BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951022 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23098
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE FOR THE LEAD TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD UNDERWENT A LASER LEAD EXTRACTION DUE TO POOR SENSING ON THE LEAD. AN UPGRADE SYSTEM WAS PLANNED. THE SUBCLAVIAN VEIN WAS OCCLUDED SO IT WAS DECIDED TO EXPLANT THE ENTIRE SYSTEM AND RE-IMPLANT A NEW SYSTEM ON THE RIGHT SIDE AT A LATER DATE. THE PATIENT WAS PACEMAKER DEPENDENT SO A TEMPORARY PACING WIRE WAS IMPLANTED UNTIL THE NEW SYSTEM IS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R 4470| 4136| 4524| 4518| E030| N118| 0185