BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED BIONICS

    MDR report key: 764331 · Received September 22, 2006

    Report

    Report Number
    MW1040491
    Event Type
    Other
    Date Received
    September 22, 2006
    Report Date
    September 22, 2006
    Manufacturer
    ADVANCED BIONICS CORP
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE T-MIC OF MY PLATINUM BTE COCHLEAR IMPLANT - A PRODUCT OF ADVANCED BIONICS CORP, A WHOLLY OWNED SUBSIDIARY OF BOSTON SCIENTIFIC CORP- HAS MADE TELEPHONE CONVERSATIONS EXTREMELY DIFICULT FOR ME. WHEN I VISITED MY AUDIOLOGIST AT HOSP, HE THOUGHT THERE MIGHT BE SOME MOISTURE IN THE T-MIC WHICH WAS CAUSING THE PROBLEM. I TRIED ANOTHER T-MIC THAT HE HAD AND DIDN'T HAVE ANY OF THE PROBLEMS I DID WITH MINE. WHEN I GOT BACK TO MY HOME, I TRIED TO ELIMINATE THE MOISTURE BY PLACING- IT IN THE HAL-HEN DRI-AID KIT WHICH WAS INCLUDED WITH MY BTE. THIS WAS UNSUCCESSFUL. WHAT IS MY NEXT STEP? THIS PRODUCT IS STILL UNDER WARRANTY AND I WOULD LIKE TO REMEDY THIS SITUATION BEFORE THE WARRANTY EXPIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED BIONICS T-MIC MCM ADVANCED BIONICS CORP CI - 5625 -310 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other