MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The lead introducer broke off inside the patient.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology dr; irvine CA 92618
• Manufacturer Contact: linda phan ; 26 technology dr; irvine, CA 92618
• MDR Report Key: 20315905
• Report Number: 3002968685-2024-00204
• Device Sequence Number: 20834490
• Product Code: EZW
• UDI-Device Identifier: 10810005340080
• UDI-Public: 10810005340080
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 1801
• Device Lot Number: AS1GC31012
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Female