MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number	3708660
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2025 product type extension.Product id 37612 serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2025 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: 15-jun-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 experienced a shocking sensation with some movement on the right side of the body and a shocking sensation with physical touch to the left side of the posterior head, occasionally while laying down or sleeping.Impedances were tested and no abnormalities were found.Environmental/external/patient factors that may have led or contributed to the issue were not known or reported to the manufacturer representative (rep).Extensions were explanted and new extensions were implanted.The issue was resolved.

• Brand Name: ACTIVA
• Common Device Name: Stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23458334
• Report Number: 2649622-2025-30847
• Device Sequence Number: 12780914
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: (01)00613994749116(17)190528
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 11/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 05/28/2015
• 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 Sex: Female