BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2062630 · Received April 4, 2011

    Report

    Report Number
    3006556115-2011-00148
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT WAS REPORTEDLY EXPERIENCING POOR PERFORMANCE. X-RAY RESULTS SHOWED A FOLDED ELECTRODE ARRAY. SURGERY TO EXPLANT THE PT'S DEVICE WILL BE SCHEDULED.

    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