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

Model Number CI532

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 19, 2020.

Event Description

Per the clinic, the patient developed an infection at the implant site (not device related) and was treated with antibiotics (type, date and duration not reported).The device was subsequently explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.

Event Description

Per the clinic, it was reported that the patient developed an abscess (staph infection) (specific date not reported) at the incision site and subsequently underwent a skin revision surgery on (b)(6) 2021.

Event Description

Correction: the initial mdr submitted on june 19, 2020, was filed inadvertently.The patient did not have an infection on (b)(6) 2020 and the device was not explanted on (b)(6) 2020.Per the clinic, the patient was placed under general anaesthesia on (b)(6) 2021, for an abscess needle aspiration.The issue did not resolve and the abscess returned on (b)(6) 2021.The patient was placed under general anaesthesia on (b)(6) 2021, for the second skin revision surgery.Subsequently, the patient was treated with oral antibiotics for a duration of 14 days and topical antibiotics for a duration of 7 days.

• 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: 10172651
• MDR Text Key: 195710781
• Report Number: 6000034-2020-01531
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)180912(17)200911
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022,11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2020
• Device Model Number: CI532
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2022
• Distributor Facility Aware Date: 11/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male