BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19955223 · Received August 9, 2024

    Report

    Report Number
    3027386225-2024-00084
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT STATED THAT THEIR STOMACH FELT LIKE IT WAS BEING HIT WITH A JACK HAMMER 3 TIMES IN A ROW (AND THAT THIS SENSATION HAPPENED MULTIPLE TIMES). THE PATIENT ALSO SAID THAT THEY EXPERIENCED VIBRATIONS THAT FELT LIKE PREGNANCY KICKS. THE PATIENT'S ENTERRA THERAPY SYSTEM HAS BEEN TURNED OFF UNTIL THE REPAIR IS COMPLETED, LEAVING THEM WITH INCREASED NAUSEA AND STOMACH PAIN. THE PATIENT HAD SURGERY FRIDAY, ON (B)(6) 2024, TO REPAIR THE STIMULATOR. THE WHOLE THING WAS REPLACED. THIS IS HER 5TH STIMULATOR. THE STIMULATOR HAS BEEN VERY SUCCESSFUL. HER FIRST IMPLANT WAS (B)(6) 2009. PATIENT SAID IT HAD BEEN A ROUGH WEEK BUT SHE IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205479 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other