BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2090806 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00220
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF TINGLING DOWN THE SIDE OF HER NECK FROM THE IMPLANT AND A METALLIC TASTE. THE PATIENT REPORTED PAIN ON PALPATION OF THE HEADPIECE AT THE IMPLANT SITE. THE SURGEON OBSERVED TISSUE SOFTNESS AT THE IMPLANT SITE. THE PATIENT'S DEVICE WAS EXPLANTED. THE SURGEON REPORTED NO SIGNS OF INFECTION. THE PATIENT IS BEING MONITORED.

    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 15 YR Required Intervention