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 Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 7, 2018, by cochlear limited on behalf of cochlear americas.Exemption number (b)(4).

Event Description

Per the clinic, the patient developed an infection resulting in the decision to explant the device.The implanted device remains at this time.However, explant is planned but has not taken place at the time of this report.Additional information has been requested but has not been made available at the time of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2018.This report is filed on october 05, 2018.(b)(4).

• 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: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7854187
• MDR Text Key: 119486965
• Report Number: 6000034-2018-01863
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)180109(17)200108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

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: 01/08/2020
• 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: 09/27/2018
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• 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: 59 YR