BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3904325 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10880
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS NOT RETURNED FOR TESTING AND EFFORTS TO OBTAIN ADDITIONAL DETAILS WERE UNSUCCESSFUL. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REASON THE LEAD WAS REMOVED FROM SERVICE WAS DUE TO NOISE WHICH WAS BEING OVERSENSED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED FROM SERVICE DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384318 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L 1190| 4136| 4456| K062