BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173170 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11667
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED FOR ANALYSIS. SET SCREW MARKS WERE NOTED ON BOTH TERMINAL PINS. ELECTRO-CAUTERY DAMAGE AND CUTS WERE NOTED ON THE LEAD INSULATION. THE CONDUCTOR COILS WERE SLIGHTLY DEFORMED NEAR THE LEAD TIP. BLOOD/BODY FLUID WERE OBSERVED IN THE LEAD LUMEN. THE LEAD WAS DETERMINED TO BE ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATION WAS NO ABLE TO BE CONFIRMED BY ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) LEAD HAD DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    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 83 YR Required Intervention MISMATCH| S603| 4456| 4469| S606