MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075); Ulcer (2274)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 06, 2018, (b)(4).

Event Description

Per the surgeon the patient developed an ulcer and infection at the implant site resulting in breakdown of skin.Subsequently, the patient was treated with oral and topical antibiotics and wound care (dates not reported).There are plans to explant the device and allow infection to heal; however, has yet to occur as of the date of this report.

Manufacturer Narrative

Per the surgeon, it was reported that the device was explanted on (b)(6) 2018.

• Brand Name: NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7572321
• MDR Text Key: 110162882
• Report Number: 6000034-2018-01220
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317(11)130206(17)150205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2015
• Device Model Number: CI24RE(S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2013
• 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: 65 YR