BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 3920702 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14319
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THRESHOLD TEST WITH AUTO CAPTURE, THE PULSE GENERATOR EXHIBITED A CAPTURE ANOMALY. THE DEVICE WAS REPROGRAMMED TO UNIPOLAR FIXED OUTPUT. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396024 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1