BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952077 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23216
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. SET SCREW MARKS WERE NOTED ON THE IS-1 TERMINAL PIN, AND THE DISTAL AND PROXIMAL HIGH VOLTAGE TERMINAL PINS. NO DISCERNABLE SET SCREW MARKS WERE NOTED ON THE IS-1 RING. MULTIPLE CUTS WERE NOTED IN THE LEAD INSULATION ALONG WITH BLOOD/BODY FLUID NOTED IN THE LUMENS DUE TO THE CUTS. THERE WAS NO SUTURE SLEEVE RETURNED ON THE LEAD. ELECTRICAL RESISTANCE TESTING OF THE CONDUCTOR PATHS SHOWED THE LEAD TO BE IN SPECIFICATION. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING DEFIBRILLATION THRESHOLD (DFT) TESTING WITH THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD A FAULT MESSAGE WAS RECEIVED INDICATING AN OPEN CIRCUIT DETECTED. THE TERMINAL PIN WAS VERIFIED TO BE IN THE PROPER PORT OF THE DEVICE HEADER AND THE SHOCKING IMPEDANCE MEASUREMENTS WERE IN RANGE AT 56 OHMS. THE POCKET WAS REOPENED AND THE LEAD WAS EXPLANTED. THERE HAD ALSO BEEN REPORTS OF HIGH DFTS EVEN AFTER LEAD REPOSITIONING. A NEW LEAD WAS IMPLANTED AND THE ISSUE RESOLVED. TO DATE, THERE HAVE BEEN 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 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention 0181| E110| 4135| 0185