BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR RF OUS

    MDR report key: 4140311 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05904
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 15, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 GOOD FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED VIA TTM. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE PT WAS BROUGHT INTO THE CLINIC AND IT WAS CLINICALLY RESOLVED BY A SUCCESSFUL SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29928 ACCENT SR RF OUS IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC. CRMD PM1210

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR