BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR

    MDR report key: 4130759 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16103
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    August 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    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. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT CODED AND HAD LOW BP. ATTEMPTS TO GET FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. THE REPORTING NURSE WAS NOT ON DUTY AT TIME OF PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608405 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 7001/65, ABD10877, 1688TC/46, JR032162