BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3042717 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04910
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    April 15, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THE PATIENT WAS NOT ABLE TO EAT AS MUCH. IT WAS ALSO NOTED EVER SINCE THE PATIENT EXPERIENCED THE SHOCKING AND BURNING SENSATION, ¿IT DOESN¿T SEEM TO BE WORKING LIKE IT WAS.¿ THE PATIENT ONLY EXPERIENCED THE BURNING SENSATION ONE TIME. IT WAS ALSO REPORTED THE PATIENT HAD PAIN IN THE AREA FOR A COUPLE OF WEEKS AFTER THAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HER SYMPTOMS RETURNED. HER SYMPTOMS INCLUDED BEING "FULL ALL THE TIME, NAUSEATED ALL OF THE TIME, LOSING WEIGHT, AND BACK TO TAKING HER MEDICATION WHICH SHE ALMOST COMPLETELY DISCONTINUED PRIOR TO THIS INCIDENT." IT WAS STATED BY THE PATIENT SHE WAS GOING TO STOP USING HER FEEDING TUBE AND WAS "SO DISAPPOINTED." A BURNING SENSATION, AND A SHOCKING OR JOLTING SENSATION WAS ALSO NOTED. IT WAS STATED THE SYMPTOMS BEGAN "ABOUT ONE MONTH PRIOR TO REPORT" WHEN SHE WAS AT WORK "PUSHING A PATIENT IN WHEELCHAIR AND ALSO PERFORMING OTHER ACTIVITIES OF BENDING THAT WERE REQUIRED WHILE ASSISTING A PATIENT, THEN SHE NOTICED THIS SHOCKING BURNING SENSATION AT HER IMPLANTABLE NEUROSTIMULATOR (INS) SITE." IT WAS NOTED THE PATIENT'S INS FELT "THAT WAY FOR ABOUT 30-45 MINUTES AND THEN WAS SORE FOR 3 WEEKS BUT IT WAS NOT SORE OR TENDER AT THE TIME OF REPORT." THE PATIENT SAW HER HEALTHCARE PROVIDER (HCP) A FEW DAYS AFTER THE INCIDENT AND WAS TOLD "EVERYTHING WAS FIRING CORRECTLY." THE PATIENT HAD ANOTHER APPOINTMENT SCHEDULED WITH HER HCP FOR (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH THEIR DOCTOR ON (B)(6) 2013 AND THEIR DEVICE CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNCLEAR AND THERE WERE NO ABNORMAL IMPEDANCES. IT WAS NOTED THAT THE PATIENT¿S STIMULATION WAS INCREASED TO 7.5 LAST MONTH. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY/ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147378 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR