BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050132 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05691
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. IT WAS REPORTED THE PATIENT WAS LOST TO FOLLOW-UP SINCE IMPLANT AND HAD FOLLOWED-UP IN CLINIC AFTER THE SYNCOPAL EPISODE. NO FURTHER INFORMATION WAS AVAILABLE. RECORDS INDICATE THIS DEVICE AND LEAD REMAIN IN SERVICE. 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 IMPLANTED WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXPERIENCED FATIGUE AND DIZZINESS FOLLOWED BY SYNCOPE. THE PATIENT FELT SYMPTOMATIC AFTER DOING PHYSICAL LABOR AND INQUIRED IF A LEAD COULD HAVE DISLODGED. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149564 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening K063| 4470| 4471