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 Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2017, by (b)(4).

Event Description

Per the clinic, the patient reportedly developed an inner ear infection and was subsequently treated with antibiotic ear drops.The implanted device remains and the patient continues to clinically managed by their healthcare provider.

• 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
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6970152
• MDR Text Key: 90024671
• Report Number: 6000034-2017-01884
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)170406(17)190405
• 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
• Report Date: 10/03/2017

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: 04/05/2019
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/23/2017
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention