BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1833582 · Received September 7, 2010

    Report

    Report Number
    3006556115-2010-00434
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PERILYMPH FISTULA WAS CORRECTED AND THE PT WAS SUCCESSFULLY IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT DURING THE IMPLANT SURGERY, THE PT REPORTEDLY EXPERIENCED A PERILYMPH FISTULA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention