BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873792 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17581
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR (B)(4) LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. THE PROXIMAL SHOCKING COIL WAS SEPARATED FROM THE MEDICAL ADHESIVE BONDING AT THE DISTAL END, AND THE DISTAL SHOCKING COIL WAS SEPARATED FROM THE MEDICAL ADHESIVE BONDING AT THE PROXIMAL END. THIS RV LEAD PASSED THE DIRECT CURRENT (DC) RESISTANCE TEST. THE INITIAL ALLEGATION OF LEAD DISLODGEMENT WAS NOT CONFIRMED. THE CONDUCTIVE PATHS WERE SHOWN TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IMPLANTED, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ECHOCARDIOGRAPHY SHOWED THIS RV LEAD WAS IMPLANTED IN THE LEFT VENTRICLE (LV) INSTEAD OF THE RV. THE LEAD WENT THROUGH THE ATRIAL SEPTUM, AND WAS PLACED IN THE LATERAL WALL OF THE LV. THIS PATIENT MAY HAVE HAD AN ATRIAL SEPTAL DEFECT BEFORE THE LEAD WAS IMPLANTED. ALSO, THIS PATIENT'S EJECTION FRACTION IMPROVED FROM 32 TO 62% SINCE IMPLANT, AND VENTRICULAR TACHYCARDIA WAS NON-INDUCIBLE. THE PHYSICIAN DECIDED THIS PATIENT NO LONGER NEEDED THE DEVICE, SO THE ENTIRE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. A CAT SCAN WAS PERFORMED, AND THE DEVICE HAD NOT CHANGED POSITION. THERE WERE NO ADVERSE PATIENT EFFECTS 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 62 YR 0185