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

Model Number	97725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Ambulation or Postural Difficulties (2544)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 977d260 (serial: (b)(6)); product type: 0215-screening device; implant date (b)(6) 2024; explant date (b)(6) 2024.Brand name surescan; product id 977d260 (serial: (b)(6)); product type: 0215-screening device; implant date (b)(6) 2024; explant date (b)(6) 2024.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.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a trial patient who was using an external neurostimulator (ens).It was reported that about 2 hours after implanting the trial leads the patient had a loss of sensation in their legs.The patient turned off the system and about 30 minutes later reported having a loss of strength in their legs.The patient was unable to stand or walk and went to the er.A doctor removed the trial system so they could have an mri and it was found that they had an epidural hematoma from t3 down to l2 with severe compression the whole way.Required emergency surgical evacuation of hematoma.The patient regained full strength in their legs and still had some sensation changes but with dramatic improvement.
Additional Manufacturer Narrative
Continuation of d10: product id 977d260 serial# (b)(6) implanted: (b)(6) 2024 explanted: (b)(6) 2024 product type screening device.Product id 977d260 serial# (b)(6) implanted: (b)(6) 2024 explanted: (b)(6) 2024 product type screening device.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
Rep provided the serial number of the wens.

• Brand Name: INTELLIS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18858141
• Report Number: 2182207-2024-01463
• Device Sequence Number: 3338096
• Product Code: LGW
• UDI-Device Identifier: 00763000689469
• UDI-Public: 00763000689469
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2025
• Device Model Number: 97725
• Device Catalogue Number: 97725
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/27/2024
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male