BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050025 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04558
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD AND PACEMAKER PRESENTED TO THE EMERGENCY ROOM AFTER NOT FEELING WELL. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THERE WAS NO RV CAPTURE AND PACING IMPEDANCES WERE GREATER THAN 2000 OHMS. THE PATIENT WAS THEN SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS CAPPED AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153187 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4457| 1290| K063| 4471| 4469