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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI22M
Device Problem No Device Output (1435)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on 1 october 2020.
 
Event Description
Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.
 
Manufacturer Narrative
It has now been reported that the device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.This report is submitted on december 10, 2020.
 
Event Description
It has now been reported that the device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.
 
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Brand Name
NUCLEUS 22
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key10610806
MDR Text Key209327658
Report Number6000034-2020-02654
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 12/10/2020,11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCI22M
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2020
Distributor Facility Aware Date11/20/2020
Date Report to Manufacturer11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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