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

Model Number	1201
Medical Device Problem Codes	High impedance (1291); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Frequency / Polyuria (2275); Urinary Incontinence (4572); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an snm tined lead had symptoms previously well-controlled that gradually got worse over 2-3 weeks.On checking their remote, the patient noticed a red error light, which could not be cleared over the phone.In clinic, the clinician programmer displayed 3 electrode open impedances and programming around the errors temporarily was performed, but patient symptoms did not improve.X-rays were taken with no issues found.The patient reported having no recent falls or trauma only bumped the back of their head lightly with no suspected damage.Patient underwent a successful full revision.They reported feeling well with bowel and bladder symptoms improved and no error codes.No other patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon.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; 26 technology dr; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50130183
• Report Number: 2124215-2026-41684
• Device Sequence Number: 5675077
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)231023(17)261023
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 08/20/2026

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: AL1NA31633
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: 64 YR
• Patient Sex: Female