BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20056054 · Received August 23, 2024

    Report

    Report Number
    3027386225-2024-00095
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 24, 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 IS GETTING A SYSTEM EXPLANT BY DR OLSOFKA AFTER A POCKET SITE INFECTION FOLLOWING HER IMPLANT ON (B)(6) 2024. OTHER THAN THE INFECTION, THE PATIENT HAS REPORTED POSITIVE IMPROVEMENT OF THEIR GP SYMPTOMS SINCE RECEIVING THE THERAPY. WILL BE SEEKING RE IMPLANTATION OF A NEW ENTERRA SYSTEM IN THE NEAR FUTURE WHEN THEY AND DR OLSOFKA DEEM THEY ARE AGAIN READY FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231490 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other