BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3821193 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09274
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    June 12, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE COMPLICATED NATURE OF THIS EVENT THE COMPLETE NARRATIVE OF THE PATIENT¿S ISSUES WAS INCLUDED FOR CLARITY. HOWEVER, THIS PARTICULAR MANUFACTURER'S REPORT PERTAINS EXCLUSIVELY TO THE RESTORE ULTRA DEVICE (SERIAL NUMBER (B)(4)), WHICH WAS THE SECOND DEVICE THE PATIENT HAD IMPLANTED. FOR INFORMATION ABOUT THE FIRST DEVICE (RESTORE SENSOR, SERIAL NUMBER (B)(4)) SEE MANUFACTURER'S REPORT # 3004209178-2013-04411 CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTS HE RECEIVED A CALL FROM PHYSICIAN, BUT WILL BE SEEING PATIENT LATER TODAY. REPORTS PATIENT HAS SENSOR INS AND TWO OCTAD LEADS IMPLANTED 7 DAYS AGO. REPORTS WHEN STIMULATION IS ON AND INS IS PRESS, PATIENT FEELS INTERMITTENT STIMULATION SUGGEST TO CALLER TO CHECK IMPEDANCE AND TURNS STIMULATION OFF AND PALPATE THE AREA TO SEE IF HE CAN REPRODUCE THE SAME INTERMITTENT STIMULATION. WHILE STIMULATION IS TURNED ON AND OFF. STATES IMPEDANCES GOOD AT IMPLANT. POST IMPLANT WITHIN A COUPLE DAYS PT REPORTED LOSING STIM SENSATION. PALPATION AT INS SITE RECREATES LOSS OF STIM AND ASSOCIATED WITH CHANGE IN IMPEDANCES. IMPEDANCES CHANGE FROM ALL BEING IN 900 RANGE TO ALL BEING IN 9000 RANGE. HAS IN TWO 1X8 DIRECT CONNECTS. CANNOT PROGRAM AROUND IT. WILL PLAN TO DO A REVISION. WILL HAVE TO CONSIDER GOING BACK IN AND CHECKING CONNECTIONS. IT WAS REPORTED THERE WERE ¿RECHARGING PROBLEMS.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A CHANGE TO STIMULATION WHEN PRESSURE WAS APPLIED TO THE POCKET SITE. IT WAS STATED THAT THE PATIENT HAD DIFFICULTY WITH COUPLING AND RECHARGING. THE IMPEDANCES WERE NOTED ON ELECTRODES 13, 14, AND 15 WERE BETWEEN 6,000 AND 7,000 OHMS. THE CHANGE IN STIMULATION/IMPEDANCE COULD NOT BE REPLICATED PRIOR TO REVISION. INTRAOPERATIVE TESTING FOUND ALL CONTACTS TO HAVE IMPEDANCES BETWEEN 600 AND 1,000 OHMS. WHEN THE LEADS WERE CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), THE ELECTRODES 13, 14, AND 15 REGISTERED IMPEDANCES GREATER THAN 10,000 OHMS. IT WAS NOTED THAT THE LEADS WERE REVERSED IN THE HEADER BLOCK AND THEN WHEN SWITCHED, ALL ELECTRODE PAIRS MEASURED NORMAL IMPEDANCES. IT WAS ALSO NOTED THAT THE INITIAL 8 ¿ 15 CONTACT LEAD ¿SEEMED TO INSERT FURTHER IN THE 0 ¿ 7 PORT¿ ON THE HEADER BLOCK. THE COUPLING WAS CHECKED WITH THE INS BACK IN THE POCKET AND RESULTED IN 8 COUPLING BARS. IT WAS FURTHER REPORTED THAT THE PATIENT SENSATION WAS NOT TESTED INTRAOPERATIVELY, BUT WOULD BE TEST POSTOPERATIVELY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BOTH LEAD WERE AFFECTED WITH THE ISSUE. THE LEADS WERE REPORTEDLY DIRECTLY CONNECTED INTO THE HEADER BLOCK. NO SCAR TISSUE WAS VISIBLE DURING THE IMPLANT. THE PATIENT OUTCOME WAS NOT REPORTED. IT WAS FURTHER REPORTED WHEN THE PATIENT¿S POSITION CHANGED THE STIMULATION WOULD ¿GO OFF AND ON BECAUSE THE IMPEDANCES WERE GOING UP AND DOWN SIGNIFICANTLY.¿ IT WAS REPORTED THAT THE INS WAS SCHEDULED TO BE EXPLANTED NEXT WEEK IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE INS IMPLANT LOCATION WAS IN THE LUMBAR/BUTTOCK REGION. THE PRODUCT INSTALLED WAS DANGEROUS AND DEFECTIVE. THE LEADS WERE NOT PROPERLY CONNECTED. THE DEVICE DID NOT CHARGE AND HAD A DEFECTIVE CIRCUIT. THE DEVICE CAUSED THE PATIENT INJURIES, DAMAGE AND WORSENED THE CHRONIC PAIN. THIS RESULTED IN THE PATIENT HAVING TO UNDERGO MULTIPLE SURGERIES FOR AN ENTIRE YEAR. THIS EVENT CAUSED AND CONTINUED TO CAUSE THE PATIENT GREAT MENTAL, PHYSICAL AND NERVOUS PAIN AND SUFFERING. IT WAS ADDITIONAL REPORTED THAT THE PRODUCT WAS DEFECTIVE WHEN IT LEFT THE CONTROL OF THE DEVICE MANUFACTURER. THE PRODUCT AT THE TIME OF INJURY WAS BEING USED IN THE MANNER INTENDED AND USED IN THE MANNER THAT WAS REASONABLE FORESEEABLE BY THE DEVICE MANUFACTURER INVOLVING A SUBSTANTIAL DANGER NOT READILY APPARENT. ADEQUATE WARNINGS OF THE DANGER WERE NOT GIVEN. THE PATIENT BELIEVED THAT HIS INJURIES WILL RESULT IN SOME PERMANENT DISABILITY TO HIM, ALL TO HIS GENERAL DAMAGES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SPINAL CORD STIMULATOR (SCS) DEVICE IMPLANTED ON (B)(6) 2013 AND EXPLANTED ON (B)(6) 2013, AND A RESTORE ULTRA RECHARGEABLE IMPLANTED ON (B)(6) 2014. ON (B)(6) 2013 IT WAS REPORTED THAT THERE WAS A ¿LOOSE WIRE¿ IN RIGHT BUTTOCK WITH UP AND DOWN STIMULATION INTENSITY WHEN THE GENERATOR MOVED IN THE POCKET. ON (B)(6) 2013 IT WAS NOTED THAT THERE WAS AN INTERMITTENT ELECTRICAL CONNECTION FAILURE OF THE SCS SYSTEM, AND INCONSISTENT PAIN RELIEF. A REVISION OF THE SCS GENERATOR ELECTRODE LEADS ATTACHMENT WAS DONE. IT WAS NOTED THAT THERE WAS A FAILURE OF THE SCS SYSTEM AND HIGH ELECTRODE IMPEDANCES. THE ELECTRODES LEADS WERE REMOVED AND EXAMINED AND DID NOT APPEAR TO BE CONTAMINATED. THEY WERE REPORTEDLY PUT BACK IN THEIR ORIGINAL LOCATIONS AND STILL SHOWED HIGH IMPEDANCE AT 3 OF THE ELECTRODES. THIS WAS REPORTEDLY TRIED 3 TIMES WITH THE SAME RESULT. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) PLACED THE LOWER LEAD IN THE UPPER ORIFICE AND THE UPPER LEAD IN THE LOWER ORIFICE; IMPEDANCES WERE CHECKED, AND IT WAS FOUND THAT THE SYSTEM WAS WORKING NORMALLY AND THE PATIENT HAD STIMULATION IN THE APPROPRIATE AREAS OF THEIR BACK. THE POCKET WAS ENLARGED SLIGHTLY AND THE ORIGINAL DEVICE WAS PLACED BACK IN THE POCKET AND 2-0 SILK SUTURE WAS USED AS AN ANCHOR. THE POCKET WAS THEN CLOSED. ON (B)(6) 2013 IT WAS NOTED THAT THE PATIENT HAD RECHARGING PROBLEMS PRIOR TO THE REVISION AND THERE WAS A FAILURE OF THE CHARGING CIRCUITRY. ON (B)(6) 2013 IT WAS NOTED THAT THE REVISION REPORTEDLY RESTORED CONTINUOUS ELECTRICAL CONTACT WITH THE ELECTRODE LEADS; HOWEVER, SOON AFTER THE PATIENT REPORTEDLY DEVELOPED AND INABILITY TO PROPERLY CHARGE THE RECHARGEABLE BATTERIES IN THE IMPLANT AND IT WAS DECIDED TO REPLACE THE UNIT. THE DEVICE WAS REPLACED AND IT WAS NOTED THAT THERE WAS APPARENT GOOD FUNCTION OF THE NEW SCS GENERATOR. IT WAS NOTED THAT A MANUFACTURER REPRESENTATIVE CHECKED THE IMPEDANCES AND LATER CHECKED THE RECHARGING CIRCUITRY AND IT APPEARED TO BE NORMAL. IT WAS LATER REPORTED THAT THE PATIENT HAD A HEADACHE AFTER LEAD IMPLANT ON (B)(6) 2013 AND WAS GIVEN TYLENOL. IT WAS NOTED THAT THE HEADACHE RESPONDED TO TYLENOL AND WAS RESOLVED. HEMATOCRIT, HEMOGLOBIN, AND UREA/CREA RATIO WERE FLAGGED AS ¿L¿ ON THE PATIENT¿S BLOOD WORK. IT WAS NOTED THAT THE PATIENT HAD FALLEN 1 TIME IN THE 6 MONTHS PRIOR TO (B)(6) 2013. IT WAS FURTHER NOTED THAT AFTER THE SURGERY TO REPLACE THE DEVICE THE PATIENT¿S PAIN WAS A 6 OUT OF 10 AND WAS SUBSIDING. IT WAS REPORTED THAT THERE WAS SPINAL CORD STIMULATOR DYSFUNCTION AND THAT THERE WAS A MECHANICAL COMPLICATION OF A NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. IT WAS FURTHER NOTED THAT THE MEAN CORPUSCULAR HEMOGLOBIN TEST WAS FLAGGED AS ¿L¿ ON THE PATIENT¿S BLOOD WORK. IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE REPLACED ON (B)(6) 2013 AND THAT THE PATIENT WAS COMPLAINING THAT THE STIMULATION WAS TOO HIGH IN THEIR BODY WHICH COURSES AROUND TO THE ABDOMEN CAUSING NAUSEA. IT WAS LATER REPORTED THAT ON (B)(6) 2013 THERE WERE NO APPARENT SURGICAL COMPLICATIONS. ON (B)(6) 2013 X-RAYS OF ELECTRODE PLACEMENT WERE REPORTEDLY REVIEWED AND FOUND NO CHANGE IN POSITIONS. IT WAS NOTED THAT THE PATIENT HAD A SPINAL CORD STIMULATOR (SCS) DEVICE PLACED ON (B)(6) 2013; HOWEVER, THERE WERE PROBLEMS WITH HIGH IMPEDANCE AND IT WAS REVISED ON (B)(6) 2013. SINCE THAT TIME THE CHARGING CIRCUITRY OF THE DEVICE SEEMED TO BE FAILING AND IT WAS ELECTED TO REPLACE THE GENERATOR. IT WAS NOTED THAT THE PATIENT REPORTED AN INABILITY TO CHARGE THE UNIT ADEQUATELY. ON (B)(6) 2013 THE RESTORE SENSOR WAS EXPLANTED AND REPLACED WITH A RESTORE ULTRA. ON (B)(6) 2013 THE PATIENT¿S WHITE BLOOD CELL COUNT WAS NOTED AS ¿H¿ AND THEIR CREATININE WAS NOTED AS ¿L.¿ ON (B)(6) 2013 IT WAS NOTED THAT SCS LEADS WERE REMOVED WITH TIPS IN TACT IT WAS NOTED ON (B)(6) 2013 THAT THE PATIENT RETURNED TO THEIR HEALTH CARE PROVIDER (HCP) OFFICE. THE PATIENT HAD A TRIAL STIMULATOR PUT IN AND HAD VERY GOOD RESULTS WITH IT BUT AT THE TIME OF THE REPORT IT WAS NOT WORKING. (OTHER INFORMATION REASONABLY SUGGESTS THAT THE PATIENT HAD A PERMANENT IMPLANT AT THIS TIME). THE PATIENT WAS REPORTEDLY NOT ABLE TO GO TO WORK BECAUSE OF THE PAIN. ON (B)(6) 2013 IT WAS NOTED THAT THE PATIENT WAS STILL HAVING BACK PAIN BUT IT WAS A DIFFERENT TYPE OF BACK PAIN. X-RAY FILM DEMONSTRATED A VERY SOLID FUSION AND IT WAS NOTED THAT THEY WOULD START THE PATIENT ON THERAPY. ON (B)(6) 2013 IT WAS NOTED THAT THE PATIENT HAD STILL NOT GOTTEN ADEQUATE RELIEF WITH THEIR STIMULATOR AND THAT THEY WOULD PROBABLY HAVE TO PUT PADDLES IN. ON (B)(6) 2013 IT WAS NOTED THAT THE PATIENT WAS DOING REASONABLY WELL. THE PATIENT REPORTEDLY HAD TO TAKE PAIN MEDICINE AT NIGHT BUT WAS BACK WORKING. IT WAS THEN NOTED THAT THE PATIENT HAD A REVISION OF THEIR SPINAL CORD STIMULATOR ON (B)(6) 2013. IT WAS FURTHER NOTED THAT THE PATIENT HAD AND SPINAL CORD STIMULATOR (SCS) DEVICE PLACED ON (B)(6) 2013 AND IT WORKED VERY WELL BUT LATER SHOWED INTERMITTENT CONTACT ELECTRONICALLY GIVING INCONSISTENT PAIN RELIEF. THE SYSTEM WAS REPORTEDLY TESTED EXTERNALLY AND FOUND HIGH IMPEDANCES WITH REGARD TO ONE OF THE ELECTRODES AND IT WAS ELECTED TO REVISE THE SYSTEM. DURING THE REVISION PROCEDURE THE LOWER LEAD, WHICH HAD EIGHT ELECTRODES, STILL SHOWED HIGH IMPEDANCE AT THREE ELECTRODES. IT WAS NOTED THAT THE HCP TRIED THREE TIMES WITH THE SAME RESULT. THE LEADS WERE THEN CLEANED OFF AND THE LOWER LEAD WAS PLACED IN THE UPPER ORIFICE AND THE UPPER LEAD WAS PLACED IN THE LOWER ORIFICE IMPEDANCES WERE CHECKED AGAIN AND IT WAS FOUND THAT THE SYSTEM WAS WORKING NORMALLY. CONDITION POST PROCEDURE WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299044 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 Required Intervention| S