BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 1875000 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17862
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION CONFIRMED BLOOD IN THE LEADS LUMEN. RESISTANCE AND PRESSURE TESTING WERE PERFORMED TO DETERMINE THE LEADS ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS REVEALED THE LEAD WAS ELECTRICALLY CONTINUOUS. ANALYSIS FOUND THE OUTER INSULATION OF THE LEAD TO BE FULLY INTACT. ANALYSIS CONCLUDED THE BLOOD MOST LIKELY ENTERED THE LEAD THROUGH THE TERMINAL PIN OPENING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A REVISION PROCEDURE WAS PERFORMED. THIS ATRIAL LEAD WITH NON-BOSTON SCIENTIFIC CRM DEVICE AND RIGHT VENTRICULAR LEAD WERE REMOVED DUE TO AN INFECTION. UPON REMOVAL, A VISUAL INSPECTION REVEALED BLOOD IN THIS LEAD AND THE LEADS COLOR HAD CHANGED. IT WAS THOUGHT THERE WAS INSULATION DAMAGE. THE LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention