BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3890540 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04440
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 1, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. 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 PT WAS SEEN IN CLINIC WITH INAPPROPRIATE AUTO MODE SWITCH AND FAR FIELD R WAVE OVERSENSING WAS OBSERVED. REPROGRAMMING WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28220 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR