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dennis100
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« on: December 31, 2018, 09:45:30 AM »

Device Problem Malposition of device
Event Date 01/03/2011
Event Type  Injury   
Event Description
It was reported by a company representative that a vns pt was scheduled to undergo repositioning of the generator. The pt had recently undergone vns re-implant surgery on (b)(6) 2010 and now was scheduled to have generator repositioning due to discomfort from the present generator positioning. Further info was received from a company representative indicating the pt had cancelled her surgery due laboratory abnormalities, including a high ammonia level per pt that caused procedure to be postponed. At the moment, no appointment has been scheduled. Good faith attempts to obtain additional info from the treating neurologist have been unsuccessful to date.
 
Event Description
Operative notes were received from the (b)(6) 2011 repositioning surgery. The patient had indicated that she had been unhappy with the location of the generator as the lead was too tight and the battery was too close to her clavicle and shoulder. The note indicated that the lead was coiled up in scar tissue from the previous vns battery underneath the pocket of the old battery. Once the surgeon freed the lead up, there was plenty of loose lead in the subclavicular region; however, it was still a bit tight in the neck. Therefore, he opened the neck incision, cut and removed one of the tie-downs and then cut the second tie-down and lowered it inferiorly, anchored that one to the sternocleidomastoid muscle but in a lower area which freed up more of the lead in the neck region. He then created a new pocket for the generator. Post-operative diagnosis was neck pain from the vns lead.
 
Event Description
On (b)(6) 2011 additional information was received when the physician reported that he referred the patient to a surgeon for repositioning of the generator. The surgery took place on (b)(6) 2011. The generator was repositioned along with the lead body; the lead on the nerve was not adjusted. The device was interrogated and system diagnostics showed results within normal limits with a dcdc code of 2 and lead impedance showing ok. The patient's generator was let at previous settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1975979
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dennis100
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« Reply #1 on: December 31, 2018, 09:46:38 AM »

Model Number 103
Event Date 06/01/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013, noted that the patient experienced worsening of seizures and hospitalization over the summer. It was noted that his course was complicated by hyperammonemia on depakote and very poor nutrition. It was noted that the depakote was discontinued and clobazam was started. He was given a g tube and is getting isosource 1. 5 and has not been allowed to eat or drink by mouth. The patient's mother indicated that the patient is now having daily seizures that are mild - just repetitive movement of his eyes with unresponsiveness that lasts less than 30 seconds. It is unknown if the worsening of seizures is above pre-vns baseline frequency. An attempt to obtain additional information has been unsuccessful to date.
 
Event Description
Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: the information reported on supplemental mfr. Report #01 was incorrect and should have been reported at 12/30/2013 rather than 12/30/2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3513178
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dennis100
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« Reply #2 on: December 31, 2018, 09:47:22 AM »

Model Number 102
Event Date 05/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received which provide the patient's seizure history. It was stated that the patient is still having seizures daily. The patient's last seizure was a grand mal seizure that lasted 2 minutes that day, and prior to this was the same type and length of seizure on (b)(6) 2013. The patient has continued with nocturnal events semiology of complex partial seizures per his baseline. He began having daily episode of quick head drops about one week prior to this date. His mother noted drainage from his left ear and had scheduled a follow up appointment to the ear nose throat doctor. It was noted that prior ear infections have been a trigger for the patient's epilepsy and mcad related hypoglycemia. Following a neuro metabolic consult, genetic testing confirmed the patient had mcad. Following the introduction of banzel, the patient became seizure free with associated improved cognition and psychomotor activation. Drop seizures returned in clusters with recurrent ear infections. They continued to increase in their daily frequency to greater than one hundred per day despite increasing doses of banzel and increased use of benzos. In addition, they were less responsive to use of the vns magnet. However, the notes also mention that the patient's mother was observed to be using the magnet incorrectly and was instructed on the correct use of the magnet during this office visit. The patient is experiencing nightime seizures which resolved with the addition of banzel; however, it was stated that it was unclear when they began to reoccur nightly. During the patient's last visit, the patient's lack of consciousness and multiple drop attacks of unclear etiology were noted resulting in patient hospitalization. During hospitalization, increased ammonia was noted. In addition, the patient was markedly responsive to iv, concluding that his presenting state was metabolic related. The patient's medication was increased and the eeg was conclusive for non-epileptic as well as epileptic events. At follow up, the patient's cognition was markedly improved over prior visits. In regards to the daily episodes of quick head drops that started a week prior, which had the semiology of non-epileptic events associated with hypoglycemia and increased metabolic needs. Attempts for additional information were made; however, they were unsuccessful. No additional information was provided.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2013. The generator was returned for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. 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 device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3192841
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dennis100
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« Reply #3 on: December 31, 2018, 09:48:18 AM »

Model Number 104
Event Date 10/17/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the patient recently underwent a battery replacement on (b)(6) 2012 and the device was turned on in the operating room. Since the replacement surgery the patient was admitted to the hospital on (b)(6) 2012 due to nausea and vomiting. On (b)(6) 2012, the patient had started coughing and the mother stopped the stimulation with the magnet and took the patient to see his physician who decreased his settings and the coughing stopped. The son then started having dizziness and a blood test at that time revealed that the patient's ammonia level was high. One of the patient's seizure medications was tapered down at that point. During that time, the patient stopped eating and had decreased appetite. On (b)(6) 2012, the patient started having nausea and vomiting. The patient's mother was unsure if it occurred during stimulation or not. On (b)(6) 2012, the patient was taken to the emergency room due to the vomiting not stopping. Blood tests in the emergency room revealed that the patient's ammonia level was okay but the potassium level was low. During this time, the patient's dizziness had persisted according to the mother. The patient was sent home that same day and was still nauseated. The reporter stated that the physician believed that the patient had a distended bladder. On (b)(6) 2012, the patient was taken to the emergency room again and was given medications to help with the nausea and vomiting and was sent home. On (b)(6) 2012, the patient began experiencing severe dizziness and vomiting. The patient was taken to the hospital on (b)(6) 2012 and was admitted to the hospital. On (b)(6) 2012, the device was temporarily disabled until monday, (b)(6) 2012 to see if there is any improvement in the patient's condition. The reporter stated that the patient was still in the hospital on (b)(6) 2012 and the physicians have diagnosed the patient with a bladder disorder and don't seem to think there is an actual problem. The reporter also mentioned that the physicians have also explained that the patient has slow bowel movements which may be contributing to nausea, vomiting, and the eating disorder the patient was experiencing. It was later reported on (b)(6) 2012, the physicians haven't been able to identify the recent cause of the vomiting and other issues since the recent tests were "negative", so the patient may be readmitted to the hospital soon. The patient's settings have been decreased to half of what they were on date of implant, but it was still unclear if the issues had been resolved with this change. The patient had his device programmed off, and is still experiencing the events. On (b)(6) 2012 a physician at the hospital reported that he did not have enough information to know if the patient's events were related to vns as he is not too familiar with the patient. The patient's neurologist wondered if there could be anything leaking from the vns generator that could cause the nausea and vomiting resulting in weight loss the patient has been experiencing. The neurologist stated that she doubts that the device is leaking but that she doesn't know what is causing the patient's issues. The neurologist stated that the patient's nausea, vomiting, and dizziness are not associated with stimulation. She stated that they disabled the vns but the symptoms persisted. No causal or contributory programming or medication changes preceded the onset of the events. The patient does not have a medical history of nausea and vomiting prior to vns but does have a history of decreased appetite prior to vns.
 
Event Description
The patient's mother reported that the patient had a 51 day hospitalization for nausea and vomiting in (b)(6) 2012 that was ultimately found to be due to a reaction from two seizure medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2917858
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dennis100
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« Reply #4 on: January 01, 2019, 04:25:17 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2015
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized two weeks after vns placement with altered mental status, hyperammonemia, and a metapneumovirus infection. The hyperammonemia improved slightly over the course of her hospitalization, but did not return to normal. After a few days of being unresponsive, it was reported that the patient woke up spontaneously. A review of device history records for the lead and generator shows that no unresolved non-conformances were found. The device met all specifications for release and were sterilized prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7958576
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