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

Model Number	1101
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
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 had surgery to revise their neurostimulator.Initially, the patient had difficulty with keeping their implant charged.The patient was educated on charging steps, but the patient moved forward with swapping their neurostimulator for a non-recharge version.The patient is doing great.They have not had any episodes of incontinence since.

• 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: 24242800
• Report Number: 2124215-2026-05970
• Device Sequence Number: 15945340
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: (01)10810005340066
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 05/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1101
• Device Catalogue Number: 1101
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female