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

Model Number	5101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro code qon.Block g4: additional premarket/ 510 (k) p190006.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.A risk review was completed using the rechargeable snm ipg hazard analysis and confirmed that the events of infection and pocket erosion (including breached skin) were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) that the implant dehisced through the skin.During the initial implant of this device, the patient had difficult wound healing; however, the wound eventually healed.Later on, the patient experienced erosion at the implant site.The device was explanted, and the patient was treated with antibiotics for infection.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) that the implant dehisced through the skin.During the initial implant of this device, the patient had difficult wound healing; however, the wound eventually healed.Later on, the patient experienced erosion at the implant site.The device was explanted, and the patient was treated with antibiotics for infection.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code qon.Block g4: additional premarket/ 510 (k) p190006.H11: as the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.There was no report of a device performance allegation.A risk review was completed using the rechargeable snm ipg hazard analysis and confirmed that the events of infection and pocket erosion (including breached skin) were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 25107660
• Report Number: 2124215-2026-24692
• Device Sequence Number: 9292687
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)240417(17)270417
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: Health Professional
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G197423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 04/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female