MAUDE Adverse Event Report: COCHLEAR LTD . NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.; MCM, PRODUCT CODE:

Model Number CI24R (CS)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Neuropathy (1983); Complaint, Ill-Defined (2331); Meningitis (2389); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient was hospitalized on (b)(6) 2015 due to meningitis, sinusitis, epidural empyema and pott's puffy tumor.On (b)(6) 2015 the patient's internal magnet was removed for mri purposes.The patient was treated with flagyl every 8 hours for six week duration.Upon discharge from the hospital (date not reported) the patient was treated with two different antibiotics (durations not reported).Per report on december 10, 2015 the issues have resolved and the patient is doing well.The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient underwent a surgical procedure on (b)(6) 2016 to have a new internal magnet placed.This report is filed february 16, 2016.The implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
• Type of Device: MCM, PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR LTD .; 14 mars rd; po box 629; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: nicole hille ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5325952
• MDR Text Key: 34323686
• Report Number: 6000034-2015-02638
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

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 Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention