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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_ENS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858); Headache (1880); Muscular Rigidity (1968); Pain (1994); Staphylococcus Aureus (2058); Visual Disturbances (2140); Test Result (2695)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
Literature citation: wetherington b, khan tw. Epidural abscess during a spinal cord stimulator trial: a case report. Pain practice. 2018. Doi. 10. 1111/papr. 12691. Please note this date is based off of the article¿s revision acceptance date as the specific event date was not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead. Information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: asku. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Article abstract: the authors presented a case of an acute-onset methicillin-sensitive staphylococcus aureus epidural abscess 72 to 96 hours into a trial of a percutaneous spinal cord stimulator. The patient had no prior medical history of an immunocompromised state or other significant risk factors. Reported event: the patient was a (b)(6)-year-old immunocompetent female with a long history of back pain associated with lumbar degenerative disc disease and episodic lumbar radiculopathy. Conservative management included physical therapy, cognitive behavioral therapy, chronic oral narcotics, adjuvant medications, and various minimally invasive interventional procedures. Prior history also included lumbar discectomy. After limited response to conservative therapy, she decided to pursue an scs trial with traditional tonic stimulation. Two grams of intravenous cephazolin was administered prior to incision. The skin was then prepared with chlorhexidine, and two trial leads were placed under sterile conditions using fluoroscopy guidance. The epidural space was accessed at t12 to l1. Tonic stimulation was mapped without difficulty after confirmation of dual lead placement under fluoroscopy in the dorsal epidural space at t9 to 10. The insertion site was covered with sterile dressing and adhesive tape. The patient was discharged home shortly after the procedure with no complaints or signs of complications. On day 3, the patient reported a greater than 50% reduction in baseline pain; however, they also reported a focal sharp incisional pain at the trial lead insertion site. She was evaluated in clinic and was found to be afebrile, hemodynamically stable, and without neurological deficits. The insertion sites were clean, dry, and showed no signs of drainage, erythema, or induration. On day 4, she became subjectively febrile with increasing back pain. She presented to an outside hospital where the leads were removed. The insertion sites at the skin were swabbed, cultured, and would eventually be suggestive for methicillin-sensitive staphylococcus aureus. The patient was recorded as being afebrile with leukocytosis before being discharged home on oral cephalexin. On day 5, she developed a headache and returned to the outside hospital where she had nuchal rigidity, photophobia, and was febrile. Broad-spectrum intravenous antibiotics consisting of vancomycin and ceftriaxone were started, and the patient was then transferred to our institution. At our facility, an mri of the lumbar spine demonstrated an epidural fluid collection from t11 to l2. Antibiotics were broadened to intravenous vancomycin, cefepime, and ampicillin. Blood cultures and gram stain were negative. Findings from a complete blood count (cbc) test were consistent with leukocytosis with a white blood cell count of 15,300 cells/ll. A lumbar puncture was performed that demonstrated 200 red blood cells/ll, 2,350 white blood cells/ll, increased protein at 254 mg/dl, glucose of 53 mg/dl, and many neutrophils. Results of cerebral spinal fluid gram staining were negative and no organism was grown on culture. On clinical examination, the patient demonstrated increased focal back pain without neurologic compromise. Weakness, numbness, or myelopathy was not appreciated on examination. Surgical intervention was deferred. The patient was ultimately discharged home with 6 weeks of intravenous cefepime. At a follow-up appointment, a repeat mri of the lumbar spine demonstrated a resolving epidural abscess. There were no further complications reported or anticipated.
 
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Brand NameEXTERNAL NEUROSTIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7844492
MDR Text Key119154383
Report Number3007566237-2018-02636
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_STIMULATOR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
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