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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI632
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Per the clinic, the patient was treated with 16 and 21 day courses of oral steroids (specific date not reported) due to an unknown reason.Additional information has been requested but has not been made available as of the date of this report.
 
Event Description
Correction: the initial mdr submitted on january 05, 2024 was filed inadvertently.Steroid was administered prior to implantation.
 
Event Description
Per the clinic, the device was explanted on (b)(6) 2024, and the patient was reimplanted with another cochlear device during the same surgery.
 
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Brand Name
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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 Key18450175
MDR Text Key332170580
Report Number6000034-2024-00303
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,Followup
Report Date 03/22/2024,02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2024
Distributor Facility Aware Date02/05/2024
Date Report to Manufacturer02/05/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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