BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 4903652 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08766
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 26, 2015
    Report Date
    November 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    PMA / PMN Number
    P960004/S014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NEVER RETURNED. 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION INDICATED THE LEAD WAS SEVERED APPROXIMATELY 95 MILLIMETERS FROM THE TERMINAL PIN, WITH ONLY THE PROXIMAL SEGMENT BEING RETURNED. THE RETURNED SEGMENT PASSED CONTINUITY TESTING WHICH CONFIRMED IT WAS ELECTRICALLY CONTINUOUS. THE ALLEGATION MADE AGAINST THE LEAD COULD NOT BE CONFIRMED THROUGH ANALYSIS OF THE RETURNED SEGMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, BLOOD WAS NOTED TO HAVE CONTAMINATED THE BODY OF THE LEAD. THE PHYSICIAN BELIEVED THE LEAD WAS FRACTURED SO IT WAS EXPLANTED AND REPLACED PRIOR TO POCKET CLOSURE. THE LEAD WAS NEVER IN SERVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, BLOOD WAS NOTED TO HAVE CONTAMINATED THE BODY OF THE LEAD. THE PHYSICIAN BELIEVED THE LEAD WAS FRACTURED SO IT WAS EXPLANTED AND REPLACED PRIOR TO POCKET CLOSURE. THE LEAD WAS NEVER IN SERVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444955 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4470 771426

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR