MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR

Model Number 1101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2023

Event Type  Injury  

Event Description

The patient underwent the explant surgery due to receiving an electrical shock (220v) from an external source which lead to a loss of efficacy.Though the neurostimulator was working correctly, the device was explanted.

Event Description

See section h, number 6, for an investigation update.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS, INC; 26 technology drive; irvine CA 92618
• Manufacturer Contact: azucena eulloqui ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 16998480
• MDR Text Key: 315907017
• Report Number: 3002968685-2023-00069
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: 10810005340066
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 07/26/2023

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: 02/05/2022
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2019
• 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