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

Model Number	97702
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Energy Output Problem (1431)
Health Effect - Clinical Codes	Pain (1994); Hyperresponsive to stimuli (4538); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated they wanted to check to see if their stimulator was working as patient didn't think it was.Patient said they had massive issues.Patient clarified they were having intense pain behind their right ear, in their neck, above and below their eyes, and were sensitive to light on the right side.Patient confirmed these were the symptoms the stimulator is supposed to help with.Patient said their doctor was in another state, so they wanted to check over the phone first before having to go out to their doctor.Patient did not have their programmer with them at the time of the call as they said they were in the process of moving and the programmer was packed away.Agent reviewed if patient could find the programmer, patient could call back for help checking implant/therapy status over the phone, otherwise the patient was redirected to their healthcare provider to further address the issue.Pt called back stating they did not find their programmer and would like the manufacturer representative (rep) to come out and check their device.Pt would like to meet with a rep in their state before going to see healthcare provider (hcp)  in the other state.Reviewed the process of contacting the rep.Redirected to hcp to contact the rep.Provided  national answering service (nas) number  to provide to hcp.Patient reported that patient met with a rep.Rep was unable to find the cause.Rep adjusted the stimulator.The pain is still present but has lessened in intensity.Hcp requested a cat scan of patient's implant to check for any movement, which was performed and sent to him; however, patient is yet to hear back.Rep reported the electrodes have shifted.Patient is going to hcp for an exam and surgery.Rep to meet with another rep during that appointment.
Additional Manufacturer Narrative
Continuation of d10: product id: 3487a-56, lot# v919796, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 3487a-56, serial/lot #: (b)(6), ubd: 18-jan-2016.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.
Event or Problem Description
Additional information was received from the manufacturer representative (rep).It was reported that the cause of electrode movement was not known.Patient did not know what event or action resulted in the electrodes moving.According to patient, a revision surgery is planned for 3/14.Additional information was received from the manufacturer representative (rep).It was reported that patient underwent explant of old system due to dual lead migration and replacement with leads for supraorbital and infraorbital lead placement.A return of pain was noted.Leads had migrated.Therefore, leads replaced on (b)(6) 25.The revision resolved the reported issue.The manufacturer representative (rep) indicated they would send any further information as they become aware.

• 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: 21414348
• Report Number: 3004209178-2025-03160
• Device Sequence Number: 8215074
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 08/14/2020
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 02/19/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female