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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 07/08/2009
Event Type  Malfunction  
Event Description

It was reported that multiple magnet activations were displayed during the interrogation of a pt's generator. Add'l info received revealed the pt had not used the magnet since his seizures are controlled. The neurologist swiped the magnet and multiple magnet activations were displayed again. Following, the neurologist contacted the mfr for support and he was told that after fifteen magnet swipes, the issue would resolve due to the pt's generator being at roll-over time. The neurologist programmed the pt to 0 ma in magnet mode and after swiping the magnet 15 times, the issue resolved. Good faith attempts to obtain add'l data have been unsuccessful to date. The event had no detrimental effect on product performance and was corrected once 15 magnet activations were registered following the total operating time rollover.

 
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Brand NamePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1493782
Report Number1644487-2009-01606
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/08/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number521408
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2007
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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