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

Model Number CI632

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Per the clinic, it was reported that there was a tip foldover with the device during initial implantation performed on (b)(6) 2019.The patient was taken back into the operating room on (b)(6) 2019, in order to explant the device.The patient was reimplanted with another cochlear device during the same surgery.

• 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
• MDR Report Key: 9084948
• MDR Text Key: 159078993
• Report Number: 6000034-2019-01961
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)190712(17)210710
• 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
• Report Date: 09/19/2019,08/30/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2021
• Device Model Number: CI632
• 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: 09/19/2019
• Distributor Facility Aware Date: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention