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

Model Number CI622

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 17, 2020.

Event Description

Per the clinic, the patient experienced wound breakdown at the incision site beginning (b)(6) 2020, and was treated with topical and oral antibiotics for several weeks (specific duration not reported).The patient developed an infection and underwent a skin debridement and closure of the wound on (b)(6) 2020, and was treated with intravenous antibiotics.However, the issue could not be resolved; the patient experienced an open wound with granulation, and an extrusion of the receiver/stimulator, resulting in the decision to explant the device on (b)(6) 2020.The patient has not been reimplanted with a new device as of this report.

Manufacturer Narrative

This report is submitted on 30 october 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, nsw 2109 ; AS 2109
• MDR Report Key: 10544552
• MDR Text Key: 207303058
• Report Number: 6000034-2020-02499
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)190628(17)210627
• 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: 10/09/2020

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: 06/27/2021
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR