BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2910664 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15501
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOTBEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE REPLACEMENT PROCEDURE, THE ELECTRODE TIP SEPARATED FROM THE LEAD DUE TO INDUCED DAMAGE FROM THE USE OF TRACTION FOR THE EXPLANT VERSUS LASER EXTRACTION. THE LEAD ELECTRODE WAS LEFT IN THE PECTORAL MUSCLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18921 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4136| S606| 1290| 4457