BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2831628 · Received November 9, 2012

    Report

    Report Number
    3006556115-2012-00497
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE THAT THE PATIENT EXPERIENCED A PERILYMPH GUSHER DURING IMPLANT SURGERY. 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
    1 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO Required Intervention| S