BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2992937 · Received March 1, 2013

    Report

    Report Number
    3006556115-2013-00076
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY FELL FROM BED WHILE SLEEPING AND BEGAN EXPERIENCING LOSS OF LOCK BETWEEN THE INTERNAL DEVICE AND THE EXTERNAL EQUIPMENT. THE PATIENT REPORTED VERTIGO AND PAIN AT THE IMPLANT SITE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING CHANGES WERE MADE. THE ISSUE WAS NOT RESOLVED. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89295 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR