MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 1101

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Wound Dehiscence (1154)

Event Date 10/21/2022

Event Type  Injury  

Event Description

The patient underwent explant surgery due to wound dehiscence.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology dr.; irvince CA
• Manufacturer Contact: sandra valencia ; 26 technology dr.; irvine, CA
• MDR Report Key: 15797806
• MDR Text Key: 303646161
• Report Number: 3002968685-2022-00118
• 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: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

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?: No
• Device Operator: Other
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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
• Treatment: TINED LEAD, MODEL 1201
• Patient Age: 52 YR
• Patient Sex: Female