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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 Date 06/01/2011
Event Type  Injury  
Event Description

Reporter indicated a vns patient had prophylactic generator replacement surgery due to increased seizure frequency. Attempts for further information are in progress. The explanted generator has been returned and is currently in product analysis.

 
Event Description

Product analysis was completed on the returned vns generator. There were no performance or any other type of adverse conditions found with the pulse generator, and the generator performed per specifications. All attempts to the reporter for additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2253955
Report Number1644487-2011-02210
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2006
Device MODEL Number102
Device LOT Number011114
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/30/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/20/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/23/2004
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: 09/19/2011 Patient Sequence Number: 1
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