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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 01/15/2015
Event Type  Malfunction  
Event Description

It was reported that the nurse was having issues performing interrogations with her programming system. The programming system displayed an ¿unable to open port: the system cannot find the file specified¿ error message. The connections were checked, the programming wand battery was replaced, and the programming wand was reset; however, the issues did not resolve. Clinic notes were received indicating that the issues were believed to be due to the serial adaptor of the tablet device. The suspect serial cable has not been returned to date.

 
Event Description

It was reported that the serial cable was disposed by the facility and cannot be returned for analysis.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4494052
Report Number1644487-2015-03779
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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