MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 12, 2019.

Event Description

It was reported that the patient experienced pain with and without device use.The patient was hospitalized and administered oral antibiotics (date and duration not reported).Reprogramming attempts were made; however the issue could not be resolved.The implanted device remains and the child is being clinically managed by the healthcare provider.

• Brand Name: NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8330049
• MDR Text Key: 135851553
• Report Number: 6000034-2019-00169
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)100305(17)120304
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Date Device Manufactured: 03/05/2010
• 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): Hospitalization; Required Intervention