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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 11/20/2009
Event Type  Malfunction  
Event Description

During mfr review of vns programming history for a pt, it was noted a magnet mode diagnostics test resulted in low output current on (b)(6) 2009. Systems diagnostics tests were within normal limits. The low output current warning on the magnet mode test is a result of the user not swinging the magnet before performing the magnet mode diagnostics test. The low output current result is likely due to the generator comparing the last magnet swipe output to the newly programmed magnet mode output current which had not been delivered yet. The "magnetcount" variable was not being updated upon initial interrogation of the generator. The magnetcount was obtained from the last programming session on the handheld from the last generator. The reason the warning message was not displayed that a magnet swipe had not been detected is due to the way the handheld software obtains the magnetcount variable to determine if the message should be displayed. This will be implemented in v8. 0 software upgrade of the handheld computers. It will provide a software fix for scenarios in which performing a magnet mode diagnostic without performing a magnet swipe will not result in the warning message that a magnet swipe was not detected.

 
Manufacturer Narrative

Code analysis of programming history.

 
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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 Key2006844
Report Number1644487-2011-00290
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/20/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/20/2011
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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