BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3111111 · Received May 7, 2013

    Report

    Report Number
    3006556115-2013-00187
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    December 1, 2012
    Report Date
    April 16, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT IN (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SWELLING AT THE IMPLANT SITE, FEVER AND VOMITING. THE PATIENT REPORTEDLY HAD AN AIR BUBBLE OVER THE IMPLANT SITE. THE PATIENT IS CURRENTLY EXPERIENCING PAIN AT THE IMPLANT SITE. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE AND EXTERNAL EQUIPMENT EXCHANGED, HOWEVER, THIS HAS NOT RESOLVED THE ISSUE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFORMATION. ONCE MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199892 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention