BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1871542 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17281
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED CONSISTENTLY HIGH PACING IMPEDANCES INCLUDING SOME MEASUREMENTS WHICH WERE OUT OF RANGE. SENSING AND THRESHOLD MEASUREMENTS WERE STABLE.

    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 69 YR H177| 4087| 0157| N119| 4543