MAUDE Adverse Event Report: AXONICS; NEUROSTIMULATOR

Model Number 1201

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/12/2020

Event Type  malfunction  

Event Description

Tined lead was not deploying properly when it came out of the sheath.The tined lead kept moving and the doctor did not feel comfortable leaving the lead in.The lead was explanted and a new lead was obtained to complete the case.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer Contact: peter vu ; 26 technology drive; irvine, CA ; 9493364590
• MDR Report Key: 9946878
• MDR Text Key: 191722485
• Report Number: 3002968685-2020-00034
• 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: 04/09/2020

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: Health Professional
• Device Expiration Date: 04/17/2022
• Device Model Number: 1201
• Device Catalogue Number: 1201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• 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