BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3981216 · Received August 5, 2014

    Report

    Report Number
    2124215-2014-15033
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ADDITIONALLY, THERE WERE SET SCREW MARKINGS NOTED ON THE TERMINAL PIN. THE RETURNED PORTION OF LEAD SEGMENT PASSED ALL ELECTRICAL TESTING. THE ALLEGATION COULD NOT BE CONFIRMED, THE LEAD DAMAGE FOUND WAS LIKELY INDUCED DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO INFECTION. ADDITIONALLY PRIOR TO EXPLANT, IT WAS NOTED THAT THIS LEAD WAS OVERSENSING WHILE PROGRAMMED UNIPOLAR WHICH LED TO A DECREASED PACING RATE. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457696 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L| R K063| 4136| 4457