MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CS)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/13/2019

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient experienced device retention issues.Troubleshooting was performed; however, the issue could not be resolved due to the patient's anatomy.Subsequently, the patient underwent revision surgery on (b)(6) 2019, in order reduce the skinflap over the implant.Revision surgery was successful and the implanted device remains insitu.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9073994
• MDR Text Key: 158769917
• Report Number: 6000034-2019-01851
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019,08/29/2019

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 Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2019
• Distributor Facility Aware Date: 08/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR