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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI512
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The report is submitted on sep 30, 2021.
 
Event Description
Per the clinic, the patient experienced a magnet dislodgement during an mri.The patient's head was wrapped as recommended by cochlear.Additional information has been requested but has not been made available as of the date of this report.
 
Manufacturer Narrative
It was reported that the dislodged magnet was replaced on (b)(6) 2021.This report is submitted on oct 11, 2021.
 
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Brand Name
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
MDR Report Key12552866
MDR Text Key273982816
Report Number6000034-2021-02823
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502014564
UDI-Public(01)09321502014564(11)150501(17)170430
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2017
Device Model NumberCI512
Was Device Available for Evaluation? No
Date Manufacturer Received09/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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