BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1873956 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17783
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, LOSS OF CAPTURE AND OUT OF RANGE IMPEDANCES OF GREATER THAN 3000 OHMS. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH A FRACTURE WAS NOTED JUST BEFORE THE SUTURE SLEEVE; THEREFORE, THE LEAD WAS SURGICALLY CAPPED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 4469| T167| 0174| 4470