BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170896 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10523
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR IF THE LEAD IS RETURNED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED A CUT IN THE INSULATION RELATED TO THE REMOVAL OF THE SUTURE SLEEVE, ELECTROCAUTERY DAMAGE WAS NOTED IN THE LEAD INSULATION AND THE SUTURE SLEEVE WAS CUT. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A PRESSURE TEST OF THE OUTER INSULATION WAS NOT PERFORMED DUE TO THE ELECTROCAUTERY DAMAGE. THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION ELECTRONICALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED (B)(6) POST IMPLANT. DURING THE REVISION PROCEDURE, TISSUE WAS OBSERVED IN THE TIP OF THE LEAD. THE LEAD WAS EXPLANTED AND A NEW RA LEAD WAS SUCCESSFULLY PLACED WITHOUT INCIDENT.

    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 Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)