BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2133724 · Received June 14, 2011

    Report

    Report Number
    3006556115-2011-00300
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING LOCK ISSUES DUE TO A THICK SKIN FLAP. STEROID TREATMENT (TYPE UNK) WAS GIVEN TO HELP THIN THE PT'S SKIN FLAP, HOWEVER IT WAS UNSUCCESSFUL. DEVICE REVISION AND SKIN FLAP SURGERY IS BEING CONSIDERED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention