MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Migration (4003)

Patient Problem Hearing Impairment (1881)

Event Date 10/04/2018

Event Type  Injury  

Event Description

Per the patient's surgeon, the device was explanted on (b)(6) 2018 due to poor performance and migration of the electrode array.The patient was re-implanted with a new device during the same surgery.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 9282848
• MDR Text Key: 165195709
• Report Number: 6000034-2019-02316
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)171031(17)191030
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR