BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 4143677 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05712
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 13, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE DEVICE SHOWED INAPPROPRIATE ATRIAL SENSING, AND NO OUTPUT. THE PHYSICIAN ELECTED TO IMPLANT A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31568 ACCENT DR RF DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention