BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871526 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17078
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, IT WAS NOTED THIS RIGHT VENTRICULAR LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND REPLACED. NO RETURN OF PRODUCT IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Other