BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1944561 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19806
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE FOR THE DEVICE TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS FRACTURED. HIGH IMPEDANCES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 30 YR Required Intervention E102| T180| 0184| 4469