MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; implanted subcortical electrical Stimulator (motor disorders)

Model Number	37602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 7482a40 lot# serial# (b)(6) implanted: (b)(6) 2009 explanted: (b)(6) 2026 product type extension product id 3389s-28 lot# va0b4f5 implanted: (b)(6) 2013: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 7482a40, serial/lot #: (b)(6), ubd: 09-mar-2013, udi#: (b)(4); product id: 3389s-28, serial/lot #: (b)(6), ubd: 04-jun-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 patient (pt) scheduled for routine battery change (eri) for left implant.Noticed lump on neck and swelling at implantable neurostimulator (ins) site.There was a concern for infection, cultures were taken and the left system was explanted.Manufacturer representative (rep) indicates the issue was resolved.

• Brand Name: ACTIVA
• Common Device Name: implanted subcortical electrical Stimulator (motor disorders)
• 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: 25152991
• Report Number: 3004209178-2026-08144
• Device Sequence Number: 10757166
• Product Code: MRU
• UDI-Device Identifier: 00763000519223
• UDI-Public: (01)00763000519223(17)231214
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 12/14/2023
• Device Model Number: 37602
• Device Catalogue Number: 37602
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 06/27/2022
• 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 Sex: Male