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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24R (CS)
Medical Device Problem Code Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Code Pain (1994)
Date of Event 09/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report is submitted on sept 30, 2021.
 
Event or Problem Description
Per the clinic, the device was explanted on (b)(6) 2021 due to pain and non-auditory sensations.There are no plans to reimplant the patient with another cochlear device as of the date of this report.
 
Additional Manufacturer Narrative
Device analysis has indicated device failure.Device analysis report attached.This report is submitted on october 29, 2021.
 
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Brand Name
NUCLEUS 24 CONTOUR
Common Device Name
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
MDR Report Key12552136
Report Number6000034-2021-02985
Device Sequence Number3501807
Product Code MCM
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P970051
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/13/2021
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
Operator of Device Lay User/Patient
Device Model NumberCI24R (CS)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Initial Date Received by Manufacturer 09/10/2021
Supplement Date Received by Manufacturer10/13/2021
Initial Report FDA Received Date09/30/2021
Supplement Report FDA Received Date10/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age31 YR
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