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

Model Number NEU_ENS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Irritation (1941); Nerve Damage (1979); Pain (1994); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Disc Impingement (2655)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the patient's surgeon who implanted the spinal cord stimulator (scs) left him in great pain and distress.Patient reported the device was taken out after he did "damage" to the patient.No further complications were reported/anticipated.

Event Description

Additional information received from a consumer (con).It was reported that the patient was going to undergo a trial with the device for five days in an attempt to relieve long-standing pain in their upper hips.This resulted in severe nerve irritation, possible nerve damage to their lower right leg and foot, and an overnight hospital stay.They were originally told that the only negative outcome was that they might only experience 50% relief from the pain.Within an hour of implant, the patient complained of discomfort behind their right knee and the pain began to migrate down their right leg.The right electrode was removed, but the patient was writhing in pain every 30-60 seconds.They were programmed and felt appropriate tingling on the left side.A healthcare professional (hcp) stated that a nerve was probably inflamed and the pain should subside within an hour or two, but it did not.The patient was then told it would take 10-12 hours, then several days, for the pain to stop.They continued to feel pain in their right leg and foot and suffered agonizing pain overnight in the hospital and they did not sleep.On (b)(6) 2019, the second electrode was removed from the left side and the trial was abandoned.They were prescribed gabapentin for the nerve pain, a steroid dose pack, and a muscle relaxer.The patient went home from the hospital and the pain was less severe and easing the next day.On (b)(6) 2019, they stated shooting pain disrupted their sleep throughout the night and they suffered severe distress throughout the day.The pain continued and the patient had an mri done on (b)(6) 2019, which showed a disc bulge that was new from their last mri in 2018.They were unable to conclude when the bulge had developed; whether it was there during the insertion of the electrodes or whether a lead had been run over the bulge during the procedure.The patient had a transforaminal epidural done on (b)(6) 2019.

Manufacturer Narrative

Continuation of d11: product id neu_unknown_lead, lot# unknown, implanted: 2019-08-05 explanted: (b)(6) 2019, product type lead product id neu_unknown_lead lot# unknown, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type lead patient code c50499 was removed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8955860
• MDR Text Key: 156297731
• Report Number: 3007566237-2019-01877
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR