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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
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/14/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per the patient's surgeon, the device was explanted on (b)(6) 2019 due to non-use.
 
Additional Manufacturer Narrative
The device analysis report is attached.This report is submitted on april 23, 2020.
 
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Brand Name
NUCLEUS 24
Common Device Name
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key9845808
Report Number6000034-2020-00750
Device Sequence Number16334751
Product Code MCM
UDI-Device Identifier09321502002325
UDI-Public(01)09321502002325(11)090309(17)110308
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P970051
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/08/2011
Device Model NumberCI24M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Initial Date Received by Manufacturer 02/20/2020
Supplement Date Received by Manufacturer03/31/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date04/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age35 YR
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