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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 10/02/2008
Event Type  Malfunction  
Event Description

It was reported to the manufacturer that the programming wand was not establishing communication with patient's generator. Troubleshooting did not resolve the issue. Issues with patient's generators have been ruled out as a back system was used immediately which resolved the communication issues and the patient's generator was successfully programmed. A replacement wand was sent to the site which had no further issues and the defective wand was returned to the manufacturer for product analysis.

 
Manufacturer Narrative

Device malfunction is 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 Key1220044
Report Number1644487-2008-02631
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/03/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2008
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 Manufacturer10/29/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/03/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2008
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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