BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2024260 · Received March 8, 2011

    Report

    Report Number
    3006556115-2011-00087
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO REPORTED PAIN AND SWELLING AT THE IMPLANT SITE. THE PT WAS ALSO REPORTEDLY EXPERIENCING POOR SOUND QUALITY WITH THE DEVICE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE. THE COMPANY IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION.

    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 39 YR