MAUDE Adverse Event Report: Mainstay Medical Limited ReActiv8; ReAcitv8 System

Model Number	5100 / 8145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency department with fever, and the wounds were red, hot, and tender on palpation of both incisions following the lead revision procedure on (b)(6) 2026.Reference: mfg report # 3021520203-2026-0076.There was discharge at the implantable pulse generator (ipg) site.There were no signs of infection during the device activation post-revision procedure on (b)(6) 2026.The patient was treated with antibiotics (intravenous and oral).Blood and cultures were taken, confirming infection.The type of infection was not disclosed to mainstay medical limited (mml).As a result, the device was explanted, and wound washout was performed.The ipg and leads were successfully removed without complications.There was no report of patient harm or injury.The leads were kept by the hospital for culture analysis.The ipg and lead device history records, including sterilization, were reviewed.No relevant nonconformances were found.
Additional Manufacturer Narrative
Mml# (b)(4).

• Brand Name: ReActiv8
• Common Device Name: ReAcitv8 System
• Manufacturer (Section D): Mainstay Medical Limited; clonmel house, forster way; swords, co. dublin K67F2 K3; EI K67F2K3
• Manufacturer Contact: liza dominguez ; 2159 india street; suite 200; san diego, CA 92101 ; +1(619)206-3331
• MDR Report Key: 25788597
• Report Number: 3021520203-2026-00088
• Device Sequence Number: 9384275
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151121112417231217
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: Lay User/Patient
• Device Model Number: 5100 / 8145
• Device Catalogue Number: 5100 / 8145
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Male