BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2082643 · Received May 2, 2011

    Report

    Report Number
    3006556115-2011-00204
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAS A SHARP PAIN IN THE AREA OF THE IMPLANT DEVICE THAT WORSENS WITH DEVICE USE. PALPATION OF THE HEADPIECE RESULTS IN PAIN. IN 2009, THE PATIENT DISCONTINUED USE OF THE EXTERNAL EQUIPMENT DUE TO PAIN. DEVICE TESTING SHOWED THAT THE PATIENT'S DEVICE IS FUNCTIONING. THE PATIENT IS REQUESTING DEVICE EXPLANT.

    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 46 YR