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	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was unable to start therapy sessions.There was no report of patient harm or injury.The clinical specialist troubleshot the issue with the patient and confirmed out-of-range/high-impedance readings on the left lead.The device was reprogrammed to unilateral stimulation on the right side only, while a revision surgery could be scheduled.The patient was able to initiate therapy.The patient underwent revision surgery to replace the left lead.During the revision of the left lead, the right lead showed high impedance on one electrode.Both leads were removed completely, and two new leads were implanted without complicaitons.
Additional Manufacturer Narrative
(b)(4).Other device replaced.Model: 8145 description: reactiv8 implanatable stimulation lead serial number: (b)(6).Udi#: (b)(4).
Event or Problem Description
It was reported that the patient was unable to start therapy sessions.There was no report of patient harm or injury.The clinical specialist troubleshot the issue with the patient and confirmed out-of-range/high-impedance readings on the left lead.The device was reprogrammed to unilateral stimulation on the right side only, while a revision surgery could be scheduled.The patient was able to initiate therapy.The patient underwent revision surgery to replace the left lead.During the revision of the left lead, the right lead showed high impedance on one electrode.Both leads were removed completely, and two new leads were implanted without complicaitons.
Additional Manufacturer Narrative
(b)(4).Other device replaced.Model: 8145 description: reactiv8 implanatable stimulation lead serial number: (b)(6).Udi#: (b)(4).Following the lead revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).The lead assemblies were received for analysis.The alleged out-of-range (oor) was confirmed.Visual inspection of the left lead under a lab microscope revealed rounded, fractured coil wires across all coils.Visual inspection of the right lead under a lab microscope revealed one rounded, fractured coil wire.Both leads failed functional testing due to observed fractured coils.A review of the implant images revealed issues with the implant technique.H6 updated.

• 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: 24818989
• Report Number: 3021520203-2026-00042
• Device Sequence Number: 9693602
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641121112317241101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 05/05/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG