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

Model Number	1201
Medical Device Problem Codes	Fracture (1260); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Fecal Incontinence (4571)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) experienced an increase in fecal incontinence.When attempting to increase stimulation, a red indicator light was observed on the remote.The ins was charged; however, the red indicator light persisted.Troubleshooting was performed over the phone, including switching between programs, without resolution, as a continuous red indicator light remained present on both programs.No recent falls were reported.An appointment was scheduled for further evaluation and in-person troubleshooting with the clinical specialist.Additional information received indicated that evaluation identified a fractured lead.The patient subsequently underwent explant and reimplant of the system.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block g4: pma number: p190006.Concomitant product: model number/catalog number: 5101.Serial number: (b)(6) batch/lot number: ax1g192926.Model/catalog description: neurostimulator.Unique identifier (udi) #: ((b)(4).

• 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: 50135939
• Report Number: 2124215-2026-41826
• Device Sequence Number: 13401891
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)250217(17)280217
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Consumer,Health Professional,Company Representative
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1U252971
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/04/2026
• Date Device Manufactured: 02/17/2025
• 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: 62 YR
• Patient Sex: Female