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

Model Number	1701
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/30/2025
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 the patient cancelled the permanent implant procedure due to leg pain occurring after the pne leads were pulled.The patient had their gabapentin dosage increased and was prescribed a five-day course of steroids, though the patient was still experiencing some pain.The patient said the pain was felt in both legs.The patient saw their primary care provider and believed it was triggered by the stimulation of their nerve.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon.Premarket / 510(k) # (g4) - additional premarket / 510(k) # p190006.This report is being filed for a correction to field h6.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 leg pain occurring after stimulation from pne leads 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 the patient cancelled the permanent implant procedure due to leg pain occurring after the pne leads were pulled.The patient had their gabapentin dosage increased and was prescribed a five-day course of steroids, though the patient was still experiencing some pain.The patient said the pain was felt in both legs.The patient saw their primary care provider and believed it was triggered by the stimulation of their nerve.The physician concluded the prolonged discomfort was not related to the pne 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: 23512857
• Report Number: 2124215-2025-81434
• Device Sequence Number: 9704663
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: (01)10810005340134
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/09/2026

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: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK1000061
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female