BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3093776 · Received April 30, 2013

    Report

    Report Number
    3006556115-2013-00169
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    December 1, 2012
    Report Date
    April 9, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL AND HIS HEAD IN (B)(6) 2012. THE PT'S IMPLANT SITE WAS SWOLLEN AND THE PT WAS TREATED WITH ANTI-INFLAMMATORY STEROIDS (TYPE UNK). THE SWELLING WAS REDUCED AND THE DEVICE APPEARED TO HAVE MIGRATED. IN (B)(6) 2013, THE SITE WAS FIRM TO TOUCH, BUT THERE WAS NO SIGN OF INFECTION. ON (B)(6) 2013, PREDNISONE (1 MG/KG) WAS PRESCRIBED FOR TWO WEEKS. THE PT'S DEVICE WAS DISPLACED AND BECAME EXPOSED. THE DEVICE WAS EXPLANTED. THE PT'S IMPLANT SITE IS REPORTEDLY HEALING WELL. REIMPLANT WILL BE SCHEDULED IN SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187352 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Required Intervention