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Adverse Event Report

COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM   back to search results
Model Number CI24RCS
Device Problem Emergency table stop failure
Event Date 11/19/2002
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the patient hit their head on the side of table when trying to climb into a chair. As a result of the impact the magnet was dislodged from the magnet pock and was sitting over the receiver/stimulator. Due to the improper location of the magnet no telemetry was obtained when checked at the clinic. An integrity test was conducted and showed that it was possible to find a very small area over the receiver coil where the implant would function. This position showed that the magnet has dislodged by approximately 2cm. Whilst holding the coil in the correct position, all tests of the receiver stimulator integrity gave normal results, including telemetry. The patient was re-implanted. A tear in the silicone carrier around the magnet was observed. There was a kink in wires of the antenna coil. Multiple kinks and bends along the electrode array lead consistent with explantation were observed. The ball electrode lead was severed close to the stimulator body. When the magnet was placed at the original position, the device passed all the tests stimulator body. When the magnet was placed at the original position, the device passed all the tests conducted to confirm proper operation of the stimulator. The device failed all the tests conducted when the magnet was positioned halfway on top of the receiver/stimulator. The device was explanted because the magnet was dislodged due to an external impact. Operation of the stimulator was confirmed when the magnet was returned to its original position.

 
Event Description

The device was explanted as the dislodged magnet could not be reinserted. 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 NumberCI24RCS
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 Key441015
MDR Report Key452017
Event Key428094
Report Number6000034-2003-00049
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberCI24RCS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/30/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Date Manufacturer Received02/25/2003
Was Device Evaluated By Manufacturer? Yes
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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