MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	B35300
Medical Device Problem Codes	Electromagnetic Interference (1194); High impedance (1291); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient has noticed a big change in how often they are needing to charge their implant.The manufacturing representative (rep) stated that the patient has had the same settings since (b)(6) 2025 and the average recharge time is 40 minutes with having to charge every day to every other day.Prior to an mri on (b)(6) 2025, the patient was charging every 3-4 days or even 5 days and now it's like every 2.5 days and would not deplete the battery before recharging.Upon review of recharge logs, caller said patient charged to 100% on (b)(6) 2025, the depleted down to 0% on (b)(6) 2025.On (b)(6) 2025, patient charged to 100%, but then it went back to 0% again by (b)(6) 2025.This is a new phenomenon the patient started experiencing a couple weeks after they got an mri.After interrogating the battery, the rep found a high impedance on 9b.The impedance reading was over 5,000 ohms in monopolar and over 10, 000 ohms in bipolar.Patient had a fall on (b)(6) 2025 that was on the left side of their body and in their "forehead area," which is what started the need for getting the mri.At the time of the fall, an impedance check was done and everything was green.The rep pulled up that impedance test and said the actual readings for 9b were 2100 ohms in monopolar and 6600 ohms in bipolar.Patient is not programmed on 9b, but they are programmed in ring mode on 10.The caller stated that they have since created an additional group where they are adding stimulation to 9b and they are up to 1.6 ma on the 9b segment to see if they wash out the impedance.When asked about x-ray imaging of the affected area, rep had imaging of the battery, but nothing of the lead or where it connects to the extension.Rep will try to get x-ray imaging of that area to see if there is visible damage to the lead.In the meantime, they will continue to program the patient while avoiding use of the 9b segment.
Additional Manufacturer Narrative
B3: date is approximate.Year is 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Percept
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 50916993
• Report Number: 3004209178-2026-16420
• Device Sequence Number: 5369815
• Product Code: MRU
• UDI-Device Identifier: 00763000564346
• UDI-Public: (01)00763000564346(17)260828
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: B35300
• Device Catalogue Number: B35300
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 09/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female