BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2061014 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06733
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN ELECTED TO LEAVE THE IMPLANTED WITH NO CHANGE TO AID WITH DIAGNOSTICS. 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 DURING NORMAL DEVICE CHANGE OUT, THE RIGHT ATRIAL (RA) LEAD WAS FOUND DISLODGED. IT WAS NOTED THAT HIGH ATRIAL THRESHOLD MEASUREMENTS WERE OBSERVED AT THAT TIME. 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 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0180| T165| E110| 4479