BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3060079 · Received April 11, 2013

    Report

    Report Number
    3006556115-2013-00138
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    November 1, 2011
    Report Date
    March 15, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT WAS EXPLANTED IN (B)(6) 2011. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFO; ONCE FURTHER INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154290 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention