MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Insufficient Information (3190)

Patient Problem Hearing Impairment (1881)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 02, 2019.

Event Description

Per the clinic, the patient experienced poor performance with the device.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted september 02, 2019.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8751448
• MDR Text Key: 149760668
• Report Number: 6000034-2019-01042
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)160307(17)180306
• Combination Product (y/n): N
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019,08/06/2019

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 Expiration Date: 03/06/2018
• Device Model Number: CI24RE (L24)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2019
• Distributor Facility Aware Date: 06/10/2019
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 09/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR