MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B35200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an upcoming mri appointment so patient services reviewed mri compatibility considerations and mri mode with the caller.Caller said they would reach out to the patient's healthcare provider about potentially getting an mri report.Caller also reported the patient's relevant medical history and reported the patient hadn't ever been able to get an mri with their first system because the "wire" had been broken.Caller stated the patient's hcp had discovered the issue shortly after the patient was implanted and stated the connection had just been not right and the hcp didn't want to go in to fix it so soon, so the patient just had to "live with it" and hadn't been able to get an mri.Caller stated the hcp had to do work arounds to program the patient's therapy settings and the patient had trouble with their dyskinesia because of it but then they replaced the battery and fixed the issue on (b)(6) 2025 and then the caller was told by the patient's team that with the replacement, the patient was now able to get an mri.Caller and patient to follow up with the patient's hcp to request a potential mri report.They may call back for further assistance on reviewing mri mode in the future.Documented reported event.No further action was taken by patient services.
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.

• Brand Name: PERCEPT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 24246315
• Report Number: 3004209178-2026-01713
• Device Sequence Number: 13254333
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)230228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 02/03/2026

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: 02/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 03/01/2021
• 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 Age: 74 YR
• Patient Sex: Female