MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was hospitalized due to excessive bleeding from blood thinners.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: linda phan ; 15515 sand canyon ave; irvine, CA 92618
• MDR Report Key: 22010496
• Report Number: 3002968685-2025-00132
• Device Sequence Number: 12735732
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 011081000534005911240214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: Other
• Device Model Number: 1601
• Device Catalogue Number: 1601
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male