BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1953929 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24130
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS LEAD CAUSE/CONTRIBUTED TO THE PERFORATION OF THE SUPERIOR VENA CAVA (SVC). THE IMPLANT TEAM HAD CALLED A CODE, THE PATIENT WAS STABILIZED AND THE PUNCTURE APPEARED TO HAVE CLOSED ON IT'S DOWN WHEN OBSERVED VIA VENOGRAM. THE NEXT DAY, THE PATIENT RECEIVED A NEW LEAD AND GENERATOR WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening