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); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with the neurostimulator presented with a red light displayed on their remote control during ongoing use.Device interrogation identified an initial connection error, which was cleared.Open impedances were observed on electrodes e1 and e2.Multiple impedance checks were performed with the patient in different positions, and the impedance status varied with positioning.Based on the troubleshooting results, a conductor wire fracture was suspected.No troubleshooting resolved the issue.The patient underwent a revision surgery for both the neurostimulator and tined lead on (b)(6) 2026.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon.Block d10: model number/catalog number: 4101.Serial number: (b)(6).Batch/lot number: ax1t052526.Model/catalog description: 410.Unique identifier (udi) #: (b)(4).Block g4: additional premarket / 510 (k): p190006.Detailed product investigation has not been provided.We complete a good faith effort to obtain information.Because the product investigation is unknown at this time, we are unable to provide the product investigation and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 50533584
• Report Number: 2124215-2026-46537
• Device Sequence Number: 5963451
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)231201(17)261201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: Health Professional
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1NC31234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female