BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 6095033 · Received November 11, 2016

    Report

    Report Number
    3004209178-2016-23729
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    November 10, 2016
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3888-33, LOT # V119988, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-33 , LOT # V110194, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT WAS A POST-PLACEMENT OF A NEUROSTIMULATOR SYSTEM. HE HAD GOOD COVERAGE OF HIS PAIN LOCATION; HOWEVER HE WAS HAVING BREAKTHROUGH PAIN IN THE MID TO LOWER BACK. THIS PAIN RADIATED TO THE BILATERAL ANTERIOR THIGHS AND THE PATIENT HASNT HAD IMAGING SINCE 2005. THE PATIENT STATED THAT HIS PAIN IS WORSE WITH PROLONGED SITTING OR STANDING. HE HAS PAIN WITH BOTH FLEXION AND EXTENSION MANEUVERS. HE HAS TRIED MULTIPLE COURSES OF PHYSICAL THERAPY IN THE PAST WITH ABSOLUTELY NO BENEFICIAL RESPONSE. ON (B)(6) 2010, THE PATIENT HAD COMPLAINED THAT HIS BACK WAS GETTING WORSE. HE UNDERWENT AN EPIDURAL STEROID INJECTION AT L 2/3 WITH CATHETER TO L 3 /4. THE PATIENTS OSWESTRY SCORE WAS 33 OUT OF 60 INDICATING MODERATE FUNCTIONAL IMPAIRMENT. IT WAS REPORTED THAT THE PATIENT HAD A 20%-25% IMPROVEMENT FOLLOWING THE LAST INJECTION. ON (B)(6) 2010, THE PATIENT HAD ANOTHER EPIDURAL STEROID INJECTION AT L 2/3 WITH CATHETER TO L 3/4. THE DAY OF THE INJECTION, THE PATIENT REPORTED A 29 OUT OF 60 ON AN OSWESTRY SCORE INDICATING MODERATE FUNCTIONAL IMPAIRMENT. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT REPORTED THAT HIS GROIN PAIN WAS ALL GONE, BUT HE STILL HAD SOME PAIN IN HIS LEFT THIGH AND KNEE. THE PATIENT HAD HIS THIRD TRANSFORAMINAL EPIDURAL STEROID INJECTION AT THE L3-4 LEVEL. THE PATIENTS OSWESTRY SCORE WAS 35 OUT OF 60 INDICATING MODERATE FUNCTIONAL IMPAIRMENT. THE PATIENTS SYMPTOMS WERE CONSISTENT WITH A RESIDUAL LEFT L3 RADICULOPATHY. ON (B)(6) 2011, THE PATIENT WANTED TO GET HIS STIMULATOR WORKING AGAIN. THE PATIENT INDICATED AN OSWESTRY SCORE OUT OF 35 OF 60 INDICATING MODERATE FUNCTIONAL IMPAIRMENT. THE PATIENT HAD A VERY WELL-FUNCTIONING SUBCUTANEOUS PERIPHERAL NERVE FIELD SYSTEM IMPLANTED PRIOR TO HIS LAST SURGICAL FUSION. DURING THE FUSION, THE SUBCUTANEOUS LEADS WERE REMOVED AND THEN REPLACED AT THE COMPLETION OF THE PROCEDURE. HIS IMPLANTABLE NEUROSTIMULATOR WAS ALSO MOVED TO A POSITION WITHIN THE LUMBAR WOUND. THE PATIENT STATED THAT IT WAS VERY DIFFICULT FOR HIM TO CHARGE HIS SYSTEM AND THAT HE DID NOT SENSE ANY PARESTHESIA WHEN HE ACTIVATES HIS IMPLANTABLE NEUROSTIMULATOR. IMPEDANCE CHECKS DID NOT REVEAL ANY OPEN CIRCUITS. THE PATIENT HAD HIS SUBCUTANEOUS LEADS REPLACED AND HIS IMPLANTABLE NEUROSTIMULATOR RELOCATED TO THE RIGHT BUTTOCK AS HE WISHES TO RECAPTURE HIS OLD STIMULATION PATTERN. THE PATIENT HAD DIFFUSE TENDERNESS IN THE MID TO LOWER LUMBAR SPINE AND PARASPINAL MUSCLES. THERE WERE NO PARASPINAL SPASMS NOR TRIGGER POINT. THE IMPLANTABLE NEUROSTIMULATOR WAS EASILY PALPATED WITHIN THE MIDLINE LUMBAR WOUND. PREOPERATIVE FILMS REVEALED THAT THE LEADS COILED UP IN A CIRCULAR FASHION WITHIN THE MIDLINE WOUND. TWO OF THE FOUR LEADS WERE STILL ANCHORED AND THESE LEADS WERE FREED FROM THE FASCIA AND ALL ANCHORING SUTURE MATERIAL WAS REMOVED. THE GENERATOR AND ALL FOUR LEADS WERE THEN EXPLANTED WITHOUT DIFFICULTY. TWO NEW LEADS WERE PLACED AT S2-S3 SEGMENT WITHOUT DIFFICULTY AND THE PATIENT RECEIVED EXCELLENT PARESTHESIA RESPONSE. EACH LEAD WAS ANCHORED TO THE FASCIA WITH MEDICAL ADHESIVE INSIDE EACH ANCHOR. EACH LEAD WAS ANCHORED TO THE FASCIA WITH 2-0 SILK SUTURES. THE LEADS WERE WELL ANCHORED AND IN GOOD POSITION, VERIFIED BY ANTERIOR-POSTERIOR FLUOROSCOPY. A NEW POCKET WAS CREATED AT THE RIGHT BUTTOCK AND THE LEADS WERE SUCCESSFULLY TUNNELED TO THE POCKET AND CONNECTED TO EXTENSIONS AND COVERED BY A BOOT AND THE BOOT WAS SECURED WITH 0 SILK FREE TIES. EACH EXTENSION WAS CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR AND THE CONNECTION SECURED WITH THE SUPPLIED SCREWDRIVER. THE IMPLANTABLE NEUROSTIMULATOR WAS PLACED IN THE POCKET FACING UPWARDS AND ANCHORED TO THE FASCIA WITH TWO 0-SILK SUTURES. THE WOUNDS WERE CLOSED WITH 2-0 VICRYL INTERRUPTED SUBCUTANEOUS SUTURES WITH STAPLES FOR SKIN CLOSURE. THE PATIENTS MEDICAL HISTORY INCLUDE LUMBAR RADICULOPATHY, LOW BACK PAIN, POSTLAMINECTOMY LUMBAR SYNDROME, AND A HISTORY OF AN INJURY AT WORK IN (B)(6) OF 2010 WITH A SECONDARY L4-5 AND L5-S1 FUSION. THE PATIENT HAS A HISTORY OF PRIOR LUMBAR FUSION WITH CHRONIC LOW BACK AD RIGHT GREATER THAN LEFT THIGH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747183 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 40 YR Required Intervention