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

Model Number	977119
Medical Device Problem Codes	High impedance (1291); Malposition of Device (2616); Charging Problem (2892)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator (ins).The reason for the call was patient said they are having an issue with charging the ins.Patient stated that it is very hard to charge and it is very painful.When it finally makes a connection, it is like it is sticking up on one end like it's ready to pop through the skin.If they touch it just right with the charger it is an excruciating pain, otherwise it is just very terrible.The issue started on (b)(6) 2026 where the ins was oozing and that wednesday they started to have pain while charging while on vacation.Patient has an appointment with their healthcare provider (hcp) on thursday.Patient stated their hcp said to call and coordinate for a local representative to be present.The patient was redirected to their hcp to further address the issue.
Event or Problem Description
Additional information was received from the manufacturer representative (rep).It was reported that there were high impedances.Electrode 1-32547.2-40000.3-26249.Reprogramming.During planned pocket revision on 9/25/26 the surgeon will check leads and impedances.A device site infection was also reported with fluid discharge and pain at the ins site.Surgeon has planned to revise ins in the pocket and check for infection.The issue is ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.
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 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 ; +1(763)526-5677
• MDR Report Key: 50870172
• Report Number: 3004209178-2026-16141
• Device Sequence Number: 15758935
• Product Code: LGW
• UDI-Device Identifier: 00763000984687
• UDI-Public: (01)00763000984687(17)280628(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 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: 09/21/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 07/06/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female