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

Model Number	1601
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271)
Date of Event	03/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, patient felt a "pop" in their tailbone area and reported feeling pain after the pop sensation.Prior to the trial period, the patient had never experienced that sensation.The patient was in the stage 1 trial and doing well.The pain eventually went away.On (b)(6) 2020, patient reported experiencing pain across their low back while driving home from a doctor appointment unrelated to the device.Patient was unable to correlate the pain to any occurrence.During this time, the patient reported to the clinical specialist (cs) that they were unsure when they last felt stimulation from the device, but believed it stopped around the same time as the onset of the low back pain.Patient was having difficulty connecting their patient remote to the trial stimulator (epg).Attempts were made to resolve the issue by checking all connections and restarting the patient remote and trial stimulator, but results remain the same.On (b)(6) 2020, the patient met with the cs and doctor.The doctor observed the patient's back and noted that it looked normal.The cs connected to the trial stimulator using their clinician programmer and noticed an error message had displayed stating to replace the trial stimulator.The trial stimulator was replaced as a result and the issue was able to be resolved.The patient was able to feel stimulation.
Additional Manufacturer Narrative
A review of the device history records found no non-conformances.
Event or Problem Description
See section h, number 6, event problem and evaluation codes.
Additional Manufacturer Narrative
The error code that displayed was due to multiple microprocessor watchdog resets.Further evaluation and testing are required to determine the root cause.
Event or Problem Description
See section h, number 6, event problem and evaluation codes and section h, number 10, additional manufacturer narrative.
Additional Manufacturer Narrative
Further analysis of the returned epg found voltage/temperature shifts that started on (b)(6) 2020.Pending further evaluation and testing to determine what may have caused the shifts.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9936326
• Report Number: 3002968685-2020-00029
• Device Sequence Number: 701797
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 08/03/2020

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 Model Number: 1601
• Device Catalogue Number: 1601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020; 03/11/2020; 03/11/2020; 03/11/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/07/2020; 06/05/2020; 07/03/2020; 07/31/2020; 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1