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	Implant Pain (4561)
Date of Event	04/04/2024
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 a clinical study patient experienced pain at the trial procedure site.They patient received oxycodone, plexeril, and mobic.The investigator reported this adverse event was procedure related.It was later reported that no further information was available, including the outcome of the incident.The participant exited the clinical study immediately after the trial procedure.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.Block h11: investigation details: 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.Based on this investigation, the investigation conclusion code of 'known inherent risk of device' was chosen as the allegation relates to "implant pain" which is addressed in the product labeling and risk documentation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that a clinical study patient experienced pain at the trial procedure site.They patient received oxycodone, plexeril, and mobic.The investigator reported this adverse event was procedure related.It was later reported that no further information was available, including the outcome of the incident.The participant exited the clinical study immediately after the trial procedure.

• 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: 22668620
• Report Number: 2124215-2025-52113
• Device Sequence Number: 7440196
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: (01)10810005340059(11)230619
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/24/2026

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: 1601
• Device Catalogue Number: 1601
• Device Lot Number: AE1R633790
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 02/24/2026
• Date Device Manufactured: 06/19/2023
• 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 Sex: Unknown