MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACITV8 IMPLANTABLE PULSE GENERATOR

Model Number	8145
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported being unable to feel the therapy.X-rays were taken and confirmed that the leads had migrated from the bilateral l3 transverse processes.Reportedly, the patient has a high body mass index (bmi) and has difficulty getting around and getting up from sitting.A review of the intraoperative imaging and post-implant imaging confirmed that both leads were displaced.There was a difference in loop location between intraoperative imaging and post-fluoro imaging, with the loop and resulting lead pulled down an entire 1-2 levels when the patient was standing.The loop likely moved with the skin, displacing both leads due to the large bmi.The patient underwent a revision procedure to replace the two leads.Both leads were removed completely, and two new leads were implanted without complications.There were no functional issues with the removed leads, and they were discarded at the facility.Therefore, no actual device evaluation could be performed.The device history record was reviewed.No relevant nonconformances were found.Following the lead revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).
Additional Manufacturer Narrative
Mml # (b)(4).

• Brand Name: REACTIV8
• Common Device Name: REACITV8 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 ; 6192063331
• MDR Report Key: 25452855
• Report Number: 3021520203-2026-00068
• Device Sequence Number: 12950056
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641125092217280901
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/09/2026

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: 05/11/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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: Unknown