BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3197681 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11059
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    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: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BELIEVED SHE WAS GETTING ¿ZAPPED¿ EVERY TIME SHE ATE SOMETHING AND HER STOMACH DISTENDED. THE PATIENT STATED, ¿ANYTIME I EAT MORE THAN 4-5 BITES, I END UP WITH THIS PAINFUL ELECTROCUTION-TYPE SENSATION RIGHT UNDER THE DEVICE THAT ZAPS ME EVERY FEW SECONDS¿IT HURTS BAD¿I END UP STICKING MY FINGER DOWN MY THROAT TO GET FOOD OUT THEN ZAPPING STOPS¿WEIRD HUH.¿ IT WAS NOTED THAT THE PATIENT WAS GOING TO CALL THE DOCTOR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE TALKED WITH A DOCTOR¿S OFFICE IN AN ATTEMPT TO GET THE PATIENT PROGRAMMED, AND THE OFFICE WAS CONSIDERING IT. THE PATIENT¿S GI DOCTOR WANTED NOTHING TO DO WITH THE DEVICE, AND BOTH THE PATIENT AND THE REPRESENTATIVE HAD A CALL INTO THE PATIENT¿S TREATING DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299011 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR