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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient developed swelling and granulated tissue at the implant site.Subsequently, revision surgery was performed in (b)(6) 2016 in order to removed the granulation.An additional revision surgery was performed on the skinflap in (b)(6) 2016 (specific date not reported).The implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6101310
• MDR Text Key: 59834521
• Report Number: 6000034-2016-02294
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)150717(17)170717
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2016

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 Expiration Date: 02/17/2017
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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