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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM
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COCHLEAR LTD. NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM Back to Search Results
Model Number CI22M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Missing Value Reason (3192)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
This report is filed february 17, 2016.
 
Event Description
Per the patient's surgeon, the device was explanted on (b)(6) 2015, due to the patient requiring regular mri scans.There are currently no plans to reimplant the patient with a new device as of the date of this report, february 17, 2016.
 
Manufacturer Narrative
This report is filed may 10, 2016.
 
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Brand Name
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device
MCM
Manufacturer (Section D)
COCHLEAR LTD.
14 mars rd
lane cove, nsw 2066
AS  2066
Manufacturer Contact
bianca hanlon
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key5439706
MDR Text Key38281223
Report Number6000034-2016-00352
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P840024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI22M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2016
Was Device Evaluated by Manufacturer? Yes
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;
Patient Age29 YR
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