BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3024015 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04306
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 8, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 'PANCREATITIS AND EVERY DISEASE A DIABETIC WOULD HAVE EVEN THOUGH SHE DID NOT DRINK.' THE PATIENT REPORTED THAT SHE STARTED HAVING SEIZURES 'SIX YEARS AGO' AND THEN THEY STOPPED, BUT NOW THE SEIZURES STARTED HAPPENING AGAIN, 'TWO MONTHS' PRIOR TO THE REPORT. THE PATIENT WAS GOING THROUGH CHEMO FOR (B)(6) DAMAGE TO HER LIVER. THE PATIENT ALSO FELL 'A COUPLE MONTHS' PRIOR TO THE REPORT AND SUSTAINED A BROKEN RIB. THE PATIENT REPORTED THAT IT TOOK 'FOUR TRIPS' TO THE EMERGENCY ROOM (ER) BEFORE SHE GOT AN X-RAY TO CONFIRM SHE HAD A BROKEN RIB 'WITH A CHUNK MISSING.' THE PATIENT STATED SHE WAS 'VOMITING AGAIN, JUST LIKE SHE DID NOT HAVE IT IMPLANTED ANYMORE.' THE THERAPY REPORTEDLY WORKED FOR 'ABOUT THREE MONTHS' AND THE PATIENT STARTED GETTING SICK AGAIN. THE PATIENT GOT SICK DAILY AND THEN IT STOPPED, BUT AT THE TIME OF THE REPORT THE PATIENT 'DID NOT EVEN GET OFF THE COUCH.' THE PATIENT STATED THAT THE NEXT STEP WAS TAKING HER STOMACH OUT, BUT SHE DID NOT WANT TO DO THAT. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013. A WEEK LATER IT WAS REPORTED THAT THE DEVICE RETURNED TO ITS DEFAULT SETTING OF '5' AFTER BEING TURNED UP. THE ASSOCIATED SIGNS AND SYMPTOMS WERE REPORTED TO BE SEVERE ABDOMINAL PAIN. HOSPITALIZATION WAS NOT REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY AND NON-SERIOUS ILLNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT HAD BEEN HAVING SYMPTOM RETURN FOR "SEVERAL MONTHS." ON (B)(6) 2013, THE HEALTHCARE PROVIDER (HCP) REPROGRAMMED THE DEVICE AND THE PATIENT REPORTEDLY "GOT GOOD RELIEF" FOR TWO DAYS, BUT THEN THE SYMPTOMS RETURNED. THE PATIENT REPORTEDLY "JUST WANTED TO DIE BECAUSE, THEY WERE SO MISERABLE." IT WAS NOTED THAT THE HCP WANTED TO INCREASE CURRENT TO 7.5 MILLIAMPS (MA) AND IT WOULD NOT STAY, BUT ISSUE WAS RESOLVED BY THE END OF THE CALL BY PROGRAMMING IN VOLTS BASED ON DESIRED CURRENT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT ¿JUST WANTED IT OUT BECAUSE SHE WAS SO MISERABLE¿ NOT ¿JUST WANTED TO DIE BECAUSE SHE WAS SO MISERABLE.¿ IT WAS ALSO REPORTED THAT UNDER THERAPY MEASUREMENTS, THE CLINICIAN PROGRAMMER INDICATED AN IMPEDANCE AND A VOLTAGE OF ¿???¿. AFTER THE IMPEDANCE MEASUREMENT TEST WAS RUN, THE QUESTION MARKS RESOLVED AND NORMAL IMPEDANCE AND VOLTAGE READINGS WERE GIVEN. IT WAS ALSO REPORTED THAT THE PATIENT HAD LOST ALL OF HER TEETH AND WAS DIZZY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT PATIENT EXPERIENCED TREMENDOUS PAIN AT NEUROSTIMULATOR SITE (INS) AND THE INS NEVER HELPED WITH SYMPTOMS. THE PATIENT WAS IN SO MUCH PAIN THAT SHE HAD TO LAY IN FETAL POSITION ON THE COUCH. THE PATIENT STATED THIS DOES NOT HAPPEN EVERY DAY BUT AT LEAST ABOUT 2 TIMES PER WEEK. IT WAS NOTED THAT ON THE DAYS THAT THE PAIN IN TREMENDOUS, HER PAIN LEVEL WAS ABOUT A 15 AND ON THE OTHER DAYS THE PAIN LEVEL WAS ABOUT A 6. THE PATIENT WANTED TO HAVE THE IMPLANT REMOVED SINCE IT NEVER REALLY HELPED HER. THE PATIENT STATED SHE WANTED TO STOP HAVING TO TAKE HER PAIN MEDICATION OF ¿SABOXENE.¿ THE PATIENT REPORTED THAT WENT TO HEALTH CARE PROVIDER 2 TIMES AND TRIED TO INCREASE STIMULATION, BUT WAS UNABLE TO. THE PATIENT MENTIONED THAT HE CALL SOMEONE BUT DOES NOT KNOW IF IT WAS A MANUFACTURER REPRESENTATIVE OR MANUFACTURER. THE PATIENT STATED SHE DID NOT FEEL THAT STIMULATION HAS EVER MADE HER FEEL BETTER. THE PATIENT STATED SHE HAS STILL BEEN GETTING SICK, AND VOMITING LIKE SHE WAS PRIOR TO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126306 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other