BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213566 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-06576
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 THE RIGHT ATRIAL (RA) LEAD DID NOT DISLODGE BUT COULD NOT PACE AND HAD POOR SENSING AFTER THE SURGICAL PROCEDURE (MYECTOMY) THREE MONTHS HAD PASSED. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY USING THE SAME DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313713 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R 0292| 4470| E142