BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131447 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13889
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    January 22, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT DURING THE REPLACEMENT OF THIS RIGHT VENTRICULAR LEAD A CLEAR FRACTURE OF THE LEAD WAS NOTED. THE VENTRICULAR LEAD WAS LEFT INSITU WHILE THE RIGHT ATRIAL COMPETITOR LEAD AND DEVICE WERE SUCCESSFULLY REMOVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS NOT CAPTURING AND AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED WITH NO SENSING. A LEAD FRACTURE WAS ALLEGED. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE TECHNICIAN REPROGRAMMED THE DEVICE TO AAI AND A FOLLOW UP WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT DURING A FOLLOW UP LOW OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THIS RIGHT ATRIAL LEAD. FLUOROSCOPY NOTED THAT THIS LEAD OUTER INSULATION DAMAGE AND EXPOSED WIRES. THE RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED, AND WILL NOT BE RETURNED. THE DEVICE WAS REPLACED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611310 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4136| S606| 4457