MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	5101
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Paresthesia (4421); Implant Pain (4561); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block d10: model number/catalog number: 1201 serial number: (b)(6).Batch/lot number: al10002104 model/catalog description: tined lead unique identifier (udi) #: (b)(4).Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.
Event or Problem Description
It was reported the patient experienced pain at their implant site.The patient also reported sporadic tingling down both legs and feet and pain at the lead insertion site as well.The physician recommended turning off their device and ordered an x-ray.Also, the physician told the patient to contact the local care team to do some reprogramming to see if it could help after the x-ray results come back.The patient also mentioned the physician noted the neurostimulator is slightly elevated in the pocket.The patient believes the pain subsided after turning off their device and will monitor their symptoms until the x-ray results come back and attempt to reprogram.Additionally, the patient has not had any other treatment for this event.The patient had all of the same symptoms even with the device off.Then the patient had surgery to explant their neurostimulator and tined lead.

• Brand Name: AXONICS
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 15515 sand canyon ave; irvine CA 92618
• Manufacturer (Section G): AXONICS INC; 26 technology dr; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25446858
• Report Number: 2124215-2026-30726
• Device Sequence Number: 13127777
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)250109(17)280109
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G201574
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 01/09/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female