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	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mml # (b)(4).Other device explanted.Model: 8145.Description: reactiv8 implantable stimulation lead.Serial numbers: (b)(6).Udi #s: (b)(4).
Event or Problem Description
It was reported that the patient experienced pain at the implantable pulse generator (ipg) pocket site and decided to have the device explanted.The ipg and leads were removed completely without any complications.No report of patient harm or injury.The reactiv8 system is functional, and no allegation of a product malfunction; no parts were returned for analysis.The device history record was reviewed.No relevant nonconformances were found.

• Brand Name: REACTIV8
• Common Device Name: REACTIV8 IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 25000055
• Report Number: 3021520203-2026-00011
• Device Sequence Number: 15905921
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151124091217261004
• 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: 2025
• Device Explanted Year: 2025
• 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): 01/21/2026

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: 12/22/2025
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White