BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRONTIER II

    MDR report key: 3953887 · Received July 23, 2014

    Report

    Report Number
    2017865-2014-15740
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    January 13, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NKE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431626 FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC., CRMD 5586 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 1058, (B)(4),1888, (B)(4)