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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 10/04/2008
Event Type  Malfunction  
Event Description

It was reported that a physician was receiving an error message whenever she tried to use her programming wand. A manufacturer representative was present, switched out wands, and the issue resolved. Routine troubleshooting was performed however, the error message was still present. The physician's wand was replaced and sent back to the manufacturer for analysis. The evaluation of the returned device has not been completed at the time of this report.

 
Manufacturer Narrative

Conclusions: device failure suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NamePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1216047
Report Number1644487-2008-02611
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/04/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/24/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/04/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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