BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3962073 · Received July 28, 2014

    Report

    Report Number
    3007566237-2014-02102
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FIVE TIMES SPANNING FROM (B)(6) 2003 TO (B)(6) 2004 FOR NAUSEA, VOMITING, ABDOMINAL PAIN, AND HYPOKALEMIA ((B)(6) 2003 NAUSEA, VOMITING, ABDOMINAL PAIN; (B)(6) 2003 NAUSEA, VOMITING, ABDOMINAL PAIN; (B)(6) 2003 ABDOMINAL PAIN, NAUSEA, AND HYPOKALEMIA; (B)(6) 2004 ABDOMINAL PAIN; (B)(6) 2004 NAUSEA, VOMITING, AND ABDOMINAL PAIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437844 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization