BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 17526831 · Received August 12, 2023

    Report

    Report Number
    MW5133768
    Event Type
    Injury
    Date Received
    August 12, 2023
    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

    PATIENT HAD CARDIAC ARREST AND DEVICE APPEARS TO BE UNDERSENSING ON VENTRICULAR LEAD. LEAD MANUFACTURED BY GREATBATCH MEDICAL. CASE: (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
    2244731 ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB GREATBATCH MEDICAL 511212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown