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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 07/01/2008
Event Type  Malfunction  
Event Description

It was reported that the serial adapter cable and the wand were malfunctioning. Reporter has been facing communication problems when using the wand with other handhelds and his handheld with other wands. Troubleshooting was performed and the system was returned for product analysis. Product analysis on the wand revealed that the serial adapter cable is the problem component due to an intermittent conductor. A known good bench serial data cable was substituted and all communication errors cleared.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1133586
Report Number1644487-2008-01953
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
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
Device MODEL NumberMODEL 250
Device LOT Number521375
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/06/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received07/24/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2006
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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