MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB CI622 - COCHLEAR IMPLANT SYSTEM ELECTRODE ARRAY ASSEMBLY; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problems Increased Sensitivity (2535); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Pain (1994); Swelling/ Edema (4577)

Event Date 08/02/2023

Event Type  Injury  

Event Description

Per the audiologist, the patient experienced an ear infection (not device related), pain and loud sounds and he refused to wear his processor.An integrity test was performed under a general anaesthetic.The implant remains in-situ.

Manufacturer Narrative

This report is submitted on october 24, 2023.

• Brand Name: CI622 - COCHLEAR IMPLANT SYSTEM ELECTRODE ARRAY ASSEMBLY
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvigen 14; molnlycke, 435 3 3; AS 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvigen 14; molnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17992873
• MDR Text Key: 326348126
• Report Number: 6000034-2023-03426
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)211223(17)231222
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male