BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2163457 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07965
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO PRINTOUTS OR MEMORY DOWNLOAD HAS BEEN SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). NO FURTHER INFORMATION ON THIS DEVICE AND LEAD HAVE BEEN REPORTED AND OUR RECORDS INDICATE THAT THEY STILL REMAIN IMPLANTED AND 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.

    Additional Manufacturer Narrative · 1

    THE TS REPRESENTATIVE PROVIDED SOME POSSIBLE REASONS WHY THE IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. THE TS REPRESENTATIVE ALSO REQUESTED THAT A SAVE TO DISK BE PERFORMED SO THAT MORE IN DEPTH ANALYSIS COULD BE PERFORMED. ONCE THE DATA IS ANALYZED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, A REVIEW OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REVEALED THAT THE PACING IMPEDANCE MEASUREMENTS ON THIS LEFT VENTRICULAR (LV) LEAD WERE ABOVE 2,000 OHMS FOR (B)(6). HOWEVER, THE IMPEDANCES DURING THE LAST TWO FOLLOW UPS WERE 450 AND 800 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other