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

Model Number	977118
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Discomfort (2330); Ambulation or Postural Difficulties (2544); Paresthesia (4421); Swelling/ Edema (4577); Insufficient Information (4580); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient reported they can feel the stimulation in their arms but not their neck and in their legs but not their lower back.Patient stated if they turn the stimulation up they can feel it in their neck and back, but then it is tingling in their arms and legs so much they can't move them and they have to decrease it back down to where they're not feeling it where they want to.Patient stated they went back to the doctor today to get the device programmed, but they do not remember if they were on group a, b, or c.Patient mentioned they could feel the stimulation in their back really good and a little bit in their legs and sort of up their neck and a little in their arms, but now they feel it in their arms and legs not their neck or lower back.Agent reviewed therapy information as well as role of rep and redirected patient to their healthcare provider to further address.Patient reported handset was not charging and seemed to indicate the cord was loose in the port, although agent could not confirm this.Patient reported using dual adapter and, even with handset cord individually plugged in, handset would not charge.Agent sent request to repair for powercord.Patient requested larger size belt; agent sent request to repair.Patient commented last time they were sent supplies they were overnighted.Patient inquired as to when id card would be sent; agent reviewed.
Additional Manufacturer Narrative
B5 updated 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: 50865290
• Report Number: 3004209178-2026-16088
• Device Sequence Number: 21505539
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• UDI-Public: (01)00763000984656(17)280714(20)01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 977118
• Device Catalogue Number: 977118
• 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: 09/21/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 07/14/2026
• 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...."
• Patient Age: 63 YR
• Patient Sex: Female