MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B35300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that within the first month of the first implantable neurostimulator (ins) being implanted, their scalp never healed well and they developed a staph infection.As a result, the whole dbs system was explanted about 2 months later and this year a new dbs system was implanted.Agent documented reported event.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3400060 (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2025; explant date (b)(6) 2025 brand name sensight; product id b3400060m (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2025; explant date (b)(6) 2025 brand name sensight; product id b3300542m (serial: (b)(6)); product type: 0200-lead; implant date (b)(6) 2025; explant date (b)(6) 2025 brand name sensight; product id b3300542 (serial: (b)(6)); product type: 0200-lead; implant date (b)(6) 2025; explant date (b)(6) 2025 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 PARKINS
• 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: 50820336
• Report Number: 3004209178-2026-15865
• Device Sequence Number: 18694641
• Product Code: MHY
• UDI-Device Identifier: 00763000564346
• UDI-Public: (01)00763000564346(17)270714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: No
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male