BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1334394 · Received March 3, 2009

    Report

    Report Number
    3006556115-2009-00109
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 12, 2009
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S SKIN AT THE IMPLANT SITE HAS SUNKEN IN, DUE TO THE ABSENCE OF BONE FROM THE REVISION MASTOIDECTOMY. THE SITE HAS BECOME A SITE OF CHRONIC EXTERNAL INFECTION, AND THIS PREVENTS THE PATIENT FROM WEARING SOME OF HER EXTERNAL EQUIPMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAS BEEN PICKING AT THE SKIN. MASTOID SURGERY TO RESOLVE THE ISSUE HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention