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	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient was unable to initiate therapy sessions.The clinical specialist performed troubleshooting with the patient and identified that all electrodes on the left lead were out of range/had high-impedance readings.There was no report of patient harm or injury.As a result, the patient underwent scheduled revision surgery to replace the left lead.The implanting physician decided to replace both leads.The right lead was functional but was replaced only as a precaution.The end cap of the right lead remained in the patient during the explant.Reportedly, unrelated to the alleged malfunction, the implantable pulse generator (ipg) was relocated from the right buttock to the right flank as a precautionary measure.There was no alleged issue or product deficiency with the ipg.The procedure was successful and without complications.Following the lead revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).

• 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: 25674925
• Report Number: 3021520203-2026-00080
• Device Sequence Number: 21262968
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 0105391527772064112311271726120121DOR918796816
• 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: 2025
• 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): 09/11/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 182 LB
• Patient Race: White