BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3042197 · Received April 4, 2013

    Report

    Report Number
    3006556115-2013-00131
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    August 7, 2012
    Report Date
    March 17, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT WAS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES AND OPEN ELECTRODES. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE PT IS REPORTEDLY PROGRESSING WELL SINCE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138220 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention