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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 02/11/2015
Event Type  Malfunction  
Event Description

It was reported that the handheld device showed a "check sum¿ error message. It was confirmed that there were no issues with the wand battery. The handheld was not plugged into the power outlet and a hard reset did not resolve the issue. Interrogation was attempted in a different area of the room but the issues continued. The components of the programming system were switched out but the source of the issue could not be located. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Product analysis was completed for the handheld device and software flashcard. No anomalies associated with the handheld device or software flashcard were noted during testing. The handheld device and software flashcard performed according to functional specifications. Information was received that the issue was resolved with the new tablet. The handheld device serial cable will not be returning 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 Key4582152
Report Number1644487-2015-04090
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 02/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073773
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/20/2006
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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