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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE (CA)
Device Problem Expulsion (2933)
Patient Problems Necrosis (1971); Tissue Breakdown (2681)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced a skin flap necrosis and tissue breakdown, the patient also experienced electrode extrusion posterior to the pinna.Subsequently, the patient was treated with topical antibiotics.There are plans to explant the device; however, this has not occurred as of the date of this report.
 
Event Description
Per the clinic, the device was explanted on (b)(6) 2024, and the patient was re-implanted with another cochlear device during the same surgery.Additional information has been requested but has not been made available as of the date of this report.
 
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Brand Name
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key18718691
MDR Text Key335521109
Report Number6000034-2024-00548
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/24/2024,03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/20/2016
Device Model NumberCI24RE (CA)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2024
Distributor Facility Aware Date03/27/2024
Event Location Hospital
Date Report to Manufacturer03/27/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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