BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 369994 · Received January 2, 2002

    Report

    Report Number
    2029203-2001-00126
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    February 1, 2001
    Report Date
    December 21, 2001
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED IN AN ATTEMPT TO REPOSITION THE ELECTRODE ARRAY INSIDE THE COCHLEAR. DURING THE SURGERY, IT WAS REPORTED THAT THE ELECTRODE APPEARED TO BE "CRUNCHED" AND ONE OF THE CHANNELS MEASURED HIGH IMPEDANCES. FOR THESE REASONS, THE DECISION WAS MADE TO REPLACE THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100H *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO