BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4121734 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07585
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 24, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 GOING FORWARD. EVAL: FINAL ANALYSIS COULD NOT CONFIRM THE REASON FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED UNACCEPTABLE THRESHOLDS. THE CAN WAS ALSO DAMAGED. THE DEVICE WAS NOT EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32452 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR