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 06/17/2022

Event Type  malfunction  

Event Description

The patient underwent an lead revision due to high impedance.

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: cherilyn johnson ; 26 technology drive; irvine ; 9493366329
• MDR Report Key: 14876681
• MDR Text Key: 295062234
• Report Number: 3002968685-2022-00068
• 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
• Report Date: 06/30/2022

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 Expiration Date: 06/23/2023
• 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: 06/16/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2021
• 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 Age: 65 YR
• Patient Sex: Female