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 Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator (ins).The reason for call was patient reported they are not able to charge the implant for a month.Patient stated they are getting code 4100 and 4101 when they are trying to charge the implant.Patient mentioned they have an appointment today with a different doctor and will bring up the issue to them.Agent asked patient if they have had falls or trauma and patient said no, but they have always had trouble charging the implanted neurostimulators since they got the implant about a year ago.Agent reviewed meaning of the message and recommend patient consult with healthcare provider for next steps.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the manufacturer representative (rep).It was reported that the patient states a few months ago her device "stopped working" and she could not connect her handset to the implantable neurostimulator (ins).Patient states she called patient services about the communication issues and was redirected to her surgeon for replacement.She would like to have a non-rechargeable device so the patient had their device removed and replaced.The issue was resolved.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
• 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: 50915691
• Report Number: 3004209178-2026-16403
• Device Sequence Number: 20219957
• Product Code: LGW
• UDI-Device Identifier: 00763000540302
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 08/28/2025
• 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: 09/28/2026
• Date Device Manufactured: 09/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female