BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4021874 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14568
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A POST OPERATION WOUND CHECK. FAR R WAVE OVER SENSING RESULTED IN MULTIPLE INAPPROPRIATE AUTO MODE SWITCH (AMS) EPISODES. THE ICD WAS REPROGRAMMED. THE PATIENT IS DOING WELL. NO FURTHER IMPEDANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498105 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR