BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2910318 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16051
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ONE DAY AFTER THE IMPLANT OF THIS RIGHT ATRIAL (RA) LEAD, CAPTURE WAS NOTED IN THE VENTRICLE. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE LEAD WAS IN THE VENTRICLE. THE RA LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18579 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R