MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE STIMULATION LEAD

Model Number	8145
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient underwent revision to replace the right lead due to an out-of-range electrode, consistent with a high-impedance failure.The system is programmable to another working electrode; however, the patient required magnetic resonance imaging (mri), so the lead was replaced.The entire lead was removed, and a new lead was implanted without complications.There was no report of patient harm or injury.Unrelated to the oor failure, the patient requested that the implantable pulse generator (ipg) be moved to the flank area while in procedure.No allegation of an ipg deficiency or discomfort in the current ipg pocket site.The procedure was successful without complications.The explanted lead was discarded at the hospital, and therefore, no actual device analysis can be performed.The device history record was reviewed.No relevant nonconformances were found.Following the lead revision and ipg relocation, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).

• 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 ; 6192063331
• MDR Report Key: 25235307
• Report Number: 3021520203-2026-00058
• Device Sequence Number: 21421793
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641123041817260401
• 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: 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
• Report Date (Section B): 05/20/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 98 KG