BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3223458 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10234
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    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 A LEAD REVISION WAS DONE ON BOTH RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS AFTER DISLODGMENT. UPON INTERROGATION, THE RA LEAD WAS ALSO UNDER SENSING AND WAS NOT CAPTURING AT MAXIMUM OUTPUT. THE RV LEAD SHOWED FLUCTUATIONS IN PACING THRESHOLD MEASUREMENTS FROM 0.5V @ 0.4MS AND 2.3V @ 0.4MS SINCE IMPLANT. THE RA AND RV LEADS WERE SUCCESSFULLY REPOSITIONED WITH GOOD OUTCOME. SENSING, THRESHOLDS AND IMPEDANCE MEASUREMENTS WERE ALL NORMAL AND WITHIN RANGE. THE LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322952 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R