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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
Additional information was requested regarding patient and device details; however, could not be made available as of the date of this report.Should more information be provided, a supplementary report shall be submitted.This report is submitted december 21, 2017.
 
Event Description
Per the clinic, it was reported that the patient experienced a dislodgment of the internal magnet and subsequently underwent revision surgery on (b)(6) 2017, in order to place a new magnet in the pocket.
 
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Brand Name
ASKU
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7136223
MDR Text Key95447823
Report Number6000034-2017-02234
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/27/2017
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 Model NumberASKU
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2017
Initial Date FDA Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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