BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4140086 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05963
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 PT PRESENTED IN CLINIC FOR NORMAL F/U WITH AUTOMATIC MODE SWITCH EPISODES DUE TO WHAT APPEARED TO BE FOR R WAVE OVERSENSING. REPROGRAMMING THE DEVICE WAS SUGGESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34399 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR