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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
Device Problem Device Displays Incorrect Message
Event Date 06/01/2009
Event Type  Malfunction  
Event Description

It was reported that a physician's handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. The physician was notified that the phenomenon occurs with pt's generators whose total operating time and total on time has rolled over. The physician was also notified that the event will resolve on its own once 15 magnet activations have registered following the total operating time rollover. 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.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1479460
Report Number1644487-2009-01533
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/19/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number584960
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/19/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2008
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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