NUCLEUS 22 CI22M NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for NUCLEUS 22 CI22M NA manufactured by Cochlear Ltd.

Event Text Entries

[187040005] This report is submitted on 31 march 2020.
Patient Sequence No: 1, Text Type: N, H10

[187040006] It was reported that the device was explanted on (b)(6) 2020 due to the patient's need to undergo mri's for medical reasons. The patient was re-implanted with new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00913
• MDR Report Key: 9901207
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-30
• Date of Report: 2020-03-05
• Date of Event: 2020-02-05
• Date Mfgr Received: 2020-03-05
• Date Added to Maude: 2020-03-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KRISTEL KOHNE
• Manufacturer Street: 1 UNIVERSITY AVENUE
• Manufacturer City: MACQUARIE UNIVERSITY, NSW 2109,
• Manufacturer Country: AS
• Manufacturer Postal: 2109,
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NUCLEUS 22
• Generic Name: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Product Code: MCM
• Date Received: 2020-03-30
• Returned To Mfg: 2020-03-05
• Model Number: CI22M
• Catalog Number: NA
• Lot Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR LTD
• Manufacturer Address: 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-30