MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 7, 2020.

Event Description

Per the clinic, the patient experienced an infection which resulted in no connection to the implant.The device was explanted on (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on may 5, 2020.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9679741
• MDR Text Key: 178102822
• Report Number: 6000034-2020-00347
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)170130(17)190129
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2019
• Device Model Number: CI24RE (ST)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR