BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPG 37800

    MDR report key: 17966824 · Received October 19, 2023

    Report

    Report Number
    3027386225-2023-00001
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    May 22, 2023
    Report Date
    September 21, 2023
    Manufacturer
    ENTERRA MEDICAL
    Product Code
    DJZ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL WITH END STAGE KIDNEY DISEASE AND NAUSEA / VOMITING. IMPEDANCE CHECK ON IMPLANTED DEVICE DISPLAYED: LEAD 2 >20,000 OHMS, BATTERY READING LOW. END STAGE RENAL DISEASE. ENTERRA IMPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96150 IPG 37800 GASTRIC STIMULATOR DJZ ENTERRA MEDICAL IPG 37800 N/A 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Hospitalization