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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE(CA)
Device Problems Loose or Intermittent Connection (1371); Intermittent Shock/Stimulation (2287)
Patient Problem Hearing Impairment (1881)
Event Date 04/20/2022
Event Type  Injury  
Event Description
Per the clinic, the patient experienced sound intermittencies.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2022.The patient was re-implanted with a new device in the same procedure.
 
Manufacturer Narrative
This report is submitted on may 23, 2022.
 
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Brand Name
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key14479341
MDR Text Key292474416
Report Number6000034-2022-01445
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 Health Care Professional
Type of Report Initial
Report Date 05/23/2022,04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24RE(CA)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/23/2022
Distributor Facility Aware Date04/29/2022
Date Report to Manufacturer04/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexFemale
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