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

Model Number	2201
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a massage done.The massage session included the area of the ipg (neurostimulator) and tined lead insertion site.Patient was not receiving effective therapy.X-rays were performed and results show the lead had migrated inward.The patient decided to have the system explanted due to recovery time for a lead revision surgery.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10171467
• Report Number: 3002968685-2020-00049
• Device Sequence Number: 2142909
• Product Code: EZW
• UDI-Device Identifier: 10810005340158
• UDI-Public: 10810005340158
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/05/2020
• Device Model Number: 2201
• Device Catalogue Number: 2201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1