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
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 discomfort around the implantable pulse generator (ipg).The patient has a low body mass index (bmi), which causes the skin to stretch.The patient requested an explant.The ipg and two leads were completely removed without complications.Although requested, the device was not returned due to facility policy.No actual device evaluation can be performed.The ipg and leads device history records were reviewed.No nonconformances were found.

• 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: 25415668
• Report Number: 3021520203-2026-00066
• Device Sequence Number: 5840002
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151125032417270423
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: White