BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1852727 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14511
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    March 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4), VISUAL INSPECTION REVEALED THE CONDUCTOR COILS WERE DEFORMED AT 190 AND 210 MILLIMETERS (MM) FROM THE TERMINAL PIN. THE INSULATION WAS BENT 393, 402, 412, AND 445 TO 448 MM FROM THE TERMINAL PIN. FURTHER VISUAL INSPECTION FOUND THE CATHODE AND ANODE COILS WERE FRACTURED 445 MM FROM THE TERMINAL PIN. ANALYSIS COULD NOT CONFIRM A LEAD DISLODGEMENT, HOWEVER THE OBSERVED FRACTURE COULD HAVE CONTRIBUTED TO THE INCREASED PACING IMPEDANCE MEASUREMENTS.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING THRESHOLDS AND PACING IMPEDANCES. THE PACING IMPEDANCES WERE GREATER THAN 2000 OHMS. TECHNICAL SERVICES (TS) SUGGESTED TRYING DIFFERENT VECTORS, WHICH WAS PERFORMED AND THE PACING THRESHOLDS REMAINED HIGH. IT WAS STATED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. IT WAS DETERMINED THAT THE LEAD HAD DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS SYSTEM CONTINUES TO HAVE HIGH OUT OF RANGE LV PACING IMPEDANCE MEASUREMENTS. TS DISCUSSED POSSIBLE CAUSES AND TROUBLESHOOTING OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)