BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3781195 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08280
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    September 18, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT # N327373, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON DECEMBER 2013, ¿THEY REDID IT¿, AND WHEN THEY DID THEY DID SOME FILLING OF THE BONE SO THEY COULD GET THE PADDLES WHERE THEY WANTED IT. THAT WAS WHY IT DIDN¿T WORK THE FIRST TIME. AFTER THEY RE-DID IT THE PATIENT WOKE UP AND THEIR RIGHT SIDE WAS SORE. THEY SAID THEY HAD TO REDO IT BECAUSE IT WAS ORIGINALLY PUT IN TOO SHALLOW, AND IT WAS VERY CLOSE TO WORKING ITS WAY OUT OF THE SKIN AND COMING TO THE SURFACE.

    Description of Event or Problem · 1

    THE MANUFACTURING REPRESENTATIVE STATED THAT THEY SAW THE PATIENT NUMEROUS TIMES FOR REPROGRAMMING. THE LAST TIME THEY SAW THE PATIENT HE WAS REPROGRAMMED AND THOUGHT THE STIMULATION WAS IN A GOOD AREA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE TEST STIMULATOR ¿WORKED PHENOMENALLY, I COULD HAVE BEEN YOUR POSTER CHILD.¿ WHEN THE PERMANENT IMPLANT WAS PUT IN 4 MONTHS LATER ¿THEY PUT IT IN THROUGH THE THORACIC END INSTEAD OF THE LUMBAR AND THEY CAME DOWN AND I HAD SPINAL ARTRESION- THEY COUN¿T FIT THE PADDLE IN THE HOLE SO THEY RANT IT ALONG THE OUTSIDE.¿ THE PATIENT WAS TOLD THEY COULD OFFSET THIS WITH REPROGRAMMING. THE DOCTOR SAID ¿THERE IS NO CORRELATION BETWEEN MAXIMUM STIMULATION AND THE RELIEF OF PAIN¿. THE DEVICE WAS LAST ADJUSTED ABOUT 3 WEEKS AGO OR MORE AND THEY COULD GET IT TO DO THE TINGLING VIBRATION WHERE THEY WANT IT BUT IT WAS NOT WORKING. WITH THE TRIAL THE PATIENT DID NOT HAVE SWELLING AND WAS NOT WAKING UP IN THE MIDDLE OF THE NIGHT BECAUSE OF PAIN. THE DEVICE HAS BEEN TURNED OFF FOR 5 DAYS AND WHEN THE PATIENT TURNED IT BACK ON, HE ACTUALLY FELT A LOT BETTER WITHOUT IT BECAUSE HE DID NOT HAVE THAT MISERABLE CONSTANT TINGLING VIBRATION CASE. SO THE DEVICE HAS BEEN LEFT OFF. THE PATIENT WANTS THE ELECTRODES THAT WERE USED IN THE TRIAL STIMULATION AND WAS GOING TO CALL HIS IMPLANTING DOCTOR TO DISCUSS THIS. THE PATIENT ALSO WANTED TO KNOW IF A CT SCAN WAS GOING TO BE ENOUGH TO SEE IF THERE WAS A PROBLEM. IT WAS NOTED THAT THE PATIENT RECENTLY DEVELOPED A TORN ROTATOR CUFF AND THEY WANT TO DO AN MRI. IT WAS LATER REPORTED ON (B)(4) 2014 THAT THE PATIENT HAD LEAD REPLACEMENT IN (B)(6) 2013 BECAUSE HIS PAIN CONTROL WAS ONLY A 2-3 WHEREAS THE TRIAL WAS MAGIC, AT A 10 FOR PAIN CONTROL. THE PATIENT WAS TOLD WITH INITIAL IMPLANT IT TAKES TIME FOR THE BODY TO HEAL, FLUID TO BE ABSORBED SO IT COULD TAKE UP TO A YEAR TO GET OPTIMUM RESULTS. THE PATIENT WANTED TO KNOW IF THIS ALSO APPLIES WITH REVISIONS SUCH AS HE HAD LAST DECEMBER. THE PAIN CONTROL WAS MUCH BETTER BUT THE PATIENT WANTED TO KNOW IF THIS WAS THE BEST HE COULD GET OR WAS IT POSSIBLE THAT IN TIME IT WOULD IMPROVE DUE TO HEALING, LIKE INITIAL IMPLANT. THE PATIENT¿S RIGHT FOOT WAS PARALYZED AND THE REASON HE RECEIVED THE DEVICE IMPLANT WAS THAT HE WAS HAVING A DIFFERENT SURGERY BEFOREHAND AND IT WAS SUPPOSED TO HAVE BEEN PERFORMED BY A WORLD FAMOUS SURGEON HOWEVER THERE WAS A MISCOMMUNICATION AND A 3RD YEAR RESIDENT PERFORMED THE SURGERY AND PUSHED TOO HARD ON THE DRILL AND BROKE SOME BONE. SCREWS WERE STILL PLACED IN L4-5 AREA AND WHEN THE PATIENT WOKE UP HIS WHOLE RIGHT SIDE FROM THE HIP DOWN WAS PARALYZED. SINCE THEN IT HAS IMPROVED SOMEWHAT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED THAT THEY COULD NOT GET THE LEAD WHERE THEY WANTED IT BECAUSE OF THE PATIENT'S SPINAL CONDITION. IT WAS NOTED THAT THEY HAD TO "CHISEL AWAY THE BONE" TO GET THE LEAD PLACED. THE PATIENT HEARD THEM SAYING THEY THOUGHT THEY COULD JUST TURN THE STIMULATION UP. ALSO, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS STICKING OUT SO THEY REPOSITIONED IT. THE PATIENT REPORTED THAT THE INS DEVICE WAS IMPLANTED TO TREAT THEIR LOW BACK BUT IT NEVER HELPED THAT AREA. THEY WERE TOLD BY THE MANUFACTURER'S REPRESENTATIVE THAT THE DEVICE WAS NOT SET UP FOR THEIR BACK BUT WAS SET UP FOR THEIR LEGS. WHEN THE REPRESENTATIVE REPROGRAMMED BECAUSE THE PATIENT COMPLAINED OF STIMULATION IN THE WRONG LOCATION, THEY FELT TINGLING IN THEIR LEG AND IT WOULD GO NUMB. THE PATIENT STATED THAT THEY WERE ON THEIR WAY HOME FROM THE HEALTHCARE PROFESSIONAL'S (HCP) OFFICE AND WOULD PULL OVER TO DECREASE THE STIMULATION FROM 4.8 VOLTS TO 1.25 VOLTS BECAUSE OF THE NUMBNESS. WHEN THE NUMBNESS WAS DECREASED THE NUMBNESS WOULD GO AWAY. THE PATIENT CONFIRMED THAT THE TRIAL (DONE A YEAR PRIOR TO IMPLANT OF THE DEVICE) WAS "PHENOMENAL" AND ADDRESSED THEIR LOW BACK PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259851 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention