BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950853 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22679
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR IF THE LEAD IS RETURNED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED SEVERED 146 MM FROM THE TERMINAL PIN. VISUAL INSPECTION NOTED WEBBING DAMAGE TO THE TRILUMEN INSULATION 300 - 315 MM FROM THE TIP. ANALYSIS CONFIRMED THE RS - CONDUCTOR COIL WAS FRACTURED 315 MM FROM THE TIP. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED AND THE INFORMATION REPORTED WITH THE LEAD, IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE. A LEAD FRACTURE WAS SUSPECTED AND THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 4469| 0185| 0158| T165| T125