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

Model Number	1101
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator (ins) had surgery to remove and replace their ins and tined lead.The patient had been getting good symptom relief, but reported burning sensation when charging their ins.The patient had their system replaced with a new non-rechargeable ins and tined lead.There were no complications noted with the procedure.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Udi for concomitant product, tined lead: block d10:.Model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: al1ua02133.Model/catalog description: tined lead.Unique identifier (udi) #: (b)(4).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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50069735
• Report Number: 2124215-2026-40574
• Device Sequence Number: 10078563
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: (01)10810005340066(11)201026(17)230126
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/17/2026

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: 01/26/2023
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Device Lot Number: AX1H163715
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 10/26/2020
• 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