MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR NUCLEUS CI612 COCHLEAR IMPLANT; IMPLANT, COCHLEAR

Model Number P774600

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Cochlear implant ci612 electrode coiled during implantation.

• Brand Name: COCHLEAR NUCLEUS CI612 COCHLEAR IMPLANT
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 10350 park meadows drive; lone tree CO 80124
• MDR Report Key: 16452168
• MDR Text Key: 310345275
• Report Number: 16452168
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P774600
• Device Catalogue Number: P774600
• Device Lot Number: 1020240317269
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Female