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

Model Number CI522

Device Problem Expulsion (2933)

Patient Problems Fistula (1862); Unspecified Infection (1930)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 29 october 2019.

Event Description

Per the clinic, the patient experienced extrusion of the receiver-stimulator and a mastocutaneous fistula which resulted in infection at implant site.The patient was treated with iv and oral antibiotics however the issue could not be resolved, resulting in explant of the device on (b)(6) 2019.

Manufacturer Narrative

This report is submitted 04 december 2019.- attachment: [157160 device analysis report.Pdf].

• 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, nsw 2109 ; AS 2109
• MDR Report Key: 9248362
• MDR Text Key: 164116212
• Report Number: 6000034-2019-02175
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180209(17)200208
• 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: 11/15/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR