BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3040045 · Received April 3, 2013

    Report

    Report Number
    3006556115-2013-00143
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    November 16, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S IMPLANT SITE HAS HEALED AND THE PATIENT HAS RESUMED DEVICE USE. THE PATIENT'S DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT WITH REDNESS AND A SORE AT THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED BACTROBAN FOR TEN DAYS ON (B)(6), 2012 AND INSTRUCTED TO STOP DEVICE USE DURING THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135912 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention