BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17531892 · Received August 12, 2023

    Report

    Report Number
    MW5138803
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    104 SIC COUNTS SINCE (B)(6) 2020 (83 ON (B)(6) 2020). SVC DEFIB IMPEDANCE TREND WERE AROUND IS0 OHMS AND HAVE DECREASED SINCE (B)(6) 2020 TO AROUND 120 OHMS. NOISE IS NOTED ON THE ATRIAL AND VENTRICULAR EGM SUGGESTIVE OF EMI. RV LIA TRIGGERED ON (B)(6) 2019 WAS DUE TO THE WAND (IN AIRPORT SECURITY) BEING HELD OVER THE PATIENT'S DEVICE FOR 2-3 MINUTES. SHE NOTED HE RECEIVED A SHOCK FOR THIS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216590 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC 4543 AND 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown