BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1133423 · Received August 22, 2008

    Report

    Report Number
    3006556115-2008-00446
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    December 11, 2007
    Report Date
    July 24, 2008
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE AUDIT OF THE PREVIOUSLY REPORTED SURGERY FOR THE PT, IT WAS DISCOVERED THAT THE PT'S SECOND SURGERY WAS NOT REPORTED. ACCORDING TO THE INFO PROVIDED FROM THE FIELD, THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING ADDITIONAL INFO. WHEN MORE INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1