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

Model Number CI522

Device Problem No Device Output (1435)

Patient Problem No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device; however the issue could not be resolved.The device was explanted on (b)(6) 2020.Reimplantation with a new device is planned; but has yet to occur as of the date of this report.

• 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: 10475332
• MDR Text Key: 205108999
• Report Number: 6000034-2020-02286
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180710(17)200709
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/01/2020,08/12/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2020
• Distributor Facility Aware Date: 08/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR