BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2831239 · Received November 6, 2012

    Report

    Report Number
    3006556115-2012-00493
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO DEHISCENCE AT THE IMPLANT SITE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFORMATION IS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Required Intervention