BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1842202 · Received August 25, 2010

    Report

    Report Number
    3006556115-2010-00402
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED INTERMITTENCY FOLLOWED BY LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PT'S DEVICE WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    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 4 YR