BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3240383 · Received July 18, 2013

    Report

    Report Number
    3006556115-2013-00352
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE PT HAD VIRAL LABYRINTHITIS AND DID NOT HAVE MENINGITIS. THE SURGEON REPORTED THAT THE PT'S INFECTION IS NOT RELATED TO THE PT'S IMPLANTED DEVICE. THE PT IS BILATERALLY IMPLANTED. THE DOCTOR'S OFFICE REPORTED THAT THEY ARE UNABLE TO DETERMINE WHICH EAR AND WHICH DEVICE WAS THE CAUSE OF THE LABYRINTHITIS. THE PT IS USING THE IMPLANTED DEVICE. THE PT IS REPORTEDLY DOING WELL. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED IN THE ICU WITH THE DIAGNOSIS OF LABYRINTH INFECTION WITH MENINGITIS SYMPTOMS. THE PT RECEIVED IV ANTIBIOTICS MEDICATIONS INCLUDE ROCEPHIN 1300 MG INJECTION, AND ROCEPHIN 652 MG, VANCOMYCIN 260 MG. THE PT WAS OBSERVED FOR EQUILIBRIUM FOR 48 HOURS. NO FEVERS WERE OBSERVED SINCE (B)(6) 2013. THE PT WAS SENT HOME WITH CIPRODEX DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336130 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Hospitalization| R