BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1051597 · Received May 19, 2008

    Report

    Report Number
    3006556115-2008-00152
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ADVANCED BIONICS CORP
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE MONTHS AFTER DEVICE EXPLANT AND REIMPLANT, THE PT REPORTEDLY COMPLAINED THAT POOR PERFORMANCE IS WORST THAN THAT OF THE EARLIER DEVICE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS LLC COCHLEAR IMPLANT. IT WAS NOTED THAT ONLY A PARTIAL INSERTION WAS POSSIBLE DUE TO THE PT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP CI-1400-02H

    Patients

    Seq Age Sex Outcome Treatment
    1