BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2900956 · Received January 3, 2013

    Report

    Report Number
    3006556115-2012-00606
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S ELECTRODE ARRAY WAS PARTIALLY INSERTED IN THE COCHLEA. THE PT UNDERWENT SURGERY TO REPOSITION THE ELECTRODE ARRAY ON (B)(6) 2012. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION; ONCE MORE INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention