MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS® HYBRID S12; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (S12)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 12/02/2022

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2022 due to poor performance, pain and non-auditory sensations.The patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

Per the clinic, the patient underwent multiple revision surgeries (specific dates not reported).This report is submitted on december 22, 2023.

• Brand Name: NUCLEUS® HYBRID S12
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16065636
• MDR Text Key: 306316073
• Report Number: 6000034-2022-03899
• Device Sequence Number: 1
• Product Code: PGQ
• 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,Followup
• Report Date: 12/29/2022,11/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (S12)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Distributor Facility Aware Date: 12/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 12/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male