BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2971854 · Received February 19, 2013

    Report

    Report Number
    3006556115-2013-00048
    Event Type
    Injury
    Date Received
    February 19, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT IS REPORTEDLY EXPERIENCING NO RESPONSE WITH STIMULATION. PROGRAMMING ADJUSTMENTS HAVE BEEN ATTEMPTED, HOWEVER THIS HAS NOT RESOLVED THE ISSUE. REVISION SURGERY HAS BEEN SCHEDULED; HOWEVER, THE SURGEON WANTS TO REMOVE THE DEVICE FROM THE IMPLANTED EAR AND IMPLANT ON THE OPPOSITE SIDE EAR DESPITE STRONG ENCOURAGEMENT THAT THIS IS NOT APPROVED OR RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72414 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention