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 Code	Urinary Frequency / Polyuria (2275)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with the neurostimulator (ins) had a red light on their remote.The patient denies any falls or trauma.The patient also reported loss of efficacy of device and worsening of symptoms.Troubleshooting occurred in the physician's office and upon connecting to the clinician programmer, there was an ipg error message "impedance out of range," open impedances.The device showed that it has been off for the last 30 days.X-rays have been ordered.The patient underwent lead revision.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon.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 ; 300 boston scientific way; marlborough, MA 01752
• MDR Report Key: 50531574
• Report Number: 2124215-2026-46581
• Device Sequence Number: 20346395
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: (01)10810005340141(11)240409(17)270409
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: Health Professional
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Device Lot Number: AL1R443018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 04/09/2024
• 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: 56 YR
• Patient Sex: Female