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

Model Number	1201
Medical Device Problem Codes	Communication or Transmission Problem (2896); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a snm tined lead contacted the representative after observing abnormal indicator lights on the remote control.The patient initially reported a solid red indicator light; however, during a subsequent discussion with the representative, both a solid red and green indicator light were reported.Troubleshooting was performed, including attempts to reprogram around electrode 2, which exhibited an open impedance.Reprogramming was unsuccessful.During follow up evaluation, the patient's remote again displayed a red indicator light, and open impedances were identified on three electrodes.Additional information received indicated that therapy was subsequently turned off, and the patient underwent system removal and replacement procedure.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block g4: pma number: p190006 model number/catalog number: 4101 serial number: (b)(6) batch/lot number: ax1t052526 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: 50515500
• Report Number: 2124215-2026-46279
• Device Sequence Number: 21134818
• 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: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: AL1NC31234
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/31/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female