BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1810758 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00516
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DIAGNOSTIC TEST RESULTED IN HIGH LEAD IMPEDANCE READING INDICATING A POSSIBLE LEAD DISCONTINUITY. PATIENT HAD FULL REVISION SURGERY. NO SERIOUS INJURY WAS REPORTED. GENERATOR AND LEAD WERE DISCARDED AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011863

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR