BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D

    MDR report key: 6085905 · Received November 8, 2016

    Report

    Report Number
    2938836-2016-13882
    Event Type
    Death
    Date Received
    November 8, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT PRODUCT WAS OUT OF SERVICE ON (B)(6) 2016. 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
    737860 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3231-40Q 3369508

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1258T/75, BRT011742| 2088TC/52, BER046438| 7122Q/58, BNY011711