BEUDAMED
    FDA Adverse Event Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2992693 · Received March 1, 2013

    Report

    Report Number
    3006556115-2013-00069
    Date Received
    March 1, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCES ONGOING INTERMITTENCY AND LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE SURGEON WILL PURSUE DEVICE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89411 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR