BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1832097 · Received September 3, 2010

    Report

    Report Number
    1644487-2010-02013
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERI = YES FLAG WAS OBSERVED DURING DIAGNOSTIC TESTING. THE TEST RESULTS WERE 7/LIMIT/HIGH/YES. THE HIGH LEAD IMPEDANCE IS REPORTED ON MDR 1644487-2010-02015. THE PT'S DEVICE WAS PROGRAMMED OFF AND THE PT WILL NOT UNDERGO REVISION SURGERY AT THIS TIME. A BATTERY LIFE CALCULATION WAS PERFORMED USING THE PT'S PROGRAMMING HISTORY AVAILABLE IN THE IN-HOUSE DATABASE AND IT WAS FOUND THAT THERE WERE SEVERAL YEARS REMAINING UNTIL ERI = YES. THIS MDR IS BEING SUBMITTED TO CAPTURE THE PREMATURE END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016065

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR