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

Model Number	8145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the emergency room (er) due to an infection in the midline incision with pus.A neurosurgeon on call explanted the device.Mainstay medical limited (mml) representative was not notified until after the explant.Mml was advised that the implantable pulse generator (ipg) and two leads were removed without complications.It is unknown whether a culture was taken to confirm the type of infection or whether the patient was treated with antibiotics.No other information was available, and no devices were returned for evaluation.The ipg and lead device history records, including sterilization, were reviewed.No relevant nonconformances were found.
Additional Manufacturer Narrative
Mml# (b)(4) other device explanted model: 5100 description: reactiv8 implantable pulse generator serial number:(b)(6) udi #: (b)(4).

• 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: 50095379
• Report Number: 3021520203-2026-00098
• Device Sequence Number: 10005880
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 0105391527772064112511061728110121S1012374721
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 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: 07/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 210 LB
• Patient Race: White