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

Model Number	8145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mml#: (b)(4).
Event or Problem Description
It was reported that the patient underwent secondary surgery to remove the lead fragments left in the patient.The patient was having the reactiv8 system removed due to no improvement in pain.During the explant, it was noted that the patient had a significant amount of scar tissue surrounding both leads.After prolonged attempts at removal, one lead fractured.All devices were removed, except for the lead fragment, which was left in place.The physician decided to abort the procedure and rescheduled the patient for the secondary procedure to remove the lead fragment.The removal was successful and without complications.There was no report of patient harm or injury.
Event or Problem Description
It was reported that the patient underwent secondary surgery to remove the lead fragments left in the patient.The patient was having the reactive 8 system removed due to no improvement in pain.During the explant, it was noted that the patient had a significant amount of scar tissue surrounding both leads.After prolonged attempts at removal, one lead fractured.All devices were removed, except for the lead fragment, which was left in place.The physician decided to abort the procedure and rescheduled the patient for the secondary procedure to remove the lead fragment.The removal was successful and without complications.There was no report of patient harm or injury.
Additional Manufacturer Narrative
Mml# (b)(4).The removed lead fragment was discarded at the hospital.The device history record was reviewed.No relevant nonconformances were found.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: 24812490
• Report Number: 3021520203-2026-00040
• Device Sequence Number: 15835749
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641122042117250501
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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: 44 YR
• Patient Sex: Female
• Patient Race: White