BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212667 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09030
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS CURRENTLY BEING DONE ON THIS LEAD. ONCE ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THE LEAD WAS RETURNED SEVERED IN 2 SEGMENTS FOR A TOTAL LENGTH OF 448 MM. THERE WERE STRETCHED CONDUCTOR COILS AND DEFORMED COILS NOTED. ADDITIONALLY THE INSULATION WAS CUT AND THERE WAS DRIED BODILY FLUID AS WELL AS AN EXTRACTION STYLET FOUND INSIDE THE LEAD. THE LEAD MAY HAVE BEEN DAMAGED AT EXPLANT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ENTIRE SYSTEM WAS EXPLANTED FOR INFECTION. DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE DEVICE SETSCREW WAS STUCK. THE DEVICE AND LEADS WERE EXPLANTED. DURING EXPLANT, THIS LEAD MIGHT HAVE BEEN DAMAGED DUE TO BEING STUCK IN THE DEVICE HEADER. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314423 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4554| 4470| H217| 1280| 4469| 0184