BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT AR

    MDR report key: 4191947 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04555
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 6, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: COMPLAINT COULD NOT BE CONFIRMED. NORMAL ELECTRICAL CHARACTERISTICS AND DEVICE FUNCTION WERE MEASURED THROUGH ALL MECHANICAL, ELECTRICAL, AND THERMAL STRESS TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE PULSE GENERATOR WOULD NOT PACE AT MAX OUTPUT. THE PULSE GENERATOR WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28812 ACCENT AR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR