MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	B35200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: 3708660 lot# serial# (b)(6) implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type extension.Product id 3708660 lot# serial# (b)(6) implanted:(b)(6) 2017, explanted: (b)(6) 2017, product type: extension.Product id 3387s-40 lot# va0k227 implanted: (b)(6) 2014, explanted: (b)(6) 2026 product type lead.Product id: 3387s-40 lot# va0k227 implanted: (b)(6) 2014, explanted: (b)(6) 2026, product type lead.Product id 3391s-40 lot# va1dch7 implanted: (b)(6) 2017 explanted: (b)(6) 2017 product type lead.Product id: b35200 lot# serial# (b)(6) implanted: (b)(6) 2021, explanted: (b)(6) 2021 product type implantable neurostimulator.Section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #:(b)(6), ubd: 19-may-2018, udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(6) , ubd: 04-aug-2021, udi#:(b)(4) ; product id: 3387s-40, serial/lot #:(b)(6), ubd: 25-mar-2017, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(6) , ubd: 25-mar-2017, udi#: (b)(4).Product id: 3391s-40, serial/lot #:(b)(6), ubd: 11-oct-2019, udi#: (b)(4).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 there was a lack of efficacy of the implanted system.A full system explant was performed, and the entire system was removed.A full system replacement was subsequently conducted, with a new system implanted targeting a different area.
Additional Manufacturer Narrative
Continuation of d10: product id: 3708660, serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension, product id: 3708660, serial# (b)(6), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: extension.Product id: 3387s-40, lot# va0k227, implanted: (b)(6) 2014, explanted: (b)(6) 2026, product type: lead, product id: 3387s-40, lot# va0k227, implanted: (b)(6) 2014, explanted: (b)(6) 2026, product type: lead.Product id: 3391s-40, lot#: va1dch7, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.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
Additional information was received from manufacturer representative (rep).Rep reported multiple programming attempts were performed with limited efficacy.Patient has had much improved results after new implant.Rep reported the customer discarded the device.The information was confirmed by a physician.

• 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 ; 7635265677
• MDR Report Key: 24390839
• Report Number: 3004209178-2026-02788
• Device Sequence Number: 21396972
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)230814
• Combination Product (Y/N): N
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 08/14/2023
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 08/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female