BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3053329 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04949
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS ANALYZED. VISUAL INSPECTION OF THE LEAD CONFIRMED THE LEAD TIP HAD BECOME SEPARATED AND WAS MISSING. STRETCHING OF THE DISTAL SECTION OF THE LEAD WAS ALSO OBSERVED, LIKELY DUE TO THE EXPLANT PROCEDURE. THE ELECTRODE TIP HAD BEEN PULLED OUT OF THE DISTAL END OF THE LEAD BODY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. WHEN THIS LEAD WAS BEING REMOVED, THE LEAD TIP BEGAN SEPARATING FROM THE LEAD BODY AND BECAME DETACHED FROM THE LEAD BODY AFTER IT WAS REMOVED FROM THE PATIENT. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156209 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Hospitalization| L| R 4294| 0460| 1280| 1180| S606| 4459