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

Model Number	97702
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Electric Shock (2554)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_lead product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_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.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for the call was the caller stated that since friday, they had been getting jolted by the batteries in their lower back and neck.The caller added that they were also having a shock type wave in their neck where the lead was.The caller stated the jolting started over the weekend and was progressing and getting worse.The caller noted they had not had any falls, injuries, or accidents before this began.The caller turned the stimulation completely off a while ago to see how it would work without the stimulation, and the stimulation was still off.The caller stated it was like a burning sensation in their neck where the lead was.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.The agent sent an email to registration to update address and phone number.
Additional Manufacturer Narrative
Continuation of d10: product id 97702, serial# (b)(6), product type: implantable.Neurostimulator product id neu_unknown_lead, serial# unknown.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21411875
• Report Number: 2182207-2025-00493
• Device Sequence Number: 8523452
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2025

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: 02/28/2021
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 02/23/2025
• Date Device Manufactured: 09/04/2019
• 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...."
• Patient Age: 53 YR
• Patient Sex: Female