BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1932349 · Received December 17, 2010

    Report

    Report Number
    2017865-2010-05418
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    October 12, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED, CAUSE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE CAUSE OF DEATH WAS PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death 7121Q/52, (B)(4), 2088T/46, (B)(4)