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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
Event Date 01/10/2011
Event Type  Malfunction  
Manufacturer Narrative

Method: analysis of programming history performed.

 
Event Description

It was reported by the treating neurologist that the vns patient was seen for a routine follow up appointment, it was noted upon interrogation of the vns generator that multiple magnet activations were displayed on the same line. No patient treatment decisions were affected as a result of the magnet display error. Further review of the generator programming history that was downloaded from the physician's hand held and returned to manufacturer, revealed that the generator total operating time had rolled over. 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
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1989748
Report Number1644487-2011-00208
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/10/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number537103
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/10/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2007
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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