BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1955182 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00344
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 19, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK DUE TO T-WAVE OVERSENSING. REVIEW OF THE STORED ELECTROGRAM NOTED OVERSENSING OF P-WAVES ON THE VENTRICULAR CHANNEL. THE R-WAVES HAD DECREASED AND THE CAPTURE WAS INCREASED. AN X-RAY SHOWED THE LEAD HAD DISLODGED. REPOSITIONING WAS SUCCESSFUL, BUT THE LEAD DISLODGED AGAIN TWO DAYS LATER. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention