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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 09/08/2008
Event Type  Malfunction  
Event Description

Initial reporter indicated that their programming wand was getting the error message "error establishing communication. " the battery in the wand was checked and it was "fine" and the programming system was not plugged into the wall. The wand is at manufacture pending completion of product analysis.

 
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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 Key1190683
Report Number1644487-2008-02421
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 09/08/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/06/2008
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? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/08/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2004
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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