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	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) had a red indicator light on the remote.Upon connection to the clinician programmer (cp), there was an error noted and only one electrode was functioning.The patient reported involvement in a severe vehicle accident approximately 18 months prior, after which symptoms had returned.It was noted that the lead was damaged with a suspected fracture from the accident.At the time, the patient had recovered from the accident and continued using the device on the remaining functional electrode for symptom relief.Additional information received indicated that the patient underwent system explant and replacement procedure.The patient was reported to be doing well and satisfied following the revision procedure.
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: ax1t029065.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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50150612
• Report Number: 2124215-2026-42088
• Device Sequence Number: 21167499
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)230501(17)260501
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,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: Lay User/Patient
• Device Expiration Date: 05/01/2026
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1K531083
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/01/2023
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Race: White