BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 3923105 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14433
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 1, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION POST-IMPLANT, THE PULSE GENERATOR EXHIBITED A LEAD IMPEDANCE MEASUREMENT ANOMALY. THE DEVICE EXHIBITED HIGH LEAD IMPEDANCE ON BOTH THE CHANNELS. AN INTERRUPTION IN THE TELEMETRY CHANNEL WAS SUSPECTED. THE DEVICE REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT THE DEVICE WAS EXPLANTED AND REPLACED ON 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401270 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention