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Adverse Event Report

COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM   back to search results
Model Number CI24M
Device Problem Device failure
Event Date 06/03/2003
Event Type  Malfunction  
Event Description

The recipient stopped responding to sound after an accident. Using the appropriate diagnostic equipment, it was determined that the device is not functioning according to manufacturer's specifications. Explantation/reimplantation surgery is yet to be scheduled. The healthcare professional has been informed that the explanted device should be returned to cochlear ltd.

 
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Brand NameNUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device24 CHANNEL COCHLEAR IMPLANT
Baseline Brand NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Baseline Generic NameCOCHLEAR IMPLANT
Baseline Model NumberCI24M
Baseline Device FamilyCOCHLEAR IMPLANT
Baseline Device 510(K) Number
Baseline Device PMA NumberP840024
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed06/25/1998
Manufacturer (Section F)
COCHLEAR LTD.
14 mars road
lane cove, nsw
AUSTRALIA 2066
Manufacturer (Section D)
COCHLEAR LTD.
14 mars road
lane cove, nsw
AUSTRALIA 2066
Manufacturer Contact
marilyn nelson, r.n.
400 inverness drive south
suite 400
englewood , CO 80112
(303) 790 -9010
Device Event Key455276
MDR Report Key466331
Event Key441929
Report Number6000034-2003-00112
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberCI24M
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Date Manufacturer Received06/03/2003
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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