BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4153575 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16473
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 13, 2014
    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 Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAR P-WAVE OVERSENSING WAS OBSERVED WHEN THE PATIENT WAS IN SINUS RHYTHM. THE DEVICE SENSITIVITY WAS REPROGRAMMED, HOWEVER, THE OVERSENSING STILL CONTINUED. FURTHER PROGRAMMING CHANGES WERE MADE AND NO FURTHER ISSUES WERE SEEN. THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631736 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2233-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1