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Adverse Event Report

COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM   back to search results
Model Number CI24R (CS)
Device Problem Emergency table stop failure
Event Date 05/20/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

After 15 months of use, this pt received no apparent functional benefit from the device. Based on the results of follow up radilogical studies, it was hypothesized that the pt's 8th cranial nerve was either missing or underdeveloped (i. E. Congenital anomaly), and the device was surgically explanted in 2004.

 
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Brand NameNUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device24 CHANNEL COCHLEAR IMPLANT
Baseline Brand NameNUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Baseline Generic Name24 CHANNEL COCHLEAR IMPLANT
Baseline Catalogue NumberNA
Baseline Model NumberCI24R (CS)
Baseline Device 510(K) Number
Baseline Device PMA Number
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
patti arndt, ccc-a
400 inverness drive south
suite 400
englewood , CO 80112
(303) 790 -9010
Device Event Key516851
MDR Report Key527678
Event Key500912
Report Number6000034-2004-00157
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberCI24R (CS)
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Date Manufacturer Received05/24/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
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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