BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1021224 · Received March 21, 2008

    Report

    Report Number
    3006556115-2008-00142
    Event Type
    Injury
    Date Received
    March 21, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    ADVANCED BIONICS WAS NOTIFIED THAT THE PATIENT REPORTEDLY DEVELOPED AN INFECTION ON THE IMPLANT SITE. THE PATIENT WAS REPORTEDLY TREATED WITH INTRA-VENOUS ANTIBIOTICS (TYPE UNKNOWN) IN THE HOSPITAL, THE PATIENT WILL FOLLOW THIS TREATMENT FOR 10 DAYS. THE IMPLANT SURGEON REPORTED THAT THE PATIENT'S ANTIBIOTICS TREATMENT WENT WELL AND THE PT WOULD CONTINUE TO TAKE ORAL ANTIBIOTICS TO AVOID THE BACTERIAL BIOFILM OVER THE DEVICE. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. WHEN MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention