BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 5820155 · Received July 25, 2016

    Report

    Report Number
    2938836-2016-06442
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI(DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, AN ALERT FOR INHIBITED THERAPY WAS OBSERVED. FAR-FIELD P WAVE OVERSENSING WAS SUSPECTED. PROGRAMMING CHANGES WERE MADE AND NO MORE ALERTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473756 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1359-40QC P000023493

    Patients

    Seq Age Sex Outcome Treatment
    1