BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050180 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03275
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER THIS RV LEAD WILL BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE FOLLOW-UP CHECK, IT WAS OBSERVED THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN CHANGED FROM BIPOLAR TYPE TO UNIPOLAR TYPE. AN X-RAY WAS THEN PERFORMED, AND LEAD FRACTURE WAS NOTED. A REVISION PROCEDURE IS SCHEDULED FOR THE NEAR FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 1298| S603| 4470| 4469