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

Model Number	1101
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Urinary Incontinence (4572)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon.Block g4: premarket / 510(k) # - additional premarket/510(k) p190006.Block h11: udi for concomitant product, tined lead: (b)(4).
Event or Problem Description
It was reported that a patient had an unknown date of lead migration and decreased efficacy of therapy, and no known injury or trauma.The patient contacted their physician's office in late (b)(6) 2025, unsure of the exact date, and had x-rays done of their device placement.The images confirmed there was lead migration, and the patient was offered to contact their representative for possible reprogramming or to schedule a revision procedure.The patient declined both options at that time and wanted to think about their options, and the representative was not contacted at this time of the event.The patient then called their office again on (b)(6) 2026 with increased discomfort at the ins site and a continued decrease in efficacy and wanted to move forward with the revision procedure.The representative was notified on (b)(6) 2026, and the patient is scheduled for their revision on (b)(6) 2026.The patient had a full device revision of both ins and lead on (b)(6) 2026 as scheduled.There are no other issues or complications reported.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon block c2/d10: model# 1201 sn# (b)(6).Model: tined lead udi# (b)(4).Block g4: premarket / 510(k) # - additional premarket/510(k) p190006 block h11: the device was not available for return therefore physical analysis could not be performed.Review of images provided showed lead migration.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.A risk review was completed and confirmed that the events of discomfort, incontinence, urinary, pain and migration were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that a patient had lead migration and decreased efficacy of therapy with no known injury or trauma.The patient contacted their physician's office in late (b)(6) 2025 and had x-rays done of their device placement.The images confirmed there was lead migration, and the patient was offered to contact their representative for possible reprogramming or to schedule a revision procedure.The patient declined both options at that time and wanted to think about their options, and the representative was not contacted at this time of the event.The patient then called their office again on (b)(6) 2026 with increased discomfort at the ins site and a continued decrease in efficacy and wanted to move forward with the revision procedure.The representative was notified on (b)(6) 2026.The patient had a full device revision of both ins and lead on (b)(6) 2026 as scheduled.There are no other issues or complications reported.

• 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: 24574305
• Report Number: 2124215-2026-13812
• Device Sequence Number: 16041240
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: (01)10810005340066(11)210614(17)240614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Expiration Date: 06/14/2024
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Device Lot Number: AX1G176068
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 06/14/2021
• 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: TINED LEAD (1201) SN: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female