MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	1201
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro code: qon.Block g4: pma number: p190006.Concomitant product: model number/catalog number: 4101.Serial number: (b)(6).Batch/lot number: ax1t038473.Model/catalog description: neurostimulator.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) underwent a lead revision due to loss of efficacy.During the procedure, difficulty was encountered with intubation.Multiple attempts were required to establish the airway, during which bleeding and foaming from the mouth were observed, and oxygen levels decreased.Additional support was called, and the patient was subsequently stabilized.The procedure was then completed, and the patient was reported to be stable post-operatively.Over the weekend following the procedure, the patient experienced a stroke.The hospital contacted the representative requesting assistance to place the device in magnetic resonance imaging (mri) mode for an emergency mri.The representative was informed of an emergency situation at that time.Follow up communication confirmed that the patient had experienced a stroke and died unrelated to the device or the procedure.The date of death is unknown.No further information was available regarding the relationship of these events to the device or procedure at the time of reporting.
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) underwent a lead revision due to loss of efficacy.The lead was explanted and replaced; the procedure was completed as planned.No patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block g4: pma number: p190006 concomitant product: model number/catalog number: 4101 serial number: ax1t038473 batch/lot number: ax1t038473 model/catalog description: neurostimulator unique identifier (udi)# (b)(4) the device was not returned for analysis; therefore, a technical analysis could not be performed.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 event of loss/no stimulation can be related to revision surgery (loss of therapy or long-term ineffective therapy, etc.) (repeat exposure to surgical risks) 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 cause not established.

• 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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25690770
• Report Number: 2124215-2026-35468
• Device Sequence Number: 13183673
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)230712(17)260712
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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 Expiration Date: 07/12/2026
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1L732116
• Was Device Available for Evaluation?: No
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: 07/10/2026; 08/04/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/05/2026; 08/31/2026
• Date Device Manufactured: 07/12/2023
• 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: 70 YR
• Patient Sex: Male