• 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 CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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 CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI622
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 08/04/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced poor performance with device use. Imaging confirmed incorrect placement of the electrode array. Subsequently, the device was explanted on (b)(6) 2020, and the patient was reimplanted with another cochlear device during the same surgery.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS 2109
MDR Report Key10470275
MDR Text Key204865959
Report Number6000034-2020-02255
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/31/2020,08/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI622
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2020
Distributor Facility Aware Date08/10/2020
Event Location Hospital
Date Report TO Manufacturer08/31/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
-
-