BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1864194 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16142
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD NOTED SETSCREW MARKS ON BOTH TERMINALS. THE LEAD PASSED CONDUCTOR RESISTANCE, HIGH POTENTIAL, AND INSULATION PRESSURE TESTING, CONFIRMING BOTH THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL DISLODGED ONE DAY POST-IMPLANT. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 48 YR Life Threatening| R 1888TC| S602| 4469| 4456