I was reading the FDA MAUDE REPORTS and found this.
Everyone needs to read the reports.
Adverse Event Report
CYBERONICS DEFIBRILLATOR FOR SEIZURE back to search results
Event Description
Mother called to report that her daughter who is mentally impaired started to scream because of programming difficulties and inappropriate shock. She also got blister on her arm at the implantation side. Pt was then explanted, but the lead was remained and was determined that the lead became loose. After surgery and explantation, pt stopped screaming. Reporter stated that they filed a law suit and also learned that the suspect device was recalled.
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Type of Device DEFIBRILLATOR FOR SEIZURE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CYBERONICS
Device Event Key 1047587
MDR Report Key 1078777
Event Key 1036708
Report Number MW5007720
Device Sequence Number 1
Product Code LYJ
Report Source Voluntary
Report Date 07/22/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/22/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Other
Is the Device an Implant? No
Is this an Explanted Device?