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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 05/05/2011
Event Type  Injury  
Event Description

Reporter indicated a vns pt was having a "significant increase" in seizures and had vns generator replacement surgery performed. The generator is not at end of service per the reporter. The explanted generator has been returned and is currently in product analysis. Attempts for further information are in progress.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2115025
Report Number1644487-2011-01226
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2008
Device MODEL Number102R
Device LOT Number015227
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/16/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/05/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2006
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: 06/02/2011 Patient Sequence Number: 1
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