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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, PRODUCT CODE:
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COCHLEAR LTD . NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.; MCM, PRODUCT CODE: Back to Search Results
Model Number CI512
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hearing Impairment (1881)
Event Type  Injury  
Manufacturer Narrative
The implanted device remains.
 
Event Description
Per the clinic, the patient experienced poor performance with device use.The patient will undergo revision surgery; however, surgery has not been scheduled to date.The implanted device remains.
 
Manufacturer Narrative
Correction: the implanted date is (b)(6) 2011; not (b)(6) 2011 as previously reported.Per the clinic, the device was explanted on (b)(6) 2016; during the same surgery the patient was re-implanted with a new device.This report is filed may 11, 2016.
 
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Brand Name
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
Type of Device
MCM, PRODUCT CODE:
Manufacturer (Section D)
COCHLEAR LTD .
14 mars rd
po box 629
lane cove, nsw 2066
AS  2066
Manufacturer Contact
nicole hille
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5333431
MDR Text Key34638554
Report Number6000034-2015-02658
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2015
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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