BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781931 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09996
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 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
    AR, US
    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 THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO NOISE. LOW, OUT OF RANGE, PACING LEAD IMPEDANCE WAS ALSO OBSERVED. NO ANOMALIES WERE DETECTED WITH DIAGNOSTIC IMAGING AND NOISE COULD NOT BE REPRODUCED IN-CLINIC. HIGH VOLTAGE THERAPY WAS DEACTIVATED AND PATIENT WAS PLACED IN A LIFE VEST. THE PATIENT HAS ELECTED NOT TO UNDERGO ANY LEAD REVISION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259376 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 2088TC/46 CAT074433