BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT SR RF OUS

    MDR report key: 2193252 · Received August 5, 2011

    Report

    Report Number
    2017865-2011-05326
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    November 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCENT SR RF OUS IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM1210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death 1888TC/52, (B)(4)