BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1860633 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15283
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE WE WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY SIX MONTHS AGO, THE CLINICIAN NOTED IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS ON THE RIGHT ATRIAL LEAD. AS A RESULT, THE DEVICE WAS PROGRAMMED VVIR 70. DURING A DEVICE CHANGEOUT PROCEDURE, THE LEAD WAS FOUND TO BE FRACTURED. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention S603| 4086| 4457| 4087| 1298| 4473