MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 12/13/2023

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023.The patient was re-implanted with another cochlear device during the same surgery.

Event Description

Per the clinic, the patient developed an infection at the implant site.Subsequently, the patient was treated with oral antibiotics and hospitalised overnight for administration of iv antibiotics (specififc date and duration not reported).

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• 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: 18550271
• MDR Text Key: 333313784
• Report Number: 6000034-2024-00268
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)171114(17)191113
• 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: 03/19/2024,02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2019
• Device Model Number: CI532
• 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: 03/19/2024
• Distributor Facility Aware Date: 02/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male