BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1851921 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14549
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE LEAD IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXPLANTED AND REPLACED AFTER EXHIBITING LOSS OF CAPTURE AND HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THERE WAS NO EVIDENCE OF DISLODGEMENT OR A FRACTURE. ANOTHER ATRIAL LEAD WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS. LEAD RETURN FOR ANALYSIS HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4513| H179| 0157| 4469