MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Head Injury (1879)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 31, 2020.

Event Description

Per the clinic, the patient experienced magnet dislodgement subsequent to sustaining a head trauma.The implanted device remains.Surgery to replace the magnet is planned but has not yet occurred as of the date of this report.

Manufacturer Narrative

It was reported that the patient underwent revision surgery on 14 december 2020 to reposition internal magnet.The implanted device remains.This report is submitted on 29 january 2021.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11099006
• MDR Text Key: 224744218
• Report Number: 6000034-2020-03630
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)180413(17)200412
• Combination Product (y/n): N
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2020
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR