BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20136872 · Received September 4, 2024

    Report

    Report Number
    3027386225-2024-00102
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 21, 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

    REGISTERED NURSE REPORTED THAT THEY HAVE A PATIENT THAT HAS A IMPLANTED GASTRIC PACE MAKER THAT IS GIVING HIM PAINS AND IS SHOCKING HIM. PATIENT WAS REFERRED TO AN ENTERRA PHYSICIAN. NO FOLLOW-UP INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900019 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other