BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781876 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10036
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 19, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT HIGH CAPTURE THRESHOLD WAS OBSERVED. AN ECHOCARDIOGRAM SHOWED THAT THE LEAD HAD PERFORATED THE MYOCARDIUM. THE LEAD WAS SUCCESSFULLY REPOSITIONED AT A LATER DATE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS ASYMPTOMATIC THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259245 DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7172Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention