BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3901199 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12589
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 2, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACER-DEPENDANT PATIENT PRESENTED IN CLINIC AFTER EXPERIENCING SYMPTOMATIC EVENTS. NOISE ON THE VENTRICULAR CHANNEL WAS NOTED VIA STORED EGMS. INHIBITION OF PACING UP TO 7.5S WAS NOTED. THE SYSTEM WAS LATER EXPLANTED DUE TO NON-RELATED REASONS AND THE LEAD WAS REPLACED. THE PATIENT CONDITION AFTER THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378957 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR