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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LIMITED ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced magnet dislodgements(specific date not reported).Surgery to replace the magnet was completed on (b)(6) 2023.The implanted device remains.
 
Event Description
Correction: this mdr was a duplicate.Any further information will be provided with report number: 6000034-2023-02320.
 
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Brand Name
ASKU
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
MDR Report Key17253479
MDR Text Key318350001
Report Number6000034-2023-02116
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
Type of Report Initial,Followup
Report Date 09/05/2023,08/15/2023
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? Yes
Device Operator Lay User/Patient
Device Model NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2023
Distributor Facility Aware Date08/15/2023
Event Location Hospital
Date Report to Manufacturer08/15/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/04/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/04/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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