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); Abscess (1690); Unspecified Infection (1930)

Event Date 02/25/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an abscess in the incision line and subsequently was treated with oral antibiotic (specific date and duration not reported).However, it was reported that the infection reoccurred and the patient was treated again with oral antibiotic (specific date and duration not reported).Following these events, the patient was presented again for wound dehiscence and subsequently, underwent a skin revision procedure on (b)(6) 2021 and was administered with iv (duration not reported) and oral antibiotics (two weeks course).

Event Description

Per the clinic, the device was explanted on (b)(6), 2022.There are no plans to reimplant the patient with a new device as of the date of this report.

• 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
• MDR Report Key: 12850532
• MDR Text Key: 281073244
• Report Number: 6000034-2021-03575
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)210105(17)230104
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022,03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2023
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Distributor Facility Aware Date: 03/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female