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

Model Number	8145
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient required magnetic resonance imaging (mri); however, one electrode of the left lead exhibited out-of-range/high-impedance failure.The other remaining electrodes on the left lead are usable.Due to the oor electrode, the device was explanted so the patient can have an mri.The patient reported that the device was effective in treating low back pain and that they have not used it since 2023.Unrelated to the event, during explant, the distal tip of the lead was accidentally sheared and was left inside the patient.The physician attempted to retrieve it but was unsuccessful.The implantable pulse generator (ipg) and two leads were removed.There was no report of patient harm or injury as a result.
Additional Manufacturer Narrative
Mml# (b)(4).Other device explanted.Model: 8145.Description: reactiv8 implantable stimulation.Serial number: (b)(6).Udi #: (b)(4).Model: 5100.Description: reactiv8 implantable pulse generator.Serial number: (b)(6).Udi#: (b)(4).This was initially submitted on july 6, 2026 but was rejected.Corrected the implant date.

• 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: 50900164
• Report Number: 3021520203-2026-00085
• Device Sequence Number: 6001250
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 0105391527772064112203191725030121D20931907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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?: Yes
• Date Returned to Manufacturer: 07/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 220 LB
• Patient Race: White