BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4192276 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04107
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 13, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. FINAL ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE PULSE GENERATOR EXHIBITED A LOSS OF CAPTURE WHEN THE ATRIAL LEAD WAS INSERTED AND THE PULSE GENERATOR WAS PLACED INTO THE POCKET. THE LEAD AND PULSE GENERATOR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31328 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR