BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20039298 · Received August 22, 2024

    Report

    Report Number
    3027386225-2024-00091
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 18, 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

    PATIENT WEIGHTS ONLY 100 LBS, BATTERY WAS CAUSING PAIN DUE TO ITS SIZE ON HER SMALL FRAME. IT WORKED FOR HER FOR A WHILE, BUT THE PAIN WAS TOO MUCH FOR HER TO DEAL WITH. TODAY THEY ARE REMOVING IT AND DOING A PYROLOPLASTY. HOSPITAL DISPOSED OF DEVICES; NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26000 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other