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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Impairment (1881); Unspecified Infection (1930); Shock (2072)

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient developed an infection at the implant site.The patient also experienced a performance decrement and reports "shocks" with and without device use.Subsequently on (b)(6) 2015 the patient had a pe tube placed and a polyp was excised from the tympanic membrane.The implanted device remains.

Manufacturer Narrative

Per the clinic, the device was explanted (b)(6) 2015.This report is filed april 7, 2016.

Manufacturer Narrative

This report is filed may 9, 2016.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD .; 14 mars rd; po box 629; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5257948
• MDR Text Key: 32403094
• Report Number: 6000034-2015-02433
• 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,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention