BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3890233 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04475
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 20, 2011
    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

    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 A PATIENT WAS IN ATRIAL TACHYCARDIA WHICH THE DEVICE APPROPRIATELY DIAGNOSED AS SVT IN THE VT MONITOR ZONE. THE VENTRICULAR RATE ACCELERATED INTO THE FIB ZONE. ATP WAS APPLIED DURING CHARGING, AND THE RHYTHM SLOWED BACK DOWN TO THE VT MONITOR ZONE. VT EVENTS WERE USED AS RECONFIRMATION AND THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY FOR SVT. THE SHOCK BROKE THE RHYTHM AND THE PATIENT RETURNED TO SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34369 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention