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

Model Number OSI200

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 16, 2023.

Event Description

Per the clinic, the patient experienced insufficient healing, exposing the implant.There are plans to explant the device; however, this has not occurred as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient underwent a skin revision surgery (specific date not reported) in order to excise the excess skin.The implanted device remains.This report is submitted on march,13 2023.

Manufacturer Narrative

Correction : additional narrative/date in h10, was previously reported incorrectly.This has now been updated accordingly.Per the clinic, the patient underwent a skin revision surgery (specific date & reason not reported).The implanted device remains.Additional information has been requested but has not been made available as of the date of this report.This report is submitted on march,14 2023.

Manufacturer Narrative

Correction: the previous mdr submitted on march 14, 2023 was filed inadvertently.No skin revision surgery has occurred.Per the clinic, the device was explanted (specific date not reported).There are no plans to reimplant the patient with a new device as of the date of this report.This report is submitted on may 23, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced wound dehiscence.This report is submitted on (b)(6), 2023.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16172714
• MDR Text Key: 307473915
• Report Number: 6000034-2023-00193
• Device Sequence Number: 1
• Product Code: PFO
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OSI200
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2023
• 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
• Patient Sex: Male