BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1901441 · Received November 4, 2010

    Report

    Report Number
    3006556115-2010-00542
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 27, 2005
    Report Date
    October 15, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED IRRITATION AND CRUSTING AT THE IMPLANT SITE. THE PT WAS PRESCRIBED IRVXOL GEL. ON (B)(6) 2006 THE PT'S WOUND WAS DRAINED. ON (B)(6) 2007 THE PT UNDERWENT DEVICE REPOSITIONING SURGERY DUE TO REFERRED PAIN. THE PT CONTINUED TO EXPERIENCE PAIN. THE PT'S DEVICE WAS EXPLANTED. THE PT'S REPORTEDLY DOING WELL AFTER EXPLANATION.

    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 49 YR Required Intervention