BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954196 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24540
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITIED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THERE WAS SLIGHT NOISE ON THE SURFACE ELECTROGRAM NOTED. THERE WERE MARKERS SHOWING ATRIAL PACE VERSUS VENTRICULAR PACE WHICH INDICATES LOSS OF CAPTURE. THE LOSS OF CAPTURE WAS VERIFIED BY PERFORMING THRESHOLD TESTING IN THE HIGHEST OUTPUTS. A REVISION PROCEDURE WAS PERFORMED. WHEN THE LEAD WAS REMOVED FROM THE DEVICE, NORMAL IMPEDANCE MEASUREMENTS WERE OBSERVED. THE PHYSICIAN INDICATED THERE WAS A KINK/BEND IN THE LEAD DUE TO HOW HE PLACED THE LEAD INTO THE POCKET. THE LEAD WAS RECONNECTED TO THE DEVICE AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN WAS NOT COMFORTABLE LEAVING THE LEAD IMPLANTED AND EXPLANTED 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 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4470| T177| E110| 0180