BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3032197 · Received March 29, 2013

    Report

    Report Number
    3006556115-2013-00120
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE REPOSITIONING SURGERY WENT WELL AND THE PT'S DEVICE HAS BEEN ACTIVATED. THE PT IS DOING WELL AND REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S ELECTRODE HAD EXTRUDED. A SURGERY WAS PERFORMED TO REPOSITION AND REINSERT THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131028 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention