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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional information was requested regarding patient and device details; however, could not be made available as of the date of this report.Should more information be provided, a supplimentary report shall be submitted.This report is submitted december 21, 2017.
 
Event Description
Per the clinic, the decice was explanted in (b)(6) 2017 (specific date not reported) in order for the patient to undergo an mri.Following the mri, the patient was reimplanted with another cochlear device.
 
Manufacturer Narrative
Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2017-02321.
 
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Brand Name
NUCLEUS 24
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7136411
MDR Text Key95445026
Report Number6000034-2017-02272
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24M
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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