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

Model Number 1101

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Impaired Healing (2378)

Event Date 02/12/2021

Event Type  Injury  

Event Description

The company was made aware that the physician performed a lead revision due to lead exposure and delayed healing at the incision site.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• Manufacturer Contact: cherilyn johnson ; 26 technology drive; irvine, CA ; 9493366329
• MDR Report Key: 12611197
• MDR Text Key: 279258840
• Report Number: 3002968685-2021-00046
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2021

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?: No
• Device Operator: Other
• Device Expiration Date: 07/01/2022
• Device Model Number: 1101
• Device Catalogue Number: 1201
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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