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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 05/27/2008
Event Type  Malfunction  
Event Description

Reporter indicated a display error was noted when viewing a pt's magnet activations on a (b) (4) vns computer. Usually the magnet activations are shown as one magnet activation per line, but in the case of this display error, the computer screen displayed several activation times on the same line in a decreasing order. Programming history was received from the site and did not indicate any magnet activation anomalies. The computer and flashcard were later returned for product analysis. Analysis of the returned computer did not identify any anomalies during testing using the ac adapter or the main battery with a full charge. During the flashcard analysis, it was identified that the archive databases contained 2 different sets of pt data. The most likely cause for the database anomaly can be associated with the flashcard being inserted into another (b) (4) computer. No other anomalies were identified.

 
Manufacturer Narrative

Analysis of programming history.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1338635
Report Number1644487-2009-00453
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/05/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number584948
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/16/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/05/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2007
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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