BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20257939 · Received September 19, 2024

    Report

    Report Number
    3027386225-2024-00107
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 20, 2024
    Report Date
    August 22, 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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT SAID HE HAD SEVERE ISSUES FOR 6WKS UNTIL THE IPG WAS REPLACED. HE DIDN'T SPECIFY WHAT THE ISSUES WERE. PATIENT CALLED REQUESTING TO SPEAK WITH SOMEONE TO DISCUSS BEING IMPLANTED WITH A BAD BATTERY. PATIENT SAID IT CAUSED SEVERE ISSUES FOR 6WKS UNTIL IT WAS REPLACED. PATIENT STATED HE DID FOLLOW UP WITH HIS PROVIDER TODAY (B)(6) 2024 AND WAS TOLD TO CONTACT ENTERRA MEDICAL. PRODUCT WAS RETURNED TO THE MANUFACTURER. NO ISSUES WERE FOUND WITH DEVICE.

    Description of Event or Problem · 0

    IMPLANTING SURGEON REPORTED A BATTERY CHANGE FOR HER PATIENT IN JULY THAT RESULTED IN PAIN AT THE POCKET. IMPEDANCE WAS WITHIN RANGE. SHE DECIDED TO CHANGE THE BATTERY AGAIN, AS THE PATIENT DID NOT REPORT POCKET PAIN PRIOR. UPON BATTERY CHANGE, THE PATIENT IS NO LONGER IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488298 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other