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	Impaired Healing (2378)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Mainstay medical limited (mml) received information that the device was explanted due to persistent oozing from the wound at the implantable pulse generator (ipg) site.No mml representative was present during the device explant.However, the entire reactiv8 system was reported to have been removed without complications.A culture was taken, but the results were not provided to mml.It is also unknown if the patient was treated with antibiotics.No other information was provided.There was no report of patient harm or injury.The device was never switched on post-implant.The device was not returned for evaluation; therefore, no actual device analysis could be performed.However, the device history record, including sterilization, was reviewed.No relevant nonconformances were found that would have contributed to the alleged wound-healing issue.
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: 25174201
• Report Number: 3021520203-2026-00057
• Device Sequence Number: 18760405
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151125060617270624
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 04/14/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White