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

Model Number CI622

Device Problem Biocompatibility (2886)

Patient Problem Unspecified Infection (1930)

Event Date 11/23/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 23, 2020.

Event Description

Per the clinic, the patient developed an infection at the implant site.The patient was treated with iv antibiotics for a duration of 6 weeks; however, treatment was unsuccessful, resulting in breakdown of the skin flap.Subsequently, the device was explanted on (b)(6) 2019.There are currently no plans to re-implant the patient, as of the date of this report.

Manufacturer Narrative

This report is submitted on 16 april 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: 9868190
• MDR Text Key: 187039457
• Report Number: 6000034-2020-00788
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)190824(17)210823
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2021
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR