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

Model Number Z382660

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Pain (1994)

Event Date 05/08/2018

Event Type  Injury  

Event Description

An elderly female patient had a cochlear implant placed on right side approximately 3 years ago.After the implant, she began to develop pain over the magnet site of her implant and was not able to wear the device due to the pain.There was a ct scan earlier this year that showed something overlying the magnet area of the implant.The patient underwent surgical exploration and removal of a cochlear implant template approximately 2 weeks later.

• Brand Name: NUCLEUS
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 10350 park meadows drive; lone tree CO 80124
• MDR Report Key: 12041120
• MDR Text Key: 257434591
• Report Number: 12041120
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Z382660
• Device Catalogue Number: Z382660
• 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: 06/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30660 DA