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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.GEN MODEL 102

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CYBERONICS, INC. GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 06/01/2008
Event Type  Injury   Patient Outcome  Other
Event Description

Initial reporter indicated that the pt had manic episodes after the device was turned on about two weeks after implant in 2008. Physician stated that "pt had no previous psychiatric history. Family reported that pt has high elevated moods (being too happy) and had uncontrollable giggling and laughing. " additionally, reported "when pt first came into the appointment, he was quite reserved, but after awhile he was being quite talkative and kept on saying he's 1 years old. " pt was at 0. 25ma, 30, 500, 30sec, 5min, magnet 0. 5ma, 500 and so physician turned the device to 0ma. After that, the pt calmed down and slept a lot. A week later, the physician turned pt back up to 0. 25, 30, 500, 30sec, and 20 min off. The pt is reported to be doing fine currently.

 
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Brand NameGEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section G)
Manufacturer Contact
michelle carroll
100 cyberonics blvd., ste. 600
houston , TX 77058-
(281) 228 -7200
Device Event Key1075937
MDR Report Key1098144
Event Key1055175
Report Number1644487-2008-01781
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/08/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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