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

Model Number CI24RE (ST)

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the electrode array was partially inserted in the cochlea, resulting in the decision to explant the device.The device was explanted on (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is filed on june 24, 2019.

• Brand Name: NUCLEUS FREEDOM COCHLEAR 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
• MDR Report Key: 8580952
• MDR Text Key: 144093274
• Report Number: 6000034-2019-00691
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317(11)180328(17)200327
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2020
• Device Model Number: CI24RE (ST)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention