BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1931516 · Received December 17, 2010

    Report

    Report Number
    2124215-2010-23193
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WHO RECEIVED THIS LEAD PASSED AWAY DURING THE IMPLANT PROCEDURE. THERE WERE NO ALLEGATIONS AGAINST THE LEAD OR ITS FUNCTIONALITY. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED A SEPARATE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SUCCESSFULLY PLACED AND THE PATIENT WAS PACED WITH A PACING SYSTEM ANALYZER (PSA). THAT LEAD WAS DISCONNECTED FROM THE PSA, WITH THE PATIENT EXHIBITING AN INTRINSIC RHYTHM, WHILE THE SUTURING OF THE LEAD INTO PLACE BEGAN. THE PATIENT BEGAN TO EXHIBIT BRADYCARDIA, AND THE LEAD WAS RECONNECTED TO THE PSA AND CAPTURE WAS RESTORED AT HIGH OUTPUTS. THE PATIENT'S HEART THEN APPEARED TO EXHIBIT PULSELESS ELECTRICAL ACTIVITY FOR A PERIOD OF TIME BEFORE BEING REVIVED. THIS LEAD WAS THEN IMPLANTED IN A DIFFERENT LOCATION IN A SUCCESSFUL ATTEMPT TO OBTAIN IMPROVED PACING THRESHOLDS, AND ALSO CONNECTED TO THE DEVICE. AS THE DEVICE POCKET WAS BEING CLOSED, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION, WHICH THE DEVICE DETECTED AND CONVERTED TO A SINUS RHYTHM. THE PATIENT THEN WENT INTO ANOTHER VENTRICULAR ARRHYTHMIA, WHICH THE DEVICE AGAIN SUCCESSFULLY DETECTED AND CONVERTED. DURING POST-SHOCK PACING, CAPTURE WAS INITIALLY OBSERVED BUT WAS SUBSEQUENTLY SLOWLY LOST, DESPITE INCREASING DEVICE OUTPUTS TO THE MAXIMUM SETTING. CODE WAS CALLED, BUT THE ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 0185| E030| 4470