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

Model Number CI24RE (L24)

Device Problem Expulsion (2933)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient developed a wound breakdown around the implant site, exposing the receiver/stimulator.It was also a reported infection (site of infection not confirmed).The patient was treated with antibiotics (type and date not reported).There are plans to explant the device and to re-implant the patient with a new device; however, this has not occurred as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: the previous mdr submitted on april 05,2023, was filed inadvertently.No infection has occurred.Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023 in order to explant the device and underwent a skin flap revision surgery.There are no plans to reimplant the patient with another cochlear device as of the date of this report.

• 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: 16679782
• MDR Text Key: 312671572
• Report Number: 6000034-2023-01165
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)140816(17)160815
• 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: 05/02/2023,04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2016
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2023
• Distributor Facility Aware Date: 04/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male