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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 07/09/2008
Event Type  Malfunction  
Event Description

It was reported that a programming wand was not working. Troubleshooting did not resolve the issue. The programming wand was returned to the manufacturer for analysis. It was identified that the serial data cable had an intermittent conductor which produced communication errors. It was also visualized that the strain-relief grommet was dislodged rendering the strain-relief function ineffective. It was confirmed that the dislodged strain-relief grommet did not compromise the integrity of the serial data cable connections.

 
Manufacturer Narrative

Device failure occurred, 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
michael carroll
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1085039
Report Number1644487-2008-01736
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/09/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2008
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 Manufacturer07/11/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/09/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2004
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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