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

Model Number	37612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Scar Tissue (2060); Tissue Breakdown (2681)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 9 months ago, the patient noticed a scab on their head "above the left side of the dbs." the scab on their head was checked by numerous people in those 9 months.The patient reported to the hospital to have an mri.It was noted that upon arrival, the patient had an open wound on the left side of their head over the top of their burr hole cap.The patient's healthcare provider (hcp) and a manufacturer representative (rep) were notified of the issue, and the patient was advised to go to the hospital as soon as possible for evaluation.There, they learned there was an infection within the scab.A team of neurosurgeons "removed the scab and took out all the leads that were part of that." (left side system - lead, burr hole cap, and extension were removed on (b)(6) 2026).The patient stated that the rep's decision saved their life.There were no known contributing factors.The issue was resolved.
Additional Manufacturer Narrative
D10.Section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), ubd: (b)(6) 2022, 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.

• Brand Name: ACTIVA
• 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: 50090938
• Report Number: 3004209178-2026-12815
• Device Sequence Number: 18620168
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: (01)00643169864238(17)200914
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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 Expiration Date: 09/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 10/25/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 110 LB