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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 08/28/2008
Event Type  Malfunction  
Event Description

It was reported that a programming wand was not working properly due to a "cinched" cord. The site does not know the cause for the "cinched" cord. A new wand was sent to the site, and the old wand has been returned to the manufacturer for analysis.

 
Manufacturer Narrative

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

 
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Brand NamePROGRAMMING WAND
Type of DevicePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
houston , TX 77058-2017
2812287200
MDR Report Key1191503
Report Number1644487-2008-02358
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/28/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2008
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? Yes
Date Returned to Manufacturer09/08/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/28/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2004
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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