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

Model Number	37603
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 explanted: (b)(6) 2025 product type extension.Section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(6), ubd: 15-apr-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 the patient underwent a battery change and an extension revision on (b)(6).The manufacturer representative stated that the patient developed an infection in the left ipg pocket, which appeared red and puffy.The physician decided to remove the left chest battery and the left-sided extension due to the infection.The representative was notified of the infection on (b)(6), and the explant procedure was performed on (b)(6).
Additional Manufacturer Narrative
Continuation of d10: product id 37603 serial# (b)(6) implanted: (b)(6) 2022 explanted: (b)(6) 2025 product type implantable neurostimulator.Product id 3708660 serial# (b)(6) implanted: (b)(6) 2016 explanted: (b)(6) 2025 product type extension.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 received from rep indicating cause of the revision on july 24th was impedances were detected on the extension during a battery replacement procedure due to battery depletion.Impedances were resolved with extension revision.It is unknown when infection was first observed.Patient has since had their new battery and extension placed on (b)(6) 2025.The rep is not aware of any issues with the system since new battery and extension were placed.

• 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 ; 7635265677
• MDR Report Key: 22910222
• Report Number: 3004209178-2025-14532
• Device Sequence Number: 9130806
• Product Code: MHY
• UDI-Device Identifier: 00763000384340
• UDI-Public: (01)00763000384340(17)230414
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 10/18/2021
• 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: 69 YR
• Patient Sex: Male