BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 3923124 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14442
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 17, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ONE MONTH POST OPERATION FOLLOW UP, IT WAS NOTED THAT THE IMPLANT SITE WAS SWOLLEN AND THE PATIENT HAD DEVELOPED A HEMATOMA. ON (B)(6) 2014 THE POCKET WAS OPENED TO ADDRESS THE SWELLING AND HEMATOMA. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401406 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention