BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1871097 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17247
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED DURING THE IMPLANT PROCEDURE. RA LOSS OF CAPTURE (LOC) WAS OBSERVED AT HIGH OUTPUT LEVELS HOWEVER UNDER FLUOROSCOPY THE LEAD APPEARED STABLE. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IN SERVICE AND USE IT FOR SENSING AND NOT PACING. 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 4480

    Patients

    Seq Age Sex Outcome Treatment
    1