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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hearing Impairment (1881); Undesired Nerve Stimulation (1980)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 30, 2019.
 
Event Description
Per the clinic, the device was explanted on (b)(6) 2019, due to poor performance from onset and facial nerve stimulation.The patient was reimplanted with another cochlear device during the same surgery.
 
Manufacturer Narrative
This report is submitted on 1 may 2020.
 
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Brand Name
NUCLEUS 24
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS  2109
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key9528774
MDR Text Key172999096
Report Number6000034-2019-02934
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
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;
Patient Age23 YR
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