MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The guidewire broke requiring surgical intervention.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA 92618
• Manufacturer Contact: seema mulla ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 18514874
• Report Number: 3002968685-2024-00004
• Device Sequence Number: 12559774
• Product Code: EZW
• UDI-Device Identifier: 10810005340080
• UDI-Public: 10810005340080
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/15/2024

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: Health Professional
• Device Expiration Date: 07/05/2026
• Device Model Number: 1801
• Device Lot Number: AS1F731005
• 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: 12/22/2023
• Initial Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female