BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3040052 · Received April 3, 2013

    Report

    Report Number
    3006556115-2013-00132
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 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 THE PATIENT IS EXPERIENCING PAIN AT THE IMPLANT SITE AND COVERS THE WHOLE SIDE OF THE HEAD. THE PAIN REPORTEDLY DECREASE SLIGHTLY WITH REMOVAL OF THE PROCESSOR. THE IMPLANT SITE IS TENDER TO THE TOUCH, HOWEVER, NO VISIBLE SWELLING OR INFECTION HAS BEE NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS AND RECEIVED I.V. AUGMENTIN. THE ENT CONSULTANT DOES NOT BELIEVE THERE IS ANY INFECTION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFORMATION, ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136622 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention