BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20292351 · Received September 24, 2024

    Report

    Report Number
    3027386225-2024-00106
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD THE BATTERY REPLACED TWO WEEKS BEFORE (B)(6) 2024; POST-OP, HE BEGAN TO EXPERIENCE A SHOCKING SENSATION IN THE POCKET AREA, RADIATING TO THE STOMACH AREA. THE SHOCK WAS PAINFUL AND MIRRORED THE DEVICE CYCLING SETTING OF 4 SECONDS ON AND 1 SECOND OFF. HE PRESENTED TO HIS GI THAT AFTER TRYING TO SWITCH POLARITIES AND DIFFERENT COMBINATIONS BETWEEN THE LEADS AND THE CASE THAT WERE PROVED UNSUCCESSFUL, HE OPTED TO TURN THE DEVICE OFF FOR PATIENT COMFORT. THE PATIENT WAS SCHEDULED FOR SURGERY, AND A LAPAROSCOPIC COMPLETE SYSTEM EXCHANGE WAS PERFORMED, INCLUDING MOVING THE POCKET FROM THE LEFT TO THE RIGHT ABDOMINAL SIDE. THE PATIENT EXPERIENCED PAIN/DISCOMFORT AND HAD THE DEVICE TURNED OFF, WHICH CAUSED HIS NAUSEA AND VOMITING TO WORSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137157 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other