BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 4062559 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-08400
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 THE PULSE GENERATOR EXHIBITED LOW LEAD IMPEDANCE ON THE ATRIAL CHANNEL. DURING REVISION THE SET SCREW APPEARED TO BE IMPROPERLY TIGHTENED. THE SET SCREW WAS RETIGHTENED AND THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37513 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention