BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 2781455 · Received October 10, 2012

    Report

    Report Number
    2017865-2012-08918
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    April 28, 2012
    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
    TX
    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

    THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 83 YR Death (B)(4)