BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3910524 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09521
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION ON THE LEAD WAS PERFORMED. ANALYSIS COULD NOT CONFIRM THE ALLEGATION AS THE LEAD PASSED THE INSERTION TESTS. THE LEAD APPEARED TO BE VERY SLIGHTLY BENT FROM THE TERMINAL PIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD COULD NOT FULLY INSERT INTO THE COMPETITOR DEVICE'S HEADER SUCCESSFULLY. THE PHYSICIAN THOUGHT IT WAS GETTING HELD UP AT THE SIGHT OF WHERE THE WHITE INSULATION SLEEVE STARTED. THE PHYSICIAN WAS ABLE TO TIGHTEN THE SET SCREW ON THE COMPETITOR DEVICE BUT THE LEAD MEASUREMENTS DID NOT MATCH WITH WHAT THE ANALYZER HAD, AND NOTICED THAT THE PIN DID NOT ADVANCE FAR ENOUGH INTO THE HEADER SO THE SET SCREW WAS LOOSENED AND THE LEAD WAS REMOVED. A COMPETITOR LEAD WAS THEN USED WITHOUT A PROBLEM. THIS RV LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388743 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 0293