MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 1201

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The patient underwent revision surgery due to lead detachment.

Event Description

See section h, number 6 for health effect-impact codes updated.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA 92618
• Manufacturer Contact: linda phan ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 17375318
• MDR Text Key: 319654617
• Report Number: 3002968685-2023-00096
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: 10810005340141
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/22/2023

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 Expiration Date: 02/01/2024
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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: 70 YR
• Patient Sex: Female