BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR

    MDR report key: 3925678 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15223
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 23, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PULSE GENERATOR EXHIBITED A SETSCREW ANOMALY. THE DEVICE WAS NOT IMPLANTED AND NEW DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404854 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR