BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3884739 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12211
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP. THE ICD WAS POST PACED T WAVE OVER SENSING ON THE VENTRICULAR LEAD WHICH WAS NOTED ON A REAL TIME EGM. THE ICD WAS REPROGRAMMED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361367 UNIFY ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR