MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Migration (4003)

Patient Problem Deafness (1801)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 12, 2019.

Event Description

Per the clinic, the patient experienced a migration of the electrode resulting in response to sound stimulation.The implant remains in-situ.

Manufacturer Narrative

This is a correction to the wording of the description of the problem.This report is filed on february 22, 2020.

Event Description

The initial report failed to add "no response" so the problem should read: per the clinic, the patient experienced a migration of the electrode resulting in no response to sound stimulation.The implant remains in-situ.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9455888
• MDR Text Key: 170432291
• Report Number: 6000034-2019-02750
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)150106(17)170105
• Combination Product (y/n): N
• PMA/PMN Number: P840024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/12/2019,01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2017
• Device Model Number: CI22M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2019
• Date Report to Manufacturer: 11/19/2019
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention