MAUDE Adverse Event Report: Mainstay Medical Limited ReActiv8; 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	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The mainstay medical limited (mml) representative received information from the physician that the patient developed a confirmed infection, which led to the explantation of the reactiv8 system.No mml representative was present during the explant procedure.According to the physician, the infection originated at the implantable pulse generator (ipg) site.The patient was treated with antibiotics; however, the infection subsequently spread to the lead midline incision.The specific antibiotic administered was not disclosed.As a result of the infection, the physician elected to explant the entire system, including the ipg and all leads.Although the infection was confirmed, the physician did not provide the infection type.During device removal, one lead fractured; however, the physician successfully retrieved the remaining lead fragment.No explant tool was used during the procedure.The explanted ipg and leads were not returned to mml; therefore, no device evaluation could be performed.A review of the device history record, including sterilization records, was conducted and identified no relevant nonconformances.
Additional Manufacturer Narrative
Mml # (b)(4).Other device explanted.Mode: 8145, description: reactiv8 implantable stimulation lead, serialnumbers: (b)(6), udi #s: (b)(4)."this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.".

• Brand Name: ReActiv8
• 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: 50003349
• Report Number: 3021520203-2026-00093
• Device Sequence Number: 10659205
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015112507301727081221944510H5565
• 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
• Report Date (Section B): 07/22/2026

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: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White