MAUDE Adverse Event Report: COCHLEAR LIMITED 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  malfunction  

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 re-implanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted on december 29, 2022.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report attached.This report is submitted on march 02, 2023.

• Brand Name: NUCLEUS® HYBRID S12
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16065639
• MDR Text Key: 306316138
• Report Number: 6000034-2022-03898
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

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
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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