BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20134997 · Received September 4, 2024

    Report

    Report Number
    3027386225-2024-00100
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 13, 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

    DR (B)(6) CALLED DURING A SURGERY. A PATIENT THAT WAS IMPLANTED A FEW MONTHS AGO BECAUSE OF HER ANATOMY, HE DID A POCKET REVISION. THE DEVICE GAVE HIM THE POWER SURGE DEACTIVATION WARNING (MY WORDING IS PROBABLY WRONG). HE USED ELECTROCAUTERY BY THE DEVICE. HE TURNED THE DEVICE BACK ON WITH NO FURTHER PROBLEMS. THE SAFETY FEATURE DEACTIVATED THE DEVICE DURING A SURGERY. PATIENT UNDERWENT A REVISION SURGERY TO ADJUST PLACEMENT OF THE IPG BASED ON SURGEON'S DISCRETION. DEVICE TURNED OFF AS DESIGNED DUE TO POWER SURGE. DEVICE WAS TURNED BACK ON AND PATIENT IS DOING WELL. NO FURTHER ACTION TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875166 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other