BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3901306 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12694
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER POSITIONING THE LEAD, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. THE DEVICE WAS PROGRAMMED TO A HIGHER RATE AND THE VT STOPPED AFTER 15 MINUTES. THE PATIENTS BLOOD PRESSURE DECREASED AND THE HEART BARELY BEAT. ECHO REVEALED BLOOD IN THE PERICARDIUM DUE TO PERFORATION. THE PROCEDURE WAS SUSPENDED AND SURGERY WAS PERFORMED TO REMOVE THE LEAD. THE PHYSICIAN SUSPECTED PERFORATION OCCURRED DUE TO MOVEMENT INSIDE THE VENTRICLE DURING THE TACHYCARDIA EPISODE. THE PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380450 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention