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); Unspecified Infection (1930); Rash (2033)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with this neurostimulator was discharged from the hospital, and then developed a rash and redness around their incision site.The patient mentioned that their incision began to open (dehisced), resulting in an infection prior to their post op appointment.The physician removed the patient's device both implant battery and the lead, and placed the patient on antibiotics.There were no other issues or complaints mentioned at this time.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon block c2/d10: model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: al1p341454.Model/catalog description: tined lead.Unique identifier (udi) #: ((b)(4).Block g4: premarket / 510(k) # - additional premarket/510(k) p190006.

• 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: 50136176
• Report Number: 2124215-2026-41831
• Device Sequence Number: 10560334
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: (01)10810005340455(11)250507(17)280507
• Combination Product (Y/N): N
• 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: Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Model Number: 4101
• Device Catalogue Number: 4101
• Device Lot Number: AX1T097876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 05/07/2025
• 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: 52 YR
• Patient Sex: Unknown