MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; Stimulator, electrical, implanted, for essential tremor

Model Number	B35200
Medical Device Problem Codes	Unintended Collision (1429); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator.The reason for call was patient reported that the area around their implant in their chest had been giving them pain for the last couple years.Patient said that the implant itself felt flatter and different than it used to.Patient said they were a "thousand times worse" symptom wise than they were when they first got the dbs, pt said this started happening within a year of the dbs being implanted.Patient was wondering if the implanted device could leak or if the materials in the implant could be causing the issue.Patient said they had fallen in the last couple years.Agent reviewed information and redirected patient to healthcare provider.Patient said they want the dbs system removed because it doesn't work but the va insurance denied removal.Patient complained to their surgeon but they have never heard back from their surgeon.Patient said they have an appointment with managing healthcare provider in april and was told that a manufacturing representative would be coming to the appointment.Patient mentioned the only time they saw a manufacturing representative was when their controller wasn't working around the time after the implant was placed.Additional information received from manufacturing representative.Manufacturing representative reported that they will meet with patient in april.
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 essential 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 ; 7635265677
• MDR Report Key: 21777755
• Report Number: 3004209178-2025-05915
• Device Sequence Number: 18090143
• Product Code: PJS
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• 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: 2020
• 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): 04/04/2025

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: 06/14/2022
• 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: 03/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 06/22/2020
• 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