BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 3925314 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08982
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    July 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT THE DEVICE LOST RF TELEMETRY. UPON REGAINING TELEMETRY THE DEVICE PRESENTED IN BACK UP MODE. A SOFTWARE DOWNLOAD RESOLVED THE ISSUE AND THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38288 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention