BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3141123 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08497
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO THE HOSPITAL THREE DAYS AGO FOR GASTRIC CONCERNS. THE PATIENT WAS CURRENTLY IN THE HOSPITAL, WAS VOMITING AND HAD NAUSEA AND DIARRHEA, WHICH SYMPTOMS STARTED A WEEK AGO. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243105 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization