MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 31, 2020.

Event Description

Per the surgeon, the patient experienced in infection (site of infection unknown) resulting in the device being explanted on (b)(6) 2019.It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

It was reported the patient underwent 4 courses of antibiotics to treat the post-surgical scar and a prior revision surgery (date not reported).This report is submitted on 28 september 2020.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: 10474925
• MDR Text Key: 205076892
• Report Number: 6000034-2020-02323
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)190615(17)210614
• 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
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2021
• Device Model Number: CI622
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 MO