BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 6646730 · Received June 16, 2017

    Report

    Report Number
    2017865-2017-05091
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 25, 2017
    Report Date
    June 16, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC FOR THE DEVICE CHECK. UPON INTERROGATION, THE TECHNICIAN DISCOVERED SHORT DURATION AMS EVENTS CAUSED BY FAR-R OVERSENSING ON THE RIGHT ATRIAL LEAD WITHIN THE PAV DELAY. THE RIGHT ATRIAL LEAD IS A MEDTRONIC UNIPOLAR LEAD BEING USED IN BIPOLAR SETTINGS. OFF-LABEL PROGRAMMING CHANGES WERE TESTED AND RESOLVED THE OVERSENSING. THE PHYSICIAN CONFIRMED THE PROGRAMMING CHANGES TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428496 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 3064934

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR