MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 04, 2021.

Event Description

Per the clinic, the patient had a fall and experienced loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2021.The patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on july 20, 2021.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11936577
• MDR Text Key: 254270111
• Report Number: 6000034-2021-01608
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)181121(17)201120
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 MO