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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction  
Event Description

It was reported that during a prophylactic generator replacement surgery, the handheld date and time were unable to be programmed and the patient's initials were unable to be set. A different programming system was obtained and successfully programmed the patient's generator. The physician was provided a new programming tablet. The handheld and flashcard are expected to be returned for analysis, but has not been received.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key4338713
Report Number1644487-2014-03383
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2014
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 NumberVRESION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/01/2014
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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