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

Model Number	1701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The company was made aware on (b)(6) 2021 that a physician discovered an infection at the lead site resulting from the basic trial.
Event or Problem Description
The company was made aware on (b)(6) 2021 that a physician discovered an infection at the lead site resulting from the basic trial.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• Manufacturer Contact: cherilyn johnson ; 26 technology drive; irvine, CA ; 9493366329
• MDR Report Key: 13003041
• Report Number: 3002968685-2021-00052
• Device Sequence Number: 17212733
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: 10810005340134
• Combination Product (Y/N): N
• Initial Reporter State: ID
• PMA/510(K) Number: P190006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 1701
• Device Catalogue Number: 1701
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown