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	04/22/2025
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 during a routine check-in by the representative on the patient, the patient mentioned that they had a urinary tract infection (uti), during the trial stage on (b)(6) 2025, which possibly started the first day of their trial.The patient was given antibiotics (nitrofurantoin) that treated the infection.The cause of the uti may have been from the catheter.The patient is not scheduled for any follow-up appointments with their urologist.The patient does not have a current uti.The local field team and health care facility were aware of the patient's uti during the time the patient went through their trial on (b)(6) 2025.Now the patient is fully recovered from the uti.There are no other patient complications.
Event or Problem Description
It was reported that during a routine check-in by the representative on the patient, the patient mentioned that they had a urinary tract infection (uti), during the trial stage on (b)(6) 2025, which possibly started the first day of their trial.The patient was given antibiotics (nitrofurantoin) that treated the infection.The cause of the uti may have been from the catheter.The patient is not scheduled for any follow-up appointments with their urologist.The patient does not have a current uti.The local field team and health care facility were aware of the patient's uti during the time the patient went through their trial on (b)(6) 2025.Now the patient is fully recovered from the uti.There are no other patient complications.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon, premarket / 510(k) # (g4) - additional premarket/510(k) p190006.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4) - additional premarket/510(k) p190006 the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.A device was not returned, and pictures were not provided, resulting in an inability to analyze the device and identify if a malfunction occurred.Based on the information available, the patient was experiencing a urinary tract infection (uti).The cause of the uti could not be established, but it is a known inherent risk of the device; therefore, an investigation conclusion code of 'known inherent risk of device' was chosen.The reported patient symptom(s) are known risks associated with this device type and indicated as such in the instructions for use.Based on the results of this investigation, no escalation is needed.
Event or Problem Description
It was reported that during a routine check-in by the representative on the patient, the patient mentioned that they had a urinary tract infection (uti), during the trial stage on (b)(6) 2025, which possibly started the first day of their trial.The patient was given antibiotics (nitrofurantoin) that treated the infection.The cause of the uti may have been from the catheter.The patient is not scheduled for any follow-up appointments with their urologist.The patient does not have a current uti.The local field team and health care facility were aware of the patient's uti during the time the patient went through their trial on (b)(6) 2025.Now the patient is fully recovered from the uti.There are no other patient complications.

• 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: 23019557
• Report Number: 2124215-2025-62711
• Device Sequence Number: 9664941
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: (01)10810005340059(11)240901
• 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,Followup
• Report Date (Section B): 11/18/2025

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: AE1S941244
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 10/24/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/18/2025
• Date Device Manufactured: 09/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PNE LEAD LOT #(B)(6); PNE LEAD LOT #(B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female