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

Model Number	977118
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a return of pain in the setting of high impedance.The high impedance was not observed on the day of surgery, and impedance values were referenced as greater than 40 ,000.Programming was changed to working electrodes.Provider will order x-ray to verify lead placement.  the issue was reported as ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.2026-jul-07 mpxr 1448886.1 (rep): additional information was received from the manufacturer representative (rep).It was reported that the rep noted the top of the right lead has migrated down to t9.2026-jul-13 mpxr 1448886.2 (rep): additional information was received from the manufacturer representative (rep).The same rep later noted conflicting information that they met with patient today with return of pain.X-rays were taken and leads are in the same position as implant day.High impedances are noted on electrodes 1,2,3,4,6,12,13,14.Rep programmed around these electrodes and the patient will updated me at a later date with pain results.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 50074932
• Report Number: 3004209178-2026-12562
• Device Sequence Number: 10320110
• Product Code: LGW
• UDI-Device Identifier: 00763000558826
• UDI-Public: (01)00763000558826(17)260328
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 04/04/2025
• 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: Female
• Patient Weight: 155 LB