MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE STIMULATION LEAD

Model Number	8145
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mml#: (b)(4) ipg information: model: 5100 description: reactiv8 implantable pulse generator serial number: (b)(6) udi#: (b)(4).
Event or Problem Description
It was reported that the patient was unable to run therapy sessions.The clinical specialist confirmed that all the electrodes on the left lead were out of range/high impedance.The patient was programmed for unilateral stimulation on the right while awaiting scheduling of the revision procedure.The patient underwent a revision procedure to replace the left lead.The left lead was removed, with the end tip left inside the patient, and a new lead was implanted.The implantable pulse generator (ipg) was replaced as a precaution only because of its age (4 years).The procedure was complete and without complications.There was no report of patient harm or injury.Following the lead and ipg revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).Although requested, no parts will be returned for evaluation, as the hospital staff kept the removed parts and discarded them.The device history record was reviewed.No relevant nonconformances were found.

• Brand Name: REACTIV8
• Common Device Name: REACTIV8 IMPLANTABLE STIMULATION LEAD
• 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: 25174200
• Report Number: 3021520203-2026-00056
• Device Sequence Number: 18760404
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641121060217240601
• 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: 2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 8145
• Device Catalogue Number: 8145
• 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: 06/02/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White