MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; NEUROSTIMULATOR

Model Number 1101

Device Problem Wireless Communication Problem (3283)

Patient Problem No Code Available (3191)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

The company was made aware on 10/22/2020 of a communication issue between the ipg (neurostimulator) and charger.The physician performed a revision surgery, and replaced the ipg, which resolved the issue.Evaluation of the returned ipg found no issues.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• Manufacturer Contact: peter vu ; 26 technology drive; irvine, CA ; 9493364590
• MDR Report Key: 10877403
• MDR Text Key: 218226891
• Report Number: 3002968685-2020-00086
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: 10810005340066
• 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: Other
• Type of Report: Initial
• Report Date: 11/20/2020

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: Lay User/Patient
• Device Expiration Date: 06/09/2022
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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