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

Model Number	97702
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.It was reported that they went to get an mri and the mri facility mentioned that they couldn't do the mri because there was metal in the stimulator and the wire was loose.Patient stated now they were sitting in a rehab facility and had been in the hospital for 4 weeks.Patient noted they were tired of being in some places that were driving them crazy.Patient asked if they needed to go back to the hospital to get the wires taken care of.Agent emailed patient physician listings.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id 3777-45 (serial: (b)(6)); product type: 0200-lead; implant date (b)(6) 2008; explant date brand name ; product id 3777-45 (serial: (b)(6)); product type: 0200-lead; implant date (b)(6) 2008; explant date 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 (pt) regarding an implantable neurostimulator (ins).The reason for call was the pt reported that the lead wire was out and the implant was not working.Pt called to inquire about how to have their implant removed.For the event date, pt stated the device has not been working for a long time.The pt was redirected to their healthcare provider to discuss the issue and potential removal of the implant.Patient mentioned that they had not used the stimulator for a while because they could not get the settings right, were not comfortable using it, and felt that it caused a burning sensation in their back.Patient also mentioned that the wire was loose.
Additional Manufacturer Narrative
Continuation of d10: product id 3777-45 serial# v064819019 implanted: 2008-01-18 product type lead product id 3777-45 serial# v064819023 implanted: 2008-01-18 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 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: 25182484
• Report Number: 3004209178-2026-08351
• Device Sequence Number: 10543862
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: (01)00643169109513(17)170414
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2017
• 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: 05/12/2026
• Initial Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 10/27/2015
• 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 Sex: Female