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

Model Number	9009
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, clinical specialist reported that trial leads had disconnected from the percutaneous extension while home care nurse was removing the dressings.The patient is paraplegic.The disconnection damaged the extension cable when the patient was lifted onto the hoyer lift.The extension was replaced and patient is doing well.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10560925
• Report Number: 3002968685-2020-00077
• Device Sequence Number: 1241127
• Product Code: EZW
• UDI-Device Identifier: 10810005340288
• UDI-Public: 10810005340288
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/21/2020

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 Expiration Date: 06/26/2021
• Device Model Number: 9009
• Device Catalogue Number: 9009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1