BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 4091991 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05110
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 16, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP AFTER A PATIENT NOTIFIER FOR HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE HIGH WAS DELIVERED. HIGH MEASUREMENT WAS NOT REPRODUCIBLE. LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22611 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DIFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. CRMD 7120Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR