BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4083608 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05458
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 2, 2013
    Manufacturer
    ST. JUDE MEDICAL INC.,CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 WAS SHOCKED WHEN THE DEVICE OVERSENSED NOISE ON THE LEAD. THE PATIENT WAS NOT SYMPTOMATIC AND NO INJURY OCCURRED. THE LEAD SHOWED LOW IMPEDANCE MEASUREMENTS AND SENSING ABNORMALITIES. THE LEAD WAS EXPLANTED AND REPLACED WITH A MEDTRONIC LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23681 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC.,CRMD 7120Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention