BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2844989 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10737
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    October 30, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT'S SYMPTOMS WERE "GETTING WORSE" AND WERE "PARTICULARLY BAD" THE MORNING OF THE REPORT. IT WAS NOTED THAT THE SYMPTOMS HAD BEEN "BAD ON AND OFF FOR ABOUT A MONTH." THE PATIENT REPORTEDLY WAS "GENERALLY DISSATISFIED," AND WANTED AN "INCREASE AND ADJUSTMENT" IN STIMULATION. LESS THAN 2 WEEKS LATER, IT WAS REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE "WITHIN" 200 OHMS - 800 OHMS. IT WAS NOTED THAT THE VOLTAGE AND CYCLE ON WAS INCREASED, AND THE PATIENT WAS DUE BACK IN THE DOCTOR'S OFFICE. TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT WAS RECEIVING HELP. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2012. IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL IN A SERIOUS CONDITION. IT WAS STATED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2012 DUE TO SYMPTOMS "GETTING WORSE AND WORSE." IT WAS NOTED THAT THE PATIENT WAS STILL AT THE HOSPITAL AT THE TIME OF THE CALL, AND MAY BE RELEASED SOON. IT WAS STATED THAT THE PATIENT'S BOWELS WERE "CHECKED," AND THE COLONOSCOPY AND ENDOSCOPY "TESTS OCCURRED OVER THE WEEKEND." THE PATIENT REPORTEDLY WAS "SUFFERING," WANTED TO GET THE DEVICE "RAISED UP" TO HELP REDUCE HER SYMPTOMS, AND "JUST NEEDED AN ADJUSTMENT." IT WAS STATED THAT DURING INTERROGATION, THE DEVICE SHOWED A READING OF 3.2 VOLTS, EVEN THOUGH HER ORIGINAL SETTING WAS 6 VOLTS. THE DOCTOR REPORTEDLY INDICATED THAT THERE WAS A "LEAK IN THE LEADS OR SOMETHING" THAT CHANGED THE PATIENT'S SETTINGS. IT WAS NOTED THAT THE DOCTOR ATTEMPTED TO INCREASE THE VOLTAGE TO 3.4 VOLTS, BUT THE PATIENT STATED "SEVERAL TIMES IT WAS NOT HELPING." IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL 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 Hospitalization| R