BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2173217 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11975
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE CLINIC SCHEDULED THE PATIENT FOR AN OFFICE VISIT AND AN ECHOCARDIOGRAM. THE PATIENT DID NOT SHOW UP FOR THE APPOINTMENT AND HAS NOT RESPONDED TO THE CLINIC THREE PHONE MESSAGES LATER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY ONE YEAR LATER WE RECEIVED INFORMATION THAT THE PACING IMPEDANCE MEASUREMENTS CONTINUED TO REMAIN OUT OF RANGE. IT WAS ALSO REPORTED THAT THE LV PACING CONFIGURATION WAS LV TIP TO RV COIL. IN PREVIOUSLY REPORTED INFORMATION, THE RV IMPEDANCE HAD ALSO BEEN OUT OF RANGE THE DURATION OF THE LV PACING IMPEDANCE. BASED ON THE LV CONFIGURATION, IT WAS POSSIBLE THAT IF THERE WAS AN ISSUE WITH THE RV LEAD IT COULD ALSO PRESENT AN OUT OF RANGE ISSUE WITH THE LV LEAD. A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED DUE TO THE DEVICE BATTERY BEING AT END OF LIFE (EOL). THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS THOROUGHLY TESTED IN UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE PACING IMPEDANCE AND PACING THRESHOLD MEASUREMENTS WERE BOTH IN ACCEPTABLE RANGES. VENTRICULAR FIBRILLATION (VF) INDUCTION TESTING WAS ALSO PERFORMED WITH APPROPRIATE DETECTION, DELIVERY, AND CONVERSION OF THE RHYTHM. THE LV LEAD ALSO PRESENTED MEASUREMENTS WITHIN NORMAL LIMITS. THE LV AND RV LEADS REMAIN IN SERVICE WITH THE NEW DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY SEVEN MONTHS LATER, OUT OF RANGE IMPEDANCES WERE OBSERVED WITH THE NEW DEVICE. THE RV LEAD WAS REPLACED AND AFTER USING A DEDICATED BIPOLAR LEAD, THE LV LEAD IMPEDANCES WERE WITHIN NORMAL RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEFT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND NOT SEEN SINCE 2006. IN A REVIEW OF THE HISTORICAL DATA THE PACING IMPEDANCES HAD BEEN OUT OF RANGE SINCE AS LONG AS THE INFORMATION FROM THE LEAD DAILY TREND WAS VIEWABLE (52 WEEKS). TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR H177| 0157| 5076| 4543