BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ST VR

    MDR report key: 4153518 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16441
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE DUE TO SVT EPISODES. THE PHYSICIAN INTERROGATED THE DEVICE AND SUSPECTED THAT ONE EPISODE WAS A TRUE VT, BUT DIAGNOSED AS SVT AND NO THERAPY WAS DELIVERED. THE PHYSICIAN REPROGRAMMED THE DEVICE. ALL ELECTRICAL VALUES WERE GOOD. THE PHYSICIAN WILL MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632052 FORTIFY ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R