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

Model Number CI24RE (ST)

Device Problem Expulsion (2933)

Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972); Swelling (2091)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 13 2020.

Event Description

Per the clinic, the patient developed skin infections with swelling at the implant site and was treated with oral antibiotics (date and duration not reported).It was reported that the patient developed further skin necrosis of the skin flap and subsequent extrusion of the receiver-stimulator.The patient was hospitalized in (b)(6) 2020 (specific date not reported) and was treated with iv antibiotics (duration not reported).The device was explanted (b)(6) 2020 and it is unknown if there are plans to reimplant the patient with a new device as of the date of this report, (b)(6) 2020.

Manufacturer Narrative

This report is submitted on 8 october 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, nsw 2109 ; AS 2109
• MDR Report Key: 10262277
• MDR Text Key: 198489415
• Report Number: 6000034-2020-01833
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)190530(17)210529
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/29/2021
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR