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

Model Number	1201
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Discomfort (2330); Weight Changes (2607)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator (ins) experienced migration of the tined lead.The patient experienced pain and their lead was poking out of their insertion site.They turned off their stimulation and took an x-ray.There is an explant surgery scheduled.Additionally, the patient denied any trauma to their implant site, but they did report losing a significant amount of weight.The patient had surgery to explant their ins and tined lead.The local care team was not in attendance.There was no patient complications reported.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block d4: udi for concomitant product, neurostimulator: model number/catalog number: 5101.Serial number: (b)(6).Batch/lot number: ax1g200111.Model/catalog description: neurostimulator.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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50133405
• Report Number: 2124215-2026-41779
• Device Sequence Number: 16080644
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)240201(17)270201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1N241460
• 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: 07/09/2026
• Initial Report FDA Received Date: 08/04/2026
• Date Device Manufactured: 02/01/2024
• 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; Hospitalization; Other
• Patient Age: 49 YR
• Patient Sex: Male