BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 18004556 · Received October 25, 2023

    Report

    Report Number
    3027386225-2023-00014
    Event Type
    Death
    Date Received
    October 25, 2023
    Date of Event
    March 25, 2023
    Report Date
    July 24, 2023
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    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

    THE PATIENT HAD AN UNEVENTFUL GASTRIC STIMULATOR PLACEMENT. SHE HAD STOMACH TO ANTERIOR ABDOMINAL WALL ADHESIONS THAT WERE TAKEN DOWN AT THE BEGINNING OF THE CASE. THE LEADS WERE PLACED INTO THE DESIGNATED AREA OF THE STOMACH. AN EGD WAS PERFORMED, AND THE PATIENT HAD SOME RETAINED FOOD IN THE STOMACH, WHICH IS NOT UNCOMMON. THE SCOPE WAS USED TO GENTLY MOVE THE FOOD ASIDE SO THE AREA OPPOSING THE LEADS COULD BE VISUALIZED. THE REMAINDER OF THE CASE WAS STANDARD, INCLUDING SEWING THE LEADS INTO PLACE AND PLACING THE BATTERY. THE FOLLOWING MORNING THAT PATIENT COMPLAINED OF ABDOMINAL PAIN AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. SHE WENT TO (B)(6). THERE SHE WAS REPORTED TO HAVE A PERFORATION. SHE BECAME SEPTIC LATER THAT NIGHT AND CODED. SHE WAS TAKEN TO THE OPERATING ROOM AND FOUND TO HAVE A PERFORATION SO THE DEVICE WAS REMOVED DUE TO CONTAMINATION. SHE REMAINED IN CRITICAL CONDITION AND DIED THE FOLLOWING DAY. THERE IS NO ASSOCIATION OF HER DEATH WITH THE STIMULATOR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022944 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 N/A 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death