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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 01/01/2008
Event Type  Malfunction  
Event Description

Reporter indicated that the programming wand did not work. Troubleshooting was done by manufacturer representative and wand still would not work. Products have been requested, but have not been returned to manufacturer to date.

 
Manufacturer Narrative

Device malfunction is suspected, but did not cause or contribute to a serious injury or death.

 
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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 Key1236210
Report Number1644487-2008-02575
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/26/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2008
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? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/26/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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