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

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433); Insufficient Information (4580)
Date of Event	08/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature citation: busch nl, hoffman pr, kusyk dm, patterson m, tomycz nd.Percutaneous to paddle lead revision in spinal cord stimulation: a case series.Pain med case rep.2025 aug;9(4):205-209.A2 age: please see b5.B3 event date: the date of each reported event was unavailable, the articles publication date has instead been used at this time.Continuation of d10: product id neu_unknown_lead lot# unknown product type lead, ubd: unknown, udi#: unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Reported events: 1.A 53 year-old man experienced insufficient pain relief with their percutaneous lead and opted to convert to a paddle lead to address the issue.It was noted the patient had their percutaneous lead for five years prior to conversion and that the patient had undergone a previous revision of unknown nature.2.A 69-year-old man presented with chronic pain syndrome characterized by worsening pain that originates in the posterior aspect of the neck and radiates to the occipital region and throughout the head.He was previously evaluated by a neurologist and orthopedic surgeon and tried multiple forms of conservative medical management (cmm) for pain management, including physical therapy, epidural steroid injections, chiropractic treatment, cervical facet nerve blocks, and botox injections.Each therapy provided insignificant or transient pain relief while his pain progressed.The patient had multiple back surgeries to additionally treat lumbar pain, which were also unsuccessful.A lumbar spinal cord stimulation (scs) implant controlled the lumbar pain, but the head and neck pain was not relieved with a cervical percutaneous scs system due to two previous migrations of the lead.The patient underwent removal of the percutaneous lead and c2 laminectomy, and surgical implantation of a paddle lead scs system from a different manufacturer.The patient initially had good coverage of neck pain and occipital headaches with the replacement system.3.A 64-year-old man underwent a left-sided l4-l5 hemilaminectomy and discectomy after developing severe back pain and left l5 radicular pain from an occupational injury.The patient underwent a second surgery for recurrent disc herniation that occurred shortly after the first surgery.He was implanted with a percutaneous scs system 3 years after the second back surgery due to persistent pain.The percutaneous system provided sufficient pain relief for 9 years before the patient developed distal left lower extremity pain and sympathetic dystrophy in the left foot that persisted after pulse generator replacement.The patient elected to undergo removal of the percutaneous scs lead and pulse generator and t9 laminectomy, with surgical implantation of a paddle lead scs system from a different manufacturer.The patient experienced good pain relief with their replacement system.It was noted the patient had utilized percutaneous leads for 13 years prior to converting to the paddle lead replacement.Please see the attached literature article.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24658904
• Report Number: 2182207-2026-00754
• Device Sequence Number: 11191744
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male