BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911958 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16729
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THE PRESENCE OF SET SCREW MARKS ON THE LEAD TERMINAL PIN, AN UNKNOWN STYLET WAS INSERTED IN THE LEAD AND PUNCTURE HOLES WERE NOTED IN THE LEAD INSULATION. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A PRESSURE TEST OF THE OUTER INSULATION WAS NOT PERFORMED DUE TO THE PUNCTURES. ADDITIONAL TESTING WAS CONDUCTED WITH A PACING SYSTEM ANALYZER (PSA) AND ACCEPTABLE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. ANALYSIS DID NOT CONFIRM THE HIGH IMPEDANCE MEASUREMENTS, HOWEVER, DID CONFIRM THE PUNCTURES IN THE LEAD.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS IMPLANTABLE DEFIBRILLATION LEAD; HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE OBSERVED WHEN CONNECTED TO THE DEVICE. PACING IMPEDANCE MEASUREMENTS VARIED FROM 1,700 OHMS UP TO 2,100 OHMS WHEN THE LEAD WAS CONNECTED TO ANOTHER MANUFACTURER'S PACING SYSTEM ANALYZER (PSA). TO PREVENT AN ADDITIONAL VEIN STICK, THE PHYSICIAN PUNCTURED THE LEAD INSULATION WITH A NEEDLE IN THE PROXIMAL PORTION TO PLACE A GUIDE WIRE, WHICH WAS THEN ADVANCED INTO THE VEIN. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17080 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0283

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR E162| 0283| 4076