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

Model Number CI512

Device Problem Device Stops Intermittently (1599)

Patient Problem Deafness (1801)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.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.

Manufacturer Narrative

This report is submitted on 9 october 2020.

• 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
• MDR Report Key: 5336232
• MDR Text Key: 34746267
• Report Number: 6000034-2015-02656
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: 970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR