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

Model Number	3708660
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id b35200 lot# serial# (b)(6); implanted: (b)(6) 2025; explanted: product type implantable neurostimulator product id 3387s-40 lot # va0a3a0 serial# implanted: (b)(6) 2013; explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(6), ubd: 16-apr-2016, 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 had a tremor in their right arm that wasn't constant but was going off and on.Patient rep stated that the day after the patient's implant surgery, the patient has been experiencing this issue daily; not all day long, but they see some tremor every day in the morning.Patient rep also mentioned that the tremor happens occasionally throughout the day.Patient rep added that the surgeon who implanted the patient's implantable neurostimulator (ins)  mentioned that there was a little bend around the lead wire because the patient had the dbs for a while.Caller also stated that the surgeon had to go "above that bend for the right side" but did not clarify what they meant by that.Caller then confirmed that the patient was already scheduled for an appointment with their neurologist for november and that they were just calling to see if there's something they can do beforehand.Agent redirected the caller to the patient's hcp to further address the issue.

• 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: 23414612
• Report Number: 2649622-2025-30315
• Device Sequence Number: 15685670
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: (01)00613994749116(17)161207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 12/07/2016
• 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: 10/24/2025
• Initial Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 12/07/2012
• 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: 82 YR
• Patient Sex: Male