BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2802539 · Received October 24, 2012

    Report

    Report Number
    1644487-2012-02449
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 25, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AN IMPLANT CARD WAS RECEIVED FROM THIS PATIENT'S (B)(6) 2012 SURGERY. THE PATIENT WAS INITIALLY REPORTED TO BE UNDERGOING GENERATOR REVISION FOR NORMAL END OF SERVICE; HOWEVER, THE IMPLANT CARD INDICATED THAT THE PATIENT UNDERWENT FULL REVISION DUE TO END OF SERVICE AND A LEAD DISCONTINUITY. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL AS THE FACILITY DISCARDS AFTER EXPLANT.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 6193

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR