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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM
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COCHLEAR LTD NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM Back to Search Results
Model Number CI24RE (ST)
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Date 06/06/2015
Event Type  Death  
Event Description
Per the clinic, the patient expired on (b)(6) 2015, due to complications subsequent to undergoing an initial cochlear implant surgery on (b)(6) 2015.Additional information has been requested but has not been made available as of the date of this report, (b)(6) 2015.
 
Manufacturer Narrative
(b)(4).Device not available for analysis.
 
Manufacturer Narrative
Per the clinic, the patient underwent initial implant surgery on (b)(6) 2015.The patient underwent additional surgery (neurosurgery) on (b)(6) 2015.During this procedure the device was explanted.The patient expired on (b)(6) 2015.No further information was reported.This report is filed on (b)(6) 2015.Device not available for analysis.
 
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Brand Name
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device
MCM
Manufacturer (Section D)
COCHLEAR LTD
14 mars rd
po box 629
lane cove, nsw 2066
AS  2066
Manufacturer Contact
rebekka jeger
1 university avenue
macquarie university, nsw 2109
AS   2109
1294286300
MDR Report Key4893716
MDR Text Key19983704
Report Number6000034-2015-01265
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Audiologist
Type of Report Initial
Report Date 07/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24RE (ST)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Death; Required Intervention;
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