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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM
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COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM Back to Search Results
Model Number CI512
Device Problem Folded (2630)
Patient Problem No Code Available (3191)
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative
Device not received by manufacturer.
 
Event Description
Per the clinic, the tip of the electrode was found to be folded over in the cochlea, resulting in the decision to explant the device.The device was explanted (b)(6) 2015, and the patient was reimplanted with a new device during the same surgery.
 
Manufacturer Narrative
This report is filed march 11, 2016.
 
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Brand Name
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device
MCM
Manufacturer (Section D)
COCHLEAR LTD.
14 mars rd
po box 629
lane cove, nsw 2066
AS  2066
Manufacturer Contact
bianca hanlon
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key5199904
MDR Text Key30322037
Report Number6000034-2015-02276
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
970051
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 03/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2015
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 Age17 YR
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