BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 3920742 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14367
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0429
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 NOISE ON THE VENTRICULAR CHANNEL. A LOSS OF CAPTURE WAS ALSO NOTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397003 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 1948/58, BLR091038