BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 17523774 · Received August 12, 2023

    Report

    Report Number
    MW5130722
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    June 15, 2020
    Report Date
    February 2, 2021
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LV THRESHOLDS WAS ELEVATED AND LV IMPEDANCES WERE OOR (B)(6) 2020 09:10 *LV TIP TO LVRING LEAD IMPEDANCE 152 O HMS. (B)(6) 2020 09:00:11 " LVTIP TO LVRING LEAD IMPEDANCE 152 OHMS. (B)(6) 2020 21:00:12 LVTIP TO LVRING LEAD IMPEDANCE 1S2 OHMS. (B)(6) 2020 15:00:12 " LVTIP TO LVRING LEAD IMPEDANCE 171 OHMS. (B)(6) 2020 03:00:12 ?LVTIP TO LVRING LEAD IMPEDANCE 1824 OHMS. (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
    2234193 ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB GREATBATCH MEDICAL 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown