device was communicated with, and everything was within normal limits. The physician did not believe the status episode was related to vns as the eeg showed no true seizure activity. The patient's device was functioning as intended. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343586
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dennis100
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« Reply #29 on: July 11, 2018, 07:58:29 AM »

Model Number 302-20
Event Date 05/24/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by a physician's office that a system diagnostic test returned high impedance for the pt. The pt's output currents were disabled, and the pt reportedly had pain above his generator for approx one week. X-rays of the pt's device were taken. Attempts for further info have been unsuccessful to date. A revision surgery in the future is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2170976
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