BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1945855 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20788
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS ELECTRICALLY DEACTIVATED AND REMAINS IMPLANT. NO PLANS FOR INTERVENTION AT THIS TIME. NO ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION INDICATED THAT IN ADDITION TO DISPLAYING LOSS OF CAPTURE, THE LEAD DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCES. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS CUT AND CAPPED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE AT MAXIMUM PROGRAMMED OUTPUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4470| H229| 4518| 0158