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

Model Number CI532

Device Problem Positioning Failure (1158)

Patient Problem Injury (2348)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 15, 2019.

Event Description

Per the clinic, the device was explanted on (b)(6) 2019, due to a tip fold over of the electrode array during initial implantation.The patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted 03 december 2019.- attachment: [157173 device analysis report.Pdf].

• 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, 2109 ; AS 2109
• MDR Report Key: 9188786
• MDR Text Key: 162358437
• Report Number: 6000034-2019-02073
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)180413(17)200412
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR