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

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM 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 LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE (CA)
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on 15 october 2020.
 
Event Description
Per the clinic, the device was explanted on (b)(6) 2020 due to extrusion of the receiver-stimulator.The patient was not re-implanted with a new device.
 
Manufacturer Narrative
The device analysis report is attached.This report is submitted on november 6, 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE 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 Key10681703
MDR Text Key211429052
Report Number6000034-2020-02772
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502007320
UDI-Public(01)09321502007320(11)120515(17)140514
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/14/2014
Device Model NumberCI24RE (CA)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Date Manufacturer Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
-
-