BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3082679 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07015
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SYMPTOMS AND WAS IN THE EMERGENCY ROOM (ER) THE TWO WEEKENDS PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT NEEDED AN ADJUSTMENT ON HIS DEVICE. FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER INDICATED THAT IT WAS UNCERTAIN WHAT THE CAUSE OF THE EVENT WAS. THE PATIENT REPORTEDLY HAD "GASTRIC PM ADJUSTMENTS" ON (B)(6) 2012 AND (B)(6) 2013. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT WERE NAUSEA AND COFFEE GROUND VOMITUS. IT WAS NOTED THAT THE PATIENT REQUIRED HOSPITALIZATION. PATIENT OUTCOME WAS REPORTED AS A NON-SERIOUS ILLNESS AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185862 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization