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

Model Number	97716
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The pt reported discontinuing use of their ins for approximately 6 days due to overstimulation.They described experiencing a vibrating sensation in the lower legs, which they recognize as a sign of overstimulation.In response, the pt progressively decreased the intensity until ultimately turning the device off.Pt noted that on saturday they experienced a sudden return of pain, describing their neck as feeling "totally frozen" and noted that the pain was excruciating.Pt mentioned that they called their pain clinic and they were instructed to call the manufacturer first to see if this can be fixed over the phone.Agent asked, pt stated they had already attempted to change groups and adjust their therapy settings.Agent reviewed the role of the rep and pt services.The pt was redirected to their healthcare provider to further address the issue.Agent also reviewed nas number.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.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 patient who reported that they saw a manufacturer representative (rep) who programmed them.They reported when they feel a vibration from their implantable neurostimulator (ins) they turn off stimulator for a day or two and this works.The problem has been resolved.
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 PAIN RELIEF
• 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: 25084905
• Report Number: 3004209178-2026-07716
• Device Sequence Number: 10532997
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: (01)00643169781740(17)210928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 09/28/2021
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 10/05/2020
• 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
• Patient Age: 77 YR
• Patient Sex: Female