BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19811691 · Received July 23, 2024

    Report

    Report Number
    3027386225-2024-00089
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 24, 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 IMPLANTED (B)(6) 2024, RETURNED WITH AN INFECTION OF HER POCKET SITE. DR OLSOFKA EXPLANTED HER ENTERRA SYSTEM, WILL SEEK TO GET THE INFECTION UNDER CONTROL BEFORE EXPLORING THE IDEA OF IMPLANTING A NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964343 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other