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Adverse Event Report

COCHLEAR LTD NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN   back to search results
Model Number C122M
Event Date 01/21/1998
Patient Outcome  Required Intervention;
Event Description

The pt complained of not hearing as well as she had previously. An otoscopic exam showed the tympanic membrane was severely retracted. The surgeon inserted a ventilation tube into the tympanic membrane. Several weeks later the pt again complained of not hearing well. Psychophysical testing suggest that the electrode array has partially migrated out of the cochiea. Surgical intervention had not been scheduled as of the date of this report.

 
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Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN
Type of Device22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN
Baseline Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
Baseline Generic Name22 CHANNEL COCHLEAR IMPLANT FOR ADULTS
Baseline Catalogue NumberNA
Baseline Model NumberC122M
Other Baseline ID Number202203
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
COCHLEAR LTD
14 mars rd
lane cove
AUSTRALIA NSW 2066
Distributor
COCHLEAR AMERICAS
400 inverness pkwy., suite 400
englewood, CO 80112
Device Event Key141332
MDR Report Key144964
Event Key136127
Report Number1721493-1998-00001
Device Sequence Number1
Product CodeMCM
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/22/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberC122M
OTHER Device ID Number202518
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age4 yr
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer01/22/1998
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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