BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1061515 · Received June 17, 2008

    Report

    Report Number
    3006556115-2008-00304
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 3, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A LOSS OF LOCK WITH HIS INTERNAL DEVICE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE PT'S INTERNAL DEVICE WAS EXPLANTED. THE PT 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-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1