BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3232673 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11438
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND A COMPLETE LOSS OF CAPTURE. A HIGH PACING LEAD IMPEDANCE MEASUREMENT AND A LEAD DISLODGEMENT WERE ALSO NOTED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. ALL OTHER MEASUREMENTS WERE NORMAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333105 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| H| L