BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4883405 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-08234
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. THE LEAD INSULATION WAS NOTED TO HAVE BEEN CUT 18 CENTIMETERS FROM THE IS-1 TERMINAL PIN. THIS DAMAGE APPEARED TO BE THE RESULT OF CUTTING ACTION WITH A SHARP ITEM. THE CLINICAL OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A HEART RATE IN THE 30'S; LOSS OF CAPTURE (LOC) WAS NOTED. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429037 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R K063| 4470| 4471| MISMATCH