BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2103696 · Received May 3, 2011

    Report

    Report Number
    3006556115-2011-00249
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED EXPERIENCING SOUND QUALITY ISSUES WITH HIS DEVICE AND MILD SHOCKS WITHOUT THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED. A CT SCAN WAS PERFORMED TO REVEAL EXTRACOCHLEAR ELECTRODES. THE CTR WILL PURSUE DEVICE REVISION SURGERY.

    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