BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 2992313 · Received March 1, 2013

    Report

    Report Number
    3006556115-2013-00073
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    December 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS REPORTEDLY DOING WELL AND USING HIS IMPLANT. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING AT THE IMPLANT SITE AFTER INITIAL SURGERY. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED OVERNIGHT DUE TO A MILD FEVER AND SWELLING AT THE IMPLANT SITE. THIS SWELLING WAS NOTED TO BE A SMALL SEROMA. THE PATIENT WAS TREATED WITH ADVIL/TYLENOL, PRESCRIBED AMOXIL FOR ONE DAY AND DISCHARGED WITH CLAVULIN FOR TEN DAYS FOR EAR INFECTION PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89310 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention