MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	97791
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930)
Date of Event	12/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer, via a manufacturer representative (rep), regarding a trial patient with a wireless external neurostimulator (wens).The patient informed the rep on (b)(6) that they had a fever of 103.The patient's son told the rep the patient has had a fever for about two weeks.Patient went to hospital and leads and wens were removed.It was noted the cause was unknown, but the patient was hospitalized and antibiotics were administered to resolve the issue.
Additional Manufacturer Narrative
Continuation of d10: product id: 9772501 (serial: (b)(6)); product type: 0209-external neurostimulator; implant date n/a; explant date n/a.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id: 977d260 (lot: va37y4r039); product type: 0215-screening device; implant date (b)(6) 2025; explant date (b)(6) 2025 brand name surescan; product id: 977d260 (lot: va37n5m020); product type: 0215-screening device; implant date (b)(6) 2025; explant date (b)(6) 2025.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 from the rep indicated that the patient is currently inpatient being treated for a strep infection in her blood.The patient had leads pulled at hospital and the status of them are unknown, but likely discarded.
Additional Manufacturer Narrative
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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23878987
• Report Number: 3004209178-2025-21636
• Device Sequence Number: 4669159
• Product Code: LGW
• UDI-Device Identifier: 00763000852887
• UDI-Public: (01)00763000852887(17)290904(10)HG91Z0M
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Model Number: 97791
• Device Catalogue Number: 97791
• Device Lot Number: HG91Z0M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 09/04/2025
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female