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Adverse Event Report

COCHLEAR LTD. NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN   back to search results
Model Number CI22M
Event Date 02/03/1997
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

The pt reported no longer hearing on a few electrodes. Using the appropriate diagnostic equipment, it was determined that the device was functioning according to manufacturer's specifications except on 3 electrodes. The pt was re-programmed at the request of the child's parent. Explantation/reimplantation surgery done at the request of the child's parent. Device analysis was done and found a significant number of intermittently non-functioning electrodes. Therefore, this device was classified as not functioning within manufacturers specifications and an mdr is being filed.

 
Manufacturer Narrative

A copy of the analysis will be forwarded when a final version is available.

 
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Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN
Type of Device22 CHANNEL COCHLEAR IMPLANT
Baseline Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Baseline Generic Name22 CHANNEL COCHLEAR IMPLANT
Baseline Catalogue NumberNA
Baseline Model NumberCI22M
Baseline Device FamilyNA
Baseline Device 510(K) Number
Baseline Device PMA NumberP890027
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed10/31/1985
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 (Section G)
COCHLEAR LTD.
14 mars road
lane cove
AUSTRALIA NSW 2066
Manufacturer Contact
nancy fowler-brehm
61 inverness drive e, ste 200
englewood , CO 80112
(303) 790 -9010
Device Event Key188812
MDR Report Key194338
Event Key182660
Report Number6000034-1997-00025
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 02/25/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberCI22M
OTHER Device ID Number202022
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/15/1996
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Date Manufacturer Received02/03/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1990
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 December 31, 2008

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