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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 09/02/2008
Event Type  Malfunction  
Event Description

Initial reporter indicated that they were told by a physician "that they were having some issues with their programming wand. Batteries were changed without results. Another wand was used and everything worked perfectly. " the programming wand is being sent to manufacturer for 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 77058-2017
2812287200
MDR Report Key1190594
Report Number1644487-2008-02419
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/09/2008
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? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/09/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2005
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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