MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced magnet dislodgement after an mri (1.5 tesla).The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: the initial mdr submitted on july 20, 2023 was filed inadvertently.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 17358717
• MDR Text Key: 319378143
• Report Number: 6000034-2023-02308
• Device Sequence Number: 1
• Product Code: PGQ
• 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,Followup
• Report Date: 08/17/2023,06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2023
• Distributor Facility Aware Date: 06/29/2023
• Date Report to Manufacturer: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female