MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	B35300
Medical Device Problem Codes	Failure to Deliver Energy (1211); Battery Problem (2885); Impedance Problem (2950)
Health Effect - Clinical Code	Anxiety (2328)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complaining of battery drain faster than expected and device turning off unexpectedly.This occurred after patient programming changed from cdbs to adaptive group.Rep instructed patient on how programming change can affect battery drain rate and to recharge a day or two sooner.Also instructed to turn dbs back on.Hcp said impedances recently checked and are within normal limits.Hcp notes that underlying anxiety may be contributing to report of issue.  patient will monitor and change recharge interval timing and f/u with hcp for further issues.Patient is doing well per hcp on his programmed settings.Additional information was provided indicating that the manufacturer representative received a text from the patient reporting a 2703 error code while using adaptive therapy.The representative contacted the managing healthcare provider, who reported that the patient had recently been seen and was doing well with normal impedances.Technical support reviewed that 2703 indicates an out-of-range (oor) condition and that the system cannot deliver the programmed therapy for the group currently in use.The caller was not with the patient at the time of the call, so no further troubleshooting was performed.The patient was advised to follow up with the healthcare provider for further evaluation.Cause of changes in longevity unknown, possibly impedance related.Patient will be seen on (b)(6) 2026 for follow up.A manufacturer representative provided additional information indicating that the unexpected depletion and therapy-off event was not determined, and the most likely contributing factor was an impedance issue with segment 2a rather than normal battery depletion.The physician saw the patient on (b)(6) 2026, and the patient remained in adaptive dbs mode; segment 2a was removed due to the impedance issue.The impedance problem has not been fully resolved, but the patient is receiving therapy without segment 2a.The manufacturer representative also noted that the patient that the battery is draining faster.Session reports were attached for review, and the physician confirmed and provided the information.
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 Parkinsonian Tremor
• 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: 50871831
• Report Number: 3004209178-2026-16166
• Device Sequence Number: 16138120
• Product Code: MHY
• UDI-Device Identifier: 00763000564346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/20/2025
• 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 Sex: Male