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

Model Number	97716
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The pt reported that they had their ins removed and still had the external devices.Pt asked what they could do with the external devices left.Agent reviewed the donation/disposal process.Pt did not have the external devices during the call.  agent asked why the ins was removed, and pt said they had the ins for 6 years, 3 of those years the stimulator was not working properly.Pt stated the leads fell off, the ins was protruding through the skin, and they were in excruciating pain.Pt mentioned getting injections for their pain.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name: vectris surescan; product id: 977a260 (serial: (b)(6); product type: 0200-lead; implant date: on (b)(6) 2020; brand name: vectris surescan; product id: 977a260 (serial: (b)(6); product type: 0200-lead; implant date: on (b)(6) 2020.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 ; +1(763)526-5677
• MDR Report Key: 50792295
• Report Number: 3004209178-2026-15695
• Device Sequence Number: 9524886
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: (01)00643169781740(17)200528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Expiration Date: 05/28/2020
• Device Model Number: 97716
• Device Catalogue Number: 97716
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 05/31/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female