MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 1201

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

The company was made aware that a physician performed revision surgery due to high impedance and lead fracture.

Event Description

See section h, number 6 for investigation updates.

Event Description

See section h, number 6 for investigation updates.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA
• Manufacturer Contact: sandra valencia ; 26 technology drive; irvine, CA
• MDR Report Key: 16308978
• MDR Text Key: 308912078
• Report Number: 3002968685-2023-00018
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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?: Yes
• Device Operator: Other
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 01/11/2023; 01/11/2023
• Supplement Dates FDA Received: 02/25/2023; 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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