BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2171183 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11740
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PATIENT, IMPLANTED WITH THIS PACEMAKER PRESENTED TO THE HOSPITAL FOR SYNCOPAL EPISODES AND OVERALL BODY HEAT. THE DEVICE WAS INTERROGATED AND STORED EPISODES OVER FOUR DAYS WERE SHOWING NOISE BEING OVERSENSED AND INHIBITING PACING IN THE RIGHT VENTRICLE (RV). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SINCE ADMISSION, THERE WERE SIX ADDITIONAL EPISODES OF NOISE THAT WERE INHIBITING PACING ON TELEMETRY. ALL OTHER LEAD MEASUREMENTS WERE NORMAL AND NOISE COULD NOT BE RECREATED WITH ISOMETRICS AND POCKET MANIPULATION, HOWEVER INCREASING SENSITIVITY STILL SHOWED NOISE AND PACING INHIBITION ON TELEMETRY AND LOSS OF CAPTURE WAS OBSERVED POST ATTEMPTS TO REPROGRAM THE DEVICE ON TELEMETRY FOR 10-15 SECONDS. THE RV LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4456| 4469| 1291