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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 Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on (b)(6) 2020.
 
Event Description
Per the clinic, one day post implantation an x-ray was taken which showed that the electrodes were outside the cochlea.The device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.
 
Manufacturer Narrative
The device analysis report is attached.This report is submitted on december 4, 2020.
 
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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, 2109
AS  2109
MDR Report Key10667159
MDR Text Key211253513
Report Number6000034-2020-02793
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502032599
UDI-Public(01)09321502032599(11)190822(17)210821
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/13/2020
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 Date08/21/2021
Device Model NumberCI522
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/12/2020
Supplement Dates Manufacturer Received11/13/2020
Supplement Dates FDA Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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