BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3940264 · Received June 19, 2014

    Report

    Report Number
    3006556115-2014-00305
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY HAD AN INFECTION AT THE IMPLANT SITE POST IMPLANT SURGERY. THE PT WAS HOSPITALIZED. THE PT HAD RECOVERED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE ADD'L INFO IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359479 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R