BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA ST DR

    MDR report key: 4760319 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04691
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 25, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A FOLLOW-UP, INAPPROPRIATE AUTO MODE EPISODES WERE OBSERVED DUE TO NOISE ON THE RV AND RA CHANNELS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305267 FORTIFY ASSURA ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1