MAUDE Adverse Event Report: Axonics 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 Code	Weight Changes (2607)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator (ins) had surgery to revise their pocket on (b)(6) 2026.The same ins was used, but the pocket was moved due to excessive weight loss.There was no further patient complications reported.
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 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: 50526948
• Report Number: 2124215-2026-46283
• Device Sequence Number: 14965145
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: (01)10810005340455(11)240405(17)250405
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: Lay User/Patient
• Device Expiration Date: 04/05/2025
• Device Model Number: 4101
• Device Catalogue Number: 4101
• Device Lot Number: AX1T048320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 04/05/2024
• 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: 78 YR
• Patient Sex: Female