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 ASKU; 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 ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested regarding the brand name and model number of the implanted device: this information has been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on december 30, 2019.
 
Event Description
Per the clinic, the patient experienced a magnet dislodgement during an mri (tesla strength unknown).The patient's head was not wrapped as recommended by cochlear.The device was explanted (date unknown) and the patient was reimplanted with a new device during the same surgery.
 
Manufacturer Narrative
Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2020-00113.This report is submitted june 11, 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASKU
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS  2109
MDR Report Key9533673
MDR Text Key173163931
Report Number6000034-2019-02964
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/31/2019,05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberASKU
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/31/2019
Date Report to Manufacturer12/09/2019
Date Manufacturer Received05/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-