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	Discomfort (2330)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reportedly experienced discomfort and migration of the implantable pulse generator (ipg) and leads following a significant weight loss of approximately 70 pounds.The device was reportedly functioning as intended at the time of the event.No patient harm, injury, or adverse clinical outcomes were reported.\ \ the leads were explanted and removed completely without complication.Two new leads were implanted.To address the discomfort associated with the patient's substantial weight loss, the ipg was repositioned and implanted deeper in the same pocket site.The surgery center discarded the explanted leads, so they were unavailable for return or device analysis.\ \ a review of the device history records (dhrs) for the associated ipg and leads was conducted.No relevant manufacturing nonconformances or anomalies were identified.
Additional Manufacturer Narrative
Mml # (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 ; +1(619)206-3331
• MDR Report Key: 50832347
• Report Number: 3021520203-2026-00120
• Device Sequence Number: 10270413
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015112502031727031821607910H5420
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 08/20/2026
• Initial Report FDA Received Date: 09/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 276 LB
• Patient Race: White