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	Implant Pain (4561)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced discomfort in the implantable pulse generator (ipg) pocket site.The patient reported that the therapy was effective and provided relief from back pain; however, the patient requested an explant while covered under the study funding.There was no allegation of a product deficiency, and the patient reported that therapy was successful, enabling them to exercise and improve spinal stability.The ipg and leads were removed without complications.There was no report of patient harm or injury.No device was returned for analysis per facility policy; therefore, no device evaluation could be performed.The device history record was reviewed.No relevant nonconformance's were found.
Additional Manufacturer Narrative
Mml#: (b)(4).Other device explanted.Model: 8145, description: reactiv8 implantable stimulation lead, serial number: (b)(6), udi #: (b)(4).

• 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 ; 6192063331
• MDR Report Key: 25399572
• Report Number: 3021520203-2026-00063
• Device Sequence Number: 13441568
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151121092917231019
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/04/2026

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: 05/07/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2021
• 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: 39 YR
• Patient Sex: Female