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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 01/26/2011
Event Type  Malfunction  
Event Description

It was reported on (b)(6) 2011, that a magnet display error occurred when a doctor was visiting with a pt on (b)(6) 2011. The doctor claimed that "the date of the activations remained the same, but each time stamp would appear under the same date", that is a different index. Each index would contain the same date and time stamps, but one less time stamp than the previous index. F/u with the physician was made and the error was said to look like a pyramid shape - every entry line had one less time stamp than the previous entry. It was explained that this error was triggered by a roll-over in the counter of the patient's generator after it reaches 65536 hours, which causes the vns software to incorrectly display the magnet swipes; however a company rep stated that the patient's generator had not yet rolled over as the patient's counter was at 60698 hours on (b)(6) 2011. Good faith attempts to date for more info on the error have been unsuccessful.

 
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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 Key2022965
Report Number1644487-2011-00337
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number855099
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/26/2011
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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