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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 MODEL 250
Event Date 02/27/2012
Event Type  Malfunction  
Event Description

It was reported by a physician's assistant that the patient's magnet activations were showing the same dates and times over and over again. The physician's assistant also reported that the generator's total operating time had rolled over. No additional information was provided and attempts for additional information have been unsuccessful to date. A manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (b)(4) being mis-declared as static variable, however the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2506428
Report Number1644487-2012-00833
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 02/28/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/28/2012
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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