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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI632
Device Problems Circuit Failure (1089); Failure to Deliver Shock/Stimulation (1133); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on feb 22, 2024.
 
Event Description
Per the clinic, the patient experienced no hearing with the device because of a head trauma causing a migration of the electrode.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2024.The patient was re-implanted with a new device in the same procedure.
 
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Brand Name
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university, 2109
AS  2109
Manufacturer (Section G)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS   2109
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key18755329
MDR Text Key335930660
Report Number6000034-2024-00899
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/20/2023
Device Model NumberCI632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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