BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90K ADVANCED BIONICS

    MDR report key: 549962 · Received August 4, 2004

    Report

    Report Number
    MW1032931
    Event Type
    Malfunction
    Date Received
    August 4, 2004
    Date of Event
    August 3, 2004
    Report Date
    August 4, 2004
    Manufacturer
    ADVANCED BIONICS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH THE ADVANCED BIONIC 90K IMPLANT - ELECTRODES HAVING TO BE TURNED OFF IN PAIRS DUE TO "WIRES CROSSING OR FUSING" AKA "INTERFERENCE CAUSING WIRES TO FUSE ACROSS ELECTRODES" RESULTING IN DISTORTION OF SOUND IMPACTING HEARING/LANGUAGE DEVELOPMENT. FOUR OF THE 16 ELECTRODES HAD TO BE TURNED OFF. HAD TO GET A NEW MAP - PROGRAMMING THE REMAINING ELECTRODES TO HANDLE MORE FREQUENCIES SINCE THERE WAS A LOSS OF 4 ELECTRODES. NO ANSWERS FROM ADVANCED BIONICS AS TO WHY/HOW/WHEN THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90K ADVANCED BIONICS INTERNAL COCHLEAR IMPLANT DEVICE MCM ADVANCED BIONICS 90K AB IMPLANT *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Other