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

Model Number 1601

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/19/2020

Event Type  malfunction  

Event Description

Patient was having connection issues with the epg (trial stimulator) and percutaneous extension during the first few days of the trial period.In order to resolve the issue, an additional strain relief was added and the epg was replaced as there was concern it had become compromised.There has been no issues with the connection since the addition of the strain relief and replacement of the epg.

Event Description

See section h, number 6, event problem and evaluation codes.

Event Description

See section h, number 6, event problem and evaluation codes and section h, number 10, additional manufacturer narrative.

Manufacturer Narrative

A review of the device history records found no non-conformances.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 9973090
• MDR Text Key: 191722298
• Report Number: 3002968685-2020-00035
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: 10810005340059
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2020

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: Lay User/Patient
• Device Model Number: 1601
• Device Catalogue Number: 1601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 03/19/2020
• Supplement Dates FDA Received: 05/15/2020; 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1