BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3884844 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12227
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. A PARTIAL LEAD WITH THE LEAD TIP MEASURING 56.3CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCKS. UPON INTERROGATION, IT WAS OBSERVED THAT THE RV LEAD HAD DISLODGED INTO THE ATRIUM. DOUBLE COUNTING OF ATRIAL AND VENTRICULAR ACTIVITY CAUSED VF THERAPIES. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360175 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