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

Model Number 4101

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 01/23/2023

Event Type  Injury  

Event Description

The company was made aware that a patient underwent explant surgery due to lead exposure and possible abscess infection.

• Brand Name: AXONICS, INC
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES; 26 technology drive; irvine CA
• Manufacturer Contact: azucena eulloqui ; 26 technology drive; irvine, CA
• MDR Report Key: 16284019
• MDR Text Key: 308638873
• Report Number: 3002968685-2023-00013
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: 10810005340455
• 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: Physician
• Type of Report: Initial
• Report Date: 02/02/2023

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: 04/04/2023
• Device Model Number: 4101
• Device Catalogue Number: 4101
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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: 66 YR
• Patient Sex: Female