BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF

    MDR report key: 4110819 · Received September 23, 2014

    Report

    Report Number
    2017865-2014-17561
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    July 2, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    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. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENT'S CAUSE OF DEATH WAS ASPHYXIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589647 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death 1888TC/52,(B)(4),1888TC/46,(B)(4)