BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1875081 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18991
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS ELECTRICALLY ABANDONED AND REMAINS IMPLANTED IN THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD MICRO-DISLODGED NINE DAYS POST IMPLANT. THE PHYSICIAN OPTED TO PROGRAM THE DEVICE TO VVI 50 UNTIL FURTHER NOTICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 81 YR S603| 4456| 4479| 4469