BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYTRAK 2

    MDR report key: 2133097 · Received June 18, 2011

    Report

    Report Number
    2124215-2011-10548
    Event Type
    Death
    Date Received
    June 18, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT A PATIENT DEATH. THE PATIENT HAD BEEN PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOLLOWING A FAILED ATTEMPT TO IMPLANT A TRANSVENOUS LEFT VENTRICULAR (LV) LEAD. AN EPICARDIAL LV LEAD WAS POSITIONED, HOWEVER, LV PACING COULD NOT BE OBTAINED. THE LEAD POSITION WAS CHECKED AND THE LEAD WAS PULLED BACK. FOLLOWING LEAD MANIPULATION, RELEASE OF "BLUE" BLOOD WAS OBSERVED FOLLOWED BY SPONTANEOUS DEVELOPMENT OF VENTRICULAR TACHYCARDIA (VT). SHOCK THERAPY WAS DELIVERED WITH SUBSEQUENT BRADYCARDIA PACING. SHORTLY THEREAFTER, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION (VF). DESPITE DELIVERY OF MULTIPLE SHOCK THERAPIES, THE ARRHYTHMIA COULD NOT BE TERMINATED AND THE PATIENT DIED. THE ROOT CAUSE OF DEATH WAS ATTRIBUTED TO COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 0185| 4543| 4136| N119