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

Model Number	977119
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reason for the call was hcp reported pt felt shooting pains from under the stimulator and pt was not getting pain relief benefits from the stimulator.Hcp said pt thought there was something wrong with the stimulator.Hcp said a ct had been performed and radiologist did not see anything wrong with ins pocket site.Tss discussed issue and provided nas.Pt was redirected to managing hcp.Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was caller reported the pt was hospitalized yesterday because she was experiencing pain around the implant area and a shocking sensation on the leads.The caller said the issue started sunday early morning.Agent advised they can turn off the pt therapy.Caller said they were trying to call the pt mdt rep but no reply.The caller was redirected to their healthcare provider to further address the issue.Agent provided nas phone number.
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 specify surescan; product id (b)(4) (serial: (b)(6)); product type: 0200-lead; implant date(b)(6)2022; explant date 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: 50868160
• Report Number: 3004209178-2026-16106
• Device Sequence Number: 10661412
• Product Code: LGW
• UDI-Device Identifier: 00763000540302
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 11/28/2025
• Device Model Number: 977119
• Device Catalogue Number: 977119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 12/02/2024
• 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: Hospitalization
• Patient Sex: Female