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

Model Number	977119
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient's representative regarding an implantable neurostimulator (ins).The caller reported the patient had their therapy off because they had to go in the hospital for unrelated concerns and didn't want the therapy interfering with anything.Caller said they were trying to put the therapy back on today, but they couldn't get the patient to feel the "current." caller said patient was typically on group c with intensity set to 7, which was what they were at when the therapy was turned off.Caller stated that because the patient wasn't feeling the current, they played with the settings and lowered the amount to 5.4 to see if that would work.When they tried to increase the amount, they got an error message that said 'contact your clinician.Your therapy turned off automatically.Service code: 323.' agent reviewed information and redirected to healthcare provider to further address the issue.Agent reviewed their role and a manufacturer representative (rep).Agent explained the issue would need to be resolv ed in person.Agent advised caller to reach out to healthcare provider (hcp) directly to page a rep if they wanted to coordinate with a local rep faster.
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: Inceptiv
• 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: 50886095
• Report Number: 3004209178-2026-16259
• Device Sequence Number: 9827151
• Product Code: LGW
• UDI-Device Identifier: 00763000984687
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Model Number: 977119
• Device Catalogue Number: 977119
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 11/18/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female