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

Model Number CI532

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Impairment (1881); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 14, 2022.

Event Description

Per the clinic, the patient experienced poor performance with the device.The device was explanted on (b)(6) 2021.The patient was reimplanted with a new device during the same surgery.

Event Description

Correction: the previous or initial mdr submitted on february 14, 2022 was filed inadvertently.No device malfunction/ explantation or serious injury has occurred.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 13519492
• MDR Text Key: 285523379
• Report Number: 6000034-2022-00396
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)170301(17)190228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022,03/08/2022

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: 02/28/2019
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Distributor Facility Aware Date: 03/08/2022
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female