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

Model Number	1601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4) - additional premarket/510(k) p190006.
Event or Problem Description
It was reported that following a procedure, the patient developed an infection.The representative reported that the patient is doing well.The basic trial was successful for the patient.The infection was a urinary tract infection (uti) that the patient had, which started approximately a week after the basic trial procedure.The patient was prescribed antibiotics for the uti.The specimen was sent out for a urine culture, bacterial uti.The patient has diabetes and was on jardiance, which is known to cause utis, per the patient.The patient stopped getting utis when she went off the medication.
Event or Problem Description
It was reported that following a procedure, the patient developed an infection.The representative reported that the patient is doing well.The basic trial was successful for the patient.The infection was a urinary tract infection (uti) that the patient had, which started approximately a week after the basic trial procedure.The patient was prescribed antibiotics for the uti.The specimen was sent out for a urine culture, bacterial uti.The patient has diabetes and was on jardiance, which is known to cause utis, per the patient.The patient stopped getting utis when she went off the medication.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon.Block g4: premarket / 510(k) # - additional premarket/510(k) p190006.Block h11: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.It was confirmed the device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of infection, urinary tract was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Since the investigation findings do not clearly confirm the presence or absence of the reported problem with the device, the investigation conclusion code selected for this complaint is unable to exclude device problem.

• 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: 22820142
• Report Number: 2124215-2025-55577
• Device Sequence Number: 14887729
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: (01)10810005340059(11)241112
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/19/2026

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: 1601
• Device Catalogue Number: 1601
• Device Lot Number: AE1SB41284
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 11/12/2024
• 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: 60 YR
• Patient Sex: Female