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

Model Number	B35200
Medical Device Problem Codes	High impedance (1291); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Therapeutic or Diagnostic Output Failure (3023); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Shaking/Tremors (2515); Electric Shock (2554); Insufficient Information (4580)
Date of Event	08/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that  the patient saw service code 1703 on sunday.Caller said the patient had been feeling off.Caller said the patient was feeling like their tremors were worse.Caller said the patient was having a little chest discomfort on the side where the implantable neurostimulator (ins)  is which usually indicates they need to increase stim.Caller said the programmer was not letting the patient turn stim off.Caller said the patient went through the process of trying to turn stim off and not being able to then the chest pain went away.Caller said the patient hasn't had any falls trauma or change in activity.Caller said they contacted the hcp and were advised to call manufacturer. the caller stated that the patient was getting codes 1703 and 1098 on the patient remote.Tech services reviewed meaning of the codes.The caller will follow-up with the hcp.Hcp called in with additional information.Hcp said patient mentioned they got an error message over the weekend that said the patient's neurostimulator were delivering less therapy than requested and then the patient started experiencing a shock-like sensation in their right chest and back that occurred with any movement.Patient was admitted to the er overnight and was seen by a neurosurgery provider who recommended the patient be repr ogrammed by a manufacturing representative.
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 ; +1(763)526-5677
• MDR Report Key: 50397613
• Report Number: 3004209178-2026-14154
• Device Sequence Number: 8827273
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: (01)00763000642174(17)250714
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 07/14/2025
• Device Model Number: B35200
• Device Catalogue Number: B35200
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/23/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 07/24/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male