MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CS)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Headache (1880)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Per the surgeon, the patient experienced ongoing headaches.The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.

Manufacturer Narrative

This report is submitted on october 24, 2023.

• Brand Name: NUCLEUS 24 CONTOUR
• 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
• MDR Report Key: 17992878
• MDR Text Key: 326347980
• Report Number: 6000034-2023-03400
• 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: Physician
• Type of Report: Initial
• Report Date: 10/24/2023,09/28/2023

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 Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2023
• Distributor Facility Aware Date: 09/28/2023
• Date Report to Manufacturer: 09/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female