MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problems Device Dislodged or Dislocated (2923); Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 07, 2023.

Event Description

Per the clinic, the patient experienced infection at the implant site.The device was explanted on (b)(6) 2023.The patient was re-implanted with another cochlear device during the same surgery.

Manufacturer Narrative

Correction: the previous mdr submitted on august 15, 2023 was filed inadvertently.No magnet extrusion due to mri has occurred.Per the clinic the patient experienced a dislodged magnet during an mri.This report is submitted on september 22, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced magnet extrusion due to mri (specific date not reported).Device analysis indicated device failure.This report is submitted on august 15, 2023.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17276767
• MDR Text Key: 318549618
• Report Number: 6000034-2023-02179
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/21/2023

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: 09/02/2023
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/31/2023; 06/21/2023
• Supplement Dates FDA Received: 08/15/2023; 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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
• Patient Sex: Male