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 Problems Hearing Impairment (1881); Pain (1994)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 10, 2017, (b)(4).

Event Description

Per the clinic, the patient experienced pain and a performance decrement resulting in the decision to explant the device on (b)(6) 2017.The patient was reimplanted with another cochlear device during the same surgery.

• 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; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 6933659
• MDR Text Key: 89153683
• Report Number: 6000034-2017-01895
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)160213(17)180212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 02/12/2018
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2016
• 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: 76 YR