BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR

    MDR report key: 3920614 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14210
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PULSE GENERATOR WAS EXPLANTED ON (B)(6) 2014. A NEW PULSE GENERATOR WAS IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396346 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention