BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2833745 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10302
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED ON (B)(6) 2012 DUE TO PAIN. IT WAS NOTED THAT THE PATIENT "NEVER DID OKAY WITH THE DEVICE, BUT HER NAUSEA WAS REDUCED CONSIDERABLY." IT WAS NOTED THAT THE PATIENT "NEVER REALLY RECOVERED FROM THE IMPLANT ABDOMINAL PAIN BEFORE REMOVAL." IT WAS NOTED THAT THE PATIENT "HAD CHRONIC PAIN PRIOR TO THE IMPLANT AND SHE COULD NOT TOLERATE THE DEVICE, SO IT WAS REMOVED." IT WAS NOTED THAT A "PYLOROPLASTY AND A PARTIAL FUNDOPLICATION" WAS PERFORMED TO TREAT THE PATIENT'S SYMPTOMS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention