BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050309 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03376
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED DAMAGE TO THE CONDUCTOR COILS, INCLUDING FRACTURED COILS IN THE AREA BETWEEN 240-244 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY CAUSED BT ENTRAPMENT IN THE CLAVICLE/FIRST RIB REGION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, NO SENSING AND NO CAPTURE. IT WAS DETERMINED THE LEAD HAD FRACTURED. AS A RESULT, THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 66 YR Required Intervention 0015| 1857| 0041| 0184| 1625| 1550| 4312| T180| E110| 4469| 1746| 6931| 0040