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

Model Number	977118
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Electric Shock (2554)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported their therapy was not working properly.Patient described that they can be just laying in bed and when they cough or turn a little bit to the side they get a shocking sensation.Patient noted this occurred last night and it shocked them half to death, which agent understood as a figure of speech.Agent asked event date and patient stated it did this a little in the beginning and their manufacturing representative (rep) told them they just needed to find their groove and then it started again recently.Agent reviewed role of rep and provided nas number.The patient was redirected to their healthcare provider (hcp) to further address the issue.
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: Inceptive
• 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: 50853232
• Report Number: 3004209178-2026-16006
• Device Sequence Number: 10025849
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 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
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 10/29/2025
• 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: 55 YR
• Patient Sex: Female