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Author Topic: Shocking Sensation  (Read 103890 times)
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dennis100
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« Reply #330 on: June 07, 2019, 05:32:56 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
During a surgery consult appointment for "battery depletion," the patient reported a shocking sensation with the vns stimulation. The neurosurgeon has referred the patient for an x-ray prior to scheduling the patient for a replacement of their generator. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8578296
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dennis100
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« Reply #331 on: June 08, 2019, 06:44:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Event Description
It was reported that the patient's vns was "misfiring" and had fired 36 times in one day. The er physician indicated that the vns kept going off every minute per the patient and would not stop. Magnet disablement was recommended, but the patient and facility requested a company representative program the vns off. A second call was received from the facility. Magnet disablement resolved the issue, but it was still requested to have the vns programmed off. It was believed by the medical professional that the patient experienced painful stimulation since they requested the vns programmed off. The patient was discharged from the facility. Information was later received indicating that the ¿misfiring¿ meant the patient experienced a shocking sensation and that the medical professionals did not wish to disable the vns as they did not want the patient to have seizures. The diagnostics from the latest clinic visit after the admission were reported as within normal limits. The patient was referred for a vns lead replacement surgery due to the painful stimulation. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8654203
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dennis100
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« Reply #332 on: June 13, 2019, 03:40:34 AM »

Model Number 304-20
Device Problem Fracture
Event Type  Malfunction   
Event Description
It was reported that the patient had x-rays taken and had a lead fracture. The x-rays have not been reviewed by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
X-rays were received and reviewed by the manufacturer. Based on the images provided, no obvious source of the high impedance condition was identified. Although no gross lead fracture can be observed, a micro-fracture in the lead cannot be ruled out. A portion of the lead is possibly behind the generator and cannot be visualized, therefore a lead fracture in that portion of the lead cannot be ruled out.
 
Event Description
Additional information was received from the physician via clinic notes. They stated that the patient had an electric shock sensation in his neck which was concluded to be associated with the high impedance reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7066115
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dennis100
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« Reply #333 on: Today at 01:48:39 AM »

Model Number 304-30
Device Problem Fracture
Event Date 09/16/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Report received that a patient's vns was interrogated and high impedance was observed. The patient reported that he stopped feeling stimulation four months prior to this observation. It was reported that trauma was not suspected to have contributed to the high impedance. No surgical interventions have occurred to date. No further relevant information has been received.
 
Event Description
It was reported that the patient was feeling a shocking sensation in his chest, so the physician programmed the device off. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7261480
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