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

Model Number OSI200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 10/18/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at implant site and subsequently was treated with oral antibiotics on (b)(6) 2022 (duration not reported), however, the issue did not resolve.The patient was then treated with oral antibiotics again on (b)(6) 2022 (duration not reported) without any improvement.It was also reported that the patient experienced wound dehiscence and subsequently was treated with iv antibiotics on (b)(6) 2022 for a duration of three days.The implanted device remains.

Manufacturer Narrative

This report is submitted on december 30, 2022.

Manufacturer Narrative

It was reported that the patient was hospitalized for 3 days on (b)(6) 2022, to treat infection with iv antibiotics.This report is submitted on february 09, 2023.

• 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16076084
• MDR Text Key: 306404887
• Report Number: 6000034-2022-03908
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female