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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 08/06/2008
Event Type  Malfunction  
Event Description

It was reported to a mfr consultant that the physician had a programming wand that was not "working". The wand was returned for product analysis. The serial data cable, which produced communication errors, had an intermittent conductor. A known good bench serial data cable was substituted and all communications errors cleared. After the serial data cable was substituted, the programming wand was electrically tested and was operating within the designed limits of the final electrical test requirements.

 
Manufacturer Narrative

Device malfunction occurred, 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
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1193200
Report Number1644487-2008-02437
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/17/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2008
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 Manufacturer09/25/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/17/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2003
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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