MAUDE Adverse Event Report: AXONICS AXONICS, INC; NEUROSTIMULATOR

Model Number	1901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Incontinence (1928)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was hospitalized for hematoma.

• Brand Name: AXONICS, INC
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS; 26 technology dr; irvine CA 92618
• Manufacturer Contact: linda phan ; 26 technology dr; irvine, CA 92618
• MDR Report Key: 19336708
• Report Number: 3002968685-2024-00096
• Device Sequence Number: 14098634
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: 10810005340127
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 1901
• Device Lot Number: AK2PC31004
• 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: 05/06/2024
• Initial Report FDA Received Date: 05/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRIAL STIMULATOR, MODEL 1601
• Patient Age: 59 YR
• Patient Sex: Female