MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on june 25, 2020.

Event Description

Per the clinic, the patient experienced a magnet dislocation during an mri (tesla unknown).The patient's head was not wrapped as recommended by cochlear.The patient then developed an extrusion of the receiver/stimulator body and infection at the implant site that was treated with oral antibiotics.During the explant/re-implantation on (b)(6) 2020, there was a skin revision.

Manufacturer Narrative

Correction: it was reported that the patient underwent two mri scans on (b)(6)2 018 and (b)(6) 2019.Each procedure was performed without wrapping the patient's head per cochlear's recommendations.Subsequently, the patient experienced a dislodgment of the implant magnet and developed an infection at the implant site.The patient underwent revision surgery on (b)(6) 2019, in order to debride the skin at the implant site and re-insert the extruded magnet.There was no extrusion of the receiver stimulator as initially reported.Following the revision surgery, the patient developed a wound infection and a post-operative wound healing disorder which could not be resolved.Subsequently, the device was explanted on (b)(6) 2020.The patient was re-implanted with another cochlear device during the same surgery.This report is submitted july 6, 2020.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on jun 22, 2021.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 10193263
• MDR Text Key: 196671961
• Report Number: 6000034-2020-01538
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE(CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR