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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 Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 24, 2019.
 
Event Description
Per the clinic, the patient experienced a magnet dislodgement during an mri (tesla unknown).The patient's head was not wrapped as recommended by cochlear.Surgery to replace the magnet is yet to be performed.
 
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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
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9514212
MDR Text Key174876288
Report Number6000034-2019-03099
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502032599
UDI-Public(01)09321502032599(11)180705(17)200704
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/04/2020
Device Model NumberCI522
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/23/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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