BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3030349 · Received March 28, 2013

    Report

    Report Number
    3006556115-2013-00118
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT EXPERIENCED SWELLING OVER THE IMPLANT SITE. A SURGEON REPORTEDLY PERFORMED A PUNCTURE PROCEDURE. HOWEVER, THE PT'S DEVICE WAS EXPLANTED DUE TO DEVICE EXTRUSION. THE PT WAS IMPLANTED ON THE CONTRALATERAL SIDE WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE MORE INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127569 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention