BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 2911952 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16616
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED PACING FAILURE ON THE HOSPITAL MONITOR. THE FIELD REPRESENTATIVE CHECKED THE DEVICE AND NOTED HIGH, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. MEASUREMENTS OF GREATER THAN 3,000 OHMS WERE FOUND IN BOTH UNIPOLAR AND BIPOLAR PACING CONFIGURATIONS. HOWEVER, WHILE REVIEWING THE PROGRAMMED PARAMETERS, NORMAL PACING WAS OBSERVED, AND LEAD IMPEDANCE MEASUREMENTS WERE THEN BETWEEN 500-600 OHMS. A REVISION PROCEDURE WAS PERFORMED THAT DAY. THE DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED; NO CONNECTION ISSUE WAS NOTED. THE LEAD WAS THEN TESTED ON THE PACING SYSTEM ANALYZER (PSA), WITH NORMAL PACING IMPEDANCE, PACING THRESHOLD, AND SENSING MEASUREMENTS. THE LEAD WAS RECONNECTED TO THE SAME DEVICE AND AGAIN, NORMAL MEASUREMENTS WERE NOTED. THE DEVICE WAS CHECKED AFTER THE PROCEDURE WAS COMPLETED AND NO ISSUES WERE NOTED. THEREFORE, THIS RV LEAD AND THE SAME COMPETITIVE DEVICE REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17079 THINLINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 430-35S-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R