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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 07/01/2008
Event Type  Malfunction  
Event Description

Initial reporter indicated that "their wand would not communicate; the battery was changed without any results. The wand was able to perform a test on a demo and everything was working perfectly" when he was in a different location. Good faith attempts are being made for the product to be returned for analysis.

 
Manufacturer Narrative

Device malfunction 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
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1084418
Report Number1644487-2008-01726
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/02/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/02/2008
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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