MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 4, 2019.

Event Description

Per the clinic, the patient experienced a necrosis resulting in the device being explanted on (b)(6) 2019.The patient was re-implanted with another device at the same surgery time.

Manufacturer Narrative

Correction: additional information received on july 23, 2019, reported that this ci422 device explanted on (b)(6) 2018 due to infection and extrusion of stimulator.

Manufacturer Narrative

This report is submitted decmeber 23, 2019.- attachment: [149278 device analysis report reg.Pdf].

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8761825
• MDR Text Key: 150119657
• Report Number: 6000034-2019-01099
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)180212(17)200211
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2019,11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2020
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Distributor Facility Aware Date: 07/16/2019
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 MO