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

Model Number	B35200
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Visual Impairment (2138); Shaking/Tremors (2515); Insufficient Information (4580)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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
It was reported that patient has an upcoming mri and the neurologist didn't sign off on the form because of an impedance issue.Representative said they tried increasing stimulation on 2c and in ring mode and running it at 1.0 ma, but they couldn't get the impedance to clear.The issue was first noticed about 2 weeks ago.Patient had mri i 2025, and impedance was good at the time.The impedance ce level was greater than 5,000, but when they ran it on automatic, it gave them a value of like 21,000.The patient was redirected to their healthcare provider to further address the issue.Technical services reviewed that mri is not recommended.Also reviewed with rep that if hcp wants to override the recommendation, then it's up to the hcp, but manufacturer cannot recommend proceeding with the mri.The patient and patient rep called with follow up questions regarding reported impedance issues stating that the rep never followed up with them to discuss next steps to address high impedances.Caller wanted to know if medical affairs would override the impedance decision for mri eligibility, redirected to managing hcp.Caller indicated they had already spoken to managing hcp and were told the patient is not eligible for mri and that patient needs to explore alternatives.Caller also stated that the managing neurologist said that in their opinion the impedances are not affecting the therapy but "patient is feeling bad, tremors have returned and vision is quite poor" so they have additional concerns beyond mri eligibility.Redirected patient to discuss these concerns with managing hcp.

• 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: 25278181
• Report Number: 3004209178-2026-08891
• Device Sequence Number: 10060622
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: (01)00763000642174(17)250914
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 09/14/2025
• 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: 05/07/2026
• Initial Report FDA Received Date: 05/26/2026
• Date Device Manufactured: 09/22/2023
• 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: 69 YR
• Patient Sex: Male