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	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was unable to start therapy.There was no patient harm or injury.The clinical specialist confirmed that all impedance values were high or out-of-range.As a result, revision surgery was scheduled.The post-initial implant imaging review determined that the left lead was out-of-range (oor) due to a lateral entry point, which likely contributed to significant mechanical fatigue and subsequent lead fracture.During the revision procedure, it was determined that the left lead was fractured.The physician attempted to remove the severed left lead; however, the lead was firmly adherent.During extraction efforts, the lead fractured further.As a result, the distal tip of the left lead could not be retrieved and remains inside the patient.The physician elected to leave the retained lead fragments in place and proceeded with implantation of a new lead.No explant release tool was used during the lead removal attempt.Following the lead revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).The defective lead was discarded at the facility, and therefore, no actual device evaluation could be performed.The device history record was reviewed.No relevant nonconformances were found.
Additional Manufacturer Narrative
Mml # (b)(4).

• 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: 25452856
• Report Number: 3021520203-2026-00067
• Device Sequence Number: 18331216
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641123031317260301
• 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: 2024
• 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): 06/09/2026

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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White