BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3914612 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13077
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO NOISE ON THE VENTRICULAR LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390912 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention (B)(4)