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

Model Number	1901
Medical Device Problem Codes	Fracture (1260); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/25/2025
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 udi for concomitant product, trial stimulator: (b)(4).
Event or Problem Description
It was reported the patient had their lead explanted due to a fracture and pain during their trial.The patient experienced their bandage coming off and had a red light on their remote control.Troubleshooting was attempted and it was suspected the cable disconnected.The physician checked under the bandage and discovered the pne was fractured.The physician attempted to remove and fix the lead and dressings, but the lead had already broken off under the patient's skin.Then the physician explanted the lead.The patient was scheduled for another stage 1 trial, but they declined to move forward.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.Udi for concomitant product, trial stimulator: (b)(4).Correction: block h6: device codes.
Event or Problem Description
It was reported the patient had their lead explanted due to a fracture and pain during their trial.The patient experienced their bandage coming off and had a red light on their remote control.Troubleshooting was attempted and it was suspected the cable disconnected.The physician checked under the bandage and discovered the pne was fractured.The physician attempted to remove and fix the lead and dressings, but the lead had already broken off under the patient's skin.Then the physician explanted the lead.The patient was scheduled for another stage 1 trial, but they declined to move forward.
Event or Problem Description
It was reported the patient had their lead explanted due to a fracture and pain during their trial.The patient experienced their bandage coming off and had a red light on their remote control.Troubleshooting was attempted and it was suspected the cable disconnected.The physician checked under the bandage and discovered the pne was fractured.The physician attempted to remove and fix the lead and dressings, but the lead had already broken off under the patient's skin.Then the physician explanted the lead.The patient was scheduled for another stage 1 trial, but they declined to move forward.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon block d10: model number/catalog number: 1601 serial number: (b)(6).Batch/lot number: ae1s840625 model/catalog description: trial stimulator unique identifier (udi) #: (b)(4).Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006 block h11: investigation details: the device was returned for analysis.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 the events of discomfort, pain and fracture were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Cause not established conclusion code was selected for the lead.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem for the trial stimulator.

• 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: 23857572
• Report Number: 2124215-2025-92147
• Device Sequence Number: 5081422
• Product Code: EZW
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 1901
• Device Catalogue Number: 1901
• Device Lot Number: AK20000043
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 04/27/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/19/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: TRIAL STIMULATOR, 1601, (B)(6).; TRIAL STIMULATOR, 1601, (b)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male