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

Model Number	1701
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The company was made aware on (b)(6) 2020 of a pne lead that showed low impedance.The lead was explanted and a replacement is planned, but has yet to be scheduled.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10979381
• Report Number: 3002968685-2020-00093
• Device Sequence Number: 4258800
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: 10810005340134
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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 Expiration Date: 08/11/2021
• Device Model Number: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK1M501001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1