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

Model Number 1701

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

When the doctor was attempting to remove the needle over the pne lead, the needle stuck to the lead making it difficult to remove and pulled out the lead.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• Manufacturer Contact: peter vu ; 26 technology drive; irvine, CA ; 9493364590
• MDR Report Key: 9924805
• MDR Text Key: 191723098
• Report Number: 3002968685-2020-00028
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: 10810005340134
• Combination Product (y/n): N
• PMA/PMN Number: P180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK1K101002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1