MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 24, 2019.

Event Description

Per the patient's surgeon, it was reported that during initial implantation surgery performed on (b)(6) 2019, the surgeon experienced complications during insertion.The surgeon reportedly experienced resistance whilst inserting the electrode and sheath and as a result, the sheath allegedly became detached.Subsequently, the surgeon removed the implant, however, the sheath material could not be located and was left insitu.The patient was successfully implanted with the back-up cochlear device with no other complications reported.There were no report of patient injury associated with this event.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9513532
• MDR Text Key: 188060899
• Report Number: 6000034-2019-02924
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)190905(17)210904
• 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
• Report Date: 12/04/2019

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: 09/04/2021
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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