BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851838 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14328
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    January 7, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED, IT WILL NOT BE RETURNED FOR ANALYSIS AND, AS SUCH, THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED NOISE. THE NOISE COULD NOT BE REPRODUCED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. THE PACE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED (CAPPED). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THREE MONTHS LATER THE SHOCK IMPEDANCES WERE CONSISTENTLY GREATER THAN 125 OHMS. SURGICAL INTERVENTION WAS PERFORMED AND CAPPED THE DEFIBRILLATION PORTION OF THE LEAD. A NEW DEFIBRILLATION LEAD WAS IMPLANTED WITHOUT INCIDENT.

    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 70 YR 1284| 4518| 4470| 1861| 0158| H179| 4471| N118