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

Model Number CI522

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

Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 1, 2019, by cochlear ltd.

Event Description

Per the clinic, the recipient experienced skin flap necrosis and an infection.The flap necrosis did not respond to conservative treatment.A skin flap revision procedure was performed (date not reported), the receiver stimulator antenna was identified and carefully preserved during removal of the eschar and damaged soft tissues.The infection was treated with antibiotics topical and intravenous.The implanted device remains.

• Brand Name: NUCLEUS CI522 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
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9264630
• MDR Text Key: 164830724
• Report Number: 6000034-2019-02248
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180913(17)200912
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2020
• Device Model Number: CI522
• Date Manufacturer Received: 10/12/2019
• Date Device Manufactured: 09/13/2018
• 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): Required Intervention