MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphasia (2195); Shaking/Tremors (2515); Insufficient Information (4580)
Date of Event	09/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_ext lot# serial# unknown implanted: explanted: product type extension product id neu _unknown_lead lot# unknown serial# implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: 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 there was a loss of benefit from stimulation with the device, leading to speech problems, right leg issues, and tremor control difficulties.The device involved was a lead targeting the left vim.Initially, the patient experienced significant relief and was able to engage in work involving hands and mechanical engineering projects.However, over time, achieving the same level of control became increasingly difficult without significantly increasing the unit's settings, which then caused additional speech and right leg problems.It was noted that while the left-sided implant was functioning, it was not optimal for tremor control.An examination confirmed the loss of benefit.As a result, the lead and extension components were explanted and replaced on (b)(6) 2016, and (b)(6) 2016, respectively.The outcome was resolved without sequelae.
Additional Manufacturer Narrative
Continuation of d10: product id 3708660, serial# (b)(6), implanted: (b)(6) 2013, product type: extension.Product id 3387s-40, lot# va0buyn, implanted: (b)(6) 2013, product type: lead.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 PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; ceiba norte industrial park; memphis,tn PR 00777
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; ceiba norte industrial park; memphis,tn PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22096918
• Report Number: 3004209178-2025-09102
• Device Sequence Number: 6925966
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: (01)00613994934604(17)150228(21)NKM719497H
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 02/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 09/03/2013
• 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: 69 YR
• Patient Sex: Male