BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2171588 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11747
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS COULD NOT CONFIRM OR DENY THE DEVICE CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENTED INFORMATION. MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO BOSTON SCIENTIFIC, BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD DID APPEAR TO HAVE AN INTEGRITY ISSUE AS THERE WAS NO APPARENT PACING FUNCTIONALITY. SENSING WAS AVAILABLE. THE PHYSICIAN ELETED TO USE A DIFFERENT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1