BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2041416 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00938
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND WAS NOT REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD DISPLAYED SUDDEN HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. IN ADDITION, THE LEAD DID NOT CAPTURE APPROPRIATELY. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD COULD NOT BE REPLACED DUE TO OCCLUDED VEINS ON THE PATIENT'S LEFT BODY SIDE. DUE TO SAFETY CONCERNS, A DECISION WAS MADE TO NOT IMPLANT THE LEAD ON THE PATIENT'S OPPOSITE BODY SIDE. THE DEVICE WAS REPROGRAMMED TO VVIR PACING MODE. 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