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

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report is filed, march 16, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced poor performance with device resulting in the decision to explant and re-implant with a new device.Surgery is scheduled however, has not occurred as of the date of this report, (b)(6) 2016.The implanted device remains.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2016; during the same surgery the patient was re-implanted with a new device.Correction: the correct pma number is 130016; not 970051 as previously reported.

• 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: 5504799
• MDR Text Key: 40489001
• Report Number: 6000034-2016-00522
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130016
• 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: 04/06/2016

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: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• 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