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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI622
Device Problem Expulsion (2933)
Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681); Drug Resistant Bacterial Infection (4553)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced an infection and extrusion of receiver/stimulator, exposing the device (specific date not reported).Subsequently, the device was explanted on (b)(6) 2024.There are no plans to re-implant the patient with a new device as of the date of this report.
 
Event Description
Per the clinic, the patient experienced a skin breakdown at implant site and subsequently was treated with oral antibiotics (specific date and duration not reported).
 
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Brand Name
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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 Key18785578
MDR Text Key336281774
Report Number6000034-2024-00650
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 03/22/2024,02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2024
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2024
Distributor Facility Aware Date02/28/2024
Date Report to Manufacturer02/28/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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