BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6010491 · Received October 7, 2016

    Report

    Report Number
    3004209178-2016-21275
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THEY WERE NOT SURE THE DEVICE WAS WORKING AS THE PATIENT HAD A RETURN OF SYMPTOMS OF NAUSEA AND VOMITING. THE PATIENT HAD BEEN HOSPITALIZED SINCE (B)(6) 2016 FOR THE SYMPTOMS. THE HCP TRIED CALLING THE IMPLANTING HEALTH CARE PROVIDER (HCP), BUT THEY WEREN'T AVAILABLE. THE HCP LATER REPORTED THAT THEY WERE SENT A PATIENT PROGRAMMER AND WERE ABLE TO INTERROGATE THE DEVICE. THE HCP TALKED WITH A MANUFACTURER REPRESENTATIVE ON THE PHONE AND WAS TALKED THROUGH INCREASING THE VOLTAGE. THAT SEEMED TO HELP BECAUSE THE PATIENT HAD BEEN DISCHARGED AND HAD NOT BEEN BACK TO THE HOSPITAL. IT TOOK ABOUT A WEEK TO GET THE PROGRAMMER AND ASSISTANCE TOGETHER. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTRIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663372 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization