BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 405135 · Received July 17, 2002

    Report

    Report Number
    2029203-2002-00147
    Event Type
    Injury
    Date Received
    July 17, 2002
    Date of Event
    June 19, 2002
    Report Date
    July 17, 2002
    Manufacturer
    ADVANCED BIONICS CORP
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2/2002 THE SURGEON PERFORMED SURGERY TO DEBRIDE THE PT'S FLAP INFECTION. THE PT WAS TREATED WITH BOTH IV AND ORAL ANTIBIOTICS. IT IS REPORTED THAT THE PT HEALED AND RETURNED TO USING THE DEVICE. IN 03/2002, THE SURGEON TREATED THE PT FOR INFECTION; ETIOLOGY AND TREATMENT PRESCRIBED UNKNOWN. IN 06/2002, THE SURGEON REPORTED THAT THE PT WAS SEEN FOR AN INFECTION. AT THIS TIME, THE INFECTION WAS DIAGNOSED AS STAPH. THE DECISION WAS MADE TO EXPLANT THE DEVICE. THE PLAN IS FOR THE PT TO BE REIMPLANTED IN 2-3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention