BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3676055 · Received March 12, 2014

    Report

    Report Number
    2938836-2014-05549
    Event Type
    Other
    Date Received
    March 12, 2014
    Date of Event
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 PT THAT RECEIVED AN INAPPROPRIATE EPISODE FOR NONSUSTAINED LEAD NOISE. THE EPISODE REVEALED THAT IS A FUNCTIONAL LOSS OF CAPTURE AP EVENT HAD BLANKED OUT THE VS EVENT. THE DEVICE THEN HAD A FUNCTIONAL LOSS OF CAPTURE VP, THEN VS SHORTLY AFTERWARD. THIS SHORT VP TO VS CAUSED THE DEVICE TO DETERMINE NOISE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148627 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention