MAUDE Adverse Event Report: Mainstay Medical Limited ReActiv8; ReActiv8 Implantable Stimulation Lead

Model Number	8145
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been without therapy from the right lead for several months before the revision procedure due to a lead fracture.During this period, the patient was programmed for unilateral stimulation and reported a return of pain symptoms.The patient subsequently underwent a lead revision procedure.The fractured right lead was explanted in its entirety and replaced with a new lead without complications.The patient reported no harm or injury.The hospital discarded the explanted lead; therefore, product analysis could not be performed.As a result, the root cause of the reported lead fracture could not be determined.The device history record (dhr) was reviewed.No relevant nonconformances were found.Following the revision procedure, the reactiv8 system was activated, allowing the patient to initiate bilateral stimulation.
Additional Manufacturer Narrative
Mml# c-02471.

• Brand Name: ReActiv8
• Common Device Name: ReActiv8 Implantable Stimulation Lead
• 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: 50685203
• Report Number: 3021520203-2026-00109
• Device Sequence Number: 5253358
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 0105391527772064112212051725120121D21020722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 8145
• Device Catalogue Number: 8145
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male