BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3961680 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14591
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD FOUND THE BODY APPEARED TWISTED AND THE HELIX WAS RETRACTED. A SMALL PUNCTURE IN THE INSULATION OF THE LEAD WAS NOTED, HOWEVER WAS A SURFACE PUNCTURE. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED HIGH OUT OF RANGE MEASUREMENTS. VISUAL INSPECTION CONFIRMED THE HOLE NOTED IN THE INSULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IMPLANT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE RV LEAD WAS RE-POSITIONED TWICE AND STILL EXHIBITED AN OUT OF RANGE IMPEDANCE MEASUREMENT. A SMALL PUNCTURE IN THE INSULATION OF THE LEAD WAS NOTED. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS NOT DETERMINED. THE RV LEAD WAS EXPLANTED AND THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439181 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR E160| 0293| 0292