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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI532
Device Problem Folded (2630)
Patient Problem No Code Available (3191)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative
This report is submitted june 19, 2018.
 
Event Description
Per the clinic, the tip of the electrode was found to be folded over in the cochlea and electrodes incorrectly placed, resulting in the decision to explant the device.The device was explanted on (b)(6) 2018, and the patient was reimplanted with a new device during the same surgery.
 
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Brand Name
NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7612290
MDR Text Key111426531
Report Number6000034-2018-01293
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502032612
UDI-Public(01)09321502032612(11)171017(17)191016
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 Health Professional
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/16/2019
Device Model NumberCI532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received03/30/2018
Supplement Dates FDA Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2017
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 Age65 YR
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