BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 3910920 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13047
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 9, 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
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE INDICATED THE RESET WAS CAUSED BY AN INABILITY TO ACCESS A NON-EXISTENT MEMORY LOCATION ON (B)(4) 2013. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE CAUSE OF ACCESSING THE ANOMALOUS MEMORY LOCATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. THE DEVICE WAS NOT IMPLANTED. THE EVENT DID NOT AFFECT THE PATIENT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386546 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2259-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention