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	Implant Pain (4561)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mml#: (b)(4).Based on the available information, this complaint does not indicate a device malfunction or product deficiency.The reported discomfort and device prominence at the ipg pocket site appear to be related to patient-specific factors, including a reported fall and unspecified weight gain.Device performance was reported as effective, with no therapy-related issues.
Event or Problem Description
It was reported that the patient experienced discomfort at the implantable pulse generator (ipg) pocket site.The patient stated that the device would tilt or protrude on the superior aspect when standing.The patient further reported a fall approximately one year ago; but prior to that, the pocket site had been achy for several months.Following the reported fall, the discomfort temporarily worsened, coinciding with the device appearing to protrude from the back.The patient indicated that the discomfort subsequently resolved.The patient also reported weight gain but did not specify the amount.The patient reported that therapy had been effective, providing relief from back pain over approximately one year of use.The patient elected explant rather than revision due to improvement of back pain.There were no reported issues with device performance or therapy delivery.The ipg and associated leads were explanted without complication.There was no report of patient injury, adverse health consequences, or clinical harm associated with this event.No allegation of product deficiency was identified.The device was not returned for analysis and was disposed of at the facility; therefore, no device evaluation could be performed.A review of the device history record (dhr) was conducted, and no relevant nonconformance's were identified.

• 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: 25465020
• Report Number: 3021520203-2026-00070
• Device Sequence Number: 10095970
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151122011117240517
• 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
• Report Date (Section B): 06/10/2026

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: 05/11/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2022
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White