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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 08/22/2008
Event Type  Malfunction  
Event Description

Reporter indicated a vns therapy handheld programming system received a "failure to establish communication" error message. The programming system has been returned to the manufacturer is pending product analysis.

 
Manufacturer Narrative

Device malfunction is 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
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1172587
Report Number1644487-2008-02289
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/22/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/09/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received08/22/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2004
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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