MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	4101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Itching Sensation (1943); Post Operative Wound Infection (2446)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
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: al10024049 model/catalog description: tined lead kit unique identifier (udi) #: (b)(4) block g4: premarket / 510(k) # - additional premarket/510(k) p190006.
Event or Problem Description
It was reported that a patient with a neurostimulator and an snm tined lead was experiencing redness and itchiness in the implant site with "dots all over." their doctor advised the patient was having a reaction to the suture used and should monitor for symptoms of infection.The patient went to the emergency room after noticing their incision had opened and the device was visible.This was caused by infection, and they were given antibiotics.The patient's doctor reached out to confirm the patient would have their implant removed due to wound dehiscence.The explant was successfully completed.There was no additional patient complications 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: 50515471
• Report Number: 2124215-2026-45738
• Device Sequence Number: 10716401
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: (01)10810005340455(11)250716(17)280716
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Device Model Number: 4101
• Device Catalogue Number: 4101
• Device Lot Number: AX1T103890
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 07/16/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Unknown