BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR

    MDR report key: 4121273 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07076
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 4, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. EVAL DESCRIPTION INCLUDED: 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 EXHIBITED FAILURE TO PACE AND CAPTURE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32383 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION PM1114

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR