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	Pain (1994); Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced shocking pain at the implant site following prior back surgery.The symptoms persisted since that time.Stimulation was turned off, and the patient planned to go to the emergency room.The complication was reported as discomfort and pain.The therapy support specialist followed up with the patient but did not receive a response.The patient reported pain at the implant site but had not yet consulted the implanting physician.The device remained off, and the discomfort resolved.The patient was advised to follow up with their local team and provider to check the neurostimulator and the lead's patency.The patient has a history of falls and was seen in clinic on (b)(6) 2026 for evaluation.The provider advised keeping stimulation turned off until the revision.The patient had surgery to revise their neurostimulator and tined lead.The patient is doing well post-op.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon udi for concomitant product, tined lead: block d10: model number/catalog number: 1201 serial number: unknown batch/lot number: unknown 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: 50599932
• Report Number: 2124215-2026-46773
• Device Sequence Number: 18698342
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)230612(17)260612
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/01/2026

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: 06/11/2026
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G192314
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 06/11/2023
• 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: 44 YR
• Patient Sex: Female