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

Model Number 2201

Device Problem Material Erosion (1214)

Patient Problem Erosion (1750)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

Patient underwent a rapid weight loss program where they had lost 38 pounds in 2 months.The doctor stated the lead stress coil at the ipg (neurostimulator) site had eroded through the skin.The patient was scheduled for a full system explant on (b)(6) 2020.

Event Description

See section h, number 6, event problem and evaluation codes.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10039444
• MDR Text Key: 190504129
• Report Number: 3002968685-2020-00038
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340158
• UDI-Public: 10810005340158
• 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
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2201
• Device Catalogue Number: 2201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1