BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3954846 · Received July 17, 2014

    Report

    Report Number
    3006556115-2014-00345
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENCIES AND LOSS OF LOCK AND HEADPIECE RETENTION ISSUES. THE DOCTOR CONFIRMED THAT THE PATIENT'S THICK SKIN FLAP IS THE ISSUE. ADDITIONAL MAGNETS AND PROGRAMMING CHANGES WERE USED TO ACHIEVE LOCK; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418818 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention