BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1070423 · Received July 3, 2008

    Report

    Report Number
    1644487-2008-01499
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT GENERATOR REVISION SURGERY DUE TO BATTERY END OF SERVICE. THE EXPLANTED GENERATOR WAS SUBSEQUENTLY RETURNED TO THE MFR FOR PRODUCT ANALYSIS. DURING THIS ANALYSIS,THE BATTERY END OF SERVICE WAS VERIFIED. HOWEVER, IT WAS DETERMINED THAT A TRANSISTOR IN THE DEVICE WAS PRODUCING A CURRENT LEAKING THAT WAS ABOVE SPECIFICATION, THAT MAY HAVE CONTRIBUTED TO A PREMATURE END OF SERVICE FOR THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1