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 Problems Head Injury (1879); Failure of Implant (1924); Pain (1994)

Event Date 09/03/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma.Explant and reimplantation is planned but has not taken place at the time of this report.

Manufacturer Narrative

The device was explanted on (b)(6) 2020 secondary to pain.The patient was reimplanted with a new device during the same surgery.This report is submitted on december 23, 2020.

Event Description

The device was explanted on (b)(6) 2020 secondary to pain.The patient was reimplanted with a new device during the same surgery.

• 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: 10578074
• MDR Text Key: 208288623
• Report Number: 6000003-2020-02545
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)170824(17)190823
• 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: 12/23/2020,12/07/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2019
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2020
• Distributor Facility Aware Date: 12/07/2020
• Date Report to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR