BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952736 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23804
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 4, 2010
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED, IF THE LEAD IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL VISUAL INSPECTION NOTED ARCING DAMAGE THAT WAS EVIDENT ON THE LEAD'S RATE/SENSE POSITIVE (RS+) CONDUCTOR COIL (THE COIL HAD BEEN MELTED APART). THERE WAS LEAD-ON-CAN ABRASION IN THE INSULATION OF THE IS-1 TERMINAL LEG THROUGH TO THE RS+ CONDUCTOR COIL IN A SEGMENT 60-80 MILLIMETERS (MM) FROM THE TERMINAL PIN. THE EDGES OF THE ABRASION HAD A JAGGED OR SAWTOOTH APPEARANCE. MICROSCOPIC EVALUATION OF THE ABRADED REGION INDICATES THE INSULATION WAS DAMAGED FROM PRESSURE BETWEEN THE CAN AND THE LEADS OUTER CONDUCTOR COIL. THE FOOTPRINT OF THE DAMAGE ALSO SUGGESTS THAT THE LEAD LEG WAS SLIGHTLY TWISTED AND CURVED IN THIS AREA. THE INSIDE DIAMETER OF THE OUTER INSULATION TUBING HAS DISTINCT IMPRESSIONS OF THE ADJACENT COIL FILARS. THE MORPHOLOGY OF THE INSULATION BREACH IS INDICATIVE OF LEAD-ON-CAN CONTACT. AS THE RS+ CONDUCTOR COIL IS ELECTRICALLY TIED TO THE DEFIBRILLATION HIGH-VOLTAGE (DF-1) DISTAL CONDUCTOR, ARCING OCCURRED BETWEEN THE RS+ CONDUCTOR COIL (DISTAL HIGH-VOLTAGE) AND THE DEVICE CAN (PROXIMAL HIGH-VOLTAGE) DURING THERAPY DELIVERY. THE ASSOCIATED DEVICE IMPLANTED WITH THIS LEAD ALSO SHOWED EVIDENCE OF ELECTRICAL ARCING ON THE DEVICE CAN. THIS LEAD SUBSEQUENTLY FAILED THE ELECTRICAL CONTINUITY TEST WITH MANIPULATION ON THE RS+ CONDUCTOR. THE LEAD PASSED THE STYLET INSERTION TEST; NO OTHER TESTS WERE PERFORMED DUE TO LEAD DAMAGE.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS EXPLANTED AND REPLACED AFTER DEFIBRILLATION THRESHOLD TESTING (DFT) WAS UNSUCCESSFUL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE LEAD'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO SURGICAL REPLACEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ASSOCIATED WITH A REMOTE MONITORING ALERT FOR A LOW OUT-OF-RANGE (OOR) SHOCK IMPEDANCE MEASUREMENT. REVIEW OF DAILY MEASUREMENTS SHOWED THERE WAS ONLY ONE LOW OOR MEASUREMENT. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED A LOW OOR MEASUREMENT COULD BE RE-CREATED CLINICALLY WITH ISOMETRIC EXERCISES. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED LEAD REPLACEMENT OR TESTING THE LEAD WITH A COMMANDED SHOCK, AND ADVISED THAT A COMMANDED SHOCK COULD DAMAGE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IF THERE IS A SHORTED CONDITION WITH THE LEAD. 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0185| E030| 4470