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

Model Number	1601
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having connection issues with the epg (trial stimulator) and percutaneous extension during the first few days of the trial period.In order to resolve the issue, an additional strain relief was added and the epg was replaced as there was concern it had become compromised.There has been no issues with the connection since the addition of the strain relief and replacement of the epg.
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 and section h, number 10, additional manufacturer narrative.
Additional Manufacturer Narrative
A review of the device history records found no non-conformances.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9973090
• Report Number: 3002968685-2020-00035
• Device Sequence Number: 2741174
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/12/2020

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: 03/26/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 03/19/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/15/2020; 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1