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

Model Number	97702
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Insufficient Information (4580)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id 97702 (nma735649h); product type: 0197-implantable neurostimulator; implant date (b)(6) 2020; 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 regarding an implantable neurostimulator.The reason for call was patient reported their sti mulation was shutting off on them and the issues for both their implant began about a month ago.Patient stated the left implant shut off twice and the right implant did it once.Patient had an appointment with their healthcare provider on the (b)(6) because the right battery pack felt like it was pulling at the wires and it got to a point where it was painful and that was the least of their problem.Patient lost 105 pounds in the last 1.5 years and now both battery packs were completely visible and more exposed neither one of them were quite comfortable anymore.The implant on their butt literally felt like it was pulling it.Agent redirected patient to their healthcare plan to further address the issue.Patient mentioned it had been 5 years and usually that was how long they got before the battery started to go.

• 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: 25428761
• Report Number: 3004209178-2026-09627
• Device Sequence Number: 18713338
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: (01)00643169974883(17)200728
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2020
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 02/09/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 45 YR
• Patient Sex: Female