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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Type  Injury  
Event Description

Reporter indicated that the pt had begun having an increase in seizure activity, and had been having more "head drops" which the mother feels is what happens when the generator battery is depleted. The treating neurologist stated that the generator was tested and showed the battery to be working properly at the time of the report. The pt has since undergone a generator replacement surgery which was stated as being due to end of service. The explanted generator has been returned to the manufacturer for analysis, but analysis is not yet complete. All attempts for further info from the treating physician have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1559818
Report Number1644487-2009-02774
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/12/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2007
Device MODEL Number102
Device LOT Number014513
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/08/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/12/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/11/2009 Patient Sequence Number: 1
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