BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3880055 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03333
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 10, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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 PATIENT WHO CAME INTO CLINIC AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY FOR A SUPRAVENTRICULAR TACHYCARDIA. THE DEVICE WAS REPROGRAMMED AND REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24373 FORTIFY DR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention