BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 3901143 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12601
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 PATIENT RECEIVED AN ALERT VIA MERLIN.NET FOR NON-SUSTAINED VENTRICULAR OVERSENSING. REVIEW OF THE EGMS SUGGESTED THAT A DELAY BETWEEN THE SENSED EVENTS, LED TO AN INAPPROPRIATE TRIGGER FOR ALERT. IT WAS NOTED THAT THE VENTRICULAR BLANKING WAS CAUSING VENTRICULAR UNDERSENSING. THE DEVICE WAS REPROGRAMMED. PATIENT WILL BE CLOSELY FOLLOWED WITH REMOTE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379911 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR