BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1874970 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18059
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE ATRIAL AND VENTRICULAR LEADS WERE SURGICALLY ABANDONED AND A NEW PACING SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE. AS THE LEADS WERE ABANDONED AND NOT RETURNED; THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ALONG WITH THE PREVIOUS CLINICAL OBSERVATIONS, THE PATIENT DEVELOPED AN INFECTION. THE DEVICE AND THE REST OF THE LEADS WERE REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE HAD BEEN GREATER THAN 2500 OHMS SINCE (B)(6) 2010. IN ADDITION, THE THRESHOLDS WERE INCREASED AND THE R-WAVE AMPLITUDE WAS INCREASED. A LEAD FRACTURE WAS SUSPECTED. THE VENTRICULAR LEAD WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION AND THE IMPEDANCE DROPPED TO 300 OHMS WITH NORMAL THRESHOLDS AND AMPLITUDE. ADDITIONALLY, THE ATRIAL LEAD IMPEDANCE WAS ALSO GREATER THAN 2500 OHMS WITH NOISE VISIBLE ON THE ATRIAL CHANNEL. A CHEST X-RAY WAS PERFORMED AND CONFIRMED THAT THE LEAD WAS FRACTURED. A REVISION PROCEDURE WAS PERFORMED AND A NEW PACING SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE. THE EXISTING LEADS WERE SURGICALLY ABANDONED. DURING THE PROCEDURE, LOSS OF CAPTURE WAS NOTED ON THE VENTRICULAR CHANNEL; HOWEVER, THE PATIENT HAD AN INTRINSIC RHYTHM WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R