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

Model Number	1101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Urinary Incontinence (4572)
Date of Event	01/21/2026
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.Udi for concomitant product, tined lead: (b)(4).Block h11: investigation details: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, the product was not returned.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 discomfort, urinary incontinence, urinary tract infection, and pain was 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 the patient turned off their device due to pain.The patient stated they have chronic cystitis and makes them frequently urinate.The patient also had frequent urinary tract infections and pain in their rectum.The physician had the patient turn off their stimulation and the patient said the pain subsided but still present.Additionally, the patient had surgery to explant their neurostimulator and tined lead on (b)(6) 2026.The physician recommended the removal due to the discomfort.Per the patient, they are doing better now and there is no more pain around the site.
Event or Problem Description
It was reported the patient turned off their device due to pain.The patient stated they have chronic cystitis and makes them frequently urinate.The patient also had frequent urinary tract infections and pain in their rectum.The physician had the patient turn off their stimulation and the patient said the pain subsided but still present.Additionally, the patient had surgery to explant their neurostimulator and tined lead on (b)(6) 2026.The physician recommended the removal due to the discomfort.Per the patient, they are doing better now and there is no more pain around the site.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block d10: model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: al1h721992.Model/catalog description: tined lead.Unique identifier (udi) #: (b)(4).Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.Block h11: investigation details: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, the product was not returned.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 discomfort, urinary incontinence, urinary tract infection, and pain was 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.Correction: block h11: udi, tined lead model number and catalog description.

• 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: 24693985
• Report Number: 2124215-2026-16474
• Device Sequence Number: 10557760
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 03/28/2025
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Device Lot Number: AX1H181561
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 03/28/2022
• 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: 63 YR
• Patient Sex: Female