MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1601
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Failure of Implant (1924); Incontinence (1928)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent revision surgery due to high impedance.
Event or Problem Description
See section h, number 6 for investigation updates.
Event or Problem Description
See section d, number 4 for corrections.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA 92618
• Manufacturer Contact: james nguyen ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 19397817
• Report Number: 3002968685-2024-00101
• Device Sequence Number: 7744239
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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 Expiration Date: 07/12/2026
• Device Model Number: 1601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/16/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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 Age: 48 YR
• Patient Sex: Female