• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR LIMITED NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE(CA)
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Edema (1820); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on july 14, 2020.
 
Event Description
Per the clinic, the patient experienced oedema and infection at the implant site.The device was explanted on (b)(6) 2020.It is unknown if there are plans to re-implant the patient with another device.
 
Manufacturer Narrative
Correction: the correct date of awareness is may 11, 2020; not april 15, 2020 as previously reported on july 14, 2020.Device analysis report attached.This report is submitted on may 16, 2024.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
Manufacturer (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS   2109
Manufacturer Contact
amirah rosly
unit ug-1, vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key10269076
MDR Text Key198678472
Report Number6000034-2020-01888
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502007320
UDI-Public(01)09321502007320(11)131104(17)151103
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 05/11/2020
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 Date11/03/2015
Device Model NumberCI24RE(CA)
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received07/14/2020
Supplement Dates Manufacturer Received05/11/2020
Supplement Dates FDA Received05/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-