MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the clinic, the patient developed an infection at the implant site, resulting in the implant being exposed and extruding.Explant is planned but has not taken place at the time of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

The device was explanted on (b)(6) 2020.Iv and oral antibiotics were administered for the infection.It is unknown if there are plans to re-implant the patient with another device.This report is submitted on october 19, 2020.

Event Description

The device was explanted on (b)(6) 2020.Iv and oral antibiotics were administered for the infection.It is unknown if there are plans to re-implant the patient with another device.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM 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: 10564588
• MDR Text Key: 207891817
• Report Number: 6000034-2020-02560
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180717(17)200716
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/19/2020,09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2020
• Distributor Facility Aware Date: 09/02/2020
• Date Report to Manufacturer: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention