MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number	1901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Incontinence (1928); Foreign Body In Patient (2687)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent surgery to retrieve lead fragment.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology dr; irvine CA 92618
• Manufacturer Contact: stephanie sauceda ; 26 technology dr; irvine, CA 92618
• MDR Report Key: 19355105
• Report Number: 3002968685-2024-00097
• Device Sequence Number: 7528813
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: 10810005340127
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/20/2024

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: 1901
• Device Lot Number: AK2PB31008
• 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: 04/26/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 84 YR
• Patient Sex: Male