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

Model Number CI24RE (CA)

Device Problems Connection Problem (2900); Power Problem (3010)

Patient Problem No Code Available (3191)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced loss of connection to the internal device; however, the issue could not be resolved.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report, october 9, 2015.

Manufacturer Narrative

Per the clinic, the device was explanted (b)(6) 2015.It is unknown if the patient was reimplanted with a new device as of the date of this report, (b)(6) 2016.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; po box 629; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109 ; 1294286300
• MDR Report Key: 5139612
• MDR Text Key: 28325616
• Report Number: 6000034-2015-01998
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2006
• Is the Device Single Use?: 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
• Patient Age: 49 YR