MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE PULSE GENERATOR

Model Number	8145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mml# (b)(4).Other explanted device: model: 5100 description: reactiv8 implantable pulse generator serial number: (b)(6) udi #: (b)(4).
Event or Problem Description
It was reported that the midline incision was not fully healed.One lead was exposed outside the patient's body.The patient was a former smoker and diabetic.The patient underwent full system revision surgery.The implantable pulse generator (ipg) and the two leads were completely removed.New ipg and two leads were implanted without complications.There was no allegation regarding the device's functionality.The ipg and leads were returned for analysis.The ipg passed functional testing.Both leads were received cut into two segments.No functional testing could be performed.Visual inspection of both leads and the ipg revealed no other damages or anomalies.Following the full system revision, the reactiv8 system was activated to allow the patient to initiate bilateral stimulation (when initiated by the patient).

• 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: 25059600
• Report Number: 3021520203-2026-00055
• Device Sequence Number: 9426909
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 01053915277720641124071817270701
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 81455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White