BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3090296 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01219
    Event Type
    Death
    Date Received
    May 2, 2013
    Date of Event
    December 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE ER DUE TO A SYNCOPAL EPISODE. PATIENT WAS ADMITTED TO NEUROLOGICAL TELEMETRY WITH LEFT SIDED WEAKNESS AND SYNCOPE. THE PATIENT LATER BECAME UNSTABLE AND HYPOTENSIVE AND WENT INTO CARDIAC ARREST. PATIENT WAS RESUSCITATED, INTUBATED AND TRANSFERRED TO ICU. ONCE STABILIZED, PRESSURE DROPPED AGAIN. PATIENT STATUS DNR, PATIENT EXPIRED THE NEXT DAY OF CARDIAC ARREST AND HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191941 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death (B)(4)