MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 7, 2023.

Event Description

Per the clinic, the patient experienced pain behind his ear (keloid) and cannot tolerate wearing the processor.The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• 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: 17467630
• MDR Text Key: 320471095
• Report Number: 6000034-2023-02448
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)210416(17)230415
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2023,07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2023
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2023
• Distributor Facility Aware Date: 07/12/2023
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male