BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053333 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05183
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE IMPEDANCE REMAINED BETWEEN 1400 AND 1600 OHMS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND CALCIFICATION COVERING OVER DISTAL SHOCKING COIL AND LEAD'S TIP. DEPENDING ON HOW MUCH CALCIFICATION WAS ON THE TIP BEFORE THE LEAD WAS EXPLANTED, THE IMPEDANCE MEASUREMENT COULD HAVE BEEN AFFECTED. THE LEAD WAS ARCHIVED .

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE EXPLANT PROCEDURE, THIS LEAD REVEALED AN INCREASE IN PACING IMPEDANCE VALUES FROM 1400-1600 OHMS, THE IMPEDANCE NEVER ROSE ABOVE 2,000 OHMS AND HIGH THRESHOLDS.A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED ON THE RIGHT SIDE. THE PHYSICIAN NOTED THAT THE SUTURE SLEEVE PLACED NEAR THE LEAD HAD WENT THROUGH THE INSULATION OF THE LEAD. DURING EXTRACTION OF THE LEAD, THE STYLET WAS UNABLE TO BE INSERTED INTO THE LEAD AND FRICTION WAS NOTICED NEAR THE DISTAL COIL. A SECOND STYLET WAS USED AND WAS STILL UNABLE TO BE INSERTED INTO THE LEAD. FINALLY THE PHYSICIAN WAS ABLE TO INTRODUCE ANOTHER STYLET INTO THE LEAD. A NEW DEVICE AND LEAD WERE SUCCESSFULLY ABLE TO BE IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154841 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 0148| 1870