MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 1201

Device Problems High impedance (1291); Wireless Communication Problem (3283)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

The patient underwent lead revision surgery due to high impedance.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA 92618
• Manufacturer Contact: seema mulla ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 17861499
• MDR Text Key: 324808434
• Report Number: 3002968685-2023-00120
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340141
• UDI-Public: 10810005340141
• 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: 10/03/2023

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: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: 1201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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: 68 YR
• Patient Sex: Female