BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE+ CRT-D W/SJ4 CONNECTOR

    MDR report key: 6128720 · Received November 28, 2016

    Report

    Report Number
    2938836-2016-14562
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    October 11, 2015
    Report Date
    November 2, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 THE PRIMARY CAUSE OF DEATH WAS NON-CARDIAC. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779796 PROMOTE+ CRT-D W/SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3211-36Q 2882887

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death (B)(4) | (B)(4) | (B)(4)