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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI522
Device Problem No Device Output (1435)
Patient Problem No Code Available (3191)
Event Date 07/22/2020
Event Type  Injury  
Event Description
Per the clinic, the patient experienced a loss of connection to the internal device; however the issue could not be resolved.The device was explanted on (b)(6) 2020.Reimplantation with a new device is planned; but has yet to occur as of the date of this report.
 
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Brand Name
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key10475332
MDR Text Key205108999
Report Number6000034-2020-02286
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502032599
UDI-Public(01)09321502032599(11)180710(17)200709
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/01/2020,08/12/2020
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 Date07/09/2020
Device Model NumberCI522
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/01/2020
Distributor Facility Aware Date08/12/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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