BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874014 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18901
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SECTION OF THE LEAD WAS RETURNED WITH A SET SCREW MARK ON THE TERMINAL PIN AND SEVERED AT 21 CM FROM THE TERMINAL PIN. MELTED INSULATION WAS OBSERVED AT APPROXIMATELY 13 CM FROM THE TERMINAL PIN AND IT WAS ALSO NOTED THAT THERE WAS NO INSULATION COVERING THE COILS FROM 13 CM TO 21 CM. ANALYSIS CONCLUDED THE INSULATION DAMAGE WAS LIKELY THE RESULT OF ELECTROCAUTERY. THE RETURNED SECTION OF THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THAT PORTION OF THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. THE FIELD ALLEGATION WAS NOT CONFIRMED BY ANALYSIS, ONLY A PART OF THE LEAD WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A NON-BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT AT A DEVICE CHANGE OUT PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD MAY BE FRACTURED. HOWEVER, AT THIS TIME THE LEAD REMAINS ACTIVE AND IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A NON-BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT THE RV LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AND HIGH THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4465

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R MISMATCH| 5816| (B)(4)| 1297| 4465| 4464| (B)(4)| 1275