MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problems Communication or Transmission Problem (2896); Impedance Problem (2950)

Patient Problems Bacterial Infection (1735); Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

This report is submitted december 24, 2018.

Event Description

Per the clinic, the patient sustained a head trauma and subsequently experienced a performance decrement.It was also reported that the patient developed an infection and was administered antibiotics (date and type not reported).The patient is being clinically managed by the health care provider.

Manufacturer Narrative

Additional information: the date of awareness has been confirmed as (b)(6) 2018 and not (b)(6) 2018 as originally reported in the emdr submitted on (b)(6) 2018.This report is filed on january 17, 2019.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT 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: tamara martin ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8193203
• MDR Text Key: 131303557
• Report Number: 6000034-2018-02537
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)170105(17)190104
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2019
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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