MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1601
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The company was made aware that a physician performed a revision surgery due to high impedance.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA
• Manufacturer Contact: sandra valencia ; 26 technology drive; irvine, CA
• MDR Report Key: 16465279
• Report Number: 3002968685-2023-00030
• Device Sequence Number: 5064292
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 1601
• Device Catalogue Number: 1601
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown