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	Pain (1994); Discomfort (2330)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a trial patient via manufacturer representative who was using an external neurostimulator (ens).It was reported that the patient just reached out to report that they will be having their leads removed tomorrow. the patient has had an immense amount of surgical pain post procedure.Pt has been unable to get comfortable and healthcare provider (hcp) thinks that it is best to remove the trial leads at this time.Pt is also in agreement. pt has tried other programs and has received additional pain meds but is very uncomfortable.The cause is the issue is post surgical pain.Issue was ongoing.  hcp does all of his procedures in the hospital so he asked the patient to go to the hospital tonight for pain management and to prepare for the lead pull tomorrow.It was then reported that the patient had their lead trials removed.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(6), ubd: 05-mar-2028, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(6), ubd: 05-mar-2028, udi#: (b)(4).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
Additional information was received from the manufacturing representative via email.Rep stated they have been trying to gather additional information but there is no new information since this report was filed.Here are the most up-to-date answers that the rep can provide.Issue has been resolved.Rep was asked about status of the removed leads and rep stated customer discarded.Device not available and not returned.Information was provided by physician and confirmed.
Additional Manufacturer Narrative
Continuation of d10: product id 977d260, lot# serial# (b)(6), implanted: (b)(6) 2024, product type screening device product id 977d260, lot# serial# (b)(6), implanted: (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.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19347882
• Report Number: 3007566237-2024-00018
• Device Sequence Number: 2685337
• Product Code: LGW
• UDI-Device Identifier: 00763000689469
• UDI-Public: 00763000689469
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 08/14/2025
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 02/22/2024
• 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...."
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female