BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY QUADRA, CRT-D, DF4 CONNECTOR

    MDR report key: 2882669 · Received December 20, 2012

    Report

    Report Number
    2017865-2012-10554
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    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
    CO
    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, THE PATIENT EXPIRED. INTERROGATION OF THE DEVICE SHOWED THAT THE DEVICE UNDERSENSED FINE AND LOW AMPLITUDE VF WAVES. THE DEVICE DID NOT CONVERT THE PATIENT'S RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY QUADRA, CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3249-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death