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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 CI24RE (CA)
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Implanted device remains.
 
Event Description
Per the clinic, the patient developed swelling and granulated tissue at the implant site.Subsequently, revision surgery was performed in (b)(6) 2016 in order to removed the granulation.An additional revision surgery was performed on the skinflap in (b)(6) 2016 (specific date not reported).The implanted device remains.
 
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Brand Name
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device
MCM
Manufacturer (Section D)
COCHLEAR LTD.
1 university avenue
macqaurie university, nsw 2109
AS  2109
Manufacturer Contact
bianca hanlon
1 university avenue
macquarie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6101310
MDR Text Key59834521
Report Number6000034-2016-02294
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502007320
UDI-Public(01)09321502007320(11)150717(17)170717
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 11/07/2016
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? No
Device Operator Lay User/Patient
Device Expiration Date02/17/2017
Device Model NumberCI24RE (CA)
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/07/2016
Initial Date FDA Received11/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2015
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;
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