BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 16135093 · Received January 10, 2023

    Report

    Report Number
    2124215-2023-00913
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    December 24, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    PMA / PMN Number
    P950001/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NOISE AND OVERSENSING WITH PACING INHIBITION WERE SEEN ON THE ATRIAL CHANNEL DURING AN ATRIAL TACHY RESPONSE (ATR) EVENT AND ATRIAL PACING WAS NOT AS EXPECTED. THE NOISE WAS REPRODUCIBLE WITH ISOMETRIC TESTING IN CLINIC, AND IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A GRADUAL DECREASE IN PACE IMPEDANCE SINCE IMPLANTATION. LEAD DETERIORATION AND AN INSULATION ISSUE WAS SUSPECTED. THE PATIENT REPORTED DISCOMFORT IN THE ABSENCE OF ATRIAL PACING. SUBSEQUENTLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE, AND THE RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD HAD ALSO INCREASED RECENTLY, AND THE RV LEAD WAS ALSO SURGICALLY ABANDONED AND REPLACED. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE AS WELL FOR THE FACT IT HAD BEEN IMPLANTED FOR EIGHT YEARS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900236 IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4035 340923

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Hospitalization| R