BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3213370 · Received July 3, 2013

    Report

    Report Number
    3006556115-2013-00290
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 12, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S INTERNAL DEVICE IS POSITIONED CLOSE TO THE PINNA, CAUSING PAIN AND SENSITIVITY. THE PT IS ALSO EXPERIENCING DECREASE IN PERFORMANCE. REPOSITIONING SURGERY IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306060 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention