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

Model Number	1501
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
False negative result.Loose or intermittent connection.No clinical signs, symptoms or conditions.No health consequences or impact.Analysis of production records.This is an initial submission as investigation of the issue has not been completed as we are pending the return of the device.The report was received on (b)(6) 2020.
Event or Problem Description
Clinician programmer (cp) was not showing an impedance issue with the ipg (neurostimulator), but when using another cp, the impedance issue was shown.Also, the milliamp (ma) was fluctuating and the cp was showing and disconnecting several times to the patient's ipg even though the company representative was a foot away and parallel to the ipg.
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.
Additional Manufacturer Narrative
Correction to section h, number 6, results.Re-testing of the clinician programmer (cp) found no wireless communication problem (fda code 3248).The device used for the initial cp testing had low battery.Once it was fully charged, the cp was able to connect to the device with no issue and the cp passed all tests.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9671707
• Report Number: 3002968685-2020-00005
• Device Sequence Number: 3308217
• Product Code: EZW
• UDI-Device Identifier: 10810005340028
• UDI-Public: 10810005340028
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/02/2020

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: Other
• Device Model Number: 1501
• Device Catalogue Number: 1501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 01/05/2020; 01/05/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/06/2020; 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1