BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19723339 · Received July 11, 2024

    Report

    Report Number
    3027386225-2024-00072
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 2, 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

    PATIENT UNDERGOING FULL ENTERRA SYSTEM REPLACEMENT, AS THE UOFL GI MOTILITY TEAM HAS DEEMED THE SYSTEM LESS EFFECTIVE, DELIVERING INSUFFICIENT RELIEF OF SYMPTOMS, SINCE THE PATIENT'S BATTERY CHANGE IN 2023. PATIENT DESCRIBED WORSENING OF GP SYMPTOMS SINCE MOST RECENT BATTERY CHANGE. WOULD LIKE TO PURSUE DR STOCKER'S RECOMMENDATION TO REMOVE AND REPLACE FULL ENTERRA SYSTEM TO TRY TO ACHIEVE BETTER RELIEF OF SYMPTOMS. PATIENT IS HAVING THEIR OLD ENTERRA SYSTEM REMOVED BY DR OLSOFKA AT UOFL MAY & ELIZABETH HOSPITAL TODAY, (B)(6) 2024. DR OLSOFKA IS THEN IMPLANTING A NEW ENTERRA SYSTEM TO HOPEFULLY GET THE PATIENT BACK TO SUFFICIENT SYMPTOM RELIEF. PATIENT WAS ORIGINALLY IMPLANTED IN 2016 AND HAD A NUMBER OF SUCCESSFUL BATTERY CHANGES UNTIL 2023, AND SINCE THEN HAD BEEN EXPERIENCING WORSENING SYMPTOMS. GI AND SURGERY BELIEVE NEW LEADS IMPLANTED IN A MORE RESPONSIVE SECTION OF STOMACH MAY PRODUCE BETTER SYMPTOM RELIEF. PATIENT WAS EXPLANTED AND RE-IMPLANTED WITH NEW SYSTEM; PATIENT IS NOW DOING FINE. NO FURTHER ACTION TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314712 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown Other