BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK

    MDR report key: 2052931 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04072
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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 THE LEFT VENTRICULAR THRESHOLDS HAD RISEN AFTER CONNECTING TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THRESHOLDS CHANGED FROM 0.9V TO 1.7V. THE LEAD WAS DISCONNECTED FROM THE DEVICE AND TESTING WITH THE PACING SYSTEM ANALYZER WHICH MEASURED 1.5V. THE PACING IMPEDANCES DROPPED FROM 700 TO 550 OHMS. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IMPLANTED AND MONITOR VIA LATITUDE. THERE WAS INQUIRY AS TO THE CHANGES. THERE WAS INQUIRY IF THE LEAD HAD SLIGHTLY DISLODGED OR IF THIS ALSO COULD BE RELATED TO MEDICATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4470| 4513| N118| H175| 0184