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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 01/01/2008
Event Type  Malfunction  
Event Description

No problems were noted prior to return of device, but wand was returned to mfr and underwent product analysis. Upon analysis, it was discovered that the serial data cable had open and intermittent conductors which caused communication errors. Serial data cable was replaced with known good bench cable and all communication errors cleared. Everything else was operating within normal limits and no visual anomalies were observed.

 
Manufacturer Narrative

Device failure 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 77058-2017
2812287200
MDR Report Key1191906
Report Number1644487-2008-02186
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/05/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/02/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received09/05/2008
Was Device Evaluated By Manufacturer? Yes
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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