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

Model Number CI422

Device Problem Disconnection (1171)

Patient Problem Head Injury (1879)

Event Type  Injury  

Manufacturer Narrative

Implanted device remains.

Event Description

Per the clinic, the patient experienced a loss of connection to the device subsequent to sustaining a head injury.The implanted device remains at this time.However, explant and reimplantation is planned but has not taken place at the time of this report, november 24, 2015.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2015, and the patient was re-implanted with a new device during the same surgery.This report is filed december 2nd, 2015.Device not received by manufacturer.

Manufacturer Narrative

This report is filed may 2, 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: bianca hanlon ; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5244362
• MDR Text Key: 31967977
• Report Number: 6000034-2015-02489
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P970051
• 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: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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