BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D

    MDR report key: 4924797 · Received July 20, 2015

    Report

    Report Number
    2938836-2015-28045
    Event Type
    Death
    Date Received
    July 20, 2015
    Date of Event
    June 5, 2013
    Report Date
    July 13, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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
    468298 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3231-40 3349568

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 1788T/46, BAL22691| 7021/65, ADN16730| 4193-88, BAA159181V