BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2181023 · Received July 7, 2011

    Report

    Report Number
    1644487-2011-01523
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE (>10000 OHMS) AT RECENT APPOINTMENT. PATIENT IS SCHEDULED FOR A LEAD REVISION AND PROPHYLACTIC GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female