MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Unintended Electrical Shock (4018)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced shocking sensation with the internal device use resulting in discomfort.Subsequently, the device was explanted on (b)(6) 2023, and the patient was re-implanted with another cochlear device during the same surgery.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17008846
• MDR Text Key: 315990615
• Report Number: 6000034-2023-01617
• 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: 05/26/2023,05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2023
• Distributor Facility Aware Date: 05/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male