BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17533099 · Received August 12, 2023

    Report

    Report Number
    MW5140005
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    June 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED FFIAT ILIE LV CAPTURE MANAGEMENT SAFETY MARGIN WAS UNABLE TO BE MAINTAINED ON (B)(6) 2021. LV CAPTURE MANAGEMENT DETERMINED THAT THRESHOLD INCREASED BY 1.25 V FROM (B)(6) 2021 TO (B)(6) 2021. THIS INCREASE WAS GREATER THAN AMPLITUDE SAFETY MARGIN (+0.5 V) AND MAY HAVE COMPROMISED CAPTURE. (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
    1073120 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown