BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1052582 · Received May 22, 2008

    Report

    Report Number
    3006556115-2008-00260
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED OVERLY LOUD SENSATIONS. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT IT IS FUNCTIONING. SURGERY TO EXPLANT THE PT'S DEVICE WILL BE SCHEDULED.

    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