BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20097459 · Received August 29, 2024

    Report

    Report Number
    3027386225-2024-00097
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 30, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEBRIDEMENT OF THE POCKET WOUND DUE TO THE DEVICE PROTRUDING FROM IT. IPG WAS NOT REMOVED, AND THERAPY WAS CONTINUED POST-OP. DR. (B)(6) REPORTED THAT THE PATIENT CONTACTED HIM, STATING THAT THE DEVICE WAS "COMING OUT" OF THE POCKET. HE WAS SEEN, AND THE OFFICE AND MD DEEMED THAT THE POCKET DID NOT LOOK INFECTED; THERE WAS NO DRAINAGE. THE PATIENT WAS SCHEDULED FOR A SURGICAL DEBRIDEMENT. PATIENT HAD POCKET AREA CLEANED OUT/DEBRIDED AND IS DOING WELL. NO FURTHER ACTION TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314847 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other