BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3901240 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12673
    Event Type
    Injury
    Date Received
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 27.1CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 25.0-25.7CM FROM THE CONNECTOR PIN. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY. NOISE EPISODES WERE NOTED DURING FOLLOW-UP. INSULATION ANOMALY WAS NOTED DURING LEAD REVISION. THE LEAD WAS PARTIALLY EXTRACTED AND A NEW LEAD WAS IMPLANTED WITHOUT INCIDENT. THE PATIENT CONDITION WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380215 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention