MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED

Model Number	B35200
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that information was received from a patient regarding an external device communicator.The reason for call was patient reported that last tuesday they woke up in the hospital after having seizures and they hit their head a couple times.Patient said they called their neurologist facility on thursday and the nurse that they spoke with mentioned the possibility of the deep brain (dbs) stimulator turning off from the patient hitting their head.Patient asked if dbs could turn off from hitting their head.Patient services agent reviewed information about implanted neurostimulator and battery longevity and redirected patient to healthcare provider to further address the issue.Patient mentioned that they just spoke with a manufacturing representative, today because since last tuesday they noticed their communicator would not pair with their dbs therapy application.Patient said the communicator only powered on when it was plugged into the charging cable but when the communicator was unplugged from the charging cable the communicator was non responsive.Hard reset and troubleshooting with the medtronic representative did not resolve the issue.The issue was not resolved.An email was sent to the repair department to replace the communicator.Patient may call back for assistance pairing new communicator and checking therapy status once they receive new communicator.Patient said they didn't know the name of their managing physician and may provide it if they call back for assistance once it was known.Additional information has been received that patient called in and said they got the replacement communicator and they were able to connect to the implantable neurostimulator (ins).

• Brand Name: PERCEPT
• Common Device Name: STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
• 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: 24788546
• Report Number: 3004209178-2026-05943
• Device Sequence Number: 10011885
• Product Code: MBX
• UDI-Device Identifier: 00763000519216
• UDI-Public: (01)00763000519216(17)240228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/06/2026

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: 02/28/2024
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 02/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 35 YR
• Patient Sex: Male