BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3881176 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02202
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 18, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED FAR P WAVE OVERSENSING THAT RESULTED IN PT NOTIFIER FOR NONSUSTAINED LEAD NOISE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27902 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD1257-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR