BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR

    MDR report key: 3890400 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03575
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    February 22, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DURING A FOLLOW UP VF EPISODES WERE OBSERVED THAT LOOKED LIKE NOISE. DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28207 FORTIFY VR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD1233-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1