MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a purulent drainage from the incision site.The infection was treated with oral antibiotics.The implant remains in-situ.

Manufacturer Narrative

It has now been reported that the patient was hospitalised and had developed an abscess which was treated with iv and oral antibiotics.This report is submitted on may 5, 2020.

Event Description

It has now been reported that the patient was hospitalised and had developed an abscess which was treated with iv and oral antibiotics.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: 9914139
• MDR Text Key: 186732169
• Report Number: 6000034-2020-01117
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)160601(17)180531
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/05/2020,04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2020
• Date Report to Manufacturer: 04/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention