Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Device Stops Intermittently (1599)
Patient Problem Hearing Impairment (1881)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
This report is submitted on (b)(6) 2018.
 
Event Description
Per the clinic, the patient experienced intermittencies with the internal device, however, the issue could not be resolved.The implanted device remains.
 
Manufacturer Narrative
Per the clinic, the device was explanted on (b)(6) 2018 and the patient was reimplanted with another device during the same surgery.
 
Manufacturer Narrative
This report is filed on october 04, 2018.(b)(4).
 
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
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7442353
MDR Text Key105881201
Report Number6000034-2018-00919
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24RE (CA)
Device Catalogue NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/03/2018
Was Device Evaluated by Manufacturer? Yes
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 Age71 YR
-
-