BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1052581 · Received May 22, 2008

    Report

    Report Number
    3006556115-2008-00269
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 3, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A DECREASE IN SOUND PERFORMANCE. IN ADDITION, IT WAS ALSO REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AT THE IMPLANT SITE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT THE DEVICE IS FUNCTIONAL. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    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