BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF

    MDR report key: 3961532 · Received July 28, 2014

    Report

    Report Number
    2017865-2014-15760
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    March 19, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENTS CAUSE OF DEATH WAS INTRACEREBRAL HEMORRHAGE, HYPERTENSION AND ATHEROSCLEROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437923 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death (B)(4)