MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR OSIA OSI200 IMPLANT; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number OSI200

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Per the clinic, the patient developed a wound infection (cellulitis) at the incision site leading to wound dehiscence and exposure of the receiver/stimulator.There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on january 04, 2023.

Manufacturer Narrative

Per the clinic, it was also reported that the patient underwent attempted revision surgery (date not reported).However, the issue could not be resolved.The device was explanted on (b)(6) 2023.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.This report is submitted on january 26, 2024.

Manufacturer Narrative

Correction: the correct b4 for mdr folow-up #2 is (b)(6) 2024.This report is submitted on (b)(6) 2024.

Manufacturer Narrative

Per the clinic, the patient was placed on a 28 days course of topical antibiotics (specific date not reported).Device analysis report attached.This report is submitted on february 27, 2024.

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2024 under general anaesthetic.This report is submitted on april 17, 2024.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: hakim muhaimin jamil ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18441568
• MDR Text Key: 331858411
• Report Number: 6000034-2024-00054
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)230803(17)250802
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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