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

Model Number CI522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cerebrospinal Fluid Leakage (1772); Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the episode of meningitis; however, has not yet become available.Should further information be provided, a supplementary report shall be submitted.This report is submitted on december 12, 2019.

Event Description

Per the clinic, it was reported that the patient developed a post-operative cerebrospinal fluid leakage and an episode of meningitis.Subsequently, the patient underwent revision surgery (date not reported) in order to stop the csf leak.

• 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, 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9454404
• MDR Text Key: 170442159
• Report Number: 6000034-2019-02855
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180418(17)200417
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention