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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 250
Event Date 02/01/2010
Event Type  Malfunction  
Event Description

It was reported that the physician's hand held was not charging properly with the ac adapter cable. The physician used another working ac adapter cable and the hand held was able to be charged with no further problems. Good faith attempts to obtain power cord (ac adapter cable) for analysis have been made, but the cord has not been returned to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to death or serious injury.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1639311
Report Number1644487-2010-00646
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/15/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/15/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2007
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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