BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4860881 · Received June 22, 2015

    Report

    Report Number
    2938836-2015-06054
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    December 29, 2014
    Report Date
    April 6, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 49.0CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. 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 THE PATIENT PRESENTED IN-CLINIC WITH HEART FAILURE SYMPTOMS. THE PATIENT HAS BEEN LOST-TO-FOLLOW-UP AND THE REP WAS UNABLE TO OBTAIN INFORMATION FROM A PREVIOUS DEVICE CHECK. HIGH OUT OF RANGE PACING LEAD IMPEDANCE AND LOSS OF CAPTURE WERE OBSERVED. NOISE WAS NOT PRODUCED WITH ISOMETRICS. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PATIENT WAS WELL POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403740 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7121Q/58 3269819

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention