BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2040797 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01236
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 AND/ OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM (DATED IN (B)(6) 2011) THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. A REPLACEMENT DUAL CHAMBER PACEMAKER WAS IMPLANTED AND IS BEING USED AS A BIVENTRICULAR PACEMAKER. THE LEFT VENTRICULAR (LV) LEAD WAS INSERTED INTO THE REPLACEMENT DEVICE'S RIGHT ATRIAL (RA) PORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) IN (B)(6) 2010. THE MONITORING VOLTAGE IS 2.48 VOLTS WITH A CHARGE TIME OF 13.3 SECONDS. THE CLINIC NURSE ASKED IF THE DEVICE REPLACEMENT COULD BE SCHEDULED FOR (B)(6) AS THE PATIENT DEVELOPED AN INFECTION. TECHNICAL SERVICES INFORMED THE CLINIC NURSE THAT THE DEVICE SHOULD BE REPLACED WITHIN 90 DAYS OF ERI DECLARATION.

    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 Life Threatening 4543| 0184| H170