MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Head Injury (1879)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 06, 2022.

Event Description

Per the surgeon, the patient experienced a head trauma resulting in a dislodgement of the internal magnet.The magnet was replaced on (b)(6) 2021.

Manufacturer Narrative

The correct date of awareness was november 8, 2022.This report is submitted on january 5, 2023.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, nsw 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; no. 8 jalan kerinchi,; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 15921853
• MDR Text Key: 304874740
• Report Number: 6000034-2022-03632
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)180613(17)200612
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2020
• Device Model Number: CI24RE(CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2018
• 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): Other; Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male