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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24R (CS)
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced pain at the magnet site and subsequently, was treated with antibiotics (type, date and duration not reported).
 
Event Description
Per the clinic, the patient experienced magnet dislodgement during an mri in (b)(6) 2023 (specific tesla strength and date not reported).The device was explanted on (b)(6) 2023 and the patient was reimplanted with a new cochlear device during the same surgery.
 
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Brand Name
NUCLEUS 24 CONTOUR
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
MDR Report Key17620942
MDR Text Key321917006
Report Number6000034-2023-02699
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 01/16/2024,12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCI24R (CS)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/16/2024
Distributor Facility Aware Date12/21/2023
Event Location Hospital
Date Report to Manufacturer12/21/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/16/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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