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

Model Number	1601
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's epg (trial stimulator) disconnected from the percutaneous extension (pe).The representative met with the patient and observed the prongs inside the epg connector were bent.Per the representative, the epg was pulled from the pe and the prongs inside the epg were damaged as a result.The representative was unable to reconnect the epg to the pe.The epg was replaced and patient was reprogrammed.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10322220
• Report Number: 3002968685-2020-00061
• Device Sequence Number: 17008836
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/24/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1