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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 07/24/2008
Event Type  Malfunction  
Event Description

It was reported to manufacturer that the site was experiencing communication difficulties with the programming wand. Troubleshooting was performed which included resetting the hand held, checking the cable connections and replacing the 9v battery, none of which resolved the communication problems. The non-working programming wand was returned to manufacturer for analysis. Analysis revealed that the serial data cable which produced communication errors, had an open conductor and the wand battery was depleted. After the serial data cable and the battery was substituted, the device performed as intended.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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.
suite 600
houston , TX 77058
2812287200
MDR Report Key1134876
Report Number1644487-2008-01946
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/24/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2008
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 Manufacturer08/07/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received07/24/2008
Was Device Evaluated By Manufacturer? Yes
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 Initial

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