BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 20257217 · Received September 19, 2024

    Report

    Report Number
    3027386225-2024-00105
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS DEVICE IS POWERED OFF AND THEY'RE BEING SHOCKED. FOLLOW-UP WITH PATIENT, THEY HAVE AN APPOINTMENT TO HAVE THEIR IPG REPLACED IN SEPT. PHYSICIAN FEELS THIS SHOULD TAKE CARE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431102 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other