MAUDE Adverse Event Report: Mainstay Medical Limited ReActiv8 System; ReActiv8 Implantable Pulse Generator

Model Number	5100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a surgical procedure to explant the reactiv8 system due to a device site infection.Prior to the onset of the infection, the patient had experienced a positive therapeutic response.However, the infection resulted in painful stimulation at the implantable pulse generator (ipg) site, necessitating removal of the system.Culture was taken.No results provided to mainstay medical limited.During the explant procedure, the ipg and left lead were successfully removed intact.However, two electrodes from the right lead remained inside the patient.During extraction, the right lead was inadvertently damaged by a surgical instrument (artery clip), causing the lead to kink.The physician subsequently cut the lead proximal to the damaged section, which limited access to the distal end and left the remaining lead segment insufficiently rigid for complete removal.Despite multiple extraction attempts, the right lead fractured, resulting in retention of two electrodes.No patient harm or injury was reported as a result of this event.The explanted devices were disposed of by the facility and were therefore unavailable for evaluation.Device history records for the ipg and leads, including sterilization documentation, were reviewed.No relevant nonconformances were identified.
Additional Manufacturer Narrative
Mml #(b)(4) other device explanted model: 8154 description: reactiv8 implantable stimulation lead serial numbers: (b)(6) udi #s: (b)(4).

• Brand Name: ReActiv8 System
• Common Device Name: ReActiv8 Implantable Pulse Generator
• 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: 50168136
• Report Number: 3021520203-2026-00099
• Device Sequence Number: 5468203
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015112406121726120221566910H5347
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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
• Device Catalogue Number: 5100
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Patient Race: White