BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4143288 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05746
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 5, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOUR ROUTINE FOLLOW UP. THE PACEMAKER DISPLAYED AN ERROR MESSAGE ASKING THE USER TO EITHER END SESSION OR RESTORE DEVICE TO NOMINAL. THE USER REPROGRAMMED THE DEVICE WITHOUT ISSUE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28569 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR