BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2081365 · Received April 29, 2011

    Report

    Report Number
    3006556115-2011-00185
    Event Type
    Injury
    Date Received
    April 29, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN AN INCONSISTENT DEVICE USER. RECENTLY THE PT'S FATHER ATTEMPTED TO ATTACH THE EXTERNAL EQUIPMENT. HE PROMPTLY REMOVED IT AS THE PT WAS SHAKING UNCONTROLLABLY. DEVICE LOCK WAS OBTAINED AND IMPEDANCES WERE NORMAL. PT AND PARENT HAVE LOST CONFIDENCE IN THE DEVICE AND IS REQUESTING DEVICE REVISION SURGERY.

    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