BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3220215 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04307
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 17.1-17.7CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION. A FRACTURE OF THE INNER COIL WAS NOTED AT 1.0CM FROM THE DISTAL TIP. THE INNER COIL WAS ALSO OVER-TORQUED AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE ER AFTER RECEIVING SHOCKS. INTERROGATION SHOWED A LOW PACING LEAD IMPEDANCE AND DECREASED HIGH VOLTAGE IMPEDANCE. IMAGING OF THE LEAD SHOWED NO ANOMALIES. LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321005 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention