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

Model Number	1601
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient completed basic trial procedure on (b)(6) 2020.Patient called clinical specialist on (b)(6) 2020 and stated they were getting a red error light on the bottom of the patient remote (pr).Troubleshooting was performed by re-securing connections and switching from program to program, but unable to clear error light.The patient and clinical specialist then met in the office.The clinical specialist used their clinician programmer (cp) to connect to the patient's trial stimulator and an error message was shown.After clearing the error and reprogramming, the patient connected the remote to the trial stimulator and was still getting a red error light.The trial stimulator was replaced with a new one and after reprogramming the patient, active stimulation was achieved.
Event or Problem Description
See section h, number 6, event problem and evaluation codes.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9740902
• Report Number: 3002968685-2020-00012
• Device Sequence Number: 11216408
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 03/20/2020

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: 02/11/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1