BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3971356 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14840
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND HIGH PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. IT WAS REPORTED THAT THE OUT OF RANGE MEASUREMENTS WERE OBSERVED AFTER THE PATIENT FELL. A LEAD FRACTURE WAS SUSPECTED. SUBSEQUENTLY, THE PHYSICIAN PROGRAMMED THE DEVICE TO VVI MODE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446725 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 4469| E030| 0184| T125