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

Model Number	977118
Medical Device Problem Codes	Failure to Interrogate (1332); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer's representative regarding an external device.The reason for call was representative said the patient has had some trouble charging their implanted neurostimulator.Representative said when they connected the wireless recharger to the patient's implant, they saw a screen that said to hold it there for 20 minutes.Representative also said about 5 minutes in, the screen switched to the normal charging screen where it gives you the percentage and tells you excellent or good.Representative asked if there was something they were doing wrong or if it was normal.Agent asked representative if the patient uses the belt when they charges and representative said they do.The representative also mentioned that the patient went to charge the device the other day and it took about 1.6 hours to charge from 40% to 100%, but the patient saw the same screen when they went to put it on and it still had charge in it.They typically are able to recharge within a "normal" amount of time.Manufacturing representative (rep) states the implantable neurostimulator (ins) is superficial, but there is some "puffiness" and the patient told her that it actually seems less puffy today, so rep states perhaps there is some fluid.Agent reviewed the screen the patient is seeing and also reviewed normal recharging.The patient was advised to monitor.Rep plans to do a "hard reset" of the equipment while with the patient today.Rep was not sure when this began, but stated after april.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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: 50916874
• Report Number: 3004209178-2026-16418
• Device Sequence Number: 5776991
• Product Code: LGW
• UDI-Device Identifier: 00763000558826
• 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: Company Representative
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 06/09/2025
• 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 Sex: Male