BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3041070 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01019
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 ATRIAL (RA) LEAD EXHIBITED INCREASED PACING THRESHOLDS, DECREASED AMPLITUDE AND DIAPHRAGMATIC STIMULATION. THE PATIENT PRESENTED TO THE CLINIC WITH INCREASED HEART FAILURE SYMPTOMS. THE PATIENT WAS SENT FOR A CHEST X-RAY WHICH REVEALED THAT THIS PRODUCT HAD DISLODGED. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT UNDERWENT A SUCCESSFUL REVISION PROCEDURE. THIS LEAD WAS REPOSITIONED AND NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143965 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 0292| 4469| E142