BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 18040811 · Received October 30, 2023

    Report

    Report Number
    MW5147528
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Report Date
    October 16, 2023
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ALERT: RV BIPOLAR LEAD IMPEDANCE WARNING >3000 OHMS ON (B)(6) 2023. RV LEAD PROGRAMMED BIPOLAR PACE POLARITY AND RV TIP TO RV COIL SENSE POLARITY. PROGRAMMED MODE: VVIR OTHER ALERTS NOTED: (B)(6) 2023 03:00:16 LV TIP TO RV COIL LEAD IMPEDANCE 190 OHMS. ON (B)(6) 2023 03:00:14 LV TIP TO RV COIL LEAD IMPEDANCE 190 OHMS. PAGED ON CALL REP. 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
    2100851 RV LEAD PERMANENT PACEMAKER ELECTRODE DTB GREATBATCH MEDICAL 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown