BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 4140027 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17150
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    April 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    PMA / PMN Number
    P960004/S014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW A LAD SAFETY SWITCH WAS TRIGGERED ON THE RIGHT ATRIAL LEAD. ALL PACING IMPEDANCES APPEARED WITHIN NORMAL RANGE EXCEPT SLIGHTLY HIGHER VALUES (B)(6) 2014, WHICH WAS THE SUSPECTED TIME OUT AN OUT OF RANGE MEASUREMENT MAY HAVE OCCURRED. SOME INAPPROPRIATE ANTI TACHYCARDIA RESPONSE MODE SWITCHES WERE NOTED DUE TO MYOPOTENTIAL OVERSENSING AS A RESULT OF THE DEVICE BEING IN UNIPOLAR CONFIGURATION. TECHNICAL SERVICES DISCUSSED EVALUATION THE LEAD WHEN PROGRAMMING TO BIPOLAR CONFIGURATION. THE SYSTEM WAS EVALUATED IN THE BIPOLAR CONFIGURATION AND SHOWED NORMAL PACING IMPEDANCES, NORMAL PACING THRESHOLDS, AND NO NOISE/ARTIFACTS ON THE RIGHT ATRIAL LEAD. THE SYSTEM REMAINS IMPLANTED AND PROGRAMMED TO BIPOLAR CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW A LEAD SAFETY SWITCH WAS TRIGGERED ON THE RIGHT ATRIAL LEAD. ALL PACING IMPEDANCES APPEARED WITHIN NORMAL RANGE EXCEPT SLIGHTLY HIGHER VALUES JUNE 2014, WHICH WAS THE SUSPECTED TIME OUT AN OUT OF RANGE MEASUREMENT MAY HAVE OCCURRED. SOME INAPPROPRIATE ANTI TACHYCARDIA RESPONSE MODE SWITCHES WERE NOTED DUE TO MYOPOTENTIAL OVERSENSING AS A RESULT OF THE DEVICE BEING IN UNIPOLAR CONFIGURATION. TECHNICAL SERVICES DISCUSSED EVALUATION THE LEAD WHEN PROGRAMMING TO BIPOLAR CONFIGURATION. THE SYSTEM WAS EVALUATED IN THE BIPOLAR CONFIGURATION AND SHOWED NORMAL PACING IMPEDANCES, NORMAL PACING THRESHOLDS, AND NO NOISE/ARTIFACTS ON THE RIGHT ATRIAL LEAD. THE SYSTEM REMAINS IMPLANTED AND PROGRAMMED TO BIPOLAR CONFIGURATION. ADDITIONAL INFORMATION NOTED THAT THE LEAD SAFETY SWITCH WAS ONCE AGAIN TRIGGERED LIKELY IN JUNE 2018. THE LEAD PARAMETER APPEARED SATISFACTORY IN THE UNIPOLAR AND BIPOLAR CONFIGURATION. THE LEAD SHOWED STABLE IMPEDANCES WITH SMALL INCREASES THE PAST YEAR. NOISE WAS NOTED BUT NOT OVERSENSED IN THE BIPOLAR CONFIGURATION, THEREFORE THE SAFETY SWITCH WAS RESET AND REPROGRAMMED TO THE BIPOLAR CONFIGURATION. ATRIAL TACHY RESPONSE (ATR) EPISODES WERE LOGGED IN WHICH ELECTROCARDIOGRAMS APPEARED TO BE RA LEAD NOISE. NO ADVERSE PATIENT EFFECTS WERE NOTED. THE PATIENT WILL CONTINUE TO BE MONITORED WITH A POTENTIAL RA LEAD EXTRACTION IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620707 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4470 621212

    Patients

    Seq Age Sex Outcome Treatment
    1 4457| 4470| S606