MAUDE Adverse Event Report: COCHLEAR LTD; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Discomfort (2330)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced discomfort and developed an abscess at the implant site.The patient was treated with oral antibiotics (specific date and duration not reported), and was placed under a general anaesthetic in order to excise skin at the implant site (specific date not reported).

• Brand Name: NI
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10418600
• MDR Text Key: 203282483
• Report Number: 6000034-2020-02159
• Device Sequence Number: 1
• Product Code: MCM
• 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
• Report Date: 08/18/2020,07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2020
• Distributor Facility Aware Date: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention