BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 4130758 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16251
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING FOLLOW-UP, FALSE AMS EPISODES WERE OBSERVED DUE TO INAPPROPRIATE RATE RESPONSE SETTINGS. REPROGRAMMING CHANGES WILL BE COMPLETED DURING PATIENTS NEXT FOLLOW UP. THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607596 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3261-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1