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

Model Number CI612

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Facial Nerve Paralysis (1846); Pain (1994); Dizziness (2194)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 15, 2020.

Event Description

Per the audiologist, the patient was experiencing facial paralysis, dizziness and shooting pain in her jaw 1 week after implantation.The device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on july 28, 2020.

• 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: 10151655
• MDR Text Key: 195076649
• Report Number: 6000034-2020-01494
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)191128(17)211127
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/15/2020,07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2021
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2020
• Date Report to Manufacturer: 05/21/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR