BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 3920710 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14297
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 14, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PULSE GENERATOR MEASURED HIGH VENTRICULAR PACING THRESHOLDS AND HIGH IMPEDANCES. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. THE PATIENT WAS IN GOOD CONDITION DURING AND POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396342 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1