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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 07/02/2008
Event Type  Malfunction  
Event Description

A manufacturer representative was at a physician's office to show him how to use the programming system. When she used her programming wand, the data received light on the handheld device would flash but the data would not go through. Troubleshooting steps were taken and the issue was not resolved. Product return is pending for product analysis.

 
Manufacturer Narrative

Device failure 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 Key1085033
Report Number1644487-2008-01677
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
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 Received07/30/2008
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? No
Date Manufacturer Received07/02/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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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