BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19877794 · Received July 31, 2024

    Report

    Report Number
    3027386225-2024-00086
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ISSUE (B)(6) PATIENT CALLED BACK TO SAY HE SAW DR KURT STOCKAMP IN WHITNEY PALS AREA. THE BATTERY IS DEPLETED, AND THE PATIENT IS SCHEDULED FOR A GEN CHANGE ON 7-1. SYMPTOMS HAVE RETURNED AND HE HAS LOST ABOUT 9LBS PER MONTH FOR ABOUT THE LAST 10-12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983685 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other