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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 07/01/2008
Event Type  Malfunction  
Event Description

It was reported that a programming wand was not "working good at all times. " the wand was tested, and could perform an interrogation, and programming on a demo generator, without any problems. The wand was returned to the mfr. Product analysis revealed that the serial data cable, which produced the communication errors, had intermittent conductors. No other anomalies were identified.

 
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
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1156416
Report Number1644487-2008-02153
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/13/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2008
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 Manufacturer08/07/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received08/13/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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