BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3103165 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07463
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. 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 REPORTED WHEN STIMULATION IS ON AND OFF THE PATIENT EXPERIENCED A BURNING SENSATION AT HER IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION ABOUT A WEEK AFTER IMPLANT. THE "BURNING PAIN WAS KILLING THE PATIENT AND SHE HAD SOME NEW WEIRD BACK PAIN SHE DID NOT HAVE BEFORE AND IT WAS NOT THE ORIGINAL PAIN SHE RECEIVED HER SPINAL CORD STIMULATION (SCS) SYSTEM FOR." THE PATIENT WAS FEELING STIMULATION "STRONGLY" AT 2 VOLTS (V). IT WAS NOTED THE PATIENT WAS ALSO "FEELING COLD AND HOT TOO." IMPEDANCES MEASUREMENTS WERE PERFORMED AND ALL PAIRS WITH ELECTRODE 0 WERE GREATER THAN 10,000 OHMS. WHEN ELECTRODE 1 WAS THE REFERENCE ELECTRODE ALL MEASUREMENTS WERE IN THE THOUSANDS. NUMBERS 0 AND 4 WERE BOTH GREATER THAN 10,000 OHMS AND THE LOWEST WITH ELECTRODE 1 WAS 827 OHMS. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED THE PATIENT WAS ABLE TO FEEL STIMULATION BECAUSE ELECTRODE 0 WAS NOT BEING USED IN HER CURRENT PROGRAMMING. UPON EXAMINATION THE PATIENT'S DOCTOR DETERMINED THE PATIENT'S INS HAD "TURNED IN THE POCKET AND INSTEAD OF LYING FLAT IT FELT LIKE IT WAS LYING SIDEWAYS AND WAS PROBABLY PUSHING ON HER SCIATIC NERVE CAUSING THE BURNING/UNCOMFORTABLE SENSATION." IT WAS NOTED THE PHYSICIAN PLANNED TO RUN "TESTS" TO DETERMINE IF THE PATIENT'S NEW BACK PAIN MAY BE CAUSE BY AN INFECTION THOUGH IT WAS NOTED ALL SURGERY SITES LOOKED "GOOD AND WERE HEALING WELL." THE PHYSICIAN PLANNED TO REVISE THE PATIENT'S POCKET SITE ONCE HE DETERMINED EVERYTHING WAS "NORMAL." ADDITIONAL INFORMATION RECEIVED 2 DAYS LATER REPORTED THE PATIENT HAD BEEN PROGRAMMED ON (B)(6) 2012. IT WAS REPORTED THE PATIENT WAS "HAVING SOME PROBLEMS, MIND CONFUSION" AND SHE HAD "NOTHING BUT PROBLEMS" SINCE IMPLANT. THE PATIENT "GOT ALL MIXED UP AND WAS JUST OUT OF IT." IT WAS REPORTED THE PATIENT ALSO EXPERIENCED NAUSEA. IT WAS NOTED THE TRIAL WORKED "PRETTY GOOD AND ACCEPTABLE" HOWEVER WITH THE IMPLANT THERE WAS A WEEK WHERE THE PATIENT "WAS IN HELL WITH PAIN CAUSED BY THE IMPLANT." THE PATIENT WAS "HARDLY ABLE TO GET OUT OF BED" SINCE (B)(6) 2013. IT WAS NOTED THE INS WAS IN THE PATIENT'S LEFT HIP AND THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) SAID "SOMETHING ABOUT IT NOT BEING IN THE RIGHT PLACE AND WOULD HAVE TO BE REDONE." IT WAS REPORTED THE PATIENT'S FIRST PROGRAM WORKED WELL FOR HER LEG PAIN BUT THE PAIN MOVED UP HER LOWER RIBCAGE, JUST ABOVE HER WAIST. IT WAS NOTED THE PATIENT'S PHYSICIAN WANTED THE PATIENT TO HAVE A BODY SCAN AND A BONE SCAN PRIOR TO INS REVISION. THE PATIENT WAS PRESCRIBED OXYCODONE FOR HER PAIN BUT IT MADE HER SICK TO HER STOMACH. THE PATIENT WAS NOW ON HYDROCODONE AND HAD BEEN FOR "A WHILE" FOR HER LEGS AND IT "SEEMED TO BE THE ONLY THING THAT WOULD QUIET HER DOWN A LITTLE." THE NIGHT PRIOR THE PATIENT HAD BEEN GIVEN GABAPENTIN EVEN THOUGH SHE "HAD SOME TROUBLE WITH IT BEFORE." IT WAS NOTED THE GABAPENTIN "SEEMED TO LET THE PATIENT REST A LITTLE BIT BUT SHE WAS UP MANY TIMES DURING THE NIGHT; SHE WOULD BE OKAY FOR A FEW MINUTES AND THEN RIGHT BACK OUT OF IT." IT WAS "BELIEVED THE PATIENT HAD BEEN GIVE HALF A HYDROCODONE, 150 MG, WHICH WOULD HELP THE PATIENT FOR ABOUT AN HOUR." IT WAS UNCLEAR IF THE PATIENT'S CONFUSION WAS CAUSED BY HER DEVICE OR HER MEDICATIONS. IT WAS ALSO NOTED THE PATIENT'S SYMPTOMS WERE GETTING WORSE AND SHE WAS HAVING TROUBLE "CONTROLLING THE UNIT, FIRST IT WAS TOO HIGH THEN IT WAS TOO LOW." IT WAS REPORTED THE PATIENT WAS "READY TO TAKE IT OUT AND THROW IT AWAY." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING ¿OKAY.¿ HER DOCTOR HAD ORDERED SEVERAL LAB TESTS AND THERE WAS NO EVIDENCE OF INFECTION. THE DOCTOR WAS PLANNING ON REPOSITIONING HER BATTERY BUT IT HAD NOT BEEN SCHEDULED. IT WAS NOTED THE STIMULATOR WAS ¿WORKING WELL AND DOING WHAT IT WAS SUPPOSED TO.¿ A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204202 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention