BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19725506 · Received July 11, 2024

    Report

    Report Number
    3027386225-2024-00073
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 10, 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

    FACEBOOK COMMENT: "WIFE'S BODY REJECTED HER STIMULATOR AND HAD TO HAVE IT REMOVED. IT'S BEEN 4 WEEKS NOW AND SHE'S NOT BEEN SICK ONCE SINCE IT WAS REMOVED. REASON FOR INSTALLING IT WAS DAMAGED VAGUS NERVE FROM A NISSEN FUDAPLICATION SURGERY. NO DIABETES!" THE COMMENTER CLAIMS THAT HIS WIFE'S BODY REJECTED THE THERAPY AND HAD TO HAVE IT REMOVED. ATTACHED MANY IMAGES OF WHAT APPEARED TO BE INFECTED INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348801 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other