BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF

    MDR report key: 3875072 · Received June 16, 2014

    Report

    Report Number
    2017865-2014-13835
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    February 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS FOLLOWING PHYSICIAN WAS NOT AWARE OF THE PATIENTS DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. IT WAS SUSPECTED THAT THE PATIENT DECEASED FROM CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353365 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death 2088TC/46,CAT0256902088TC/52,BER057016