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

Model Number	1601
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
High impedance with the trial stimulator (epg).Issue was resolved by replacing the trial stimulator with another one.
Additional Manufacturer Narrative
A review of the production records found no production issues with the device.
Event or Problem Description
See section h, number 6, event problem and evaluation codes.
Event or Problem Description
See section h, number 6, event problem and evaluation codes.

• Brand Name: AXONICS
• Common Device Name: TRIAL STIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9801207
• Report Number: 3002968685-2020-00019
• Device Sequence Number: 2778074
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

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: Health Professional
• Device Model Number: 1601
• Device Catalogue Number: 1601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 02/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/03/2020; 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1