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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI22M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missing Value Reason (3192)
Event Date 03/09/2020
Event Type  Injury  
Event Description
Per the patient's surgeon, the device was explanted on (b)(6) 2020, due to elective non-use of the device.There are no plans to reimplant the patient as of the date of this report.
 
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Brand Name
NUCLEUS 22
Type of Device
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key9908874
MDR Text Key186732624
Report Number6000034-2020-01018
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2020,03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
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 Manufacturer03/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2020
Distributor Facility Aware Date03/09/2020
Event Location Hospital
Date Report to Manufacturer04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
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