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Author Topic: Anorexia  (Read 1357 times)
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dennis100
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« on: April 13, 2018, 01:53:36 AM »

Model Number 302
Event Date 06/01/2007
Event Type  Injury   
Event Description
Since i was implanted with cyberonics, inc vagus nerve stimulator in 2007, i have suffered a series of adverse reactions. These included: weight loss over a 2 month period- requiring 2 hospitalizations for dehydration -due to anorexia and abdominal pain-; severe left ear pain requiring visits to my ent and subsequent lowering of the strength of stimulation; severe shortness of breath accompanied by airway constriction, and low blood oxygen levels requiring evaluation by a pulmonologist, pulmonary function studies, and a cat scan; sleep hypopnea demonstrated by polysomnogram and a choking sensation. I must use the magnet provided by cyberonics inc at least 75% of the time. The stimulator, which was implanted for trd, never seemed to relieve my depression. Dates of use: 2007 - 2008. Diagnosis or reason for use: trd. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1033973
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dennis100
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« Reply #1 on: April 13, 2018, 01:54:04 AM »

Event Date 01/01/2009
Event Type  Malfunction   
Event Description
Voluntary report # (b)(4) was received indicating that the patient began experiencing increased neck and shoulder pain as well as increased seizures. The report date of the voluntary report was indicated as (b)(6) 2012. The physician reportedly indicated that they believed this was arthritis and referred the patient to a pain specialist. The device could reportedly be seen migrating and had "disconnected". The report indicated that the physician "decreased the voltage". The vns was reportedly removed 6 months following the initial complaint however it was not indicated if this refers to the vns lead, generator, or both. It was noted keppra and vimpat were added to the patient's treatment plan and she was already taking dilantin and gabapentin. The patient reportedly developed anorexia and is losing weight. There is a comment indicating "she is now (b)(6)" however it is not indicated what this is referring to. It was also noted that the patient is having trouble walking and has developed tremors however the patient reportedly feels these are related to the medication but it is indicated that drug levels have not been taken in some time despite requests from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2721027
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dennis100
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« Reply #2 on: April 13, 2018, 01:54:35 AM »

Model Number 102
Event Date 03/15/2013
Event Type  Injury   
Manufacturer Narrative
Date of event: new information identified when the events started.
 
Event Description
It was reported that the events resolved on (b)(6) 2013.
 
Event Description
It was reported that a vns patient since being implanted (b)(6) 2013 presented with drowsiness, with nausea, vomiting, anorexia, aspiration when feeding from the implant. No rhythmicity depending on the frequency of stimulation. The patient therapy has been titrated per their study protocol. The patient had persistence of their symptoms the parents contacted the surgeon, who offered to temporarily stop their therapy to see if there would be improvement and check relationship to their device. Symptoms partially regressed between (b)(6). They disabled their device on (b)(6), and started again with modified settings (b)(6) the 2013. In the meantime, no change in symptoms. Their following physician does not think that the symptoms are related to the stimulation, provided that the patient has since developed a cold sore and fever. Only food-initial aspirations are potentially linked, in their opinion. No change in medication was reported and no medicinal treatments.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132031
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dennis100
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« Reply #3 on: April 13, 2018, 01:55:04 AM »

Event Date 01/01/2009
Event Type  No Answer Provided   
Event Description
Rptr began to have increased neck and shoulder pain and increased seizures. The dr said it was arthritis and sent her to a pain specialist. It could be seen migrating, the device had disconnected. Decreased the voltage. Rptr finally had it removed 6 mos after her initial complaint. She was placed on additional anticonvulsants keppra and vimpat. She was already on dilantin and gabapentin. Rptr has developed anorexia and is losing weight. She is now (b)(6). She also is having trouble walking and has developed tremors. She feels it is from the medication and expresses concern that it has taken her physician so long to take drug levels when she has been wanting them done. Now he wants to take a battery of lab tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666397
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dennis100
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« Reply #4 on: April 13, 2018, 01:55:30 AM »

Model Number 105
Event Date 03/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient developed apathy and anorexia after his device was first programmed on. The physician is looking at multiple possible etiologies. The patient has pituitary dysfunction due to six brain surgeries for a pinealoma. The patient¿s device was programmed off during an office visit on (b)(6) 2014. Further follow-up revealed that the patient was last seen on (b)(6) 2014. At that time, it was noted that the patient had gained weight and had improved mental status since the device was programmed off. The patient was previously overweight and had been very talkative. Clinic notes from the patient¿s office visit stated that the patient¿s issues were likely not related to vns as the patient¿s device settings were very low. It was also noted that the patient had recently moved, and this may have had an effect on the reported events. The patient¿s device was to remain programmed off until the patient¿s next office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3792218
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dennis100
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« Reply #5 on: April 13, 2018, 01:55:59 AM »

Event Date 03/19/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was able to tolerate an output current programmed to 1. 25ma but began experiencing adverse effects when the output current was programmed to 1. 5ma. Since this programming change, the patient was experiencing anorexia, decreased appetite, constipation and urinary retention. The physician decreased the output current to 1ma; however, this did not resolve the patient¿s issues. The patient¿s device was programmed off. The patient¿s issues resolved when her device was programmed off. 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=3750550
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dennis100
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« Reply #6 on: April 13, 2018, 01:56:31 AM »

Model Number 102
Event Date 09/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing weight loss and anorexia in (b)(6) 2014 that may be related to vns. The healthcare profession indicated that the patient¿s medications may be related to the event and that the patient had a history of weight loss prior to vns. The patient¿s mother determined to proceed with device explant. It was noted that the patient had not received efficacy from his device. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received indicating that the patient did not have anorexia prior to vns. The physician stated that the patient¿s anorexia was related to vns. The explant surgery was elective and not to preclude a serious injury. It was noted that the patient¿s device settings were not able to be increased to therapeutic levels due to the patient¿s tolerability issues with anorexia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4614392

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dennis100
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« Reply #7 on: August 21, 2018, 08:43:29 AM »

Model Number 103
Event Date 12/31/2010
Event Type  Injury   
Event Description
It was initially reported that the pt has been experiencing chest pain and a feeling that the generator was moving since implant especially when taking in a breath. Pt had cardiac arrest twice in may and was in the icu at the time of the initial report. The generator was disabled and the pain was reported to have stopped. Add'l info was received from the physician's office that indicated that the pt was taken to the er after going into cardiac arrest where she was resituated and placed on a ventilator. When the pt was removed from the ventilator she would go back into cardiac arrest. It was indicated that the pt has been complaining of pain in the chest, which was described as both an irritation and supposed heart palpitations with vomiting. When the pt had a work up by the cardiologist there were no apparent issues. It is not clear to the physician if the events are in fact related to the device or psychosomatic. The pt is anorexic so it is unclear what effect that has had on the cardiac issues that pt has been experiencing. It is unk what the plan is or if interventions will be taken. The pt's mother wants vns removed. Good faith attempts for more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141191
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