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

Model Number CI24RE (S12)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a performance decrement.The device was explanted on (b)(6) 2020, and the patient was reimplanted with a new device during the same surgery.

• 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
• MDR Report Key: 10999416
• MDR Text Key: 221228679
• Report Number: 6000034-2020-03521
• 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
• Report Date: 12/14/2020,11/24/2020

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: 12/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2020
• Distributor Facility Aware Date: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR