BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4160957 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01742
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF HIGH LEAD IMPEDANCE AND HIGH THRESHOLD COULD NOT BE CONFIRMED. THE LEAD WAS RETURNED IN TWO SECTIONS 11.4 CM OF THE PROXIMAL CONNECTOR END AND 48.5 CM OF THE DISTAL TIP ELECTRODE. THE ANALYSIS OF THE LEAD SECTIONS WAS NORMAL. NO ELECTRICAL ANOMALIES OR INTERNAL SHORTS WERE IDENTIFIED. ALL DAMAGES FOUND WERE CONSISTENT WITH THAT OCCURING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD PACING IMPEDANCE WAS OUT OF RANGE AND PACING THRESHOLD WAS HIGH. THE LEAD WAS CUT, EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27303 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 7120/60

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention