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

Model Number	97702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Historical information was received from a patient (pt) regarding an implantable neurostimulator (ins).Pt mentioned historical information about their prior ins that was replaced in 2019; patient reported their old ins's leads and insulation come apart and the wires frayed, so they had to have the system removed and replaced.Agent asked if that issue happened in 2019; patient stated yes, and provided the revision date of (b)(6) 2019.Pt mentioned that their doctor who previously fixed the ins had changed practices and that new practice didn't take the patient's workman's comp that covered their ins and replacements.Agent documented reported information.No symptoms were reported.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name n/a; product id: 3708340, (serial: (b)(6)); product type: 0191-extension; implant date: (b)(6) 2006; explant date: (b)(6) 2019, brand name n/a; product id: 3708340, (serial: (b)(6)); product type: 0191-extension; implant date: (b)(6) 2006; explant date: (b)(6) 2019, brand name specify; product id: 3998, (lot: j0555274v); product type: 0200-lead; implant date: (b)(6) 2006; explant date: (b)(6) 2019, this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50087264
• Report Number: 3004209178-2026-12523
• Device Sequence Number: 13219858
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: (01)00643169109513(17)160628
• 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: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2016
• 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: 07/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 01/07/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male