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

Model Number P783831

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Bilateral profound sensorineural hearing loss.Surgeon: during the implantation of the cochlear implant doctor asked me to open the backup cochlear implant.He stated that the electrode malfunction.I reminded him about taking an x-ray prior to opening the backup and he stated that it was not a placement problem, but the device was defective.The faulty device was tagged and taken to clinician¿s office.

• Brand Name: COCHLEAR NUCLEUS
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 13059 e peakview ave; centennial CO 80111
• MDR Report Key: 12413198
• MDR Text Key: 269530841
• Report Number: 12413198
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P783831
• Device Catalogue Number: P783831
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 58