BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871889 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17202
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 26, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY THE COMPLETE LEAD WAS RETURNED. THE INSULATION WAS CUT AND TORN AROUND MOST THE CIRCUMFERENCE AND THE LEAD CONDUCTOR COILS APPEARED SEVERED 111MM FROM THE TERMINAL PIN. LABORATORY ANALYSIS CONFIRMED THAT BOTH CONDUCTOR COILS HAVE BEEN CUT AND THE LEAD INSULATION HAS BEEN CUT AND TORN 111MM FROM THE TERMINAL PIN. DAMAGE TO THE INSULATION COULD HAVE CAUSED THE PACING FAILURE AS WELL AS THRESHOLDS ISSUES, WHILE A DISLOGEMENT COULD NOT BE CONFIRMED. LABORATORY ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE AS WELL AS WHEN THE DAMAGED TO THE LEAD OCCURED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER THE IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD PACING FAILURE WAS NOTED AS WELL AS AN INCREASE IN PACING THRESHOLDS. A LEAD DISLODGMENT WAS SUSPECTED. SUBSEQUENTLY THE NEXT DAY, A REVISION TOOK PLACE AND INSULATION DAMAGE ON THE LEAD WAS REVEALED. THE LEAD WAS EXPLANTED. 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 4471

    Patients

    Seq Age Sex Outcome Treatment
    1