BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3221606 · Received July 9, 2013

    Report

    Report Number
    3006556115-2013-00331
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    March 6, 2007
    Report Date
    June 19, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERILYMPH GUSHER DURING INITIAL IMPLANT SURGERY. THE PERILYMPH GUSHER WAS REPAIRED AND THE PATIENT WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313592 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention