BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1291912 · Received January 20, 2009

    Report

    Report Number
    3006556115-2009-00050
    Event Type
    Injury
    Date Received
    January 20, 2009
    Date of Event
    December 23, 2008
    Report Date
    December 23, 2008
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THAT INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE DOCTOR'S NOTE IN 2007 INDICATED THAT THE PATIENT'S INFECTION HAS CLEARED UP. THE PATIENT'S DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE RECENT REVIEW OF THE PT'S MEDICAL RECORDS PROVIDED BY LEGAL THE COMPANY WAS INFORMED THAT THE PT REPORTEDLY HAD AN INFECTION IN THE EAR AND THE PT'S PE TUBE WAS REPLACED. THE PT WAS PRESCRIBED CIPRODEX WITH MUCINEX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention