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

Model Number	1701
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); Paralysis (1997)
Date of Event	08/01/2025
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.
Event or Problem Description
It was reported that the patient went in for a standard pne procedure.During the procedure, stimulation was delivered but no sensations were felt, even at higher amplitudes.Adjustments were made, but little stimulation was felt and the patient began to feel uncomfortable.Satisfactory test stimulation was not achieved, so the patient grew more uncomfortable and decided to abort the procedure.The patient reported to the emergency room and complained of pain and possible paralysis.The true diagnosis was unknown as the patient would not share medical information regarding their emergency room visit.There was no additional information available.
Event or Problem Description
It was reported that the patient went in for a standard pne procedure.During the procedure, stimulation was delivered but no sensations were felt, even at higher amplitudes.Adjustments were made, but little stimulation was felt and the patient began to feel uncomfortable.Satisfactory test stimulation was not achieved, so the patient grew more uncomfortable and decided to abort the procedure.The patient reported to the emergency room and complained of pain and possible paralysis.The true diagnosis was unknown as the patient would not share medical information regarding their emergency room visit.There was no additional information available.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket/510(k) p190006.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.A risk review was completed and confirmed that the event of device - loss/no stimulation, pain, paralysis 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 unable to exclude device problem.

• 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: 22884892
• Report Number: 2124215-2025-58855
• Device Sequence Number: 4849411
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: (01)10810005340134(11)250110(17)250930(10)AK10000078
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 09/30/2025
• Device Model Number: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK10000078
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 01/10/2025
• 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: Other
• Patient Age: 22 YR
• Patient Sex: Female