BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA ST DR, DF-4 CONNECTOR

    MDR report key: 3332850 · Received September 9, 2013

    Report

    Report Number
    2938836-2013-05787
    Event Type
    Injury
    Date Received
    September 9, 2013
    Date of Event
    June 21, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF THE DEVICE IN BACKUP DFO MODE WAS CONFIRMED VIA REVIEW OF THE DEVICE IMAGE. THE CAUSE OF THE DEVICE GOING INTO BACKUP DFO MODE WAS TWO SOFTWARE RESETS THAT OCCURRED WITHIN A SHORT PERIOD OF TIME. THE ROOT CAUSE OF THE SOFTWARE RESETS COULD NOT BE DETERMINED. THE REPORTED FIELD EVENT OF INAPPROPRIATE SHOCKS WAS CONFIRMED TO BE DUE TO OVERSENSING IN BACKUP DFO MODE. THE OVERSENSING IS BELIEVED TO BE RELATED TO A TRIM VALUE SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER AFTER RECEIVING MULTIPLE SHOCKS. THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445806 FORTIFY ASSURA ST DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention