BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042306 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-03863
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. A KINKED STYLET WAS RETURNED INSIDE THE LEAD. THE TERMINAL TOOL WAS RETURNED ON THE LEAD, AND WAS SEATED CORRECTLY WITH THE END CAP ENGAGED. THERE WERE SET SCREW MARKS NOTED ON THE RATE/SENSE TERMINAL PINS. THE LEAD BODY WAS TWISTED SLIGHTLY ALONG ITS ENTIRE LENGTH, AND THERE WAS BLOOD/BODY FLUID NOTED ON THE TERMINAL PIN. THIS LEAD PASSED THE CONTINUITY TEST WITH MANIPULATION. THE INITIAL ALLEGATION OF HIGH LEAD IMPEDANCE COULD NOT BE CONFIRMED BY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD, DURING IMPLANT, EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE LEAD WAS FIRST TESTED USING A COMPETITOR'S PACING SYSTEM ANALYZER (PSA), WHICH PRODUCED A PACING IMPEDANCE OF 1,3450 OHMS, AND A THRESHOLD OF 1.3 VOLTS. THE PHYSICIAN ACCEPTED THESE VALUES, AND CONNECTED THIS RV LEAD TO THE ASSOCIATED DEVICE. MEASUREMENTS WITH THE ASSOCIATED DEVICE WERE THEN TAKEN, AND PRODUCED A PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2, 000 OHMS. THE SHOCK AND SENSING VALUES WERE NORMAL AND WITHIN RANGE. THE PHYSICIAN TRIED CLEANING THE LEAD CONNECTOR, BUT THE SAME IMPEDANCE MEASUREMENTS WERE OBSERVED. THIS RV LEAD WAS THEN RECONNECTED TO THE COMPETITOR'S PSA, AND PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 4,000 OHMS WERE OBSERVED. THE DECISION WAS MADE TO IMPLANT A NEW RV LEAD. THIS WAS DONE SUCCESSFULLY, AND ALL PARAMETERS WERE WITHIN NORMAL RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1