MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	978B128
Medical Device Problem Codes	Unintended Collision (1429); Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Frequency / Polyuria (2275); Discomfort (2330); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction.It was reported that the patient had a follow-up appt in the healthcare provider's (hcp) office today after having a couple falls roughly 2 weeks ago.Patient had pain at lead and ipg site and minimal to no symptom improvement after the fall.Went in for well check today with the hcp and had a program adjustment from program 3 to program 6, stim uncomfortable still and may turn therapy off if discomfort persists.There were no out-of-range impedances and patient was sent for sacral x-rays.The patient planned on getting x-rays today or tomorrow with a follow-up with the hcp's office after results came in.The manufacturer representative was unsure of further treatment as of now.They stated that the patient had pain, discomfort/soreness/pinching/ache/pressure, return of baseline symptoms, urinary incontinence, urinary frequency, urinary urgency.Additional information was received from a manufacturing representative.It was reported that the symptoms did worsen after the fall with no improvement with program adjustments.The rep mentioned that they did not known the results of the x-ray.Program adjustments made on (b)(6) 2025 then therapy turned off on (b)(6) 2025.They stated that the patient is going in for a full lead and battery replacement with the hcp on (b)(6) 2025.
Additional Manufacturer Narrative
Section d information references the main component of the system: product id: 97800, lot# serial#: (b)(6), implanted: on (b)(6) 2024, product type: implantable neurostimulator.Section d information references the main component of the system.Other relevant device(s) are: product id: 97800, serial/lot#: (b)(6), ubd: 14-feb-2026, udi#: (b)(4).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
Continuation of d10: product id 97800 lot# serial (b)(6) implanted: (b)(6) 2024 explanted: (b)(6) 2025 product type implantable neurostimulator 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, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21588491
• Report Number: 2649622-2025-07103
• Device Sequence Number: 8757363
• Product Code: EZW
• UDI-Device Identifier: 00763000596910
• UDI-Public: 00763000596910
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 06/24/2026
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA3124J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 10/09/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 80 KG