BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19115793 · Received April 16, 2024

    Report

    Report Number
    3027386225-2024-00027
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 2, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS HE WAS EXPLANTED ON (B)(6) 2024, DUE TO HIS BODY REJECTING THE DEVICE. HE TOLD ME HE DID HAVE SYMPTOMATIC IMPROVEMENT WITH THE DEVICE, SO HE WANTED TO KNOW IF THE COMPANY HAS ANY RECOMMENDATIONS IN THIS SCENARIO. HE SAID THAT HIS SURGEON ATTEMPTED TO "WRAP THE DEVICE IN TWO LATEX FREE CONDOMS, BUT MY BODY STILL REJECTED THAT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690981 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention