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

Model Number	4101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with the neurostimulator underwent tined lead and ins revision due to pocket site pain and sensation in the leg.An x-ray was taken to see if the battery or lead have moved.Both the tined lead and the ins were revised from the left to the right.The tined lead was replaced and the ins was moved.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block d10: model number/catalog number: 1201 serial number: (b)(6) batch/lot number: al10002200 model/catalog description: 1201 unique identifier (udi) #:(b)(4) 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 ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50934074
• Report Number: 2124215-2026-51702
• Device Sequence Number: 9509163
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: (01)10810005340455(11)250218(17)280218
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: Health Professional
• Device Model Number: 4101
• Device Catalogue Number: 4101
• Device Lot Number: AX1T069001
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/18/2025
• 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: 42 YR
• Patient Sex: Unknown