MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 27 oct 2020.

Event Description

It was reported that the recipient was placed under general anesthesia at the moment of integrity test being performed.

Manufacturer Narrative

Per the clinic, the cochlear implant was evaluated on (b)(6) 2021, using the integrity test system.The results are consistent with a device malfunction.This report is submitted on 28 january 2021.

Manufacturer Narrative

This report is submitted on (b)(6) 2021.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2021.This report is submitted on 3 may 2021.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 10738909
• MDR Text Key: 213157893
• Report Number: 6000034-2020-02952
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)120215(17)140214
• 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,Followup,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2014
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 04/09/2021; 06/08/2021
• Supplement Dates FDA Received: 01/27/2021; 05/02/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention