MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24R (CS)
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on september 2, 2019.
Event or Problem Description
Per the clinic, the patient experienced a migration of the electrode array and subsequent extrusion of the array into the auditory canal.Revision surgery is scheduled; however, has yet to occur as of the date of this report.
Additional Manufacturer Narrative
It was reported that the device was explanted on 14 november 2019 and the patient was re-implanted with a new device during the same surgery.This report is submitted on 09 december 2019.
Additional Manufacturer Narrative
This report is submitted on 12 february 2020.(b)(4).

• Brand Name: NUCLEUS 24 CONTOUR
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8953053
• Report Number: 6000034-2019-01587
• Device Sequence Number: 11426532
• Product Code: MCM
• UDI-Device Identifier: 09321502002349
• UDI-Public: (01)09321502002349(11)080731(17)100730
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/30/2010
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 01/17/2020
• Initial Report FDA Received Date: 09/01/2019
• Supplement Report FDA Received Date: 12/08/2019; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR