MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977C265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during placement of the lead specify surescan mri 2x8, neuromonitoring reported loss of motor function on the left side of the patient¿s body without loss of somatosensory evoked potentials.Walking difficulty and numbness were reported.Anesthesia was reduced, the lead was removed, and the patient was closed.Following anesthesia reduction and lead removal, the patient was able to move the left leg and foot.The patient was alive with injury, and the issue was reported as 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: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50434157
• Report Number: 2649622-2026-25148
• Device Sequence Number: 18747957
• Product Code: LGW
• UDI-Device Identifier: 00763000324223
• UDI-Public: (01)00763000324223(17)300716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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 Model Number: 977C265
• Device Catalogue Number: 977C265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 07/16/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female