BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR RF OUS

    MDR report key: 3920810 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14400
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED POST-SENSED T-WAVE OVERSENSING. THE GENERATOR WAS REPROGRAMMED AND NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398325 ACCENT SR RF OUS IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR