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

Model Number	B35300
Medical Device Problem Codes	Failure to Deliver Energy (1211); Electrostatic Discharge (2149)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	09/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a lightning strike in their backyard overnight and when the patient woke up in the morning, the therapy was off.Representative states they asked the patient's father if they had to charge the battery up to turn it back on and the father said no, the battery was still charged but it was off and they could connect with the patient programmer and turn the therapy back on.Representative also mentioned the patient has dystonia.Patient's father said they would have noticed if the therapy was off when the patient went to bed.The caller also mentioned that the patient called them back today and they were able to run an mri test and all impedances were "normal".
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: 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: 50946111
• Report Number: 3004209178-2026-16586
• Device Sequence Number: 15840875
• Product Code: MRU
• UDI-Device Identifier: 00763000564346
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 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: 09/26/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/16/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male