BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2911512 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16081
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT NORMAL FOLLOW UP, THIS LEAD DISPLAYED A CONDUCTOR FRACTURE DUE TO SUSPECTED CLAVICULAR CRUSH. THIS WAS CONFIRMED VIA A CHEST X-RAY. CURRENTLY, THE LEAD REMAINS IMPLANTED AND IN USE. A REPLACEMENT PROCEDURE WILL LIKELY BE SCHEDULED FOR THE NEAR FUTURE, HOWEVER NOTHING HAS BEEN PLANED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17662 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1