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

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Facial Nerve Paralysis (1846)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed, (b)(6) 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced facial nerve paralysis beginning on (b)(6) 2016.On (b)(6) 2016 the patient was prescribed prednisone and an anti-viral medication (duration not reported).The implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
• Type of Device: PGQ: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR LTD.; 14 mars rd.; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: nicole hille ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5443951
• MDR Text Key: 38441047
• Report Number: 6000034-2016-00328
• Device Sequence Number: 1
• Product Code: PGQ
• 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
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• 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): Required Intervention
• Patient Age: 51 YR