BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 2250218 · Received September 15, 2011

    Report

    Report Number
    2017865-2011-06661
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    December 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. CONTINUED: 1158T/86, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death 7121/65, (B)(4), 1888TC/52, (B)(4),