BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 13675597 · Received March 4, 2022

    Report

    Report Number
    2124215-2022-01940
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    January 3, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526264993
    PMA / PMN Number
    P960004/S014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, NOISE, OVERSENSING, AND PACING INHIBITION. THE PATIENT DID NOT EXPERIENCE ASYSTOLE AS A RESULT OF THE PACING INHIBITION. SURGICAL INTERVENTION WAS UNDERTAKEN. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030541 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4470 700579 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H