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

Model Number	9009
Medical Device Problem Codes	High impedance (1291); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: qon.Additional premarket/510k: p190006.
Event or Problem Description
It was reported that during the initial implant procedure for the external neurostimulator, the tined lead initially tested within range, but repeated impedance checks showed open values on all electrodes.Multiple reconnections and impedance tests were attempted without resolution.The physician reopened the incision, confirmed intact lead integrity.The percutaneous extension was replaced and all impedances were tested within normal limits.The case was completed using the replacement extension.There were no complications reported.
Event or Problem Description
It was reported that during the initial implant procedure for the external neurostimulator, the tined lead initially tested within range, but repeated impedance checks showed open values on all electrodes.Multiple reconnections and impedance tests were attempted without resolution.The physician reopened the incision, confirmed intact lead integrity.The percutaneous extension was replaced and all impedances were tested within normal limits.The case was completed using the replacement extension.The patient had been doing well and reported benefiting from the therapy.This event occurred during the stage 1 trial.No further clinical complications were reported.
Additional Manufacturer Narrative
Additional product code: qon.Additional premarket/510k: p190006.
Additional Manufacturer Narrative
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.The provided images from the field were reviewed and high impedance was confirmed.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 leads impedance high and leads damaged/defective 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.
Event or Problem Description
It was reported that during the initial implant procedure for the external neurostimulator, the tined lead initially tested within range, but repeated impedance checks showed open values on all electrodes.Multiple reconnections and impedance tests were attempted without resolution.The physician reopened the incision, confirmed intact lead integrity.The percutaneous extension was replaced and all impedances were tested within normal limits.The case was completed using the replacement extension.The patient had been doing well and reported benefiting from the therapy.This event occurred during the stage 1 trial.No further clinical complications were 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: 23899171
• Report Number: 2124215-2025-93232
• Device Sequence Number: 17416336
• Product Code: EZW
• UDI-Device Identifier: 10810005340288
• UDI-Public: (01)10810005340288(11)250409(17)280409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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,Followup
• Report Date (Section B): 03/16/2026

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: 9009
• Device Catalogue Number: 9009
• Device Lot Number: ABB0000330
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/20/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/29/2026; 03/16/2026
• Date Device Manufactured: 04/09/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White