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

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, it was reported that the device was explanted on (b)(6) 2018, due to an infection.

Manufacturer Narrative

This report is filed on february 07, 2019.

Manufacturer Narrative

It was reported the infection was treated with oral and topical antibiotics (date not reported).This report is filed on march 18, 2019.

• Brand Name: NUCLEUS HYBRID L24
• 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: 8255568
• MDR Text Key: 133347096
• Report Number: 6000034-2019-00044
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)160314(17)180313
• 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,Followup
• Report Date: 02/21/2019

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: 03/13/2018
• 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: 01/16/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/25/2019; 02/21/2019
• Supplement Dates FDA Received: 02/06/2019; 03/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention