BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2070566 · Received April 19, 2011

    Report

    Report Number
    3006556115-2011-00167
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT WAS STRUCK ON HIS HEAD WITH UNKNOWN OBJECT. PATIENT IS EXPERIENCING SOUND QUALITY ISSUES, PAIN AND OVERLY LOUD SENSATION. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PATIENT'S DEVICE IS BEING CONSIDERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR