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

Model Number	97702
Medical Device Problem Codes	Break (1069); Failure to Deliver Energy (1211); Environmental Compatibility Problem (2929); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient reported their implant is not working.Patient stated they had been getting shots from their doctor at pain management and after the last shot, sometime in november, they don't feel the ins is operating.Patient said they don't feel the stimulation at all.Agent asked patient to connect with the patient programmer and patient reported seeing what agent understood to be the sync screen.Patient was able to successfully sync the programmer to the implant and confirmed the implant battery showed to have a charge, and the stimulation was on; from patient description, did not appear to be at eos.Patient increased the stimulation from 5.70 to 5.87 and said they still could not feel anything.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue; patient did not have a managing physician since their last move.Agent sent patient physician listings via physical mail, as well a s provided and explained use of nas number when they get a managing hcp.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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.
Event or Problem Description
Additional information was received from the patient.The patient stated their stimulator worked fine, then they received a shot.They went to use their unit, and it didn't work.The patient had been getting shots for the past couple months for back pain.
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.
Event or Problem Description
Additional information was received from the patient reporting the stimulator was found to have broken wires and was too old.The old stimulator was put in 2019.Data record for patient shows devices explanted.
Additional Manufacturer Narrative
Continuation of d10: product id 748951 serial# (b)(6) implanted: (b)(6) 2006 explanted: (b)(6) 2026 product type extension product id 977c165 serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2026 product type lead 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: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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 ; 7635265677
• MDR Report Key: 24028987
• Report Number: 3004209178-2026-00459
• Device Sequence Number: 8970014
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: (01)00643169109513(17)200228
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 02/28/2020
• Device Model Number: 97702
• Device Catalogue Number: 97702
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 04/01/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/26/2026; 04/17/2026
• Date Device Manufactured: 09/06/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female