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

Model Number	97713
Medical Device Problem Codes	Overheating of Device (1437); Delayed Charge Time (2586)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient.The reason for call was over the weekend the patient went to charge their implant and they got a picture of a doctor with a temperature thermometer.The patient pushed the button again and the picture went away but then a few minutes later when charging the implant they got what looked like a thermometer meaning the machine was running hot because it was very warm so they turned it off and waited a little while and proceeded on with charging.When the patient got to a certain point the machine got hot again.The issue started maybe a few times in the last couple months and this week it happened twice so the patient turned the device off and stopped charging.Patient mentioned that 4 or 5 years ago they contacted a different doctor and a representative came to the doctor's office and checked all the equipment and sent the patient on their way and told them to call back if they had any problems.Pt mentioned that it also took forever to charge the ins and it was bothering them.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: 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
• 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: 23769506
• Report Number: 3004209178-2025-20846
• Device Sequence Number: 21249539
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: (01)00643169109490(17)170628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/10/2025
• Date Device Manufactured: 06/09/2016
• 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: 59 YR
• Patient Sex: Female