BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951022 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-10895
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    November 25, 2012
    Report Date
    July 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT, VISUAL INSPECTION OF A COMPLETE LEAD IDENTIFIED TRILUMEN INSULATION DAMAGE (26-28 CM FROM THE TERMINAL PIN) WHERE THE RATE SENSE (NEGATIVE) COIL AND HIGH VOLTAGE (PROXIMAL) CONDUCTOR ARE EXPOSED. THE LEAD WAS PUT THROUGH AND PASSED ELECTRICAL CONTINUITY TESTING. THE DAMAGE APPEARS TO HAVE BEEN INITIATED BY A LOCALIZED COMPRESSIVE STRESS ON THE SURFACE OF THE TRILUMEN INSULATION. ALTHOUGH THE CLINICAL OBSERVATION OF LOW PACING IMPEDANCE, ELECTROGRAM NOISE, AND OVERSENSING, AS REPORTED IN 2012, WERE CONFIRMED THROUGH LABORATORY TESTING, THERE WAS NO EVIDENCE OF ANY CONDUCTOR FRACTURES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND DECREASED PACING IMPEDANCE MEASUREMENTS (290 OHMS). ONE EPISODE OF OVERSENSING WAS OBSERVED THAT RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). SENSING AND THRESHOLD MEASUREMENTS WERE OBSERVED TO BE STABLE AND ACCEPTABLE. IT WAS NOTED THAT THE PATIENT HAD FALLEN TWO MONTHS AGO WHICH CORRESPONDED WITH THE CHANGE IN PACING IMPEDANCE MEASUREMENTS AND OBSERVED NOISE. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD DIED IN (B)(6) 2013. THERE WERE NO REPORTS THAT THE SURGICAL INTERVENTION TO REPLACE THIS RV DEFIBRILLATION LEAD CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HEART DISEASE, DIABETES, AND HIGH CHOLESTEROL. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RV DEFIBRILLATION LEAD WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCT DEPARTMENT IN (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427887 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR E143| 4470| 0174| T165