BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2103705 · Received May 19, 2011

    Report

    Report Number
    3006556115-2011-00246
    Event Type
    Injury
    Date Received
    May 19, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT WAS REPORTEDLY HAVING SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. TESTING OF THE DEVICE REVEALED THAT THE DEVICE IS FUNCTIONING. CT SCAN REVEALED THAT THE ELECTRODE IS EXTRUDING. SURGERY TO REPOSITION THE ELECTRODE WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC. CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention