BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3121067 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07950
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 4351-35 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 4351-35 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 WAS ADMITTED TO THE HOSPITAL LAST NIGHT DUE TO CHRONIC EMESIS SYMPTOMS AND THE DOCTOR WANTED TO HAVE THE DEVICE CHECKED. IT WAS NOTED THAT THE PATIENT WAS RECENTLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT¿S DEVICE WAS INTERROGATED AND WAS WORKING PROPERLY. THE PATIENT¿S SURGEON WAS NOTIFIED OF THAT IN ORDER TO MAKE ¿DECISIONS¿ ON HER CARE. TWO DAYS LATER, IT WAS INDICATED THAT THE REPORTER COULDN'T SAY WHETHER THE PATIENT'S SYMPTOMS WERE DEVICE RELATED. HOWEVER, IT SEEMED TO BE "SIMPLE GP SYMPTOMS" DUE TO POOR DIABETES CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222586 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization