BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3843110 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09950
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 12, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿ON AND OFF¿ FOR THE PAST THREE YEARS, THE PATIENT HAD BEEN EXPERIENCING SOME PROBLEMS WITH THEIR DEVICE. THE PATIENT HAD BEEN ¿BACK AND FORTH¿ TO THE EMERGENCY ROOM WITH CHRONIC VOMITING AND WAS ALSO FEELING ELECTRICAL SHOCKS. IT WAS NOTED THAT IT WAS ¿NOT HELPING¿ THE PATIENT AND THEY HAD LOST ALMOST 50 POUNDS IN ONE MONTH JUST BY THROWING UP. THIS OCCURRED THE MONTH PRIOR AND THE PATIENT WAS STILL LOSING WEIGHT. THE PATIENT JUST LOST 8 MORE POUNDS THREE DAYS PRIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321839 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1