MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	1201
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Implant Pain (4561)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient noted feeling pain and tenderness at their implant site.The patient underwent a lead revision and the lead was replaced.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket/510(k) p190006.Block d10: concomitant product: model number/catalog number: 4101.Serial number: (b)(6).Model/catalog description: neurostimulator.Unique identifier (udi) #: (b)(4).Block h11: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Good faith effort attempts were made to try and retrieve the device, however the device was disposed by the explanting provider.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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: 50077964
• Report Number: 2124215-2026-40806
• Device Sequence Number: 10747081
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)250304(17)280304
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL10000334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 03/04/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female