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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 09/09/2011
Event Type  Injury  
Event Description

The pt's husband reported that he wanted the device removed. Per the reporter, the pt had "nothing but problems and they had to have it shut off and now they have to have it removed". Specifics were requested, but the report only stated the pt "drooled a lot and had difficulties". Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2276546
Report Number1644487-2011-02294
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/09/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/09/2011
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
Type of Device Usage Initial

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