BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3884852 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12228
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF HIGH LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO EXCESS MEDICAL ADHESIVE FOUND ON THE RING ELECTRODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, HIGH PACING LEAD IMPEDANCE WAS OBSERVED WHEN THE LEAD WAS TESTED THROUGH THE PSA. THE LEAD WAS REPLACED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360194 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR