BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19730966 · Received July 12, 2024

    Report

    Report Number
    3027386225-2024-00075
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 24, 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

    A PATIENT'S DEVICE WAS EXPLANTED BY DR (B)(6) AT (B)(6) BECAUSE AN INFECTION OF THE POCKET SITE FOLLOWING THEIR MOST RECENT BATTERY CHANGE. THE PHYSICIAN IS CURRENTLY TREATING AND MONITORING THE INFECTION, NO DEFINITE PLANS TO RE-IMPLANT A NEW ENTERRA SYSTEM UNTIL THE INFECTION IS FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301092 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Other