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	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mml#: (b)(4).
Event or Problem Description
The patient reported losing weight, and the implantable pulse generator (ipg) had become superficial and was causing discomfort at the ipg pocket site.There was no allegation of a device malfunction.The device is working as intended.There was no report of patient harm or injury.The patient requested an explant.The entire leads and ipg were successfully explanted without complications.Although requested, the leads and ipg were disposed of at the facility.No device evaluation could be performed.The leads and ipg device history records were reviewed.No relevant nonconformance's were identified.

• 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: 25273587
• Report Number: 3021520203-2026-00059
• Device Sequence Number: 18433647
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151124062817260802
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/25/2026

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: 04/28/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Race: White