BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3043266 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02575
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCES HAVE BEEN CONSISTENTLY OUT OF RANGE, WITH MEASUREMENTS >2000 OHMS FOR APPROXIMATELY THE LAST TWO MONTHS. THE LV LEAD CONFIGURATION WAS LV TIP TO LV RING. PACING THRESHOLDS IN THIS CONFIGURATION ALSO INCREASED TO 5 TO 6 VOLTS AT 0.5MS. ADDITIONAL LV PACING CONFIGURATIONS WERE EVALUATED AND LV TIP TO RV COIL SHOWED PACING THRESHOLDS OF 0.6 AT 0.5MS; SUBSEQUENTLY THE PACING VECTOR WAS REPROGRAMMED TO THAT CONFIGURATION. POTENTIAL REASONS FOR THE OBSERVATIONS WERE DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS THEY WERE ABLE TO PROGRAM AROUND THE ISSUE, THE PATIENT WILL CONTINUE WITH FOLLOW-UP. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAS INTERMITTENTLY EXHIBITED HIGH, OUT-OF-RANGE (OOR), PACING IMPEDANCES > 2000 OHMS. CAPTURE THRESHOLDS HAVE BEEN NORMAL. A CONNECTION ISSUE WAS SUSPECTED, AS ON X-RAY IT APPEARED THAT THE LEAD'S TERMINAL PIN WAS NOT PAST THE CONNECTOR BLOCK. AT THIS TIME, THE PATIENT WILL BE MONITORED AS THERE WERE NO ISSUES WITH CAPTURE AND LEAD DOES NOT GOVERN TIMING OF DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145279 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4087| 0185| 4543| N119