BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3910553 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-11405
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. VISUAL INSPECTION REVEALED THAT THE COILS AT MIDDLE REGION OF LEAD BODY WERE KINKED, STRETCHED AND WAVY. IT IS CONCLUDED THE DAMAGE MOST LIKELY DUE TO HANDLING. LABORATORY RESULT CONFIRMED THE REPORTED CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS NOT SUCCESSFULLY IMPLANTED DUE TO LEAD BODY AND CONDUCTOR DAMAGE. THE RV LEAD WAS SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388089 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R K273| 4470| 4457