MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	1201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an advanced trial, the patient stated they had good symptom relief for 1-5 days first days of the trial.Then on (b)(6), 2026, the patient started feeling stimulation in the thigh area.Their bladder symptoms returned.The patient elected to revise their lead and add the neurostimulator the next day as they had symptom relief at the beginning of the trial.The surgery took place on (b)(6), 2026.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block g4: additional premarket / 510 (k): p190006 detailed product investigation has not been provided.We complete a good faith effort to obtain information.Because the product investigation is unknown at this time, we are unable to provide the product investigation and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50568954
• Report Number: 2124215-2026-46633
• Device Sequence Number: 9927874
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: Health Professional
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/02/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male