BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4152867 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18543
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 29, 2014
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT EXPERIENCED PROBLEMS WITH RECHARGING. THE PATIENT WAS CHARGING MORE THAN EXPECTED. TEN DAYS POST IMPLANT, THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD ALREADY DEPLETED. THE INS WAS FULLY CHARGED AT IMPLANT. THE PATIENT RECHARGED THE INS AND THE RECHARGER INDICATED 50% CHARGE LEVEL AFTER 45 MINUTES. PROGRAM SETTINGS WERE: 450PW, 40 RATE, 5.6 AND 5.4 FOR AMPLITUDE. EACH LEAD CONFIGURED AS +--+. NO THERAPY IMPEDANCE WAS PERFORMED; ELECTRODE IMPEDANCES WERE WITHIN NORMAL LEVEL, ALL BETWEEN 400-500. THE MYSTIM DIARY INDICATED USAGE OF 8 HOURS ON (B)(6) 2008 AND 24 HOURS ON (B)(6) 2008. NO STIMULATION WAS REPORTED ON (B)(6) 2008. INS VOLTAGE WAS READ AT 3.735 WHEN WAS ABLE TO INTERROGATE. WHILE THE PATIENT WAS IN THE OFFICE, WAS ABLE TO RECHARGE INS 50% FULL AFTER 45 MINUTES. IT WAS STATED ¿REPROGRAMMED GROUP (2 PROGRAMS) ONE LEAD ONLY WITH AMP 3.6 AND 2.0, PW 330 AND RATE OF 60.¿ RECHARGE STATS INDICATED TYPICAL DURATION .6HOURS, TYPICAL INTERVAL 9.1. IT WAS REPORTED OVER SIX YEARS LATER THAT THE PATIENT HAD EXCELLENT STIMULATION IN THE LOW BACK AS WELL AS THE LOWER EXTREMITIES DURING THE TRIAL PHASE. THE PATIENT¿S BACK WAS FREE OF ANY EVIDENCE OF INFECTION. THE PATIENT WAS QUITE PLEASED AND THEN WENT ON TO PERMANENT IMPLANT. IT WAS NOTED THAT DURING THE PERMANENT IMPLANT PROCEDURE, WHEN THE STIMULATION WAS TESTED, THE STIMULATION WAS EXCELLENT IN THE BACK WITH STRONG STIMULATION OF THE RIGHT LEG. THEN THE PATIENT PRESENTED TO THE CLINIC WITH LOW BACK PAIN, PAIN AT THE STIMULATION INSERTION SITE AND DIFFICULTY WITH THE INS ON (B)(6) 2008. THE INS WAS ANALYZED AND FOUND TO BE DISCHARGED, THE PATIENT HAD NOT RECHARGED THE BATTERY. THE CHARGER WAS PLACED ON THE BATTERY FOR ONE HOUR AND THEN WAS CHARGED ENOUGH TO BE ANALYZED. ANALYSIS REVEALED EXCELLENT STIMULATION WITH THE RIGHTWARD LEAD. THE LEFTWARD LEAD RESULTED IN SOME DISCOMFORT IN THE RIB AREA. THE PATIENT UNDERWENT A FLUOROSCOPIC EVALUATION OF THE INS AND LEADS ANALYSIS. THE FLUOROSCOPY SHOWED THE LEADS WERE IN THE POSITION THEY WER E PLACED BUT HAD POSSIBLY MOVED IN A CEPHALAD DIRECTION BY ONE ELECTRODE. THE LEADS WERE NOTED TO BE IN EXCELLENT POSITION. REPROGRAMMING WAS THEN PERFORMED WHICH ACHIEVED EXCELLENT STIMULATION IN THE RIGHT BUTTOCK, LEG, AND BACK. THE LEFTWARD LEAD WAS PROGRAMMED WITH THE LOWEST LEADS AS POSITIVE NEGATIVE AND POSITIVE, RESULTING IN BETTER STIMULATION ACROSS THE ENTIRE BACK AREA. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT¿S RESPONSE WAS OBSERVED OVER THE NEST 1-2 WEEKS. THE FOLLOWING MEDICATIONS WERE NOTED: DILAUDID(HYDROMORPHONE), FENTANYL, LORAZEPAM, ESTRADERM AND CELEXA. THE FOLLOWING HEALTH CARE PROVIDER (HCP) VISITS WERE REPORTED: (B)(6) 2008: THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A CT SCAN. (B)(6) 2009: THE PATIENT REPORTED TO HER HCP THAT SHE FELL ON (B)(6) 2009 AND HAD NOT BEEN THE SAME SINCE. THE PATIENT HAD BACK PAIN BUT IT WAS STABLE. THE MEDICATION OF NORCO (HYDROCODONE-ACETAMINOPHEN) WAS PRESCRIBED. (B)(6) 2009: THE PATIENT PRESENTED WITH CONSTANT PAIN AND CHRONIC RADICULOPATHY. MEDICATIONS ADMINISTERED WERE LORAZEPAM AND NORCO. (B)(6) 2009: THE PATIENT REPORTED ¿PURE, EXCRUCIATING BONE PAIN.¿ THE PATIENT WAS USING THE INS THAT HELPED WITH THE SCIATICA BUT NOT THE BACK PAIN. THE LOWER BACK PAIN (LBP) WAS PROGRESSIVE AND HAD BEEN GOING ON FOR APPROXIMATELY SIX WEEKS. THE PATIENT WAS TAKING NORCO WITH LORAZEPAM, AND WAS GETTING MINIMAL RELIEF. THE PATIENT ASKED HER HCP IF SHE COULD COME IN FOR AN X-RAY TO MAKE SURE NOTHING WAS FRACTURED; HER NEXT APPOINTMENT WAS NOT UNTIL (B)(6) 2009. (B)(6) 2009: THE PATIENT PRESENTED WITH PAIN AND UNDERWENT LUMBAR SPINE X-RAYS. LUMBAR VERTEBRAL BODIES DEMONSTRATED NORMAL ALIGNMENT AND WERE WITHOUT EVIDENCE OF ACUTE FRACTURE OR DISLOCATION. DISC SPACES DEMONSTRATED NORMAL HEIGHT. THE LEADS EXTENDED SUPERIORLY OFF THE LEVEL OF THE FILM SUBMITTED. NOTHING WAS BROKEN BASED OFF OF THE X-RAY. (B)(6) 2009: ¿BAD BONE PAIN¿ WHERE SITTING WAS ALMOST IMPOSSIBLE FOR THE PATIENT WAS REPORTED. THE PATIENT DID NOT UNDERSTAND WHAT WAS GOING ON. NEXT APPOINTMENT WAS (B)(6) 2009. (B)(6) 2009: HYDROCODONE-ACETAMINOPHEN WAS ORDERED FOR THE PATIENT. (B)(6) 2009: THE PATIENT PRESENTED WITH SLOW WORSENING CHRONIC BACK PAIN. PATIENT WAS DIAGNOSED WITH LUMBAR DISC DEGENERATION. AN ADDITIONAL MEDICATION OF METHADONE WAS ORDERED. ESTRADERM AND LORAZEPAM WAS DISCONTINUED. (B)(6) 2009: IT WAS MENTIONED THAT THE PATIENT HAD CUT BACK ON THE METHADONE AS IT WAS ¿A LITTLE STRONG¿ TO TAKE DURING THE DAY. (B)(6) 2009: METHADONE WAS NOT WORKING OUT AS IT MADE THE PATIENT ¿TO OUT OF IT.¿ THE PATIENT NEEDED TO BE ABLE TO FUNCTION FOR HER JOB, SO THE DOSAGE WAS LOWERED. (B)(6) 2010: THE INS WAS NO LONGER WORKING. A NEW PADDLE WAS NEEDED. LORAZEPAM WAS REORDERED FOR THE PATIENT. (B)(6) 2010: THE PATIENT WAS TOLD THE LEADS FOR THE INS WERE PLACED IN THE WRONG COVERAGE AREA. ONE DOCTOR WANTED TO PUT A PADDLE AND HAVE THE PATIENT TITRATE HER PAIN MEDICATIONS. THE PATIENT WANTED ¿EVERYTHING TAKEN OUT.¿ (B)(6) 2010: THE PATIENT PRESENTED WITH LUMBAR SPINE BACK PROBLEMS. THE PATIENT HAD BEEN FEELING ¿TERRIBLE¿, HAD NECK PAIN WITH LOSS OF FEELING IN THE LEFT FINGERS. THE INS WAS NOT WORKING AND THE PAIN HAD INCREASED INCLUDING THE AREA IN WHICH SHE HAD SURGERY AT. THE INS WAS TENDER. THE PATIENT WANTED THE INS REMOVED, THEREFORE, THAT WAS THE PLAN. IT WAS NOTED THAT THE PATIENT STARTED TO GAIN WEIGHT IN 2009. THE PATIENT HAD A PRE-OP VISIT SCHEDULED ON (B)(6) 2010 WITH HER HCP. (B)(6) 2010: THE PATIENT PRESENTED WITH PAINFUL INS (DORSAL COLUMN STIMULATOR) AND UNDERWENT SURGERY WHICH CONSISTED OF REMOVAL OF THE INS AND LEADS. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2010: THE PATIENT HAD A FOLLOW-UP FOR THE SURGICAL REMOVAL OF THE DEVICE SYSTEM. A THIRD OF THE PAIN HAD BEEN RELIEVED AND THE POCKET PAIN IMPROVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631101 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention