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 Deliver Energy (1211); Battery Problem (2885); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was rep reported that the patient (pt) had likely had a cardioversion yesterday because the patient was having heart issues and then the patient fell and was in the icu today.Manufacturer representative (rep) said the pt's implanted neurostimulator battery was not holding a charge.Rep said the tablet displayed message therapy off, contact your clinician: therapy is turned off, cannot provide the requested therapy, amplitude will be set to 0 in all active groups when trying to connect to ins.Rep tapped "set amplitudes to 0" and then got system error: 0x2cc6bede.During the call, the representative attempted to connect to the patient's implanted neurostimulator, but got a system error message.Rep reset stimulator 2 times and tried to connect to ins again, but got same amplitudes to 0 message followed by system error.Rep tried to connect to ins with pt programmer and got service code 323.Rep said the only thing the pt could do is charge the ins.Technical services (tss) discussed likely cardioversion damage.No symptoms were reported.
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: 50934477
• Report Number: 3004209178-2026-16528
• Device Sequence Number: 9734464
• Product Code: LGW
• UDI-Device Identifier: 00763000540302
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/13/2025
• 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: 69 YR
• Patient Sex: Male