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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 09/04/2008
Event Type  Malfunction  
Event Description

It was reported to mfr that the physicians programming system was not working and a replacement was requested. Troubleshooting was performed and despite having replaced the wand battery with a known good 9v battery, communication could not be established with a demo generator using two different known working handhelds. The non-working programming wand has been returned to mfr and analysis is underway.

 
Manufacturer Narrative

Conclusions: device failure is suspected, 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
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1188719
Report Number1644487-2008-02402
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2008
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 Received09/04/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2002
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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