BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 4191938 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04574
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. EVAL: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH LOSS OF VENTRICULAR CAPTURE. A LEAD REVISION WAS PERFORMED, HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS THEN DETERMINED THAT THE ISSUE MAY BE WITH THE PACEMAKER. THE LEAD AND PACEMAKER WERE BOTH EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28805 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI PM2112

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 1888TC/58| CAE055235