BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF

    MDR report key: 3875074 · Received June 16, 2014

    Report

    Report Number
    2017865-2014-13837
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    April 5, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    FUNERAL HOME PERSONNEL. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THE PATIENTS CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE AND SEPTIC SHOCK.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353104 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death 2088TC/52,CAU1477702088TC/58 CAW119827