BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT SR

    MDR report key: 3925700 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15214
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD MEDICAL CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405257 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention