MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	B35200
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 37612 serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6) 2023 product type implantable neurostimulator product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 product type extension product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 product type extension product id 3387s-40 lot# va10dgd implanted: (b)(6) 2016 product type lead product id 3387s-40 lot# va10dgd implanted: (b)(6) 2016 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(6), ubd: 04-jan-2020, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(6), ubd: 04-jan-2020, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(6), ubd: 21-aug-2018, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(6), ubd: 21-aug-2018, 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
The manufacturer representative provided additional information indicating that elevated impedances were observed on both leads.Prior to generator replacement, contact 0 was within normal limits, and contact 1 was elevated; after replacement, contact 0 was elevated, and contact 1 was within normal limits.The physician attempted a clean and dry at the ipg connection point with no change in impedance values.The physician is aware of the findings, and no follow-up is planned at this time.Additional information was received from manufacturer representative (rep).Rep clarified the inss were replaced due to normal battery depletion.

• Brand Name: PERCEPT
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 25752468
• Report Number: 3004209178-2026-11428
• Device Sequence Number: 10517853
• Product Code: MRU
• UDI-Device Identifier: 00763000642174
• UDI-Public: (01)00763000642174(17)250628
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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: 06/28/2025
• 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: 06/19/2026
• Initial Report FDA Received Date: 07/08/2026
• Date Device Manufactured: 06/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 15 YR
• Patient Sex: Female