MAUDE Adverse Event Report: COCHLEAR AMERICAS COCHLEAR; IMPLANT, COCHLEAR

Catalog Number NUCLEUS SLIM C1632

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Removal of left cochlear implant, non functioning.Fda safety report id# (b)(4).

• Brand Name: COCHLEAR
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR AMERICAS
• MDR Report Key: 14621517
• MDR Text Key: 293619207
• Report Number: MW5110130
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NUCLEUS SLIM C1632
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 180 KG
• Patient Race: White