MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977C165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during placement of the lead 977c165 specify surescan magnetic resonance imaging (mri) 5-6-5 paddle lead, the patient experienced multiple asystole events each time the lead was introduced into the epidural space.There were prolonged periods before recovery of normal rhythm, and necessary intervention was required during the procedure.The neurosurgeon and anesthesia team aborted the procedure.The patient underwent a laminectomy without implantation of a spinal cord stimulation system and was hospitalized overnight in the intensive care unit for monitoring.The issue was resolved and the patient was reported to be stable.No patient complications have been reported as a result of this event.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.
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 MN 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23451384
• Report Number: 2182207-2025-02986
• Device Sequence Number: 15682662
• Product Code: LGW
• UDI-Device Identifier: 00763000324209
• UDI-Public: (01)00763000324209(17)280809
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 11/06/2025

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: 977C165
• Device Catalogue Number: 977C165
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 08/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Male