MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Expulsion (2933)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 25, 2021.

Event Description

Per the clinic, the patient experienced receiver/stimulator extrusion and experienced an infection and underwent abscess drainage.The patient was treated with iv and oral antibiotics (date and duration not reported).Subsequently, the device was explanted (b)(6) 2020 and has reimplantation planned but has not taken place as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on aug 05, 2021.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 11875348
• MDR Text Key: 252354169
• Report Number: 6000034-2021-01522
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)190401(17)210331
• 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: 05/14/2021

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: 03/31/2021
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention