BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 8884300 · Received August 12, 2019

    Report

    Report Number
    2017865-2019-12219
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508186
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON SUSTAINED RIGHT VENTRICULAR OVERSENSING WITH CROSSTALK WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676072 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3357-40C A000040671 05414734508186

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR