MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 5101

Device Problem Failure to Charge (1085)

Patient Problems Failure of Implant (1924); Incontinence (1928)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

The patient underwent a revision surgery due to a charging issue.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology dr; irvine CA 92618
• Manufacturer Contact: linda phan ; 26 technology dr; irvine, CA 92618
• MDR Report Key: 19149351
• MDR Text Key: 340679014
• Report Number: 3002968685-2024-00076
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: 10810005340479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Other
• Device Model Number: 5101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female