MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 4101

Device Problems High impedance (1291); Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

The patient underwent revision surgery due to high impedance.

Event Description

See section h, number 6, for an investigation update.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA
• Manufacturer Contact: azucena eulloqui ; 26 technology drive; irvine, CA
• MDR Report Key: 16886902
• MDR Text Key: 314748582
• Report Number: 3002968685-2023-00061
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: 10810005340455
• 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,Followup
• Report Date: 05/31/2023

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: 06/03/2023
• Device Model Number: 4101
• Device Catalogue Number: 4101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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
• Treatment: TINED LEAD, MODEL 1201
• Patient Age: 72 YR
• Patient Sex: Female